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The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The FreeStyle InsuLinx Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.

The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

The FreeStyle InsuLinx Meter, in conjunction with the FreeStyle InsuLinx Test Strips works on the principal of coulometric biosensor technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrochemical mediation.

The device automatically logs blood glucose results to create a customized logbook. The FreeStyle InsuLinx System has a large touch screen and a user interface designed for an easy user experience.

Users can pre-program audible and visual reminders for blood glucose testing, or other individual needs.

The FreeStyle InsuLinx System has 'plug and play' software that automatically installs on a computer without the need for a CD or internet access (via the meter's USB port and a provided cable). It also provides access to the structured reports for both the healthcare professionals and patients.

The provided document is a 510(k) premarket notification for the FreeStyle InsuLinx Blood Glucose Monitoring System, detailing its substantial equivalence to a predicate device. This submission primarily focuses on a modification to include a different lancing device and a change in the recommended cleaning and disinfection wipes. While it outlines the acceptance criteria for accuracy and precision, it does not include a detailed study proving the device meets these criteria in the traditional sense of a clinical trial report with specific patient data, expert ground truth establishment, or statistical analyses like MRMC studies.

Instead, the document asserts substantial equivalence based on the device's fundamental technology, indications for use, and performance characteristics (accuracy and precision) being identical to the predicate device (K120568). The only differences noted are related to the lancing device and the disinfectant wipes.

Here's an attempt to answer your questions based on the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document for the K152328 submission does not provide details on the sample size for any test set or the provenance of data. It asserts that the modified device is substantially equivalent to the predicate (K120568), implying that the performance data from the predicate device is applicable. To find this information, one would need to review the K120568 submission details, which are not included in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This document does not contain any information about experts or their qualifications used to establish ground truth. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not expert consensus in the way it might be for image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This document does not specify any adjudication method. This methodology is generally not applicable to quantitative measurements like blood glucose, where comparison is made against a scientific reference standard.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done or is applicable to this type of device. This device is a blood glucose monitoring system, which provides a direct quantitative measurement and does not involve human interpretation of complex data (like medical images) that would benefit from AI assistance or warrant an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is fundamentally a standalone device in terms of its glucose measurement function. The "algorithm" (coulometric biosensor technology) performs the measurement independently. There isn't a "human-in-the-loop" for the measurement itself, though a human uses the device and interprets the result. The document doesn't explicitly describe a "standalone study" in the context of advanced AI algorithms, but the core functionality is algorithm-driven by the meter and test strip.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

While not explicitly stated in this document, for blood glucose monitoring systems, the ground truth is typically established against laboratory reference methods (e.g., YSI analyzer). The document mentions "comparative method results" in the accuracy section, which refers to these lab-based reference standards.

8. The sample size for the training set

The document does not provide any information regarding a training set sample size. This type of information is usually relevant for machine learning or AI models. The FreeStyle InsuLinx Blood Glucose Monitoring System is based on established electrochemical biosensor technology, which does not typically involve a "training set" in the same way modern AI systems do. Its performance is based on the robust chemical and electrical properties of the test strip and meter.

9. How the ground truth for the training set was established

As there is no mention of a training set in the context of machine learning, there is no information on how its ground truth would have been established. For the performance validation of the underlying biosensor technology, ground truth would have been established by laboratory reference methods for the predicate device.

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The ACCU-CHEK Aviva Expert System is indicated as an aid in the treatment of insulin-requiring diabetes. The ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert System is intended to facilitate the optimization of glycemic control in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The ACCU-CHEK Aviva Expert System is intended for prescription home use only.

The ACCU-CHEK Aviva Expert meter is also indicated for the calculation of an insulin dose or carbohydrate intake based on user-entered data. The ACCU-CHEK Bolus Advisor, as a component of the Accu-Chek Aviva Expert meter, is intended for use in providing insulin dose recommendations in response to blood glucose, health events, and carbohydrate input. The ACCU-CHEK Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a preplanned treatment program from a healthcare professional. Before its use, a physician or healthcare professional must prescribe the ACCU-CHEK Aviva Expert System and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the ACCU-CHEK Bolus Advisor. Once programmed, a patient must consult with his/her physician or healthcare professional before making any changes to these ACCU-CHEK Bolus Advisor settings.

The ACCU-CHEK Aviva Expert System consists of the following which was originally cleared under K131366:

• ACCU-CHEK Aviva Expert meter
• ACCU-CHEK Bolus Advisor (a component of the Aviva Expert meter)
• ACCU-CHEK Aviva Plus test strips
• ACCU-CHEK Aviva control solutions

The ACCU-CHEK Aviva Expert system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Plus test strips and the ACCU-CHEK Aviva control solutions.

The ACCU-CHEK Aviva Expert system provides the user with the ability to measure capillary blood glucose levels when a sample of capillary blood is applied to the test strip. The meter also provides an optional insulin bolus calculator (the ACCU-CHEK Bolus Advisor) designed for use by individuals with diabetes who require insulin. This feature is optional in that a user can simply obtain a blood glucose value through capillary blood testing and does not need to use the insulin bolus calculator portion of the system if it is not desired. For the ACCU-CHEK Aviva Expert system, this bolus calculator is meant to be used by patients with diabetes on multiple daily insulin injection (MDI) therapy. In order to calculate the appropriate bolus of insulin, the ACCU-CHEK Bolus Advisor takes the measured bG, the target bG, the carbohydrate intake, the insulin-to-carbohydrate ratio, the insulin sensitivity, health events (such as exercise), the time of day, and the active insulin into account. Before using the ACCU-CHEK Aviva Expert system, a physician or healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ration, and insulin sensitivity parameters.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the performance of the ACCU-CHEK Aviva Expert Blood Glucose Monitoring system:

The document describes the ACCU-CHEK Aviva Expert Blood Glucose Monitoring system and refers to performance testing that was submitted and cleared under a previous 510(k) (K131366). The current submission (K142089) states that "The ACCU-CHEK® Aviva Expert System has not changed since this prior submission and the information submitted here is provided to support the clarification in the intended use statement." Therefore, the performance data presented is for the identical device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document presents performance data as evidence of the device meeting requirements for its intended use, but does not explicitly state predetermined "acceptance criteria" as separate rows. However, to construct a table, we can infer the acceptance criteria from the reported results, assuming the reported values met the relevant regulatory standards for blood glucose monitoring systems at the time of clearance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Accuracy Test):
  • Glucose concentrations < 75 mg/dL: 48 samples
  • Glucose concentrations ≥ 75 mg/dL: 252 samples
  • Total for accuracy: 300 samples
• Sample Size (Repeatability Test): 100 measurements for each of 5 blood samples (Total 500 measurements)
• Sample Size (Reproducibility Test): 100 measurements for each of 3 control solutions (Total 300 measurements)
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It only states that performance testing was done on the system.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide any information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set. For blood glucose monitoring systems, ground truth is typically established by a highly accurate laboratory reference method (e.g., YSI analyzer) rather than expert consensus on readings.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. Given that it's a quantitative measurement device, adjudication by experts (as in imaging) is typically not applicable; instead, the device's readings are compared directly against a reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, the provided document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study design is not typically applicable to a standalone blood glucose monitoring system, which provides a direct quantitative measurement rather than requiring human interpretation of complex data (like medical images).
• Effect Size of Human Reader Improvement with AI: Not applicable, as no MRMC study or "human reader" component in the traditional sense is described for this device. The "Bolus Advisor" is an automated calculation based on user input and measured BG, not an AI assisting human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the performance data presented (accuracy, repeatability, reproducibility) represents the standalone performance of the ACCU-CHEK Aviva Expert Blood Glucose Monitoring system. It measures glucose concentration without human interpretation of the measurement itself, and the bolus advisor function is an algorithm-only component calculating insulin dose based on provided inputs. The performance of the Bolus Advisor algorithm itself would have been validated separately as part of the K131366 clearance (though details are not provided here).

7. The Type of Ground Truth Used

The ground truth used for the accuracy assessment is strongly implied to be a laboratory reference method for glucose measurement, which is standard for blood glucose monitoring systems. The document states "method comparison data," which means the device's readings were compared against another, more accurate method. While not explicitly named, the "method comparison" implies a highly precise and accurate lab instrument (e.g., YSI glucose analyzer) as the ground truth.

8. The Sample Size for the Training Set

The document does not specify any training set sample size. This is because the device described is a blood glucose monitoring system with a fixed algorithm for glucose measurement and a predefined calculation for the bolus advisor. These types of devices generally do not involve machine learning "training" in the way that an AI diagnostic algorithm might. The algorithms are built on known chemical and mathematical principles.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, the concept of a "training set" with associated ground truth, as used in machine learning, does not align with the description of this device. The underlying principles for glucose measurement and insulin dose calculation are based on established scientific and medical models, rather than learned patterns from a training dataset.

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The EGV1.1 Pro Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The system consists of the EGV1.1 Pro meter and the EGV1.1 Pro meter only is used with the EGV1.1 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The EGV . I Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the EGV I.I meter and the EGV I.I test strips. The EGV I.I meter only is used with the EGV I.I test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

Not Found

The provided document is an FDA 510(k) clearance letter for two blood glucose monitoring systems: EGV1.1 Pro Monitoring Blood Glucose System and EGV1.1 Self Monitoring Blood Glucose System. While it states the devices are substantially equivalent to legally marketed predicate devices, it does not contain the detailed acceptance criteria or the study results that demonstrate the device meets those criteria.

FDA 510(k) clearance evaluates substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. The detailed performance data and acceptance criteria are typically part of the 510(k) submission, which is not fully included here. The provided text primarily focuses on regulatory information, indications for use, and administrative details.

Therefore, I cannot provide the requested information based on the input text alone. The document explicitly avoids detailed technical specifications and performance data.

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The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The CERA-CHEK 1070 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes controls. The CERA-CHEK 1070 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The CERA-CHEK 1070 Blood Glucose Test Strips are for use with the CERA-CHEK 1070 Blood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf.

The CERA-CHEK 1070 Control Solution is for use with the CERA-CHEK 1070 Blood Glucose Test Meter and Test strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

The CERA-CHEK Diabetes Management Software is PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose results for effective diabetes management. It is intended for use as an accessory to compatible CERAGEM MEDISYS blood glucose monitoring systems. The CERA-CHEK Diabetes Management Software's language is English.

The CERA-CHEK 1070 Blood Glucose Monitoring System consists of the CERA-CHEK 1070 Glucose Test Meter, CERA-CHEK 1070 Blood Glucose Test Strips with Code Key, CERA-CHEK 1070 Control Solution 1 and Control Solution 2, a Lancing device, and CERA-CHEK Diabetes Management Software and cable needed for installing the software on the PC and for transmitting data from meter. Control Solution 1 and Control Solution 2 are required but not included with the meter. Control Solution 1 and Control Solution 2 are always provided as a set. CERA-CHEK Diabetes Management Software and cable are required but not included with the meter. CERA-CHEK Diabetes Management Software and cable are always provided as a set.

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on the analytical performance and system accuracy of the CERA-CHEK 1070 Blood Glucose Monitoring System. The acceptance criteria are implicitly defined by the reported performance relative to a reference method (YSI 2300 analyzer) and the ranges tested.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

2. Sample Sizes and Data Provenance:

• Test Set Sample Sizes:
  • Within-run Precision: For each of 5 glucose concentrations, 5 strip lots, and 10 meters, there were 10 measurements per strip lot per meter. This totals 5 * 5 * 10 * 10 = 2500 measurements. (The text states "a total of 100 measurements per glucose concentration", which seems to contradict the previous sentence unless it's per meter type across strip lots, or a summary. Taking the more detailed description, it's 2500 total).
  • Day-to-day Precision: For each of 3 control levels, 1 strip lot (per glucose level, so effectively 3 lots used in total), and 10 meters, measured once per day over 20 days. This totals 3 * 1 * 10 * 20 = 600 measurements per each of the three levels, for a grand total of 1,800 measurements.
  • Linearity/Assay Reportable Range: 9 (or 10) glucose samples, each analyzed 5 times using 3 lots of test strips. This would be 9 (or 10) * 5 * 3 = 135 to 150 measurements.
  • System Accuracy Study (Technician vs YSI):
    • Fingertip samples: 200 participants (collected and tested twice by themselves, and once by healthcare professional).
    • Contrived samples: 20 samples.
    • Total sample comparisons to YSI for technician: 171 (≥75 mg/dL) + 47 (<75 mg/dL) = 218 data points.
    • Total sample comparisons to YSI for user: 162 (≥75 mg/dL) + 38 (<75 mg/dL) = 200 data points.
  • Alternate Site Test: A total of 100 volunteer samples. For each alternate site (Palm, Forearm, Upper Arm, Thigh, Calf), there were 5 samples < 75 mg/dL and 95 samples >= 75 mg/dL, for both professional and lay users.
  • Hematocrit Study: Five measurements for each combination of glucose concentration and hematocrit level (specific total N not given, but glucose range 21-529 mg/dL and hematocrit range 10-70%).
  • Altitude Study: Three lots of test strips and three meters were used (specific total N not given, but 3 glucose concentrations).
  • Temperature and Humidity Studies: Three test strip lots, three glucose concentrations, twelve combinations of temp/humidity, replicates of three for each combination/glucose/meter (specific total N not given).
  • Interference Studies: Whole blood from healthy volunteers (exact number of volunteers not specified, but multiple glucose levels and interferent concentrations tested).
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. However, given the manufacturer is based in Korea (Republic of Korea), it is highly probable the studies were conducted there. The studies appear to be prospectively designed clinical and analytical performance studies conducted specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth: No specific number of experts are explicitly stated as establishing the ground truth for the test set in the way one might for diagnostic imaging studies.

• For the analytical and system accuracy studies, the "ground truth" was established by laboratory reference methods, specifically the YSI 2300 Glucose analyzer for glucose measurements. The YSI 2300 is calibrated using a NIST traceable glucose standard, implying a highly accurate and standardized method for ground truth determination.
• For the usability study, "untrained lay users" were involved, but their assessment was on the "readability of the labeling" and "ease of use," not on establishing diagnostic ground truth.

4. Adjudication Method for the Test Set: Not applicable. The ground truth for the glucose measurements was established by a single, highly accurate laboratory reference method (YSI 2300), not through a consensus or adjudication process among multiple human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The studies assessed the standalone performance of the device (both technician and lay user operated) against a reference method. There is no comparison of "human readers improve with AI vs without AI assistance" as this is a blood glucose meter, not an AI-assisted diagnostic imaging device for human interpretation.

6. Standalone (Algorithm Only) Performance: Yes, standalone performance was done for the device in the context of a blood glucose meter. The "Technician vs YSI" data directly represents the standalone performance of the device when operated by a trained professional against the gold standard (YSI). The "Lay User vs YSI" data represents the performance when operated by the intended end-user.

7. Type of Ground Truth Used:
The primary ground truth used throughout the performance studies (precision, linearity, system accuracy, alternate site testing, hematocrit, altitude, temperature/humidity, interference) was laboratory reference method measurements obtained from the YSI 2300 Glucose analyzer, which is calibrated using a NIST traceable glucose standard. This is a highly objective and quantitative ground truth.

8. Sample Size for the Training Set: The document does not specify a separate "training set" sample size. For medical devices like blood glucose meters, the development and calibration ("training") of the device's algorithms or underlying chemical reactions often occur prior to these validation studies. These studies primarily serve as external validation or "test sets" to demonstrate the final product's performance. The information provided heavily details these validation studies.

9. How Ground Truth for the Training Set Was Established: As above, specific details on a "training set" and its ground truth establishment are not provided in this 510(k) summary. The development process would typically involve extensive internal testing and calibration against reference methods (like the YSI 2300) to fine-tune the device's performance before formal validation studies are conducted. The traceability to the YSI 2300 analyzer and NIST traceable glucose standard suggests that this highly accurate reference method would have been central to any internal calibration or "training" process.

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The ACCU-CHEK Aviva Expert System is indicated as an aid in the treatment of Insulin-requiring diabetes. The ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert System is Intended to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients.

The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative measurement of giucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood giucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Altemative site testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The ACCU-CHEK Aviva Expert System is intended for prescription home use only.

The ACCU-CHEK Aviva Expert meter is also indicated for the calculation of an insulin dose or carbohydrate intake based on user-entered data. The ACCU-CHEK Bolus Advisor, as a component of the Accu-Chek Aviva Expert meter, is intended for use in providing insulin dose recommendations in response to blood glucase, health events, and carbohydrate input. The ACCU-CHEK Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a preplanned treatment program from a healthcare professional. Before its use, a physician or healthcare professional must prescribe the ACCU-CHEK Aviva Expert System and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the ACCU-CHEK Bolus Advisor. Once programmed, a patient must consult with his/her physician or healthcare professional before making any changes to these ACCU-CHEK Bolus Advisor settings.

The ACCU-CHEK Aviva Expert System consists of the following:

• ACCU-CHEK Aviva Expert meter .
• ACCU-CHEK Bolus Advisor (a component of the Aviva Expert meter) .
• . ACCU-CHEK Aviva Plus test strips (K101299)
• ACCU-CHEK Aviva control solutions (K043474) .

The ACCU-CHEK Aviva Expert system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Plus test strips (cleared under K101299) and the ACCU-CHEK Aviva control solutions (cleared under K043474). The industrial design of the ACCU-CHEK Aviva Expert meter is nearly identical to that of the ACCU-CHEK Aviva Combo meter (cleared under kl 11353); the only difference between the two devices is that the ACCU-CHEK Aviva Expert meter does not have Bluetooth wireless capability and therefore cannot be connected to an insulin pump, whereas the ACCU-CHEK Aviva Combo meter does have Bluetooth capability and can be connected to an insulin pump.

The ACCU-CHEK Aviva Expert system provides the user with the ability to measure capillary blood glucose levels when a sample of capillary blood is applied to the test strip. The meter also provides an optional insulin bolus calculator (the ACCU-CHEK Bolus Advisor) designed for use by individuals with diabetes who require insulin. This feature is optional in that a user can simply obtain a blood glucose value through capillary blood testing and does not need to use the insulin bolus calculator portion of the system if it is not desired. The insulin bolus calculator algorithm is identical to the bolus calculator algorithm that was cleared during the Aviva Combo 510(k) submission (K111353). For the ACCU-CHEK Aviva Expert system, this bolus calculator is meant to be used by patients with diabetes on multiple daily insulin injection (MDI) therapy. In order to calculate the appropriate bolus of insulin, the ACCU-CHEK Bolus Advisor takes the measured bG, the target bG, the carbohydrate intake, the insulin-to-carbohydrate ratio, the insulin sensitivity, health events (such as exercise), the time of day, and the active insulin into account. Before using the ACCU-CHEK Aviva Expert system, a physician or healthcare professional must provide the patient-specific target blood glucose, insulinto-carbohydrate ration, and insulin sensitivity parameters.

Here's a detailed breakdown of the acceptance criteria and study information for the ACCU-CHEK Aviva Expert System, based on the provided 510(k) Summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood glucose monitoring systems typically align with ISO 15197 (or similar standards) for accuracy. The provided document details the accuracy of the device against a reference method. It also outlines precision performance.

2. Sample Size Used for the Test Set and Data Provenance

• Accuracy Test Set (Method Comparison):
  • For glucose concentrations less than 75 mg/dL: 48 samples
  • For glucose concentrations greater than or equal to 75 mg/dL: 252 samples
• Precision Test Set (Repeatability - Within Lot): 100 samples for each of 5 glucose levels.
• Precision Test Set (Reproducibility - Day-to-Day): 100 samples for each of 3 control solution levels.
• Data Provenance: Not explicitly stated in the provided text, but it’s typically part of a controlled clinical or laboratory study. It can be assumed to be from a prospective study, likely conducted internally or by a contracted lab, designed to evaluate the device's performance. The country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given 510(k) summary. For glucose monitoring systems, ground truth is typically established by a laboratory reference method (e.g., YSI analyzer) operated by trained laboratory professionals, rather than by medical experts establishing a diagnosis. The summary mentions "laboratory reference" implicitly by comparing results to specified mg/dL or percentage deviations.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable in the context of blood glucose meter accuracy studies. The ground truth (reference method glucose value) serves as the definitive comparator, and there is no "adjudication" necessary between multiple interpretations of this ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is used for diagnostic systems where human readers interpret medical images or data, and an AI might assist in that interpretation. The ACCU-CHEK Aviva Expert System is a blood glucose meter with an optional bolus calculator, not an imaging or interpretive AI system that a human "reads." While it has an "Expert System" and "Bolus Advisor" component, this is an algorithm that provides a calculation rather than an AI assisting human interpretation of complex medical data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance data presented (accuracy and precision) represents the standalone performance of the ACCU-CHEK Aviva Expert System as a blood glucose meter. The bolus advisor component is an algorithm that provides a calculation based on input, and its performance would be assessed algorithmically (e.g., accuracy of dosage calculation based on given parameters), which would inherently be a "standalone" algorithmic evaluation. The provided data focuses on the glucose measurement accuracy, which is the primary standalone function.

7. The Type of Ground Truth Used

The ground truth used for the accuracy study is a laboratory reference method for blood glucose measurement. This is implied by the phrasing "Results for glucose concentrations less/greater than or equal to 75 mg/dL" and the comparison to numeric deviations (± mg/dL or ± %). For such devices, a highly accurate laboratory analyzer (e.g., YSI Glucose Analyzer) is the standard for establishing ground truth.

8. The Sample Size for the Training Set

The provided 510(k) summary does not specify the sample size for any training set. Given that this device is presenting itself as substantially equivalent based on identical core technology (test strip, bG measurement algorithm, bolus calculator algorithm) to a previously cleared predicate device, extensive new training data for foundational algorithms like glucose measurement might not have been required for this specific submission if the underlying algorithms were already established and validated in the predicate. If any specific machine learning or adaptable components were newly introduced, their training data would typically be described. However, the bolus calculator algorithm is stated to be "identical" to the predicate.

9. How the Ground Truth for the Training Set Was Established

Since no training set details are provided, information on how its ground truth was established is not available in this document. If new training data were used for any component, the ground truth would likely also be established via a laboratory reference method for blood glucose values and clinical scenarios for bolus calculations.

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The Nova Max Mini Blood Glucose and ß-Ketone Monitor System is intended to be used for the quantitative measurement of glucose or ß-hydroxybutyrate (ß-ketone) in fresh capillary whole blood. It is intended for single-patient home use and should not be used for testing multiple patients. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. The Nova Max Mini Blood Glucose and ß-Ketone Monitor System is specifically indicated for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip or alternative site testing on the forearm, or ß-ketone in whole blood capillary samples obtained from the fingertip only. Glucose AST on the forearm can be used only during steady-state blood glucose conditions.

The Nova Max Mini is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on neonates.

The Nova Max Mini Blood Glucose Test Strips are intended for use only with the Nova Max Mini Blood Glucose Monitor System to quantitatively measure capillary blood glucose from the finger and forearm.

The Nova Max Mini Ketone Test Strips are intended for use only on the Nova Max Mini Blood Glucose and ß-Ketone Monitor System to quantitatively measure capillary β-hydroxybutyrate from the finger.

Nova Max Mini Glucose/Ketone Control Solutions are intended for use with the Nova Max Mini Glucose and ß-Ketone Monitor and test strips as a quality control check to verify the accuracy of test results. There are two levels of controls, (Level 2 and Level 3).

The monitor is a hand-held testing device that works in conjunction with Nova Max Mini glucose test strips to measure glucose or the Nova Max Mini β-Ketone test strips to measure ß-ketone in a whole blood sample. Monitor operation is self-prompting using three user interface buttons. In addition to measuring glucose and ketone, the monitor also stores patient test and quality control test data.

The self-prompting menu system is navigated by means of a three-button keypad. It offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts.

A "battery low" warning will alert the user to change the batteries. Battery charge state information is available on the "monitor status screen". The user can select the auto shutoff option to conserve power when the monitor is not in use. Test data and monitor setup information will be stored in a non-volatile format to prevent data loss.

Nova Max Mini Blood Glucose Test Strips: The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricyanide as a mediator and will utilize glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD) chemistry (Aspergillis sp.). The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the end of the strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood glucose result. Ten test strips will be provided with the meter kit and will also be available separately in vials of 50 strips. These test strips are manufactured by Nova Biomedical and identical to those cleared for market with the predicate Nova Max One Blood Glucose Monitor System (K112638).

Nova Max Mini ß-Ketone Test Strips: The Nova Max Mini β-Ketone test strips contain a reaction layer that contains the enzyme βhydroxybutyrate dehydrogenase (Alcaligenes fecalis) greater than or equal to 0.3 IU; mediator greater than or equal to 0.42 µg: coenzyme equal or greater than 0.28 µg and additional ingredients (polymers, buffers). The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the end of the strip, the blood is drawn into the reaction space via capillary action. This simple one-step process provides a blood ß-Ketone result displayed on the monitor. Two ketone test strips will be provided with the meter kit and will also be available separately in cartons of 10 strips. Ketone strips are individually packaged in foil pouches. The ketone test strip is identical to the strip cleared for market with the predicate Nova Max Plus Blood Glucose and ß-Ketone Monitor (K091547).

Control Solutions: The control solutions are aqueous assayed solutions, containing buffered D-Glucose. B-Ketone, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are two levels of controls, (Level 2 and Level 3). One level of control (Level 2) will be provided with the monitor and both levels will be available for sale separately from the monitor. These controls are manufactured by Nova Biomedical and identical to those cleared for market as Nova Max Plus Glucose and β-Ketone Control Solution (Κ101633).

Here's an analysis of the provided text regarding the Nova Max Mini Blood Glucose and ß-Ketone Monitor System, focusing on acceptance criteria and study details:

Missing Information/Limitations of Provided Text:

It's crucial to note that the provided 510(k) summary (K122688) for the Nova Max Mini Blood Glucose and ß-Ketone Monitor System does not contain the detailed performance study results that would directly state specific acceptance criteria and the device's performance against them, nor does it describe the methodology of these studies in detail (e.g., sample sizes for test sets, ground truth establishment, expert involvement, training set details).

The document primarily focuses on demonstrating substantial equivalence to predicate devices (K091547 and K112638) by highlighting similarities in technology, intended use, and operational principles. It states, "The performance of the Nova Max Mini Blood Glucose and β-Ketone Monitor was studied in the laboratory settings. The studies demonstrated that the device can provide glucose or ketone results that are substantially equivalent to the current methods for blood glucose and ketone measurements obtained from capillary blood." However, it does not provide the quantitative results from these "laboratory settings" studies.

Therefore, the following sections will be filled based on inferences from the general language of the document and common regulatory expectations for such devices, but direct evidence for most points is not present in the provided text.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Since specific quantitative acceptance criteria and detailed performance metrics are not explicitly stated in the provided 510(k) summary, this table is constructed based on the implied equivalence claims and common expectations for blood glucose and ketone monitoring systems. The "Reported Device Performance" is drawn from the summary's general statements about substantial equivalence.

Note: The acceptance criteria listed are inferred or typical for blood glucose monitoring systems based on ISO 15197 and FDA guidance; they are not explicitly stated in the provided K122688 document. The document primarily asserts substantial equivalence rather than presenting detailed validation data against specific criteria.

Study Details

As highlighted, the provided 510(k) summary does not contain detailed study information beyond general statements.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: The document states "studied in the laboratory settings." This implies the data was collected under controlled laboratory conditions, likely in the country of manufacturing/submission (USA, given the 510(k) owner's address). The data would be prospective in nature, as it was generated to evaluate the performance of the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. For in vitro diagnostic (IVD) devices like blood glucose and ketone monitors, ground truth is typically established using a reference laboratory method (e.g., YSI analyzer for glucose), not through expert consensus on qualitative assessment. The role of "experts" would be to perform the reference method and potentially collect samples. Their specific number or qualifications are not detailed.

4. Adjudication method for the test set:

• Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., radiology image reading). For objective measurements from IVDs against a reference method, adjudication isn't typically part of the data analysis process itself, beyond ensuring correct operation of the reference assays.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not relevant for an in vitro diagnostic (IVD) device like a blood glucose and ketone monitor. MRMC studies are typically performed for imaging devices or AI tools that assist human interpretation. This device provides a direct quantitative measurement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, this is a standalone device. Blood glucose and ketone monitors are inherently standalone devices that produce quantitative results directly. The "algorithm" is embedded in the device's software to process the electrochemical signal from the test strip. The performance studies would evaluate the accuracy and precision of the device (algorithm + hardware + strip) in producing these results without human interpretative intervention.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth would be established by a highly accurate and precise reference laboratory method for glucose and ß-ketone. For glucose, this often involves methods like hexokinase or glucose oxidase on a laboratory analyzer (e.g., YSI). For ß-ketone, a laboratory reference method would also be used.
  • The document states: "...can provide glucose or ketone results that are substantially equivalent to the current methods for blood glucose and ketone measurements obtained from capillary blood." This implicitly refers to comparison against such reference methods.

8. The sample size for the training set:

• Not applicable/Not specified. For electrochemical IVD devices like this, there isn't a "training set" in the machine learning sense. The device's calibration and algorithm are developed during the design phase using a range of samples as part of the product development and validation process, but it's not typically referred to as a "training set" in the same way as AI/ML models. The 510(k) summary focuses on the final validated performance.

9. How the ground truth for the training set was established:

• Not applicable. As explained above, there isn't a "training set" in the typical AI/ML context for this type of IVD device. The ground truth for the development and validation of the device would be established using reference laboratory methods as described in point 7.

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The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The GoodLife CS-200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GoodLife CS-200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use.

The GoodLife KP Blood Glucose Test Strips are for use with the GoodLife CS-200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.

The GoodLife CS-200 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips. It is intended for testing outside the body (in vitro diagnostic use) and intended for multiple-patient use in professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.

The GoodLife CS-200 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use.

The GoodLife KP Professional Blood Glucose Test Strip is for use with the GoodLife CS-200 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips

GoodLife CS-200 Blood Glucose Monitoring System and GoodLife CS-200 Professional Blood Glucose Monitoring System consist of:

• (1) Glucose Meter
• (2) Glucose Test Strips
• (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985.
• (4) Check Strip
• (5) Instruction for use

[Test Principle]

The GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System are electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.

[Control Solution]

The GoodLife Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System and GoodLife KP & GoodLife KP Professional Blood Glucose Test strips. There are two levels of controls (Levels 1, 2).

[Check Strip]

The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.

[Device Calibration]

The device is calibrated by Digital Code Strip. While inserting the Digital Code Strip into the coding slot, the meter will turn on automatically and complete the coding. The meter will apply formula including this parameter of code to calculate the glucose value.

This 510(k) summary provides limited details regarding the specifics of the clinical study, making it challenging to fully address all requested information. However, based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states compliance with ISO 15197:2003. This standard defines acceptance criteria for blood glucose monitoring systems. While the specific numerical acceptance criteria from the standard are not explicitly listed in this document, the submission claims that "the predetermined acceptance criteria were fully met." Without access to the full study report or the ISO 15197:2003 standard, the exact numerical performance metrics for the device against specific thresholds cannot be detailed.

Acceptance Criteria (Based on ISO 15197:2003 Claims):

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the provided 510(k) summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The submission is from a Taiwan-based company, which might suggest data could originate from Taiwan or other regions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not explicitly stated in the provided 510(k) summary. For blood glucose monitoring systems, the ground truth is typically established using a reference laboratory method (e.g., YSI analyzer), not necessarily by "experts" in the same way as image interpretation.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense for blood glucose monitoring systems. The "ground truth" is typically a quantitative measurement from a reference method, rather than a subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study is not relevant or typically performed for blood glucose monitoring systems. These studies are common for diagnostic imaging devices where human interpretation plays a significant role.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the device (GoodLife CS-200 Blood Glucose Monitoring System) is a standalone system. Its performance is measured directly by comparing its readings to a reference method, without human intervention in the result generation or interpretation. The submission states, "The GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System are electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor." This describes a standalone, automated measurement.

7. The Type of Ground Truth Used

The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method (e.g., a glucose analyzer, often a YSI analyzer), which provides a highly accurate and precise measurement of blood glucose. While not explicitly stated as "YSI" in this document, the industry standard for studies supporting ISO 15197 compliance relies on such reference methods. This falls under the category of reference standard/laboratory measurement.

8. The Sample Size for the Training Set

Not applicable and not typically mentioned for this type of device. Blood glucose meters do not usually involve a "training set" in the context of machine learning algorithms that learn from data. The device's calibration and algorithm are developed through engineering and chemical principles, not machine learning training. The "calibration" mentioned ("The device is calibrated by Digital Code Strip...") refers to a specific operational calibration for each batch of test strips, not a machine learning training process.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there isn't a "training set" in the machine learning sense for this device. The device's design, chemical reagents, and electrochemical principles are developed and validated against known glucose concentrations and reference methods during its R&D phase, but this is not framed as establishing ground truth for a "training set."

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The Nova One Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous, arterial and fresh capillary whole blood from the finger and forearm. It is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancets. The Nova One Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on neonates. Alternative site testing on the forearm should be used only during steady-state blood glucose conditions.

Nova One Blood Glucose Test Strips are for use with the Nova One Blood Glucose Monitors for quantitatively measuring glucose in venous, arterial and fresh capillary whole blood from the finger and forearm.

The monitor is a hand-held testing device that works in conjunction with Nova One glucose test strips to measure glucose in a whole blood sample. Monitor operation is self-prompting using three user interface buttons. In addition to measuring glucose, the monitor also stores patient test and quality control test data.

The self-prompting menu system is navigated by means of a three-button keypad. It offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts.

A "battery low" warning will alert the user to change the batteries. Battery charge state information is available on the "monitor status screen". The user can select the auto shutoff option to conserve power when the monitor is not in use. Test data and monitor setup information will be stored in a nonvolatile format to prevent data loss.

The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0) and ferricyanide as a mediator and will utilize glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD) chemistry. The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood glucose result.

The control solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosityadjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls.

The provided text describes the Nova One Blood Glucose Monitoring System, which is substantially equivalent to the previously cleared Nova Max One Blood Glucose Monitor System (K112638). The Nova One system has an expanded indication for use to include whole venous and arterial blood, in addition to capillary blood.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a discrete "acceptance criteria" table with numerical targets, but instead states the device's characteristics and its equivalence to a predicate device, implying that meeting the predicate device's performance is the acceptance criterion.

The text states: "The performance of the Nova One Blood Glucose Monitor was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that medical professionals can obtain blood glucose results from venous/arterial blood that are substantially equivalent to the current methods for blood glucose measurements obtained from capillary blood and in the central laboratory." And "Results of laboratory and clinical testing demonstrate that the Nova One Blood Glucose Monitor produces results that are substantially equivalent to results obtained on the predicate device."

2. Sample size used for the test set and the data provenance:

The document mentions "laboratory and clinical testing" but does not specify the sample size for the test set. It also does not explicitly state the country of origin of the data. The studies were likely prospective clinical studies given they involved healthcare professionals and lay users in "clinical settings," and "venous/arterial blood" for performance against central laboratory methods, which is typically collected prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number of experts used or their qualifications. It refers to "current methods for blood glucose measurements obtained... in the central laboratory," implying that the ground truth was established by standard laboratory procedures, which are overseen by qualified laboratory personnel and clinicians, but specific numbers or qualifications are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not mention any adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is a medical device for measuring blood glucose, not an AI-assisted diagnostic imaging or classification tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not done in this context.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device (Nova One Blood Glucose Monitor) is inherently a standalone diagnostic tool. Its performance is measured directly by comparing its glucose readings against a reference method. The "algorithm" here is the electrochemical sensor and embedded software in the device, which performs its measurement without ongoing human interpretation during the actual glucose reading process. So, yes, a standalone performance evaluation was done implicitly through the "laboratory and clinical testing."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the test set was established by "current methods for blood glucose measurements obtained... in the central laboratory." This typically refers to a highly accurate reference laboratory method, such as a YSI glucose analyzer, which is considered the gold standard for glucose measurement.

8. The sample size for the training set:

The document does not specify a separate "training set" or its sample size. Given this is a medical device approval for a glucose meter, the "training" typically refers to the development and calibration of the device's internal algorithms during its engineering phase, rather than a distinct machine learning "training set" in the common AI sense. The substantial equivalence argument also relies on the previous K112638 clearance.

9. How the ground truth for the training set was established:

As mentioned above, the concept of a "training set" with ground truth in the AI sense is not explicitly present. The device's underlying technology is stated as being "the same fundamental scientific technology" as the predicate device (K112638). This implies that the design and calibration of the device were based on established glucose measurement principles and validated against reference laboratory methods during the development of the original Nova Max One system. The current submission focuses on demonstrating equivalence and expanded indications for use.

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The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary drawn from the fingertips, venous and arterial whole blood samples. The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by health care professionals in a clinical setting:

The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.

The PRECICHEK KP Blood Glucose Test Strip is for use with the PRECICHEK NS-101 POCT Professional Blood Glucose Meter to quantitatively measure glucose in fresh capillary drawn from the fingertips, venous and arterial whole blood samples.

The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals to assess the performance of the PRECICHEK NS-101 POCT Professional Blood Glucose monitoring system and the PRECICHECK KP Blood Glucose Test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System consists of:

• (1) Glucose Meter
• (2) Glucose Test Strips
• (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985.
• (4) Check Strip
• (5) Instruction for use

[Test Principle]
The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor.

When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.

[Control Solution]
The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals to assess the performance of the PRECICHEK NS-101 POCT Professional Blood Glucose monitoring system and the PRECICHECK KP Blood Glucose Test strips. There are two levels of controls (Levels 1,2).

[Check Strip]
The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.

[Device Calibration]
The device is calibrated by implicit coding process. The code number is the last two digits of the strip lot number. The user should input the strip lot number into the memory of the meter before use.

While performing the blood glucose test, the strip lot number printed on the vial label is scanned to match the one in the memory. The meter will apply formula including this parameter to calculate the glucose value.

The provided 510(k) summary (K113314) describes the PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System. The summary states that the device's performance was evaluated against the standard ISO 15197:2003.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

The summary explicitly states that the device is compliant with ISO 15197:2003 for in vitro diagnostic test systems for blood glucose monitoring. The key performance criteria from this standard (and assuming the device met them as stated in the summary) are:

Note: The summary states, "All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met." However, it does not provide the numerical performance data in terms of specific percentages, standard deviations, or bias values. It only provides a general statement of compliance with the ISO standard.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The summary does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only mentions that compliance with ISO 15197:2003 was demonstrated. This standard typically requires a minimum number of samples for accuracy evaluation (e.g., at least 100 patient samples with a distribution across the measuring range).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the summary. For blood glucose monitoring systems, the "ground truth" (reference method) is typically established by laboratory-based glucose analyzers, not by human experts in the same way as imaging diagnostics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided in the summary. Adjudication methods like "2+1" are relevant for expert review of medical images or clinical cases, not for objective biochemical measurements like blood glucose.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and therefore not provided in the summary. The device is a blood glucose monitoring system, not a diagnostic imaging AI tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the study performed was a standalone performance evaluation of the device. The PRECICHEK NS-101 POCT system is designed to provide a direct quantitative measurement of glucose, without human interpretation in the loop to determine the glucose value itself (though human users operate the device and interpret the numerical result). The stated compliance with ISO 15197:2003 directly assesses the accuracy and performance of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method, such as a hexokinase or glucose oxidase method on a high-precision clinical chemistry analyzer. While not explicitly stated, compliance with ISO 15197 suggests that the device's measurements were compared against such a validated reference method.

8. The sample size for the training set

This information is not applicable and therefore not provided in the summary. The device in question is a biosensor-based system for direct measurement, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its calibration is described as an "implicit coding process" based on strip lot numbers, which is a manufacturing calibration rather than algorithm training.

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set" for an algorithmic model in the context of this device. The device's calibration mechanism ("implicit coding process") is described as matching a strip lot number to a formula in the meter, which is a factory-set calibration, not a learned model based on a ground-truthed training set.

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The Genesis Health Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, and the upper-arm. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

This system is intended to be used by a single person and should not be shared.

The Genesis Health Technologies test strips are for use with the Genesis Health Technologies meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, forearm and upper arm.

The alternative site testing in the Genesis Health Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The Genesis Health Technologies control solutions are for use with the Genesis Health Blood Glucose meter and test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.

Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets those criteria:

The provided text describes a 510(k) submission for a blood glucose monitoring system. Crucially, it does not provide explicit acceptance criteria with specific numerical thresholds for accuracy, nor does it detail a standalone study proving the device meets new acceptance criteria.

Instead, the submission for the Genesis Health Technologies Blood Glucose Monitoring System (model TD-4123) is based on demonstrating substantial equivalence to a predicate device, the U-RIGHT TD-4252 Blood Glucose Monitoring System (K101631). This means the focus of the "study" described is to show that the new device performs similarly or identically to an already approved device, rather than meeting a new, independently established set of performance targets.

Therefore, the table and other information below are derived from the available information, noting the absence of certain details that would be present in a submission proving performance against novel acceptance criteria.

1. Table of Acceptance Criteria (Implied by Substantial Equivalence to Predicate) and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly the performance characteristics of the predicate device that the new device aims to match. The "reported device performance" is the claim that the new device performs equivalently based on comparative testing.

Note: The "Differences" listed (e.g., power source, battery recharging, measurement unit, test strip indication light, backlight, special message, measurement mode, QC storage, day average, size, weight, data transmission capable) are modifications. For these, the claim is that despite these differences, the core performance characteristics (especially accuracy) remain equivalent.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the provided text for the comparative accuracy study.
• Data Provenance: Not explicitly stated. Given the manufacturer is based in Taiwan, it's plausible the study was conducted there, but this is not confirmed. The text does not specify if the study was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable in the context of this submission. For blood glucose monitoring systems, ground truth is typically established by comparing the device's readings to laboratory reference methods (e.g., YSI analyzer), not by expert consensus readings of images or clinical assessments. The submission does not detail the reference method or the personnel performing the reference tests.

4. Adjudication Method for the Test Set

Not applicable/not provided. As mentioned above, ground truth for blood glucose is typically a laboratory reference measurement, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC study was not done. MRMC studies are typically for image interpretation tasks where different human readers interpret cases. Blood glucose monitoring systems are automated devices, and their performance is evaluated against a laboratory reference.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The "system accuracy performance" comparison would inherently be a standalone assessment of the device (meter and test strip) against a reference standard. The text states:

• "A comparison of system accuracy performance demonstrated that the Genesis Health Technologies Blood Glucose Monitoring System and the U-RIGHT TD-4252 Blood Glucose Monitoring System are substantially equivalent."
• "Software verification and validation testing confirmed that the performance, safety and effectiveness of the Genesis Health Technologies Blood Glucose Monitoring System are equivalent to the predicate device."

These statements indicate testing of the device's inherent performance.

7. The Type of Ground Truth Used

The text strongly implies that the ground truth for "system accuracy performance" was an objective laboratory reference method. For blood glucose meters, this typically involves comparing the meter's readings to a validated laboratory analyzer (e.g., a YSI STAT PLUS Glucose & L-Lactate Analyzer) which provides highly accurate glucose measurements from the same blood samples. The exact reference method is not specified, but it would not be expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable/Not provided. The Genesis Health Technologies Blood Glucose Monitoring System is a hardware-based electrochemical biosensor system with integrated software. It is not described as an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "software modifications" mentioned would have undergone software verification and validation, but not "training" on a data set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there's no mention of a "training set" for an AI/ML algorithm.

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