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The Mission® Cholesterol Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip. The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution, and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

HDL (High Density Lipoprotein Cholesterol) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Trighcerides measurements are used in the diagnosis and treatment with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders.

Use this product at the frequency your doctor recommends for testing Total Cholesterol, and Triglycerides.

An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are

Over the Counter (home use): The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Meter, Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution and is intended to be used by a single person and should not be shared.
The Mission Cholesterol Monitoring System is designed for the quantitative measurement of Total Cholesterol (CHOL), High Density Lipoprotein Cholesterol (HDL) and Triglycerides (TRIG) in capillary whole blood from the fingertip. The Mission Cholesterol Meter is an in vitro diagnostic device consisting of a reflectance photometer that analyzes the intensity and color of light reflected from the reagent area of the test cartridge. This device measures analytes in blood once the blood is applied to dry phase test cartridges that are specifically designed for reflectance analysis.

Professional: The Mission Cholesterol Pro Monitoring System is a portable system consisting of the Mission Cholesterol Pro Meter. Mission Cholesterol Pro Test Cartridges. Mission Cholesterol Pro Optical Verifier and Mission Cholesterol Pro Control Solution and is intended for professional use in healthcare settings for multiple patient uses.
The Mission Cholesterol Pro Monitoring System is designed for the quantitative measurement of Total Cholesterol (CHOL), High Density Lipoprotein Cholesterol (HDL) and Triglycerides (TRIG) in capillary and venous human whole blood. The Mission Cholesterol Pro Meter is an in vitro diagnostic device consisting of a reflectance photometer that analyzes the intensity and color of light reflected from the reagent area of the test cartridge. This device measures analytes in blood once the blood is applied to dry phase test cartridges that are specifically designed for reflectance analysis.

Test Cartridge:
The Mission Cholesterol (Home use) Test Cartridge is a 3 in 1 Lipid Panel test device used to measure concentration of CHOL, HDL and TRIG in capillary whole blood from the fingertip. A code Chip automatically calibrates the meter with the code number of the cartridges when inserted into the meter.

The Mission Cholesterol Pro (Professional) Test Cartridge is a 3 in 1 Lipid Panel test device used to measure concentration of CHOL, HDL and TRIG in capillary and venous human whole blood. A code Chip automatically calibrates the meter with the code number of the cartridges when inserted into the meter.

Control Solution:
Both the Mission® Cholesterol (home use) Monitoring System's and the Mission® Cholesterol Pro Monitoring System's Control Solutions are used to estimate precision of meter readings for determination of total cholesterol (CHOL), high density lipoprotein cholesterol (HDL) and triglycerides (TRIG).

Optical verifier:
Both the Mission® Cholesterol (home use) Monitoring System's and the Mission® Cholesterol Pro Monitoring System's Optical Verifiers are used to verify that the meter functions properly by checking that the meter can detect a pre-calibrated value.

Here's a summary of the acceptance criteria and study findings for the Mission Cholesterol Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" values in a table. However, the linearity, precision, and bias data are direct measures of performance against presumed internal or regulatory benchmarks for acceptable accuracy and precision in cholesterol measurement devices. We will infer the reported device performance from the study results presented.

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

• Sample Size: A total of 369 patients were recruited for the clinical study.
• Data Provenance: The study was conducted at three point-of-care (POC) sites located in different geographical locations. It is a prospective clinical study as patients were recruited and tested specifically for this study. The country of origin is not explicitly stated, but given the FDA submission, it can be inferred to be compliant with US regulatory standards, likely involving data collected within the US or under equivalent standards.

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

The document does not explicitly state the number of experts. However, it mentions:

• "For professional use, patient blood was collected from fingertip and venous blood draws. Capillary blood samples from fingertip were tested at clinical sites by professionals. Venous blood samples were tested at a laboratory using an FDA cleared method."
• "The plasma concentration was confirmed by the reference method."

This implies that trained "professionals" (likely medical technicians or laboratory personnel) performed the official comparative testing, and an FDA-cleared reference method was used to establish the ground truth. No specific number or qualification (e.g., "radiologist with 10 years of experience") for these "professionals" is given beyond their professional role in clinical sites or laboratories.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The ground truth was established by comparing the device's results to an "FDA cleared method" and a "reference method" in laboratory settings. This suggests direct quantitative comparison rather than a consensus-based adjudication process typical for qualitative or image-based diagnostics.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed in the context of improving human reader performance with AI assistance. This study focuses on the device's standalone analytical performance compared to a reference method, and also includes layperson use, not assisted reading by human experts.

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

Yes, a standalone performance study was done for the device. The entire clinical study, comparing the Mission Cholesterol Monitoring System's measurements against a reference method, evaluates the algorithm's performance. Both professional operators and laypersons used the device independently to obtain results, which were then compared to the established ground truth.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparing the device's results to an FDA cleared method and a reference method (for plasma concentration).

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. The studies described are for the validation of an already developed device.

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

As no training set is described, there's no information on how its ground truth would have been established. The provided document focuses on the validation of the device through performance and clinical studies.

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The On Call Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, forearm and palm. The On Call Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid in monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, auto-disabling lancing devices.

The On call Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly).

The On Call Pro Blood Glucose Test Strips are used with the On Call Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm.

Not Found

The provided document is a 510(k) clearance letter for a medical device (On Call Pro Blood Glucose Monitoring System) and its "Indications for Use" statement. It does not contain information about the detailed acceptance criteria and study results, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device itself.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the device has been cleared based on its substantial equivalence to a predicate device, not necessarily on a new clinical study demonstrating specific performance metrics against an acceptance criterion in the level of detail requested.

Therefore, I cannot provide the requested information based solely on the text provided. Such details are typically found in the accompanying 510(k) summary or clinical study reports, which are not included in this document.

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The Mission® U120 Ultra Urine Analyzer is intended for use in conjunction with the Mission® Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite.

The instrument is intended for point-of-care, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract. It is intended for professional use only.

The Mission® Liquid Urine Controls Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for one or more of the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. It is intended for professional in vitro diagnostic use only.

The Mission® U120 Ultra Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. Without a urine analyzer, users must visually compare the reagent areas of the strip to a color chart using the naked eye. Mission® U120 Ultra Urine Analyzer also features data management and report generation capabilities.

Acceptance Criteria and Device Performance Study for Mission® U120 Ultra Urine Analyzer

This report summarizes the acceptance criteria and the study proving the device meets these criteria for the Mission® U120 Ultra Urine Analyzer, as derived from the provided 510(k) summary (K142543).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Mission® U120 Ultra Urine Analyzer were established through comparison with a predicate device (ACON U120 Urine Analyzer, K070929) and through various performance studies, including sensitivity, precision, interference, and environmental stability. The primary acceptance criteria for clinical performance were based on the agreement levels with the predicate device.

Note: The exact acceptance criteria were not explicitly stated as numerical thresholds for each analyte in the provided document beyond the general statement of "demonstrated that the intended user can follow the product instruction and obtain comparable instrument read results when using the Mission®U120 Ultra Urine Analyzer and a predicate Analyzer." The reported performance statistics (exact and within one level agreement) implicitly serve as the achieved acceptance. For Sensitivity, the achievement of specific low and high end ranges, as listed in the document, constitutes the acceptance. For Precision, 100% within +/- one block agreement was explicitly stated.

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

The primary clinical test set involved approximately 468 patient urine specimens for each analyte (sample sizes varied slightly for some analytes, e.g., 451 for Nitrite, 450 for Bilirubin, etc.). This number includes both patient-collected specimens and "few contrived urine specimens" to ensure coverage of the measuring range.

The data provenance is prospective, as it involved "patient urine specimens randomly collected from patients at each of 3 clinical sites" and "Additional study was carried out at 2 sites in US," indicating a planned data collection process for the study. The country of origin for the clinical data is the United States (2 sites in US mentioned).

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

The ground truth for the clinical test set was established by comparing the results from the Mission® U120 Ultra Urine Analyzer with those from a predicate device, the ACON U120 Urine Analyzer (K070929), rather than human experts.

The testing was performed by 9 intended users in total across 3 clinical sites (3 users at each site). Their qualifications are described as "intended users," implying they are professionals who would typically operate such devices in a point-of-care setting, but specific expert qualifications (e.g., radiologist with 10 years of experience) are not provided.

4. Adjudication Method for the Test Set

The adjudication method used seems to be a direct comparison between the results obtained from the candidate device (Mission® U120 Ultra Urine Analyzer) and the predicate device (ACON U120 Urine Analyzer). The agreement percentages (exact and within one level) are reported, indicating that the predicate device's readings served as the reference for comparison. There is no mention of an independent adjudication panel or a consensus method among multiple experts for the test set's ground truth beyond the comparison to the predicate.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study, in the traditional sense of evaluating human reader performance with and without AI assistance, was not performed. The study compared the new automated analyzer (Mission® U120 Ultra Urine Analyzer) against a predicate automated analyzer (ACON U120 Urine Analyzer), with "intended users" operating the devices. The study objective was to evaluate the performance of the new analyzer compared to the predicate and to observe operational issues. It did not focus on the effect size of how much human readers improve with AI vs. without AI assistance, as the "AI" (automated analyzer) is the primary testing modality being evaluated for its standalone performance relative to a predicate.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

Yes, a standalone study was performed. The core of the clinical study involved comparing the "Mission® U120 Ultra Urine Analyzer" reading "Mission® Urinalysis Reagent Strips" against the "ACON U120 Urine Analyzer" reading "Mission® Urinalysis Reagent Strips." This evaluates the algorithm-driven output of the Mission® U120 Ultra Urine Analyzer as a standalone device against a legally marketed predicate device. The precision, sensitivity, interference, and environmental studies also evaluate the device's performance in a standalone capacity under various conditions.

7. The Type of Ground Truth Used

For the clinical study, the reference standard (ground truth) was the performance of the legally marketed predicate device, the ACON U120 Urine Analyzer (K070929), when reading the same Mission® Urinalysis Reagent Strips. The study directly compared the results from the new device against those of the predicate. Some "contrived urine specimens" were also used, implying that these had pre-defined or known concentrations of analytes, which would also serve as a form of ground truth.

For the precision study, the "target concentration of the analyte in each control solution was confirmed with Siemens reagent strips read by Clinitek Status urine analyzer and Mission® Urinalysis Reagent Strip read by ACON U120 urine analyzer," indicating a combination of predicate devices and validated controls as ground truth.

For the sensitivity study, the "low and high end range of sensitivity" for the reagent strips were determined, which likely relied on precisely prepared samples with known analyte concentrations as the ground truth.

8. The Sample Size for the Training Set

The document does not explicitly state a separate "training set" sample size for the Mission® U120 Ultra Urine Analyzer, as it is primarily a reflectance photometer analyzing color changes rather than a complex machine learning model that typically requires a distinct training phase. The device's operation is based on pre-programmed algorithms for color interpretation.

The clinical study and other performance studies described serve as validation of the device's accuracy and functionality. If any internal calibration or parameter tuning occurred, the data used for that is not detailed in this section.

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

As mentioned above, the document does not describe a distinct training set for a machine learning algorithm. The device is an optical reader with established "tests principles" based on reflectance photometry and CMOS image sensing. The "ground truth" for its development and programming would implicitly derive from the chemical reactions on the reagent strips and the expected colorimetric responses at different analyte concentrations. These foundational principles are well-established in urinalysis technology. The sensitivity study, for instance, establishes the "low and high end range of sensitivity" for the device, which reflects its ability to correctly interpret known concentrations.

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The Mission® U120 Ultra Urine Analyzer is an urinalysis instrument intended for in vitro diagnostic use. It is intended for professional use only at point-of-care locations. The Mission U120 Ultra Urine Analyzer is intended to read Mission® Urinalysis Reagent strips (Microalbumin/Creatinine) for the semi quantitative measurement of Albumin and Creatinine. These measurements are used to assist diagnosis for kidney function.

The Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.

The Mission® U120 Ultra Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip.

The Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) are firm plastic strips that contain two reagent areas to test for Microalbumin (low concentration of albumin) and creatinine in urine. Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) are to be read by the Mission® U120 Ultra Urine Analyzer.

The Mission® Liquid Urine Controls and Mission® Liguid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.

Here's an analysis of the acceptance criteria and study information provided for the MISSION® U120 Ultra Urine Analyzer and associated reagent strips and controls:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the clinical accuracy study in terms of specific percentages for accuracy, sensitivity, and specificity. However, it presents the reported performance values. We can infer that these values were deemed acceptable for substantial equivalence.

Regarding the Precision Study:

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

• Sample Size for Clinical Accuracy: A total of 429 urine specimens were used.
• Data Provenance: The specimens were "randomly collected at three clinical sites from patients." The document does not specify the country of origin, but given the FDA filing, it's typically understood to be within the United States or from sites compliant with US regulations. The data is prospective as it involves new testing of collected specimens.

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

The document states that the clinical study data for accuracy involved comparing the Mission® U120 Ultra Urine Analyzer results against those obtained from a predicate device (Clinitek Microalbumin 2 Reagent Strips read by Clinitek Status Analyzer).

Therefore, the "ground truth" for the clinical accuracy study was established by the predicate device's readings, rather than by human experts directly interpreting raw data. No specific number of experts or their qualifications are mentioned in this context, as the comparison is device-to-device.

4. Adjudication Method for the Test Set

Not applicable. The study compares the new device's readings against a predicate device. There is no mention of an adjudication method involving human experts.

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or reported in this document. This device is an automated analyzer, not an AI-assisted diagnostic tool for human readers.

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

Yes, a standalone performance study was done. The reported accuracy, sensitivity, and specificity for Albumin and Albumin-to-Creatinine Ratio are based on the Mission® U120 Ultra Urine Analyzer's readings without human intervention. The device is described as a "reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas," indicating automated measurement.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy study was established by comparison with a legally marketed predicate device: "Clinitek Microalbumin 2 Reagent Strips (K972706) read by Clinitek Status Analyzer (K031947)." This is a common method for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices.

For the precision study, control solutions (Level 1, Level 2, Level 3) with defined target concentrations were used as ground truth.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. Given that the device is a reflectance photometer, its "training" would involve calibration and optimization during its development. This document focuses on the validation of the finished product. Therefore, no sample size for an AI/ML training set is provided.

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

As no specific "training set" in the AI/ML sense is mentioned, this question is not directly applicable. For the precision and accuracy studies, the ground truth was established as described in points 3 and 7. The device's internal calibration would have been established by the manufacturer during its development using reference materials and established laboratory methods.

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The On Call® Diabetes Management Software is an optional software accessory to be used with the compatible On Call Glucose Meters, such as On-Call Plus glucose meter, On-Call Chosen glucose meter, On-Call Vivid glucose meter and On-Call Express glucose meter for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.

Not Found

The provided document is a 510(k) clearance letter for the Acon On Call Diabetes Management Software. This document does not contain specific acceptance criteria, study details, or performance data typically associated with a clinical validation study for a medical device's performance metrics.

The letter primarily focuses on:

• Confirming the FDA's review of the premarket notification.
• Stating the device is substantially equivalent to legally marketed predicate devices.
• Listing regulatory information such as product codes, regulation numbers, and regulatory class.
• Outlining the general controls provisions of the Act and reminding the manufacturer of compliance requirements.
• Providing contact information for regulatory guidance.
• Including the "Indications for Use" statement for the device.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, a separate document detailing the clinical study or performance validation would be needed, which is not part of this 510(k) clearance letter.

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The On Call Sharp Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steady-state times (when blood glucose level is not changing rapidly). The On Call Sharp Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.

The On Call Sharp Blood Glucose Monitoring System in not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates.

The On Call Sharp Blood Glucose Test Strips are used with the On Call Sharp Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm."

The On Call Sharp Blood Glucose Control Solutions are for use with the On Call Sharp Blood Glucose Meter and On Call Sharp Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

For In Vitro Diagnostic Use

The On Call Sharp Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm and forearm. The glucose measurement is achieved by using the amperometric detection method.

The test strip has a reagent system including flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) enzyme chemistry and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.

The provided text describes the "On Call Sharp Blood Glucose Monitoring System" and its performance evaluation. Here's a summary of the acceptance criteria and the study that proves the device meets them:

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

The submission mentions compliance with EN ISO 15197:2003 "In vitro diagnostic test systems - Requirements for in vitro whole blood glucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus." This standard typically sets the accuracy requirements for blood glucose monitoring systems. While the exact numerical criteria from ISO 15197 are not explicitly stated in the provided text, the conclusion affirms that the device "meets the accuracy requirements per EN ISO 15197."

Based on the information provided, a table detailing specific acceptance criteria and reported device performance from the clinical study, particularly regarding accuracy, would typically present comparisons between device readings and a reference method (like YSI Model 2300 STAT PLUS). However, the document only broadly states that the device "meets the accuracy requirements per EN ISO 15197."

General Features and Specifications (as acceptance criteria for technical characteristics):

The specific accuracy data (e.g., mean bias, percentage of readings within certain error margins) required by ISO 15197 is not detailed in this summary. The summary only concludes that the device meets these requirements.

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

• Sample Size: The document does not specify the exact numerical sample size (number of participants or measurements) used in the clinical studies for the test set. It mentions studies were conducted with "lay persons and trained laboratory technicians."
• Data Provenance: The document does not explicitly state the country of origin. It indicates that the studies were performed using the ACON Clinical Study Protocol for the Blood Glucose Monitoring System, implying an internal or sponsored study. The clinical studies were performed to evaluate system accuracy compared to a reference method. It's a prospective study as it involves conducting clinical studies.

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

• Number of Experts: The document mentions "trained laboratory technicians" performed comparative readings. It does not specify the number of technicians involved.
• Qualifications of Experts: The experts are described as "trained laboratory technicians." Specific qualifications (e.g., years of experience, certifications) are not provided.

4. Adjudication method for the test set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "trained laboratory technicians" used the YSI Model 2300 STAT PLUS as a reference method. The comparison was between the device readings by lay persons and the results obtained by these technicians using the reference device.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed, nor is there any mention of AI assistance. This device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool.

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

The device itself is a standalone system for measuring blood glucose. The performance evaluation includes both its internal accuracy (laboratory testing) and its use by "lay persons" (human-in-the-loop). The "algorithm only" performance would be equivalent to the device's accuracy when operated correctly, which is implied by the laboratory testing and comparison to the YSI reference. The clinical study also involved assessing accuracy when used by lay persons, which is a key aspect of real-world "human-in-the-loop" performance for a self-monitoring device.

7. The type of ground truth used

The ground truth for the accuracy evaluation was established using a reference method, specifically the YSI Model 2300 STAT PLUS (K913806), which is a laboratory-grade analyzer for glucose measurement.

8. The sample size for the training set

The document does not provide information about a separate "training set" or its sample size. For medical devices like this, performance is typically evaluated against established standards and reference methods in validation studies, rather than a machine learning training/test set paradigm.

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

As no specific "training set" for a machine learning algorithm is mentioned, information on how its ground truth was established is not applicable or provided. The device relies on established electrochemical principles and calibration against reference methods.

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The On Call® Express Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative should be done only during steady-state times (when blocd glucose level is not changing rapidly).

The On Callo Express Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.

The On Call® Express Blood Glucose Monitoring System in not intended for the diagnosis of or diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call Express Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

The On Call® Express Blood Glucose Control Solutions are for use with the On Call® Express Blood Glucose Meter and On Call® Express Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

The On Call Express Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm and forearm. The glucose measurement is achieved by using the amperometric detection method.

The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the On Call Express Blood Glucose Monitoring System are based on the EN ISO 15197:2003 standard. The document states that the device "meets the accuracy requirements per EN ISO 15197:2003." Unfortunately, the specific numerical acceptance criteria from EN ISO 15197:2003 and the exact corresponding reported device performance values (e.g., % of results within ±15% or ±20% of reference for specific glucose ranges) are not detailed within the provided text. The text only provides a list of performance characteristics tested.

Therefore, the table below will list the relevant performance characteristics mentioned as being evaluated against the ISO standard in the "Laboratory Testing" section, and indicate that the exact reported performance values are not provided, but that the device meets the ISO standard.

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

• Test Set Sample Size: The document does not explicitly state the sample size (number of patients or measurements) for the clinical studies involving lay persons and trained laboratory technicians. It simply mentions "clinical studies were conducted with lay persons and trained laboratory technicians."
• Data Provenance: The document does not specify the country of origin for the data. The study involved "lay persons" and "trained technicians" using the device. It is a prospective study as it involved conducting clinical studies and laboratory testing for the device.

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

• Number of Experts: One "expert" device was used: the YSI Model 2300 STAT PLUS. The document does not specify a number of human experts involved in establishing the ground truth, but rather refers to readings obtained by "trained technicians."
• Qualifications of Experts: The ground truth was established by comparing the On Call Express Blood Glucose Monitoring System's readings to those from the YSI Model 2300 STAT PLUS (K913806), which is a laboratory reference method. The text mentions that "trained technicians" were involved in obtaining readings, implying they are qualified to operate such equipment and conduct these tests accurately. There is no mention of specific medical qualifications (e.g., radiologist with X years of experience) as this is a blood glucose monitoring device.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the traditional sense (e.g., 2+1, 3+1 consensus). Instead, the method involved direct comparison of the test device's readings with a recognized laboratory reference method (YSI Model 2300 STAT PLUS). The goal was to establish accuracy by demonstrating concordance, not to resolve discrepancies between multiple human readers.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. This type of study typically involves assessing the performance of multiple human readers on multiple cases, often with and without AI assistance. The study described focuses on the accuracy of the device itself and its usability by lay persons compared to trained technicians using a reference method. It does not evaluate human reader improvement with AI assistance. The device itself is a standalone glucose monitor, not an AI assistant to human readers.

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

Yes, a standalone performance evaluation was conducted. The "Laboratory Testing" section lists numerous tests (repeatability, precision, accuracy, linearity, interfering agents, etc.) that evaluate the system's performance independently. The "clinical studies" also assess the device's ability to provide accurate blood glucose readings on its own, with lay persons simply operating it according to instructions. The comparison to the YSI Model 2300 STAT PLUS explicitly assesses the algorithm's (and integrated system's) accuracy against a gold standard.

7. The Type of Ground Truth Used

The ground truth used was reference laboratory measurement. Specifically, the On Call Express Blood Glucose Monitoring System's results were compared to those obtained from the YSI Model 2300 STAT PLUS (K913806), which is a widely accepted laboratory reference instrument for glucose measurement.

8. The Sample Size for the Training Set

The document does not provide information regarding a specific training set or its sample size. This device is a blood glucose monitoring system, not a machine learning model that typically undergoes explicit "training" on a separate dataset in the way an AI diagnostic algorithm would. The development and calibration of such devices usually involve internal studies by the manufacturer, but the specific details of these are not disclosed as "training set" information in this 510(k) summary.

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

As no specific "training set" is mentioned in the context of a machine learning model, this question is not directly applicable. For the device's internal calibration and development, it's highly probable that similar reference laboratory methods (like YSI) would have been used, but the document does not elaborate on this.

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The Mission® Plus Hemoglobin (Hb) Testing System is for the quantitative determination of hemoglobin in non-anticoagulated capillary whole blood or anticoagulated venous whole blood in EDTA ( K2, K3, Na2) or sodium heparin. The testing system is designed for point-of-care use in primary care settings. Estimation of hematocrit is only for hemoglobin values from 12.3 to 17.5 g/dL (123 to 175 g/L).

The Mission® Plus Hemoglobin (Hb) Control Solution is intended to validate hemoglobin testing using the Mission® Plus Hemoglobin (Hb) Testing System.

The Mission® Plus Hemoglobin (Hb) Testing System is for professional in vitro diagnostic use only.

The Mission® Plus Hemoglobin Testing System consists of The Mission® Hemoglobin (Hb) Testing Meter, Test cartridge, Control Solutions, and Optical Verifier.

The Test cartridges are used with the Meter for monitoring Hemoglobin (Hb) and estimate the Hematocrit (Hct) within normal range of hemoglobin in capillary or venous whole blood. Red blood cells in the specimen are lysed to release Hb, which is converted into MHb. The shade of the color produced depends on the concentration of Hb.

The Mission® plus Hemoglobin Testing System is a small, portable, battery-powered meter to measure total hemoglobin in combination of disposable test cartridge and requires no sample preparation or reagents. The portable meter analyzes the intensity and color of light reflected from the reagent area of a Test cartridge and provides results in less than 15 seconds. The test only requires a single drop of whole blood. The meter can store up to 1,000 results data and the data can be transferred to a computer for further analysis using the USB port. The meter can be powered by 4 AAA (1.5V) batteries or an optional AC adapter.

The Mission® Plus Hemoglobin (Hb) Testing System contains an optical verifier which works with the Meter to ensure the optical detection is working properly.

The Mission® Plus Hemoglobin (Hb) Control Solution is provided with 3 levels (0, 1, 2, ) of control solutions with known concentration of hemoglobin. It is used to confirm that the test meter and Test cartridges are working together properly. The product is a liquid, stable control prepared from bovine hemoglobin with added chemicals, preservatives (0.06%) and stabilizers (14.5% of sorbitol and sugar). The control does not contain products of human origins.

The provided text describes the Mission® Plus Hemoglobin (Hb) Testing System and its comparison to a predicate device. Here's a breakdown of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing pass/fail acceptance criteria with numerical targets. However, the comparison table and discussion of tests performed imply the following performance aspects were evaluated for equivalence. The "Reported Device Performance" column synthesizes information from the various sections describing the device and its studies.

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

• Sample Size: Not explicitly stated as a numerical value for the clinical study. It mentions clinical studies were conducted at "total 4 clinical sites." For non-clinical tests, specific sample sizes for linearity, precision, etc., are not provided.
• Data Provenance:
  • Clinical Studies: Conducted at "4 clinical sites" with "Health professionals at each site" operating the device. This suggests a prospective study involving patient samples. The country of origin is not specified but is likely the US given the FDA submission.
  • Laboratory Testing: Performed as part of the "Non-Clinical Tests." The types of samples (e.g., patient, control) are not detailed for each test but generally involve various types of blood and control materials.

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

• The document does not provide details on the number or specific qualifications of experts involved in establishing ground truth for the clinical studies. The "Health professionals at each site" operated the device, implying they are qualified to perform such tests, but their specific expertise in establishing ground truth or their experience levels are not mentioned.

4. Adjudication Method for the Test Set:

• The document states that the "study data were presented for evaluating the system accuracy... compared to the results obtained from predicate device." This indicates a comparison study, but it does not specify an adjudication method (e.g., 2+1, 3+1). The "ground truth" was likely derived from the predicate device's readings or a reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was a MRMC study done? This type of study (MRMC) typically refers to evaluating multiple human readers' performance with and without a diagnostic aid on a set of cases. While the "clinical study" involved health professionals at multiple sites, it appears to be a direct comparison of the new device to the predicate device, with users' satisfaction also assessed. It is not presented as a MRMC study comparing human reader improvement with AI assistance. The device in question is a standalone hemoglobin testing system, not an AI-assisted diagnostic tool for interpretation by humans.
• Effect Size of Human Readers with/without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, a standalone performance was done. The entire submission describes the performance of the Mission® Plus Hemoglobin (Hb) Testing System itself, which operates independently to measure hemoglobin. The clinical studies compare its results to a predicate device, and the laboratory tests evaluate its intrinsic analytical performance. The device is intended for "professional in vitro diagnostic use," meaning healthcare professionals utilize the device to get a result, but the device's reading is a direct measurement, not an AI output requiring human interpretation.

7. The Type of Ground Truth Used:

• Clinical Studies: The ground truth for comparative accuracy in clinical studies was established by the predicate device (Hemopoint H2 Hemoglobin Measurement System, K032482). The study aimed to show "comparable blood Hemoglobin readings" to this predicate.
• Non-Clinical (Laboratory) Tests: For calibration, it states "Factory calibrated against CLSI H15-A3 reference method," indicating a reference method was used for ground truth. For other analytical performance tests like linearity, precision, and analytical sensitivity, the ground truth would typically be derived from highly accurate reference measurements or known concentrations of control materials.

8. The Sample Size for the Training Set:

• The document does not explicitly mention a "training set" in the context of device development. This is a point-of-care medical device, not a machine learning or AI algorithm that typically has a distinct training phase with a specific dataset. Its calibration and performance are established through traditional analytical and clinical validation.

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

• As there's no mention of a "training set" for an AI/ML algorithm, this question is not applicable. The device's foundational accuracy is rooted in its design, chemical reaction, and calibration against established reference methods (e.g., CLSI H15-A3).

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The On Call® Vivid Pro Blood Glucose Monitoring System is an electrochemical enzymatic assay. It is used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. The On Call® Vivid Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, autodisabling lancing devices.

The On Call® Vivid Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.

The On Call® Vivid Pro Blood Glucose Test Strips are used with the On Call Vivid Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the finger.

The On Call® Vivid Pro Blood Glucose Control Solutions are for use with the On Call® Vivid Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.

The On Call" Vivid Pro Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip. The glucose measurement is achieved by using the amperometric detection method.

The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.

The quality control of the On Call Vivid Pro Blood Glucose Monitoring System is performed by testing the test strip on meter with glucose control solution to confirm that the test strip and meter are working together properly. The glucose control solution contains a known concentration of glucose with preservatives in an aqueous based mixture. The control solution test result should fall within the predetermined control solution range for the given strip lot to confirm the accuracy of the On Call Vivid Pro Blood Glucose Monitoring System.

Here's an analysis of the On Call Vivid Pro Blood Glucose Monitoring System's acceptance criteria and the study proving it meets them, based on the provided text:

Acceptance Criteria and Device Performance for On Call Vivid Pro Blood Glucose Monitoring System

1. Table of Acceptance Criteria and Reported Device Performance

The provided document indicates that the device's accuracy was evaluated against the requirements of EN ISO 15197:2003 "In vitro diagnostic test systems - Requirements for in vitro whole blood glucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus."

The key performance criterion mentioned in the conclusion is "accuracy requirements per EN ISO 15197". While the document doesn't explicitly list the detailed accuracy thresholds from this standard, it states that the system meets these requirements.

Table: Acceptance Criteria (Referenced Standard) and Device Performance (Study Conclusion)

Note: The specific numerical accuracy criteria (e.g., error grid analysis outcomes, percentage of results within a certain margin of a reference method) for EN ISO 15197:2003 are not provided in this summary but are the underlying benchmark mentioned.

Other performance characteristics evaluated as part of non-clinical tests (though specific acceptance values aren't typically stated as "acceptance criteria" but rather as "specifications" for these types of devices in 510k summaries):

• Repeatability precision
• Intermediate precision
• Linearity
• Interfering agents
• Hematocrit effect
• Temperature effect evaluation (blood & control solution)
• Low battery effect
• Altitude effect
• Sample volume
• Humidity effect
• Simulated shipping study (test strip & control solution)
• Control value assignment
• Meter testing
• Software validation testing
• Electromagnetic compatibility and electrical safety testing

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

• Sample Size for Clinical Tests: The document states "Clinical studies were conducted with lay persons and trained laboratory technicians". It does not specify the exact number of participants (sample size) for these clinical studies.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, as it's a 510(k) submission to the US FDA, and the company is based in San Diego, California, it's highly probable the clinical studies were conducted in the United States. The study is prospective, as it explicitly mentions "Clinical studies were conducted" to evaluate the system's accuracy.

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

• Reference Method: The ground truth was established by the YSI Model 2300 STAT PLUS (K913806). This is a laboratory-grade reference instrument for glucose measurement, widely considered a "gold standard" in blood glucose monitoring studies.
• Number of "Experts" for Ground Truth: While the YSI 2300 STAT PLUS is an automated instrument, its operation and validation would typically be performed by trained laboratory technicians. The document implicitly refers to these "trained laboratory technicians" as performing the reference measurements, stating "compared to the YSI Model 2300 STAT PLUS... per the ACON Clinical Study Protocol for the Blood Glucose Monitoring System." The number of these technicians isn't specified, but their qualification is "trained laboratory technicians."

4. Adjudication Method for the Test Set

• No explicit adjudication method is mentioned. The comparison is directly between the result from the On Call Vivid Pro system and the established reference device (YSI Model 2300 STAT PLUS).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a typical MRMC comparative effectiveness study, as understood in the context of radiology or image interpretation where human readers interpret cases with and without AI assistance, was not conducted.
• Instead, this study compared the device's performance against a reference standard (YSI Model 2300 STAT PLUS) and evaluated the comparable results between "lay persons" (users of the device) and "trained laboratory technicians" (who often run the reference method). The focus was on the device's accuracy and ease of use for its intended users, not on improving human reader performance with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, the accuracy study comparing the On Call Vivid Pro Blood Glucose Monitoring System to the YSI Model 2300 STAT PLUS effectively represents a standalone performance evaluation of the device.
• The device, an electrochemical enzymatic assay, inherently provides an algorithmic output (the glucose reading) based on the electrochemical reaction on the test strip and the meter's calculation. Its performance is assessed independently of further human interpretation or intervention to correct its reading beyond its basic operation. The study evaluated "the system accuracy of the On Call Vivid Pro Blood Glucose Monitoring System."

7. Type of Ground Truth Used

• The ground truth used was a reference laboratory instrument's measurement (YSI Model 2300 STAT PLUS). This is a highly accurate and established method for quantifiable analyte measurement.

8. Sample Size for the Training Set

• The document does not specify a separate "training set" sample size or discuss how a training set was used. For a blood glucose monitoring system like this, the "development" or "training" of the system would typically involve extensive engineering, chemical formulation, and calibration efforts during the design phase, rather than a distinct "training set" of patient data as might be seen for AI/ML algorithms that learn from data. The clinical studies described are for validation (test set), not training.

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

• Given that a specific "training set" for an AI/ML algorithm isn't described for this device, a method for establishing its ground truth is not applicable in this context. The development of the system's internal algorithms (e.g., for converting electrical current to glucose concentration) would be based on fundamental electrochemical principles, extensive laboratory testing with known glucose concentrations, and calibration against reference methods during the device's engineering and manufacturing process.

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The On Call® Vivid Pal Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate (forearm and palm) testing sites should be used only when blood glucose level is not changing rapidly. The On Call® Vivid Blood Pal Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.

The On Call Vivid Blood Pal Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus, or use on neonates.

The On Call Vivid Pal Blood Glucose Test Strips are used with the On Call Vivid Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm.

The On Call Vivid Pal Blood Glucose Control Solution is for use with the On Call Vivid Pal Blood Glucose Meter and 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.

Not Found

The provided text is a 510(k) summary for the On Call® Vivid Pal Blood Glucose Monitoring System, which does not contain the detailed study information required to answer all aspects of your request. This document is a regulatory approval notice and focuses on the substantial equivalence determination rather than a comprehensive report of validation studies.

However, based on the information available and general knowledge of blood glucose monitoring system approvals, I can provide the following:

Device Name: On Call® Vivid Pal Blood Glucose Monitoring System

Indications for Use: The On Call® Vivid Pal Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate (forearm and palm) testing sites should be used only when blood glucose level is not changing rapidly. The device is intended for single patient use and is for in vitro diagnostic use only. It should not be used for the diagnosis of or screening for diabetes mellitus, or use on neonates.

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

The provided document does not contain a specific table detailing acceptance criteria and reported device performance. For blood glucose monitoring systems, acceptance criteria typically follow ISO 15197 standards (or similar regulatory guidelines) which specify accuracy requirements compared to a laboratory reference method. These usually involve:

• A certain percentage of results falling within ±X mg/dL (or mmol/L) of the reference for glucose concentrations below Y mg/dL (or mmol/L).
• A certain percentage of results falling within ±Z% of the reference for glucose concentrations above Y mg/dL (or mmol/L).

Without the study report, the specific numerical criteria and the device's performance against them cannot be extracted from this document.

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

This information is not available in the provided 510(k) letter. The letter is a communication of regulatory clearance, not a clinical study report. Such details would typically be found in the manufacturer's submission or detailed study reports.

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 question is not applicable to a blood glucose monitoring system. The "ground truth" for glucose measurements is established by a highly accurate laboratory reference method (e.g., YSI analyzer) performed by trained lab personnel, not by medical experts in an interpretive role like radiologists.

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

This question is not applicable to a blood glucose monitoring system. Adjudication typically refers to resolving discrepancies between multiple human readers or interpretations, which is not how glucose measurements are validated.

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 question is not applicable to a blood glucose monitoring system. This type of study design is relevant for AI-powered diagnostic imaging devices where human readers interpret images. A blood glucose monitor is a standalone measurement device.

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

Yes, a blood glucose monitoring system inherently performs as a standalone device. Its performance is evaluated by directly comparing its glucose readings to those obtained from a laboratory reference method. There is no "human-in-the-loop" interpretation step that would benefit from, or be hindered by, an AI algorithm in the context of reading the glucose value. The device's algorithm processes the electrochemical signal to produce a glucose concentration.

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

For a blood glucose monitoring system, the ground truth is established by a highly accurate laboratory reference method, such as a YSI glucose analyzer, typically using venous blood samples.

8. The sample size for the training set

This information is not available in the provided 510(k) letter. Blood glucose meters do not typically have "training sets" in the same way machine learning algorithms do. Their calibration is established during manufacturing and validated through accuracy studies. While there might be internal data used to develop and refine the electrochemical enzymatic assay and its signal processing, it's not usually referred to as a "training set" in the context of regulatory submissions for these devices.

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

As noted above, the concept of a "training set" and associated ground truth establishment for a blood glucose meter in the context of an AI/ML algorithm is not directly applicable. If any internal development involved data-driven optimization, the ground truth would still have been established using a laboratory reference method for glucose concentration.

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