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The BLE Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The BLE Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The BLE Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The BLE Smart Blood Glucose Test Strips are for use with the BLE Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The BLE Smart Blood Glucose Control Solutions are for use with the BLE Smart Blood Glucose Monitoring System to check that the meter and test strips are working together properly and the test is performing correctly.

The BLE Smart Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The BLE Smart Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The BLE Smart Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The BLE Smart Professional Blood Glucose Test Strips are for use with the BLE Smart Professional Meter to quantitatively measure glucose in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The BLE Smart Professional Blood Glucose Control Solutions are for use with the BLE Smart Professional Blood Glucose Monitoring System to check that the meter and test strips are working together properly and that the test is performing correctly.

BLE Smart Blood Glucose Monitoring System / BLE Smart Professional Blood Glucose Monitoring System consist of a meter, test strips, and control solutions (Level 1, Level 2 and level 3). These blood glucose test systems are an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BLE Smart Blood Glucose Monitoring System, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary (K160365) does not explicitly list quantitative acceptance criteria in a table format. However, it states that:

• "The device passed all of the tests based on pre-determined Pass/Fail criteria."
• "The conclusion drawn from the verification/validation activities is that the subject devices is substantially equivalent to the predicated [sic] device."

This implies that some performance metrics, likely related to glucose measurement accuracy, precision, and safety, were evaluated and met the pre-defined criteria. The predicate device (K130181, GluNEO™ Blood Glucose Monitoring System) would have had its own set of performance criteria, and the new device is deemed substantially equivalent.

For a blood glucose monitoring system, common performance metrics and their typical acceptance criteria (based on ISO 15197 or similar standards) would include:

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The GDH Professional LED Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh, and venous whole blood. The GDH Professional LED Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The GDH Professional LED Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes and/or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GDH Professional test strips are for use with the GDH Professional LED meter to quantitatively measure glucose (sugar) in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The GDH Professional control solutions are for use with the GDH Professional LED meter and GDH Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The GDH Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and venous whole blood. The GDH Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The GDH Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes and/or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GDH Professional test strips are for use with the GDH Professional meter to quantitatively measure glucose (sugar) in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The GDH Professional control solutions are for use with the GDH Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System consist of a meter, test strips, and control solutions (Level 1, Level 2 and level 3). These blood glucose test systems are in vitro diagnostic devices designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.

This 510(k) summary does not contain the detailed acceptance criteria or study results needed to complete the requested table and answer all questions directly. It provides a high-level statement that "The device passed all of the tests based on pre-determined Pass/Fail criteria." However, it does not specify the numerical criteria, the reported device performance against those criteria, or the details of the studies conducted.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states that "The device passed all of the tests based on pre-determined Pass/Fail criteria," but does not list these criteria or the specific performance metrics achieved. For a blood glucose monitoring system, typical acceptance criteria would be based on ISO 15197 (e.g., percentage of results within ±15% or ±20% of a reference method).

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 provided in the document. The document mentions "Verification, validation and testing activities" but does not specify the sample size for any of these tests or the origin/type of data (retrospective/prospective, country of origin).

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 applicable/provided in the context of a blood glucose monitoring system's analytical performance testing. Ground truth for blood glucose measurements is typically established by laboratory reference methods (e.g., YSI instrument), not by expert consensus or interpretation of images.

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

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads), not for objective measurements by a device like a blood glucose meter.

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/provided. MRMC studies and the concept of "human readers improving with AI assistance" are relevant to diagnostic imaging and AI applications, not to the performance assessment of a blood glucose monitoring system.

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 glucose. There is no "human-in-the-loop" component in terms of interpretive performance that would require this type of study. The study implies an evaluation of the device's accuracy against a reference method, which is inherently standalone performance. However, the details of this standalone performance are not provided.

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

This information is not explicitly stated but can be inferred. For a blood glucose monitoring system, the "ground truth" or reference method is typically a laboratory-grade analyzer (e.g., YSI). The document mentions "analytical performance," which strongly implies comparison to a highly accurate reference method.

8. The sample size for the training set:

This information is not applicable/provided. Blood glucose monitoring systems, as described, do not typically involve "training sets" in the machine learning sense. Their calibration and performance are based on chemical and electrochemical principles, and physical calibration processes, rather than on algorithm training with large datasets.

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

This information is not applicable/provided for the reasons stated above.

Summary of available information:

• Device Name: GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System
• Indication for Use: Quantitative measurement of glucose in capillary and venous whole blood for multiple-patient use in professional healthcare settings, as an aid to monitor the effectiveness of a diabetes control program. Not for diagnosis, screening, or neonatal use.
• Study Type: The document states that "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." This implies analytical accuracy, precision, and robustness testing. Additionally, a Disinfection Study and a Robustness Study were performed.
• Predicate Device: GluNEOTM Lite Professional Blood Glucose Monitoring System (K132966) by Infopia Co., Ltd.
• Conclusion: The device is substantially equivalent to the predicated device based on verification/validation activities.

Missing Key Information for a Comprehensive Answer:

To fully answer your request, detailed study reports providing the following would be needed:

• Specific analytical accuracy and precision criteria (e.g., according to ISO 15197)
• The actual performance results of the device against those criteria (percentage within specific error limits).
• The exact sample sizes (number of subjects, number of samples per subject) used in performance studies.
• The specific reference method used for ground truth (e.g., YSI 2300 STAT Plus Glucose & L-Lactate Analyzer).
• Details of the collected data (e.g., glucose range covered, patient demographics).

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the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED

Not Found

This 510(k) submission describes modifications to the HemoCue® HbA1c 501 Glycosylated Hemoglobin Monitoring System (K121366). The provided text indicates this is a "SPECIAL 510(k): Device Modification OIR Review Memorandum" and focuses on verifying that the modifications do not change the fundamental scientific technology or intended use of the device.

Crucially, the provided document does NOT contain a study with acceptance criteria and device performance results as typically requested for demonstrating clinical effectiveness or accuracy. Instead, it focuses on design control and regulatory compliance for minor device changes.

Therefore, many of the requested sections (sample size, experts, adjudication, MRMC, standalone performance, ground truth details, training set details) cannot be answered from this document as it does not contain information about a clinical performance study. The document explicitly states that the "INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED." This type of 510(k) often relies on demonstrating that the changes do not negatively impact the previously established performance.

However, based on the provided text, we can infer some information about acceptance criteria in a general design control context:

Acceptance Criteria and Reported Device Performance

The document states: "Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied." And further: "a statement signed by the individual responsible, that, as required by the risk analysis, all i) verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met".

This indicates that internal verification and validation activities were performed with predetermined acceptance criteria. However, the specific acceptance criteria and the quantitative or qualitative results of these activities (i.e., the "reported device performance") are not detailed in this review memorandum. The modifications are related to usability, appearance, and internal checks of the device, not its core HbA1c measurement performance.

Study Details (Based on what can be inferred/is absent from the document):

1. Sample size used for the test set and the data provenance: Not applicable or not provided. This document does not describe a clinical performance study with a test set of patient samples. The "test set" here refers to internal verification and validation tests for the modifications.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. No clinical "ground truth" establishment is described for these device modifications.
3. Adjudication method: Not applicable or not provided.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This document describes a Special 510(k) for device modifications, not a comparative effectiveness study of the device's diagnostic performance.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a point-of-care analytical device, not an AI algorithm requiring standalone performance evaluation in the typical sense.
6. The type of ground truth used: Not applicable for a clinical performance evaluation. For the modifications, the "ground truth" would be the successful functioning of the new features as per design specifications (e.g., correct light intensity check, accurate shelf-life display, proper initialization sequence).
7. The sample size for the training set: Not applicable or not provided. This is not an AI/machine learning device with a "training set."
8. How the ground truth for the training set was established: Not applicable or not provided.

In summary, the provided document is a regulatory review memorandum for a Special 510(k) focusing on design control and confirming that minor modifications do not alter the fundamental scientific technology or intended use of a previously cleared device. It does not contain the details of a clinical performance study with specific acceptance criteria, reported performance, or ground truth establishment as would be typically found for an initial clearance or a significant change requiring new performance data.

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The Element™ V Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, palm, hand, upper-arm, forearm, calf, and thigh. The Element™ V Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Element™ V Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Element™ V test strips are for use with the Element™ V meter to quantitatively measure glucose (sugar) in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the finger, palm, hand, upper-arm, forearm, calf and/or thigh.

The Element™ V control solutions are for use with the Element™ V meter and the Element™ V test strips to check that the meter and test strips are working together properly and the test is performing correctly.

This meter contains some speaking functions but has not been validated for use by the visually impaired. By adding the voice function, users can hear test results, setting conditions and warning messages (errors) while performing the test. This added function is intended to aid users for their convenience.

The Element™ V Blood Glucose Monitoring System consists of the meter, test strips and control solutions (Level 1, Level 2 and level 3). The blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

The provided text contains limited information about the acceptance criteria and details of the clinical study, making it challenging to extract all the requested information comprehensively. However, I will do my best to present the available details in the requested format.

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

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

The document does not explicitly list specific numerical acceptance criteria (e.g., accuracy percentages within certain glucose ranges) for the Element™ V Blood Glucose Monitoring System. It generally states:

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

• Sample Size (Clinical): The document states "The clinical performance evaluation... was conducted for purpose of validating the consumer use for the accuracy." It does not specify the number of participants or samples used in this clinical accuracy study.
• Data Provenance: Not explicitly stated, but the applicant company (Infopia Co., Ltd.) is based in Korea. It's common for initial studies to be conducted in the country of origin. The study is referred to as a "clinical performance evaluation," which typically implies a prospective design for validating accuracy.

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 document. For blood glucose monitoring systems, ground truth is typically established by a laboratory reference method, not by human experts interpreting results.

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

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where multiple human readers interpret data (e.g., imaging studies). For objective measurements like blood glucose, accuracy is determined by comparison to a reference standard, not by expert consensus on the device's reading.

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. The Element™ V Blood Glucose Monitoring System is a standalone device for quantitative glucose measurement, not an AI-assisted diagnostic tool that would involve human readers interpreting output or an MRMC study design.

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

Yes, the primary clinical performance evaluation described is for the standalone device (Element™ V Blood Glucose Monitoring System) measuring glucose. Its accuracy is evaluated without a "human-in-the-loop" to interpret the results beyond the user following instructions to obtain a reading. The voice function is an aid for convenience, not an interpretation element.

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

While not explicitly stated, for blood glucose monitoring systems, the ground truth for accuracy studies is universally established by laboratory reference methods (e.g., YSI analyzer, or other highly accurate, traceable laboratory-grade glucose measurement devices). It would not be expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not provided. The text focuses on the clinical performance evaluation for validation. It does not mention details about algorithm development or training sets, which are more common for AI/ML-based devices.

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

This information is not provided and likely not applicable in the context of this device's technology. As it's an electrochemical glucose meter, the "training set" concept (as understood in machine learning) is not directly relevant to its core operational principle. If any internal calibration or algorithm adjustments were made during development, they would typically rely on comparisons to laboratory reference methods, but this is not detailed.

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The Element™ Lite Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Element™ Lite Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Element™ Lite Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Element™ Lite Test Strips are for use with the Element™ Lite Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The Element™ Lite Control Solutions are for use with the Element™ Lite Meter and Element™ Lite Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

The Element™ Lite Blood Glucose Monitoring System consists of a meter, test strips and control solutions (level 1, level 2 and level 3), a lancing device and sterile lancets. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

The Element™ Lite Blood Glucose Monitoring System underwent performance testing in accordance with ISO 15197:2003 and other international standards.

Here's a breakdown of the acceptance criteria and study details, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes that "The device passed all of the tests based on predetermined Pass/Fail criteria." However, it does not explicitly list the specific acceptance criteria or the numerical performance results for the glucose measurements. It only states that clinical evaluation included method comparison, user performance, and alternative-site blood glucose measurement.

Therefore, the table can only reflect what is mentioned:

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

The document does not specify the sample size used for the test set. It mentions "Clinical evaluation included method comparison, user performance and alternative-site blood glucose measurement," but provides no details on the number of participants or samples.

Regarding data provenance, the study was conducted by Infopia Co., Ltd., which is based in the Republic of Korea. Therefore, the data likely originated from Republic of Korea. The study implicitly appears to be prospective as it involves clinical evaluation of the device's performance.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. For blood glucose meters, the "ground truth" is typically established by laboratory reference methods (e.g., YSI glucose analyzer), not expert consensus in the traditional sense of image interpretation.

4. Adjudication Method for the Test Set

The document does not provide information on any adjudication method used for the test set. Given the nature of blood glucose measurement, adjudication by multiple experts is not typically applicable in the same way as it might be for diagnostic image interpretation. The comparison would be against a reference method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. This type of study is more relevant for AI algorithms that assist human readers in tasks like interpreting medical images. The Element™ Lite Blood Glucose Monitoring System is a standalone diagnostic device for direct measurement by patients.

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

Yes, a standalone performance evaluation was conducted. The "Element™ Lite Blood Glucose Monitoring System" itself is a standalone device. The performance data discussed (method comparison, user performance, alternative-site measurement) are assessments of the device's ability to accurately measure glucose independently. There is no indication of a human-in-the-loop component for the measurement process itself.

7. The Type of Ground Truth Used

While not explicitly stated, for a blood glucose monitoring system, the ground truth for performance evaluation is typically established using a laboratory reference method (e.g., a glucose analyzer like a YSI STAT PLUS Glucose & Lactate Analyzer or equivalent). This is implied by "method comparison" studies. It is not expert consensus, pathology, or outcomes data in this context.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. As this is a direct measurement device rather than an AI/machine learning algorithm that requires extensive training data, a traditional "training set" in that sense might not exist or be explicitly identified in the same way. The device's performance is based on its chemical and electrical design, calibrated and validated against reference standards.

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

Since the document does not mention a specific "training set" for an algorithm, it also does not provide information on how ground truth for such a set would have been established. Any internal calibration or design validation would involve comparing the device's readings against established reference standards.

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The Healthpro™ Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The Healthpro™ Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The Healthpro™ Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Healthpro™ Professional test strips are for use with the Healthpro™ Professional meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The Healthpro™ Professional Control Solutions are for use with the Healthpro™ Professional meter and Healthpro™ Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Prescription Use (Part 21CFR 801Subpart D)

The Healthpro™ Professional Blood Glucose System consists of a meter, test strips and control solutions (Level 1, Level 2 and level 3). The blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

The provided text is a 510(k) summary for the Healthpro™ Professional Blood Glucose Monitoring System. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria or the details of a study that proves the device meets such criteria.

The section "8. Performance Data" states: "Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the Healthpro™ Professional Blood Glucose Monitoring System. The device passed all of the tests based on pre-determined Pass/Fail criteria."

This statement confirms that performance data exists, and the device passed tests based on criteria, but it does not provide the actual acceptance criteria or the specific results of those tests. Therefore, I cannot generate the requested table and detailed study information based on the input text.

To answer your request, the provided document is missing the following crucial information:

1. Specific Acceptance Criteria: What were the "pre-determined Pass/Fail criteria"? For a blood glucose meter, this would typically involve accuracy metrics like ISO 15197 standards (e.g., percentage of results within a certain range of a reference method).
2. Reported Device Performance: The actual measured accuracy, precision, or other performance statistics obtained during the validation studies.
3. Study Design Details: Sample size, data provenance, ground truth establishment methods, number/qualifications of experts, adjudication methods for any accuracy studies mentioned.
4. Training Set Details: Sample size and ground truth establishment for any training data (though for a blood glucose meter, the "training" would be more about calibration and internal algorithms, not typically a machine learning training set in the AI sense).

Without these details, I cannot fulfill your request for a table of acceptance criteria and proven performance, nor can I elaborate on the study specifics.

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The GluNEO™ Lite Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Glubert Lite Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The GluNEO™ Lite Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GluNEO™ Lite Test Strips are for use with the GluNEO™ Lite Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The GluNEO™ Lite Control Solutions are for use with the GluNEO™ Lite Meter and GluNEO™ Lite Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

The GluNEO™ Lite Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The GluNEO™ Lite Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, singleuse lancing devices. The GluNEO™ Lite Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GluNEO™ Lite Professional Test Strips are for use with the GluNEO™ Lite Professional Meter to quantitatively measure glucose in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips. ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The GluNEO™ Lite Professional Control Solutions are for use with the GluNEO™ Lite Professional Meter and GluNEOTM Lite Professional Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The GluNEO™ Lite / GluNEO™ Lite Professional Blood Glucose Monitoring System consists of a meter, test strips and control solutions (level 2 and level 3), a lancing device and sterile lancets. With the GluNEOTM Lite Professional Blood Glucose Monitoring System, only auto-disabling or single use lancing device must be used. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the GluNEO™ Lite / GluNEO™ Lite Professional Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to meeting the requirements of ISO 15197:2003 for performance. While the specific numerical acceptance criteria from ISO 15197:2003 are not explicitly listed in the summary, they are a well-established international standard for blood glucose monitoring systems. For the purpose of this response, I will state the criteria as per ISO 15197:2003 and then interpret the "reported device performance" based on the general statement in the document that the device "passed all of the tests based on pre-determined Pass/Fail criteria."

Implicit Acceptance Criteria (based on ISO 15197:2003 for glucose meters) and Reported Device Performance:

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The GluNEO™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The GluNEO™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The GluNEO™ Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GluNEO™ Test Strips are for use with the GluNEO™ Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The GluNEO™ Control Solutions are for use with the GluNEO™ Meter and GluNEO™ Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

The GlucoDiary is a PC-based software intended for use in home to help people with diabetes in the review, analysis and evaluation of glucose test results for effective diabetes management. It is intended for use as an accessory to GluNEO™ Blood Glucose Monitoring System.

The GluNEO™ Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The GluNEO™ Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The GluNEO™ Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GluNEO™ Professional Test Strips are for use with the GluNEO™ Professional Meter to quantitatively measure glucose (sugar) in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm. forearm, calf and/or thigh.

The GluNEO™ Professional Control Solutions are for use with the GluNEO™ Professional Meter and GluNEO™ Professional Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The GlucoDiary is a PC-based software intended for use in professional settings to help healthcare professionals in the review, analysis and evaluation of their patients' glucose test results for effective diabetes management. It is intended for use as an accessory to GluNEOTM Professional Blood Glucose Monitoring System.

The GluNEOTM Blood Glucose Monitoring System consists of a meter, test strips and control solutions (level 1, level 2 and level 3), a lancing device and sterile lancets. With GluNEO™ Professional Blood Glucose Monitoring System, only auto-disabling or single use lancing device must be used.

This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

The manufacturer carried out performance tests for the GluNEOTM / GluNEOTM Professional Blood Glucose Monitoring System in accordance with ISO 15197:2003.

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state the quantitative acceptance criteria for each performance evaluation. It only states that the device "passed all of the tests based on pre-determined Pass/Fail criteria." Therefore, the table below will reflect the type of study conducted and the general conclusion.

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

The document does not specify the sample sizes used for the clinical evaluation (method comparison, matrix comparison, user performance, and alternative-site blood glucose measurement).
The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set.

4. Adjudication Method:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the context of a blood glucose monitoring system, the ground truth would typically be established by a reference laboratory method rather than human expert adjudication of images or clinical assessments.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is more typical for imaging devices where human interpretation plays a significant role. The GluNEOTM system is an in-vitro diagnostic device for quantitative measurement of glucose.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance):

The performance data described focuses on the overall performance of the "GluNEOTM / GluNEOTM Professional Blood Glucose Monitoring System," which includes the meter and test strips. This essentially represents the "standalone" or "algorithm only" performance for a device of this nature, as the meter provides a direct quantitative reading without human interpretation of the measurement itself. The user performance study would evaluate how well users operate the system to obtain these readings.

7. Type of Ground Truth Used:

The ground truth for blood glucose monitoring systems is typically established by comparing the device's readings against a laboratory reference method (e.g., a glucose oxidase or hexokinase method performed on a clinical chemistry analyzer). While not explicitly stated, the mention of "method comparison" strongly implies this type of ground truth was used.

8. Sample Size for the Training Set:

The document does not specify a training set size. For in-vitro diagnostic devices like blood glucose meters, the development and calibration process would involve internal data, but specific "training set" sizes in the AI/machine learning sense are not typically reported in 510(k) summaries unless the device incorporates complex adaptive algorithms.

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

The document does not specify how the ground truth for any potential training set was established. As mentioned above, for a blood glucose meter, ground truth for calibration and internal development would be based on comparison to highly accurate laboratory reference methods.

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The LipidPro® Lipid Profile and Glucose Measuring System is intended for self testing (in home) and for testing outside the body (in vitro diagnostic use only). The Lipid Profile and Glucose Measuring System, which consists of a meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose in capillary whole blood. The LipidPro® Lipid Profile and Glucose Measuring System is intended to be used by a single patient and should not be shared.

The LipidPro® Total Cholesterol Test Strip, LipidPro® HDL-cholesterol Test Strip, LipidPro® Triglyceride Test Strip, LipidPro® Lipid Profile Test Strip, and LipidPro® Glucose Test Strip are for use with the LipidPro® Lipid Profile and Glucose Meter.

The LipidPro® Total Cholesterol Test Strip and the LipidPro® HDL-cholesterol Test Strip are used to measure total cholesterol (TC) and high density lipoprotein cholesterol (HDL-C) in capillary whole blood respectively and the measurements obtained are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid, and lipoprotein metabolism disorders. The LipidPro® Total Cholesterol Test Strip and LipidPro® HDLcholesterol Test Strip measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The LipidPro® Triglyceride Test Strip is used to measure triglyceride (TG) in capillary whole bloodandthe obtained measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders. Calculated LDL-cholesterol values are reported only when triglycerides are ≤ 350 mg/dL; when triglycerides are > 350 mg/dL. calculated LDL-cholesterol are not reported. The LipidPro® Lipid Profile Test Strip is used to measure TC, HDL-C, and TG in capillary whole blood at the same time.

The LipidPro® Glucose Test Strip is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand. upper arm, forearm, caff and/or thigh by diabetic patients as an aid in the management of diabetes, Glucose measurement is not to be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.

LipidPro® Total Cholesterol Control Solution, HDL-cholesterol Control Solution, Triglycerides Control Solution, and Glucose Control Solution are used to test the precision of the LipidPro® Lipid Profile and Glucose Measuring System and to detect systematic analytic deviations that may arise from reagent or analytical variation and they are for testing outside the body (in vitro diagnostic use only). LipidPro® Control Solutions are intended for use in home.

The LipidPro® Professional Lipid Profile and Glucose Measuring Systemis intended for multiple patient use in professional health care settings and for testing outside the body (in vitro diagnostic use only). The LipidPro® Professional Lipid Profile and Glucose Measuring System which consists of meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG), and glucose in capillary whole blood. The LipidPro® Professional Lipid Profile and Glucose Measuring System should only be used with auto-disabling, single-use lancing device.

The LipidPro® Professional Total Cholesterol Test Strip, LipidPro® Professional HDL-cholesterol Test Strip, LipidPro® Professional Triglyceride Test Strip, LipidPro® Professional Lipid Profile Test Strip, and LipidPro® Professional Glucose Test Strip are for use with the LipidPro® Professional Lipid Profile and Glucose Meter.

The LipidPro® Professional Total Cholesterol Test strip and the LipidPro® Professional HDLcholesterol Test Strip are used to measure total cholesterol (TC) and high density lipoprotein cholesterol (HDL-C) in capillary whole blood respectively and the measurements obtained are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid, and lipoprotein metabolism disorders. The LipidPro® Professional Total Cholesterol Test strip and ' LipidPro® Professional HDL-cholesterol Test Strip measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The LipidPro® Professional Triglyceride Test Strip is used to measure triglyceride (TG) in capillary whole blood and the obtained measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders. Calculated LDL-cholesterol values are reported only when triglycerides are ≤ 350 mg/dL; when triglycerides are > 350 mg/dL, calculated LDLcholesterol are not reported.

The LipidPro® Professional Lipid Profile Test Strip is used to measure TC, HDL-C, and TG in capillary whole blood at the same time.

The LipidPro® Professional Glucose Test Strip is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.

The LipidPro® Professional Total Cholesterol Control Solution, HDL-cholesterol Control Solution, Triglycerides Control Solution, and Glucose Control Solution are used to test the precision of the LipidPro® Professional Lipid Profile and Glucose Measuring System and to detect systematic analytic deviations that may arise from reagent or analytical variation and they are for testing outside the body (in vitro diagnostic use only). The LipidPro® Professional Control Solutions are intended for use in hospital and professional health care settings.

The LipidPro® / LipidPro® Professional Lipid Profile and Glucose Measuring System consist of a meter, test strips, and control solutions. It combines measuring systems for total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and a blood glucose monitoring system into one convenient device.

The components are a meter, five types of test strips, and four types of control solutions. There are five types of the test strips which are for total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG), a lipid profile (which combines TC, HDL-C, and TG tests) and glucose test respectively. There are also four types of the control solutions for total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose test respectively.

This appears to be a 510(k) summary for the Infopia LipidPro® / LipidPro® Professional Lipid Profile and Glucose Measuring System. This document outlines the device's intended use, comparison to a predicate device, and a general statement about performance data, but it does not contain detailed information about specific acceptance criteria and the comprehensive study results to prove those criteria were met in a table format.

The document generally states: "Clinical & Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the LipidPro® / LioidPro® Professional Lipid Profile and Glucose Measuring System. The device passed all of the tests based on pre-determined Pass/Fail criteria." However, it does not elaborate on what those pre-determined Pass/Fail criteria were or present the specific performance metrics achieved.

Therefore, I cannot directly extract the requested information as it is not provided in the input text. The input document is a summary of the 510(k) submission, confirming that studies were performed and passed, but not detailing the acceptance criteria or the specific results.

To fulfill your request, I would need access to the full 510(k) submission, specifically the sections pertaining to "Performance Data" which would include the detailed clinical and non-clinical study reports.

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The Hemocue® Hbalc 501 assay is an in vitro diagnostic test that quantitatively measures the percent concentration glycosylated hemoglobin in capillary or venous whole blood samples for clinical laboratory and point of care use. Measurement of percent HbAlc is used to monitor long-term glucose control in individuals with diabetes mellitus. Hemocue® Hbalc 501 is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.

The test is for prescription use as an aid in the management of diabetes.

The Hemocue® HbA1c 501 M Glycosylated Hemoglobin test system measures Hemoglobin A 1c in venous and capillary whole blood. The Hemocue® HbA1c 501 ™ Glycosylated Hemoglobin test system includes Analyzer. Test cartridge, Check cartridges(Monthly and Daily), Thermal printer, Barcode scanner, PC cable and fan filter. The Hemocue® HbA1c 501 ™ Glycosylated Hemoglobin test system is a fully automated boronate affinity assay for the determination of the percentage of hemoglobin A1c(HbA1c, %) in human whole blood.

The Test Cartridge consists of a cartridge and a reagent pack containing the reagents necessary for the determination of hemoglobin Alc, with a sampling area for blood collection.

The reagent pack is pre-filled with reagent solution and rinsing solution. The reagent solution contains agents that hemolyse erythrocytes and bind hemoglobin specifically as well as a boronate resin that binds to the cis-diols of glycated hemoglobin.

The blood sample (4uL) is collected at the sampling area of the reagent pack, which is then inserted into the cartridge, where the blood is instantly lysed releasing the hemoglobin and the boronate resin binding the glycated hemoglobin.

The reagent pack containing the blood sample is inserted in Hemocue® HbA1c 501 Analyzer (in which the cartridge has been placed). The cartridge is automatically rotated, placing the blood sample in the measuring zone. The total hemoglobin is photometrically measured by the diffused reflectance of the optical sensor composed of both a LED (Light Emitting Diode) and a PD (Photo Diode). The assembled cartridge is rotated and the rinsing solution washes out non-glycated hemoglobin from the blood sample, enabling photomectical measurement of glycated hemoglobin.

The provided text describes a Special 510(k) submission for the Infopia Co.,Ltd. Glycosylated Hemoglobin (HbA1c) Monitoring System. While it states that "Test results showed substantial equivalence" for clinical performance, it does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (CLOVER A1c The Glycosylated Hemoglobin Monitoring System, K082275) based on similarities in intended use, operating principle, materials, use environment, shelf life, and calibration method, along with a statement that verification, validation, and testing activities were conducted and passed.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not specified. The text mentions "clinical performance evaluation" but does not give a sample size.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Method of establishing ground truth: Not specified.

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

• Adjudication Method: Not specified.

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, this device is a stand-alone analytical instrument for measuring HbA1c, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study related to human readers improving with AI is not applicable.

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

• This device is an in vitro diagnostic device that quantitatively measures HbA1c. Its performance is its standalone performance. The "clinical performance evaluation" assessed how accurately the device measures HbA1c in blood samples.

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

• Type of Ground Truth: Not explicitly stated. For HbA1c measurements, the "ground truth" would typically be established by a reference method of HbA1c measurement (e.g., HPLC) recognized as highly accurate, against which the new device's measurements are compared.

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable for this type of medical device which is an in vitro diagnostic instrument for directly measuring a biomarker. The device relies on a chemical/optical detection system, not a machine learning algorithm that requires a training set.

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

• Training Set Ground Truth: Not applicable, as there is no training set for a machine learning model.

In summary: The provided text is a high-level 510(k) summary focusing on substantial equivalence to a predicate device for an HbA1c monitoring system. It does not contain the detailed study results, specific acceptance criteria, or methodological specifics typically found in a full efficacy study report. The key information provided is that a clinical performance evaluation was conducted and deemed "substantially equivalent," and non-clinical tests passed predetermined criteria.

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