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This UASure II Blood Uric Acid Monitoring System measures blood uric acid levels in fresh capillary whole blood drawn from fingertips. It is intended for single-patient home use by prescription and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with gout as an aid to monitor the effectiveness of uric acid control.

The UASure II Blood Uric Acid Monitoring System helps track uric acid levels but does not diagnose Hyperuricemia or Gout. Do not change medications based on test results without talking to a doctor.

The UASure II Blood Uric Acid Monitoring System includes the UASure II Meter, UASure II Blood Uric Acid Test Strips and UASure II Uric Acid Control Solution.

The UASure II Blood Uric Acid Monitoring System consists of the UASure II Blood Uric Acid Meter, UASure II Blood Uric Acid Test Strip and UASure II Uric Acid control solution. It is used for testing of blood uric acid by self-testers at home use by prescription only. The UASure II Blood Uric Acid Test Strip and UASure II Uric Acid control solution are purchased separately.

The provided FDA 510(k) clearance letter for the UASure II Blood Uric Acid Monitoring System details its intended use and general regulatory information. However, it does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria in the comprehensive manner requested.

The document only broadly states:

• "Non-Clinical Testing: [...] results demonstrate substantial equivalence to the current methods for uric acid measurements."
• "Clinical Testing: An accuracy study was conducted with home users using finger capillary whole blood. Results demonstrate substantial equivalence to the predicate system."
• "Conclusion: Clinical and analytical testing demonstrated that the UASure II Blood Uric Acid Monitoring System perform in a substantially equivalent manner to that of the predicate."

To answer your request comprehensively, information typically found in the applicant's submission (e.g., the 510(k) summary with more detailed study results, or the actual study reports) would be necessary. This includes:

1. A table of acceptance criteria and reported device performance: This would typically involve specific statistical metrics (e.g., bias, precision, correlation coefficient, Bland-Altman agreement) and their acceptable ranges, and the actual results from the study. The document does not provide these specific numbers.
2. Sample size used for the test set and data provenance: The document indicates "home users using finger capillary whole blood" but does not specify the number of samples or whether the data was retrospective or prospective, or the country of origin.
3. Number of experts used to establish ground truth and qualifications: This is not applicable in this context as this is not an imaging AI device requiring expert reads, but rather a blood diagnostic device where ground truth is established by a reference method/laboratory.
4. Adjudication method: Not applicable for this type of device. Ground truth is typically a direct measurement from a reference method.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable for this type of in-vitro diagnostic device. MRMC studies are specific to imaging devices often involving human interpretation.
6. Standalone (algorithm only) performance: For this device, "standalone performance" is essentially the device's accuracy when measuring uric acid, which is compared to a reference method. The letter states "results demonstrate substantial equivalence to the predicate system" but lacks specifics.
7. Type of ground truth used: For a blood uric acid monitoring system, the ground truth would be established by a well-calibrated, high-precision laboratory reference method for uric acid measurement. The document doesn't explicitly state what reference method was used.
8. Sample size for the training set: This refers to the data used to develop the device/algorithm. This information is not present in the clearance letter.
9. How ground truth for the training set was established: Similar to point 8, this information is not provided.

In summary, based solely on the provided FDA 510(k) clearance letter, I cannot provide the detailed information requested regarding the acceptance criteria and the specific study results proving the device meets them. The letter serves as an official clearance notice, confirming substantial equivalence, but generally does not include the granular data from the performance studies.

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The GlucoSure ADVANCE Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.

The GlucoSure ADVANCE Link Blood Glucose Monitoring System consists of the GlucoSure ADVANCE Link Blood Glucose Meter, GlucoSure ADVANCE Link Blood Glucose Test Strips and Contrex Plus 5 glucose control solution. It is used for testing of blood glucose by self-testers at home. The GlucoSure ADVANCE Link Blood Glucose Test Strips and Contrex Plus 5 glucose control solution are purchased separately. The modified device of GlucoSure ADVANCE Link Blood Glucose Meter is derived from the existing device of BGM014 Blood Glucose Meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile device. The blood glucose test strips and glucose control solution utilized in the GlucoSure ADVANCE Link Blood Glucose Monitoring System are the same as the BGM014 Blood Glucose Test Strips and Contrex Plus 5 Glucose Control Solution, previously cleared in K161299. The meter materials of GlucoSure ADVANCE Link Blood Glucose Meter are the same as the BGM014 Blood Glucose Meter. Therefore, the disinfection performance (robustness of meter to multiple cleanings and disinfections) was previously cleared in K161299.

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

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly list a table of quantifiable acceptance criteria with corresponding reported device performance, which is typical for performance claims related to new algorithms or AI-driven devices. Instead, it describes various tests performed to demonstrate substantial equivalence to a predicate device.

However, based on the nature of a Blood Glucose Monitoring System, the primary performance characteristic is system accuracy. While not explicitly a table, the document mentions that a "Usability study confirmed the system accuracy." The common standards for blood glucose meter accuracy are from ISO 15197. Without the full test reports, the specific numerical acceptance criteria and reported performance values related to accuracy are not present in this document.

The document also implies acceptance criteria for:

• Battery Life: The new device must meet an acceptable battery life, which is noted to be decreased from 1000 tests to 750 tests compared to the predicate. The implicit acceptance criterion here would be that 750 tests is still considered acceptable for the intended use.
• Memory Capacity: The new device's memory capacity of 700 test results is a decrease from 1000. Similar to battery life, the implicit acceptance criterion is that 700 results are sufficient.
• EMC and Electrical Safety: The device must comply with relevant Electromagnetic Compatibility and Electrical Safety standards.
• Software Verification and Validation (including cybersecurity): The software must be verified and validated to ensure proper function and data security, especially with the added Bluetooth functionality.
• Disinfection Performance: The meter materials are the same as the predicate, so the disinfection performance must remain acceptable, as it was previously cleared.

Table of Implicit Acceptance Criteria and Reported Performance (based on available information):

Study Details from the Provided Text:

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

   • The document mentions "A Usability study" and "Testing," but does not provide specific sample sizes (e.g., number of patients, number of blood samples) for any test set.
   • The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated. It's likely prospective for a usability/clinical accuracy study, but this is an inference.

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

   • The document states "A Usability study confirmed the system accuracy." For blood glucose monitoring systems, ground truth is typically established by comparing capillary whole blood glucose readings to laboratory reference methods (e.g., YSI blood glucose analyzer) using venous plasma or serum.
   • The number of experts and their qualifications used to establish ground truth are not specified in this summary.

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

   • No adjudication method is mentioned in the provided text. For blood glucose accuracy studies, adjudication methods (like expert consensus) are typically not directly applicable as the ground truth is established by a quantitative laboratory reference method.

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

   • No MRMC study was mentioned or performed. This device is a Blood Glucose Monitoring System, which does not involve "human readers" or "AI assistance" in the typical diagnostic imaging sense. It's a direct measurement device.

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

   • Yes, implicitly. The "system accuracy" would be a standalone performance measure of the device itself (meter + test strips + algorithm) without requiring a human interpretation component, beyond the user following instructions. The device provides a quantitative number.

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

   • The specific type of ground truth is not explicitly stated in this summary but, in the context of blood glucose monitoring systems, ground truth for accuracy studies is typically established using a laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer measuring plasma glucose).

7. The sample size for the training set:

   • This device is a measurement system, not a machine learning/AI diagnostic system in the sense that would require a distinct "training set" for an algorithm to learn from data in a traditional ML paradigm. The "algorithm" here refers to the embedded logic for glucose measurement. Therefore, no training set in the typical AI sense is mentioned or implied.

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

   • As there's no mention of a traditional "training set" for an AI algorithm, this point is not applicable based on the provided text. The device's measurement algorithm is likely developed through engineering principles and calibration rather than data-driven machine learning training.

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The BGM039 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

The BGM039 Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

BGM039 brand of Blood Glucose Monitoring System is designed to have two variation models, BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose Monitoring System. BGM039 Blood Glucose Monitoring System is the models with all the changes implemented with exception to the addition of a Bluetooth module, whereas, BGM039 Link Blood Glucose Monitoring System is implemented with all of the changes stated in the submission. The two meters use the same BGM039 Test Strip and Contrex Plus 4 Control Solution. This Premarket Notification (510(k)) is intended to demonstrate that the candidate devices to be marketed is safe and effective as the predicate device, GlucoSure HT Plus Blood Glucose Monitoring System, K202885.

BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose Monitoring System consists of the blood glucose meter and single use test strips. It is used for testing of blood glucose by self-testers at home.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as typically found in a clinical study report or a more comprehensive summary. The document is a 510(k) summary for a blood glucose monitoring system, primarily focused on demonstrating substantial equivalence to a predicate device.

However, based on the non-clinical testing section and the overall context of a blood glucose monitoring system, we can infer some general acceptance criteria for such devices, especially concerning accuracy. The FDA's guidance for blood glucose monitoring systems generally requires specific accuracy levels.

Here's an attempt to answer your questions based on the available information and common practices for blood glucose monitoring systems, with explicit mention of where information is not provided in the text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria (e.g., in terms of percentage agreement or mean absolute relative difference) nor does it provide a table of performance statistics for the accuracy test.

It mentions "accuracy test" in the non-clinical testing section, implying that such a test was conducted. For blood glucose meters, common acceptance criteria from standards like ISO 15197 (which is often referenced by the FDA) are:

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The GlucoSure Link Blood Glucose Monitoring System is comprised of GlucoSure Link Blood Glucose Meter and GlucoSure Link Blood Glucose Test Strips.

The GlucoSure Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). This system is intended for self-testing (outside the body, or In Vitro Diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of your diabetes control and should only be used by a single patient and not be shared. It is not intended to be used for the diagnosis or screening of diabetes or for use on neonates.

The GlucoSure Link blood glucose monitoring system consists of the GlucoSure Link meter, GlucoSure Link Blood Glucose Test Strips and Contrex Plus glucose control solution. It is used for testing of blood glucose by self-testers at home. The GlucoSure Link Blood Glucose Test Strips and Contrex Plus glucose control solution are purchased separately.

The modified device of GlucoSure Link glucose meter is derived from the existing device of AutoSure Voice II meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile device and removed the voice Feature.

The glucose test strips and glucose control solution utilized in the GlucoSure Link Blood Glucose Monitoring System are the same as the AutoSure glucose test strips and Contrex Plus Glucose Control Solution, previously cleared in K102037.

The meter materials of GlucoSure Link glucose meter are the same as the AutoSure Voice II meter. Therefore, the disinfection performance (robustness of meter to multiple cleanings and disinfections) was previously cleared in K150396.

The provided text does not contain detailed information about acceptance criteria and the study proving the device meets these criteria in the context of advanced AI-driven medical devices. Instead, it is an FDA 510(k) summary for a blood glucose monitoring system, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel AI algorithm's performance against specific acceptance criteria.

Therefore, I cannot extract the information required by your prompts regarding AI performance metrics, expert consensus, MRMC studies, or training/test set details for an AI model.

However, I can extract information related to the device described in the document, which is a Blood Glucose Monitoring System. Here's what I can provide based on the given text:

Device: GlucoSure Link Blood Glucose Monitoring System

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

The document mentions "linearity, precision, short sample detection, intermittent sampling, sample perturbation, temperature and humidity testing" as non-clinical testing conducted, and "method comparison and user studies for glucose" as clinical testing. It states that "results demonstrate substantial equivalence to the predicate system," but does not provide specific numerical acceptance criteria or performance metrics in a defined table format. For blood glucose monitoring systems, performance is typically evaluated against standards like ISO 15197, which define accuracy criteria (e.g., percentage of results within a certain deviation from a reference method). These specific numerical criteria and the device's performance against them are not detailed in this summary.

The document only broadly states:

• "Method comparison and user studies for glucose were conducted with home users, including evaluation of ease of use and ease of understanding of the user manual. Results demonstrate substantial equivalence to the predicate system."
• "Accuracy at extreme glucose values were also evaluated." (No specific results provided)
• "Clinical and analytical testing demonstrated that the GlucoSure Link Blood Glucose Monitoring System perform in a substantially equivalent manner to that of the predicate."

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

• Test Set Sample Size: Not explicitly stated for either non-clinical or clinical testing. The document generally mentions "method comparison and user studies."
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. Given that the submitter is Apex Biotechnology Corp. in Hsinchu, Taiwan, and the device is intended for "self-testing (outside the body, or In Vitro Diagnostic use) by people with diabetes at home," the studies would likely involve prospective collection of human blood samples in a clinical setting or by home users. However, the specific location and nature (retrospective/prospective) of the data collection are not detailed.

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

• Not applicable in the context of this device and the type of evaluation described. For blood glucose monitoring systems, the "ground truth" (reference measurement) is typically established using a highly accurate laboratory reference method (e.g., hexokinase or glucose oxidase methods on a spectrophotometer), not human expert review. The document does not mention human experts establishing ground truth.

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

• Not applicable. Adjudication processes (like 2+1 or 3+1 expert consensus) are typically used for subjective interpretations, such as image analysis for AI models. For a quantitative device like a blood glucose meter, the ground truth is a numerical measurement from a reference instrument.

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:

• Not applicable. This device is a blood glucose monitoring system, not an AI-driven image analysis or diagnostic tool that assists human readers. Therefore, an MRMC study and
  measurement of human reader improvement with AI assistance are not relevant to this device.

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

• The GlucoSure Link Blood Glucose Monitoring System itself performs the measurement. Its "algorithm" is the measurement methodology. The "standalone performance" is essentially the device's accuracy and precision compared to a reference method, which is generally what "method comparison" studies evaluate. The document indicates these studies were performed, showing "substantial equivalence."

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

• The ground truth for blood glucose measurements is typically established by laboratory reference methods (e.g., using a YSI glucose analyzer) that are highly accurate and precise. The document implies "method comparison" studies were done, which means the device's readings were compared against such a reference method.

8. The sample size for the training set:

• Not explicitly stated. For a blood glucose meter, "training" might refer to the initial development and calibration of the electrochemical system and algorithms. This information is typically part of the device's internal development process and not usually detailed as a "training set" sample size in an FDA 510(k) summary in the way it is for AI models.

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

• Similar to point 8, the "ground truth" for the development and calibration of the device would likely be established using laboratory reference methods to ensure the meter's internal algorithms accurately convert electrochemical signals into glucose readings.

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MTM301 Blood Glucose and Ketone Monitoring System: MTM301 Blood Glucose and Ketone Monitoring System is comprised of the MTM301 Blood Glucose and Ketone Meter, the MTM301 Blood Glucose Test Strips, and the MTM301 Blood Ketone test strips.

The MTM301 Blood Glucose and Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood drawn from fingertips. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.

The MTM301 Blood Glucose and Ketone Monitoring System consists of the MTM301 Blood Glucose and Ketone Meter, MTM301 Blood Glucose test strips, MTM301 Blood Ketone test strips, MTM301 Glucose Control Solution (Level 1, Level 2), and MTM301 ketone control solution (Level 1 and Level 2). The system is for self-testing of blood glucose and blood ketone. The MTM301 Blood Glucose test strips, MTM301 Blood Ketone test strips, MTM301 Glucose Control Solution, and MTM301 ketone control solution are purchased separately.
The glucose test strips utilized in the MTM301 Blood Glucose and Ketone Monitoring System are the same as the BGM009 glucose test strips previously cleared in K170267 ; The ketone test strips are the same as the KET-1 Blood Ketone test strips, previously cleared in K182593.

Here's a summary of the acceptance criteria and study information for the MTM301 Blood Glucose and Ketone Monitoring System, based on the provided FDA 510(k) Summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria (e.g., specific accuracy percentages for glucose ranges). Instead, it states that "Results demonstrate substantial equivalence to the predicate system" for various tests. The predicate system is the Nova Max Plus Blood Glucose and β-Ketone Monitoring System (K091547).

However, the "Non-Clinical Testing" and "Clinical Testing" sections indicate the types of studies performed to demonstrate this substantial equivalence.

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

The document does not explicitly state the numerical sample size for the test set used in the accuracy studies (clinical testing) or for the individual non-clinical tests.

• Data Provenance: The submitter is Apex Biotechnology Corp. in Hsinchu, Taiwan. The document does not explicitly state the country of origin of the clinical data or whether it was retrospective or prospective, but clinical studies are generally prospective for device clearance.

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

This information is not provided in the document. For glucose and ketone monitoring systems, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer) performed by trained laboratory personnel, rather than experts in the sense of radiologists.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

This is not applicable. The MTM301 Blood Glucose and Ketone Monitoring System is a self-testing in vitro diagnostic device, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

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

Yes, the device operates as a standalone system. The clinical accuracy studies evaluate the algorithm's performance in measuring glucose and ketone in capillary whole blood. The system is intended for "self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home," indicating its standalone operational nature without professional human interpretation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the type of ground truth used, but for blood glucose and ketone monitoring systems, the ground truth is typically established using laboratory reference methods (e.g., a YSI analyzer for glucose, or a high-performance liquid chromatography (HPLC) method for ketones) on venous blood samples, against which the capillary blood measurements from the device are compared. This constitutes a highly accurate, quantitative ground truth.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" sample size. For in vitro diagnostic devices like blood glucose meters, the development process typically involves internal calibration, optimization, and verification using various samples, but these are not usually referred to as a "training set" in the same way as machine learning models. The "clinical testing" described would be more analogous to an independent "test set" for performance evaluation.

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

As noted above, the document does not refer to a "training set" in the context of establishing ground truth for machine learning. The ground truth for development and testing would generally follow standard laboratory reference methods.

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GAL-1A Plus Blood Glucose Monitoring System: GAL-1A Plus Blood Glucose Monitoring System is comprised of the GAL-1A Plus Blood Glucose Meter, the GAL-1A Blood Glucose Test Strips. The GAL-1A Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

The GAL-1A Plus blood glucose monitoring system consists of the GAL-1A Plus meter and GAL-1A Test Strips. It is used for testing of blood glucose by self-testers at home.

This document describes a 510(k) premarket notification for the GAL-1A Plus Blood Glucose Monitoring System, which does not contain an AI/ML component. Therefore, the questions related to AI/ML specific criteria like "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "sample size for the training set" are not applicable.

Here's the available information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The provided text focuses on the substantial equivalence determination and does not detail specific quantitative acceptance criteria or corresponding performance data for the GAL-1A Plus Blood Glucose Monitoring System beyond the disinfectant performance. It states that "Disinfection performance (robustness of meter to multiple cleanings and disinfections) was conducted. Results demonstrate substantial equivalence to the predicate system." This implies the performance met the criteria for substantial equivalence regarding disinfection, but the numerical criteria and results are not provided.

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

The document explicitly states: "No clinical testing was conducted." Therefore, there is no test set for clinical performance and no data provenance information for such a set. For the non-clinical disinfection performance, the sample size and data provenance are not specified.

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

Not applicable, as no clinical testing was conducted and the device does not have an AI/ML component.

4. Adjudication method for the test set

Not applicable, as no clinical testing was conducted and the device does not have an AI/ML component.

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

Not applicable, as the device does not have an AI/ML component.

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

Not applicable, as the device does not have an AI/ML component.

7. The type of ground truth used

For the non-clinical disinfection performance, the "ground truth" would likely be a pre-defined standard or method for evaluating the robustness to cleaning and disinfection, which is not detailed but assumed to be met for substantial equivalence. For clinical performance, no ground truth was established as no clinical testing was performed.

8. The sample size for the training set

Not applicable, as no AI/ML component is mentioned or implied.

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

Not applicable, as no AI/ML component is mentioned or implied.

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MultiSure GK Link Blood Glucose and Ketone Monitoring System is comprised of the MultiSure GK Blood Glucose and Ketone Meter, the MultiSure GK Blood Glucose Test Strips, and the MultiSure GK Blood Ketone test strips.

The MultiSure GK Link Blood Glucose and Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood drawn from fingertips. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.

The MultiSure GK Link Blood Glucose and Ketone Monitoring System consists of the MultiSure GK Link Blood Glucose and Ketone Meter, MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone test strips, Contrex Plus 4 Glucose Control Solution (Level 1, Level 2 and Level 3), and KET-1 ketone control solution (Level 1 and Level 2). The system is for self-testing of blood glucose and blood ketone. The MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone test strips, Contrex Plus 4 Glucose Control Solution, and KET-1 ketone control solution are purchased separately.
MultiSure GK Link Blood Glucose and Ketone Monitoring System enables automatic transmission of stored data to a data management system using upload data via USB cable (optional), or mobile device with Bluetooth when the meter and data management systems are properly configured.
The glucose test strips and glucose control solution utilized in the MultiSure GK Link Blood Glucose and Ketone Monitoring System are the same as the BGM009 glucose test strips and Contrex Plus 4 Glucose Control Solution, previously cleared in K170267; The ketone test strips and ketone control solution are the same as the KET-1 Blood Ketone test strips and KET-1 ketone control solution, previously cleared in K182593.

Here's an analysis of the provided text, extracting information related to acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides information on the accuracy studies for both glucose and ketone measurements. The acceptance criteria for these are described in the device's previous clearances (K170267 for glucose and K182593 for ketone). While the exact numerical acceptance criteria are not explicitly stated within this specific 510(k) summary for this device (K201880), it notes that the systems used are the same as previously cleared products, implying they meet the previously established criteria. The reported performance is that the "Results demonstrate substantial equivalence to the predicate system."

Given the information available, a table would look like this:

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

• Sample Size for Test Set: The document does not explicitly state the numerical sample size for the "accuracy studies for glucose and ketone" or the "evaluation of ease of use." It only mentions that these studies were "conducted with home users."
• Data Provenance: Not specified within this document. The submitter is from Hsinchu, Taiwan, but the location where the clinical studies were performed is not mentioned. It is prospective, as it involves human participants (home users) in a clinical study.

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

This document does not specify the number or qualifications of experts used to establish the ground truth for the test set. For blood glucose and ketone monitoring systems, ground truth is typically established by comparative measurements against a laboratory reference method, not necessarily by expert consensus in the way a diagnostic imaging study might.

4. Adjudication Method for the Test Set:

Not applicable or specified. For glucose and ketone measurements, adjudication methods (like 2+1, 3+1) are typically used for qualitative or imaging-based assessments where human interpretation is involved. For quantitative measurements against a reference standard, direct comparison is the method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the diagnostic performance of human readers, often comparing performance with and without AI assistance, particularly in imaging diagnostics. This device is a quantitative blood analyzer for self-testing, so this type of study is not relevant.

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

Yes, a standalone performance study was done for the device itself. The "accuracy studies for glucose and ketone" assess the performance of the device (meter and test strips) in measuring blood glucose and ketone levels. While performed by "home users," the focus is on the device's ability to provide accurate readings, not on human interpretation of those readings.

7. Type of Ground Truth Used:

For the "accuracy studies for glucose and ketone," the ground truth would typically be established by a laboratory reference method. This is standard for quantitative diagnostic devices like blood glucose and ketone meters, where the device's readings are compared against a highly accurate and precise laboratory analyzer. The document states "accuracy studies," which implies comparison to a gold standard.

8. Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. This is often not explicitly detailed for diagnostic devices that rely on established electrochemical biosensor technology, as opposed to devices employing complex machine learning or AI models that require extensive "training" data. The technology itself (Glucose Oxidase for glucose, $\beta$-hydroxybutyrate dehydrogenase for ketone) is well-understood and the "training" would have been part of the initial development and calibration of the test strips and meter, not necessarily a distinct "training set" in the context of AI/ML.

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

As with point 8, the concept of a "training set" and its associated ground truth establishment isn't directly applicable in the same way for this type of device as it would be for an AI/ML diagnostic. The ground truth for the development and calibration of the technology would have been established through rigorous laboratory testing using reference methods and known concentrations of glucose and ketone.

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GlucoSure HT Plus Blood Glucose Monitoring System is intended to quantitatively measure blood glucose in fresh capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing for glucose test should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.
The GlucoSure HT Blood Glucose Test Strips are to be used with the GlucoSure HT Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

The GlucoSure HT Plus blood glucose monitoring system consists of the GlucoSure HT Plus meter and GlucoSure HT Test Strips. It is used for testing of blood glucose by self-testers at home.

The provided text describes the 510(k) premarket notification for the GlucoSure HT Plus Blood Glucose Monitoring System, which is a medical device for measuring blood glucose. The information necessary to fully answer your request regarding acceptance criteria and study proving device meets criteria (especially as it pertains to AI/algorithm performance) is not fully detailed in this document, as it focuses on the substantial equivalence to a predicate device for a glucose monitoring system, and not an AI-assisted diagnostic tool in the typical sense this question implies.

However, based on the provided text, I can infer and extract some relevant information as best as possible, particularly regarding the clinical testing and the overall performance evaluation for this type of device.

Key takeaway for AI-related questions: This document describes a blood glucose monitoring system, not an AI-based diagnostic device where radiologists or extensive adjudication methods for image analysis would typically apply. The "algorithm" mentioned refers to the measurement algorithm within the glucose meter, not necessarily a complex AI/ML algorithm for image interpretation.

Here's a breakdown based on the available text:

Acceptance Criteria and Device Performance (Inferred from device type and general FDA requirements for glucose meters):

For a blood glucose monitoring system, the primary acceptance criteria revolve around the accuracy of glucose measurements compared to a reference method. While specific numerical acceptance criteria (e.g., % within 15% range) are not explicitly stated in the provided summary, these are standard for blood glucose meters. The summary states:

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

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KET-1 System: The KET-1 Blood Ketone Monitoring System is intended to quantitatively measure $\beta$ -hydroxybutyrate ( $\beta$ -ketone) in fresh capillary whole blood from fingertips. It should only be used by a single patient and it should not be shared. Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. It is not to be used for diagnosis or screening of diabetes, or for neonatal use. The KET-1 Blood Ketone Monitoring System is comprised of the KET-1 Blood Ketone Meter and KET-1 Blood Ketone Test Strip.

The KET-1 Blood Ketone Monitoring System consists of the KET-1 Blood Ketone Meter, KET-1 Blood Ketone Test Strips, and KET-1 Ketone Control Solutions (Level 1 and Level 2). The system is for self-testing of blood ketone. The KET-1 Blood Ketone Test Strips and KET-1 Ketone Control Solutions are purchased separately.

This document describes the regulatory approval of the KET-1 Blood Ketone Monitoring System. The provided text is a 510(k) summary, which outlines the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device.

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

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

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics. Instead, it describes general categories of testing and concludes that the device demonstrates substantial equivalence. For quantitative tests like accuracy, it states that "results demonstrate substantial equivalence to the predicate system" without providing specific numbers or ranges for the acceptance criteria.

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

• Sample Size for Test Set: The document mentions an "accuracy study" conducted with "home users using finger capillary whole blood." However, it does not specify the sample size (number of participants or samples) used for this accuracy study or any other mentioned tests (e.g., precision, repeatability, linearity).
• Data Provenance: The device manufacturer is Apex Biotechnology Corp. located in Hsinchu, Taiwan. The location of the clinical study (accuracy study) is not explicitly stated, but it is reasonable to infer it would be in Taiwan or a region where the manufacturer operates or has a testing facility. The data provenance is retrospective in the sense that the studies were completed before the 510(k) submission for regulatory review. However, the accuracy study itself was likely conducted prospectively (data collected specifically for the study) from the home users.

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

This information is not provided in the document. For a blood ketone monitoring system, ground truth would typically be established by a reference laboratory method (e.g., gas chromatography-mass spectrometry or a highly accurate clinical chemistry analyzer) rather than expert human interpretation of images. The document does not specify details of the ground truth method or the personnel involved.

4. Adjudication method for the test set

This information is not applicable in the context of a blood ketone monitoring system, as it measures a quantitative analyte. Adjudication methods (e.g., 2+1, 3+1) are typically used for qualitative or diagnostic imaging studies where human experts interpret results and disagreements need to be resolved. For a quantitative measurement, the "ground truth" (reference method result) is directly compared to the device's measurement.

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

An MRMC study is not applicable to this device. This type of study is relevant for AI-powered diagnostic imaging devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The KET-1 Blood Ketone Monitoring System is a quantitative point-of-care device that measures a chemical analyte and does not involve human interpretation of complex images or AI assistance for human readers.

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

The KET-1 Blood Ketone Monitoring System is a standalone device in the sense that it provides a direct quantitative measurement of β-ketone. Its "performance" is its accuracy and precision in measuring blood ketone levels compared to a reference method, rather than a diagnostic algorithm that processes complex data for human review. The documented testing (accuracy, precision, linearity) essentially assesses the standalone performance of the device.

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

The document implies that the ground truth for the accuracy study was established by a reference method, as is standard for quantitative diagnostic devices. While not explicitly stated, clinical chemistry analyzers or other highly accurate laboratory methods would be used to obtain the "true" β-ketone values against which the KET-1 system's results are compared. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

The document does not provide any information about a training set. This is likely because the KET-1 Blood Ketone Monitoring System is a pre-calibrated electrochemical device, not an AI/machine learning model that typically requires a large training dataset. The "training" of such a device usually refers to the internal calibration and manufacturing processes, not the statistical training of a data-driven model.

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

As there is no mention of a training set in the context of an AI/ML model, the establishment of ground truth for a training set is not applicable or described. The device's calibration and internal algorithms would be developed and validated through rigorous engineering and internal testing, using precisely known, manufactured control solutions and spiked samples, rather than a labeled training dataset in the AI sense.

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The BGM014 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.

The BGM014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip.

The BGM014 blood glucose meter and BGM014 test strips are used for self-testing of blood glucose.

The provided text is a 510(k) Premarket Notification from the FDA regarding the BGM014 Blood Glucose Monitoring System. It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device.

However, the core of the request is to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically in the context of an AI-based medical device or a device requiring complex performance evaluation typically involving expert adjudication, MRMC studies, or extensive ground truth establishment.

The provided document does not contain any information about an AI-based device, nor does it detail complex study designs with human readers, expert ground truth establishment, or clinical performance studies of the type requested.

Instead, this document is a clearance letter for a blood glucose monitoring system, which is a type of in vitro diagnostic device. The performance evaluation for such devices primarily focuses on analytical accuracy (how well the device measures glucose compared to a reference method) and often basic usability/disinfection efficacy, rather than the intricate clinical performance assessment typical for AI/CADe systems.

Therefore, it is not possible to answer the specific questions about acceptance criteria and study design as requested for an AI/CADe device using the provided text.

Here's what the document does state regarding testing and equivalence:

• Non-Clinical Testing: "Disinfection (viral inactivation) and 'robustness' testing were done to qualify the recommended disinfection solutions. Results demonstrate substantial equivalence to the predicate."
• Clinical Testing: "No clinical testing was conducted."
• Conclusion: "Testing showed that the modified BGM014 Blood Glucose Monitoring Systems are substantially equivalent to the predicate."

This indicates that the clearance was largely based on non-clinical testing demonstrating the device's ability to handle new disinfection solutions, asserting its continued substantial equivalence to a previously cleared device (K161299). The "acceptance criteria" for a blood glucose meter would typically involve accuracy metrics (e.g., % of results within certain error margins of a lab reference method, often based on ISO standards), but these specific performance statistics are not detailed in this 510(k) clearance letter. The letter confirms the device meets the regulatory requirements for substantial equivalence, implying it meets the necessary performance standards, but doesn't list them.

To reiterate, the detailed questions about expert adjudication, MRMC studies, standalone AI performance, ground truth sources (pathology, outcomes), and training set information are not applicable to the type of device and information presented in this FDA clearance document.

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