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The AUTO-CHEK Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm. thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The AUTO-CHEK Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The AUTO-CHEK Blood Glucose Test Strips are for use with the AUTO-CHEK Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites. The AUTO-CHEK Control Solutions are for use with the AUTO-CHEK Meter and AUTO-CHEK Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.

The AUTO-CHEK Blood Glucose Monitoring System (BGMS) measures the glucose level in whole blood samples using a small electrical current generated in the test strips. The system consists of the followings: the AUTO-CHEK Meter, AUTO-CHEK Test Strips, AUTO-CHEK Control Solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately), a Lancing Device, Lancets, a User's manual, and a Logbook.

Here's an analysis of the provided text regarding the AUTO-CHEK Blood Glucose Monitoring System, focusing on acceptance criteria and study details. It's important to note that the provided document is a 510(k) summary for a "Special 510(k)" and primarily focuses on demonstrating substantial equivalence to a predicate device after a modification. Therefore, it does not contain extensive details about new clinical studies that would typically describe the acceptance criteria and performance as if it were a de novo submission.

The document states: "The validations were conducted in order to verify that the modified electric connector pattern has not caused any adverse effects on the safety and effectiveness of the candidate device. The test results showed that the candidate device operated effectively, accurately, and safely." This implies that the 'acceptance criteria' were likely tied to demonstrating that the modified device performed equivalently to the predicate device, which would have previously met certain accuracy standards.

The document also mentions "performance, safety, and effectiveness of the device for its intended use" as being met, but it doesn't quantify these.

Acceptance Criteria and Reported Device Performance

Given the nature of this document (a special 510(k) for minor modification), specific numerical acceptance criteria and a detailed performance table from new clinical studies are not explicitly provided.

However, for blood glucose monitoring systems, the generally accepted performance criteria (often referenced by organizations like ISO 15197) involve accuracy within certain bounds compared to a laboratory reference method. Since this document states "The test results showed that the candidate device operated effectively, accurately, and safely," and claims substantial equivalence to the predicate "COOL Blood Glucose Monitoring System," it implicitly means it met the accuracy standards expected of such devices.

Based on typical regulatory expectations for glucose meters, hypothetical (but not explicitly stated in the document) acceptance criteria and their implied fulfillment would be:

Other Study Information:

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

   • The document implies that "validations were conducted" to verify the modified electric connector pattern. However, it does not specify the sample size for any test set related to blood glucose measurement accuracy.
   • It does mention a sample size for robustness testing: "260 each of pre-cleaning and disinfection cycles." The provenance for this disinfection study is an "outside commercial testing service." No country of origin is specified for this particular study, nor is it explicitly stated if it's retrospective or prospective, though disinfection studies are typically prospective.
   • For the core glucose measurement accuracy, the document refers to substantial equivalence to the predicate, suggesting that new large-scale clinical accuracy studies were not the primary focus of this specific 510(k) submission due to the minor modification.

2. 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)

   • Not applicable / Not specified. The document does not describe a process of expert review or consensus for establishing ground truth, as it's a device for quantitative chemical measurement, where ground truth is typically established by a laboratory reference instrument (e.g., a YSI analyzer for glucose).

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

   • Not applicable / Not specified. This type of adjudication is typically used in image-based diagnostic studies involving human interpretation. For a blood glucose meter, ground truth is established by a reference chemical analyzer.

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

   • Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic tool that involves human readers/interpreters. There are no "human readers" in the context of this device.

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

   • The AUTO-CHEK Blood Glucose Monitoring System is a standalone device when performing a measurement. The "algorithm" in this context is the meter's firmware that converts the electrical current from the test strip into a glucose concentration. The document implies this "algorithm only" performance was assessed as part of the "effectively, accurately, and safely" statement by comparing it to standard glucose measurement methods (presumably the predicate device or a lab reference, though not explicitly detailed for this submission).

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

   • Implied: For blood glucose meters, the ground truth is typically established using a laboratory reference method (e.g., YSI glucose analyzer, hexokinase method) on the same blood samples. The document refers to "measurement principle" and "fundamental scientific technology" being the same as the predicate, which would have been validated against such reference methods.

7. The sample size for the training set

   • Not applicable / Not specified. Blood glucose meters typically do not have a "training set" in the machine learning sense. Their "training" involves calibration during manufacturing based on known glucose concentrations. If this refers to design validation data, it's not specified.

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

   • Not applicable / Not specified. As above, the concept of a "training set" with established ground truth in the AI/ML context doesn't apply directly to a electrochemical blood glucose meter. The calibration of the device is done against precisely known glucose concentrations.

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