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The OneTouch UltraMini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch UltraMini System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch UltraMini Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

The OneTouch UltraMini Blood Glucose Monitoring System consists of the OneTouch UltraMini Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch Lancing Device with AST Clear Cap or OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® Meter has been modified to produce the OneTouch UltraMini Meter. The OneTouch Lancing Device with AST Clear Cap is a modification (smaller size) of the existing OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap (class I, exempt device). There are no changes to any of the other system testing components compared to the currently marketed product.

The submitter for the K061118 device is LifeScan, Inc. The device is the OneTouch® UltraMini™ Blood Glucose Monitoring System which is a modification of the predicate device, the OneTouch Ultra Blood Glucose Monitoring System. The claim for the device is substantial equivalence to the predicate. The performance characteristics of the new device are the same as the predicate since there has been no change to the fundamental scientific technology.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text states: "The modified meter was tested in accordance with ISO 15197:2003(E) including System Accuracy, Clinical Accuracy, and Consumer Evaluation to assess ease of use (human factors and user acceptance)."

However, specific numerical acceptance criteria (e.g., accuracy percentages, bias limits) and the detailed study results for these criteria are not explicitly provided in the given summary. It only states that the testing was performed and confirmed equivalence.

Therefore, a table with specific numbers cannot be generated from the provided text.

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

The summary mentions a "meter equivalence study" and "Design Verification (including software verification and validation) testing." It also states "The modified meter was tested in accordance with ISO 15197:2003(E)."

• Sample Size for Test Set: The document does not specify the sample size used for the test set in any of the studies (meter equivalence, design verification, or ISO 15197 testing).
• Data Provenance (Country of Origin, Retrospective/Prospective): 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 provide any information regarding the number or qualifications of experts used to establish ground truth for any of the testing mentioned.

4. Adjudication Method for the Test Set

The document does not provide any information regarding the adjudication method used for the test set.

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

The provided summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating equivalence to the predicate device, not on human reader performance improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

The device is a blood glucose monitoring system, which inherently involves human interaction for obtaining a blood sample and reading the meter. Therefore, a purely standalone "algorithm only" performance study in the context of AI is not applicable to this type of medical device as described. The performance studies would naturally involve the device being used as intended.

7. Type of Ground Truth Used

While the document doesn't explicitly state "ground truth," for blood glucose monitoring systems, the generally accepted "ground truth" for assessing accuracy is the comparison of device readings to a laboratory reference method (e.g., YSI analyzer) performed on the same blood sample. Given the reference to ISO 15197:2003(E), which directly addresses accuracy against reference methods, it can be inferred that a laboratory reference method would have been used.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This is consistent with a device that does not employ machine learning or AI in a way that requires a separate "training set" in the conventional sense for algorithm development. The device is a modification of an existing system, and the studies focus on verifying its equivalence.

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

As no training set is mentioned or implied for an AI/machine learning algorithm, this question is not applicable based on the provided text.

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