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The Accu-Chek Guide Me Blood Glucose Monitoring System is comprised of the Accu-Chek Guide Me meter and the Accu-Chek Guide test strips.

The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.

The Accu-Chek Guide Me Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes.

The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.

Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Accu-Chek Guide Me Blood Glucose Monitoring System makes use of the Accu-Chek Guide Me meter, and the Accu-Chek Guide test strips. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the finger, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.

The Accu-Chek Guide Me Blood Glucose Monitoring System consists of the following:

• Accu-Chek Guide Me meter
• Accu-Chek Guide test strips (previously cleared in K160944)

The provided text describes the Accu-Chek Guide Me Blood Glucose Monitoring System, a device intended for quantitative measurement of glucose in fresh capillary whole blood. The submission is a Special 510(k), indicating a modification to a previously cleared device (Accu-Chek Guide Blood Glucose Monitoring System, K160944).

Here's an analysis of the acceptance criteria and study information, based solely on the provided text. Many of the requested details about the study are not present in this 510(k) summary, as it largely focuses on demonstrating substantial equivalence through comparison to a predicate device rather than presenting full clinical study results.

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

The document does not explicitly state "acceptance criteria" in a tabulated format with corresponding reported performance for the Accu-Chek Guide Me system related to analytical accuracy. Instead, it highlights that the Accu-Chek Guide test strip, measurement engine, and measurement principle used with the Accu-Chek Guide Me system have not been modified. System claims and performance have not changed. This implies that the performance of the Accu-Chek Guide Me system is expected to be identical to the predicate device (Accu-Chek Guide) because the core measurement technology is the same.

The similarities table (Table 1) however, provides specifications that could be considered performance parameters.

The key takeaway is that for the significant analytical performance aspects (test strip, measurement engine, principle, measurement range, hematocrit range), the device performance is stated to be "Same" as the predicate because these components were not modified. The document does not provide new analytical accuracy data for the Accu-Chek Guide Me system, relying on the predicate's performance.

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

The document does not provide details on specific sample sizes for a "test set" or data provenance (country of origin, retrospective/prospective) for the Accu-Chek Guide Me system. Since it's a Special 510(k) focusing on modifications that did not change the core measurement technology, new extensive analytical or clinical studies for the modified device are not detailed here. The submission relies on the established performance of the predicate device.

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. The device is a blood glucose monitoring system, and ground truth for such devices is typically established against laboratory reference methods (e.g., YSI analyzer), not by human expert consensus in the way medical imaging might require.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments by multiple human readers (e.g., in radiology studies), not for objective measurements by 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 and not provided. An MRMC study is relevant to AI/CAD systems that assist human readers in interpreting medical images. The Accu-Chek Guide Me is a standalone blood glucose meter and does not involve human readers for interpretation in this context, nor does it feature AI assistance.

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

The device itself is a standalone glucose monitoring system. The document implies that because the "Accu-Chek Guide test strip, measurement engine, and measurement principle used with the Accu-Chek Guide Me system have not been modified," its standalone performance is considered identical to the predicate device (Accu-Chek Guide, K160944). No new standalone performance study data regarding analytical accuracy is presented for the Accu-Chek Guide Me in this document. The submission focuses on demonstrating that the modifications (user interface, physical design, connectivity details) do not impact the established standalone performance.

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. However, for blood glucose meters, the ground truth for analytical accuracy studies is invariably established using laboratory reference methods, such as a YSI glucose analyzer, which is considered the gold standard for glucose measurement in clinical laboratory settings.

8. The sample size for the training set

This information is not provided. The document highlights that the core measurement technology was not changed, implying that extensive re-training or new studies for the "Guiding Me" version was not deemed necessary for the 510(k) submission as a Special 510(k). For blood glucose meters, "training sets" are usually associated with the initial development and calibration of the electrochemical measurement system and algorithms, which happened for the predicate device.

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

This information is not provided. As with point 7, ground truth for the underlying measurement technology (if considered a "training set" for the original Accu-Chek Guide system) would have been established using laboratory reference methods like a YSI glucose analyzer.

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