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Glucophone™ Blood Glucose Testing System 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 or healthcare professionals in the home and in clinical setting. Glucophone™ Blood Glucose Testing System is for testing outside the body (in vitro diagnostic use only). GlucoPhone™ Blood glucose Testing system is for use with a cellular phone. GlucoPhone™ Blood glucose Testing system is not for neonatal use and not for diagnosis or screening of diabetes. Alternate site testing is for use during times of steady state.

The Glucophone™ Meter device combined with Cell Phone (Motorola v3) is used along with the Glucophone The Test Strip to measure the glucose level in capillary whole blood.

The provided text describes the "Glucophone™ Blood Glucose Monitoring System" and its 510(k) submission. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria with numerical performance data.

Instead, the document states:

• Performance Data: "The clinical performance evaluation using the Glucophone™ Blood Glucose Monitoring System components were conducted for the purpose of validating consumer use and professional accuracy. Test results showed substantial equivalence."
• Non-clinical: "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the Glucophone "" Blood Glucose Monitoring System with respect to two predicate devices. Testing involved the verification of software requirement specifications, product requirement specifications and user interface requirement specifications from the risk analysis. The device passed all of the tests based on pre-determined Pass/Fail criteria."
• Conclusion: "The data from the clinical and non clinical tests show that the Glucophone™ Blood Glucose Monitoring System is as safe and effective as the legally marketed predicate devices, the GlucoPack™ and GlucoLab™"

Based on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide specific details on sample sizes, ground truth establishment, or multi-reader studies. The document only states that testing was performed and that the device was found to be "substantially equivalent" to predicate devices, implying that its performance met the standards of those approved devices, but without quantifying that performance or the specific criteria.

Therefore, many of the requested details are not present in the provided text.

Here's a breakdown of what can be inferred or explicitly stated from the text regarding your questions:

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

   • Acceptance Criteria: Not explicitly stated in numerical form. The implication is that the acceptance criteria are met if the device demonstrates "substantial equivalence" to the predicate devices (GlucoPack™ and GlucoLab™) in terms of "consumer use and professional accuracy," and passes "pre-determined Pass/Fail criteria" for non-clinical aspects.
   • Reported Device Performance: Not numerically reported. The text only states "Test results showed substantial equivalence" for clinical performance, and "The device passed all of the tests based on pre-determined Pass/Fail criteria" for non-clinical performance.

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

   • Sample Size (Test Set): Not specified.
   • Data Provenance: Not explicitly stated, but the submission is from a Korean company (Infopia Co., Ltd.). It is likely a prospective clinical study, given the mention of "clinical performance evaluation," but this is not explicitly confirmed.

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

   • Not specified.

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

   • 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:

   • Not applicable/Not specified. This device is a blood glucose monitor, not an AI-assisted diagnostic imaging device that uses human readers. The clinical evaluation would likely compare measurements from the device with a reference method (e.g., laboratory analyzer), not human interpretations.

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

   • This question is less relevant for a blood glucose monitoring system, as the "algorithm" is integral to the device's measurement. The clinical study implicitly evaluates the device in a "standalone" fashion (algorithm + hardware) when it states "The clinical performance evaluation using the Glucophone™ Blood Glucose Monitoring System components were conducted..."

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

   • For a blood glucose monitoring system, the ground truth would typically be a highly accurate laboratory reference method for blood glucose measurement (e.g., a YSI analyzer or similar). This is not explicitly stated but is the standard for such devices.

8. The sample size for the training set:

   • Not applicable/Not specified. For a simple electrochemical blood glucose system, there isn't typically a "training set" in the machine learning sense. Calibration and internal validation are performed during development, but this is different from a machine learning training set.

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

   • Not applicable (see point 8).

In summary, the provided 510(k) summary focuses on establishing substantial equivalence to existing predicate devices rather than providing detailed quantitative performance metrics and study designs, which are often found in more extensive clinical trial reports or full 510(k) submissions.

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