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The Lifescan FastTake® Adapter is an accessory to the Lifescan FastTake® Blood Glucose Meter. It provides a communication link between the FastTake® Meter and the Lifescan ONE TOUCH® Interface cable, neither of which is included. The FastTake Adapter is intended to be used for data transfer between a FastTake® Meter and a personal computer.

The FastTake" Adapter is an accessory to the FastTake Blood Glucose Meter. lt provides a communication link between the FastTake Meter and the ONE TOUCH® cable, neither of which is included with the Adapter. The FastTake Adapter is intended to be used for data transfer between a FastTake Meter and a personal computer.

The provided 510(k) summary for the FastTake® Adapter does not contain detailed acceptance criteria or a specific study that proves the device meets such criteria in a quantitative manner. This submission focuses on demonstrating substantial equivalence to a predicate device, the Precision Link™ Communications Box.

Here's an analysis of the information provided, trying to extract what's available for each requested point:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document is limited in providing specific, measurable acceptance criteria (e.g., success rate of data transfer, error rate, speed of transfer) and instead offers a general statement about "reliable communication" being demonstrated through verification and validation tests.

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

The document does not specify a "test set" in the context of a clinical study or a dataset with labeled ground truth. The "verification and validation tests" mentioned are likely product-level hardware and software testing, not a study involving patient data. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of data are not provided.

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

As there is no mention of a "test set" involving expert-labeled ground truth, this information is not applicable/not provided.

4. Adjudication Method for the Test Set:

Since a test set requiring adjudication by experts is not described, this information is not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC study is mentioned. This device is a communication adapter, not an AI or diagnostic device that would typically involve human readers. Therefore, this is not applicable/not provided.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

The document indicates "Software and hardware verification and validation tests" were performed, which implies standalone testing of the device's functionality. However, specific details about the methodology, metrics, or results of these tests beyond the general statement of "reliable communication" are not provided. The device itself is described as "microprocessor controlled communication devices," implying an "algorithm" (firmware/software) controls its function, and this would have been tested in a standalone manner during verification and validation.

7. The Type of Ground Truth Used:

For the "reliable communication" claim, the ground truth would likely be defined by successful data transfer operations as per the device's specifications (e.g., data transmitted equals data received, correct data formatting). This would be established through engineering and software testing protocols, not clinical outcomes or pathology. Specifics are not provided.

8. The Sample Size for the Training Set:

This device is not an AI/machine learning model that typically requires a "training set" of data in the sense of supervised learning. Its functionality is based on established communication protocols and hardware/software design. Therefore, a "training set" in this context is not applicable/not provided.

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

As there is no training set described, this information is not applicable/not provided.

In summary:

This 510(k) submission for the FastTake® Adapter is for a Class I accessory device, and its approval relies on demonstrating substantial equivalence to a predicate device (the Precision Link™ Communications Box) with "the same technological characteristics" and "the same intended use." The performance data is limited to a general statement that "Software and hardware verification and validation tests demonstrate that the FastTake Adapter provides reliable communication." This level of detail is typical for such a device classification and regulatory pathway at the time of approval (1998), where the focus is on functional equivalence rather than extensive clinical efficacy studies with detailed statistical metrics as would be expected for more complex diagnostic or therapeutic devices, especially AI-driven ones.

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