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Disposable Blood Lancet is used for capillary blood collection.

Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood collection. The device comprises a stainless needle encapsulated with a plastic needle body and protective cap, the protective cap is twisted off to expose the needle for use.

The device was sterilized by Radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.

The provided text describes the regulatory clearance of a medical device, the "Disposable Blood Lancet," and details its non-clinical testing for substantial equivalence to a predicate device. It does not involve AI or algorithms, and therefore, the requested information regarding AI-specific criteria, such as MRMC studies, training/test set details, and expert adjudication, is not applicable.

Here's an analysis based on the information provided regarding the non-AI device:

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

The acceptance criteria are implicitly derived from the non-clinical tests performed to demonstrate substantial equivalence to the predicate device. The "reported device performance" is the result of these tests.

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes used for each non-clinical performance test. It only states that "bench testing performed verifies that the performance of the proposed device is substantially equivalent." For biocompatibility, it states "biocompatibility evaluations were conducted." The provenance of the data is from non-clinical lab testing conducted by the manufacturer, SteriLance Medical (Suzhou) Inc., likely in China. The nature of these tests is retrospective in the context of the 510(k) submission, as they were completed prior to the review.

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

This question is not applicable as the device is a physical medical device, not an AI/algorithm-driven one. Ground truth is established through standardized laboratory testing and measurement procedures defined by the relevant ISO and ASTM standards. Experts in laboratory testing and quality assurance would perform and evaluate these tests, but their qualifications are not detailed beyond their adherence to the standards.

4. Adjudication method for the test set

This question is not applicable for a non-AI physical device. The testing described involves objective measurements and standardized biological evaluations.

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 question is not applicable as the device is a physical "Disposable Blood Lancet" and does not involve AI assistance or human readers in an interpretive capacity.

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

This question is not applicable as the device is a physical "Disposable Blood Lancet" and does not contain an algorithm.

7. The type of ground truth used

For the performance tests (e.g., appearance, dimensions, sharpness, binding strength, etc.), the "ground truth" is established by engineering specifications, design requirements, and applicable international standards (e.g., ISO 9626 for needle size). For biocompatibility, the ground truth is established by standardized biological evaluation methods and criteria outlined in ISO 10993 series.

8. The sample size for the training set

This question is not applicable as the device is a physical "Disposable Blood Lancet" and does not involve an AI training set.

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

This question is not applicable as the device is a physical "Disposable Blood Lancet" and does not involve an AI training set.

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