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The Disposable Safety Lancet is intended for capillary blood sampling.

The Disposable Safety Lancet is intended for capillary blood sampling. The Disposable Safety Lancet include eleven models as IV, V, W2, M3, M3 PLUS, M4, M5, M5 MINI, M6, M7, E1. The models include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G. Disposable Safety Lancet are spring-loaded lancet. Disposable Safety Lancet are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle.

The provided document is a 510(k) summary for a medical device called "Disposable Safety Lancet". It describes the device, its intended use, and argues for its substantial equivalence to a predicate device based on non-clinical tests.

However, the document does not contain any information regarding clinical studies, acceptance criteria, or performance metrics in a way that typically applies to AI/ML medical devices.

Specifically, it lacks the following information that you requested:

• A table of acceptance criteria and the reported device performance: This document does not specify any performance criteria (e.g., sensitivity, specificity, accuracy) for diagnosis or detection, nor does it present results against such criteria. The "performance" mentioned is in the context of mechanical and biocompatibility testing.
• Sample size used for the test set and the data provenance: No test set (in the context of clinical data for AI/ML) is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment related to clinical assessment is discussed.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there's no clinical test set mentioned.
• 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: The device is a physical medical lancet, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for a physical lancet in this context.
• The sample size for the training set: Not applicable for a physical lancet.
• How the ground truth for the training set was established: Not applicable for a physical lancet.

The "studies" mentioned in the document are non-clinical bench tests and biocompatibility evaluations, not clinical performance studies involving a test set, ground truth acquisition, or expert readers.

Here's a summary of the non-clinical tests that were performed and their conclusions:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

• Test Set Sample Size: Not applicable. The document refers to non-clinical bench tests and biological evaluations, not a clinical test set with patient data for performance evaluation.
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth for clinical diagnostic purposes or AI model validation is not relevant for this type of device and study.

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

• Not applicable.

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:

• No. This is a physical medical device (lancet), not an AI/ML diagnostic or assistive device.

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

• No. This is a physical medical device.

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

• Not applicable in the context of AI/ML evaluation. The "ground truth" for the non-clinical tests would be the established scientific methods and standards (e.g., cell viability for cytotoxicity, physical measurements for mechanical tests).

8. The sample size for the training set:

• Not applicable. This is a physical medical device.

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

• Not applicable.

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