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The safety lancet is intended for capillary blood sampling.

The safety lancet is single use medical device, which is designed to collect capillary blood sample.
The intended users include Healthcare personnel, patients and lay persons.
According to surface difference or structure, the Safety lancets have 7 models: XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.
XXIX, XXX model have sub model according to surface difference.
For Model XXVIII and XXX, the safety lancets consist of needle core, button, housing and spring. For Model XXIX, the safety lancets consist of needle core, button, housing, spring, and Depth adjuster ring. For Model XXXI, the safety lancets consist of needle core, top cover, bottom and spring. For Model XXXII, the safety lancets consist of needle core, top cover, bottom, small lid and spring. For Model XXXIII, the safety lancets consist of needle core, button, housing, inner sleeve and spring. And for Model XXXIV, the safety lancets consist of needle core, button, housing, bottom, Protective cap and spring.
The sterile part of the safety lancet is the needle tip.The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

This document is a 510(k) summary for a medical device called "Safety Lancet," and it does not contain information about an AI/ML powered device. The information provided is for a physical medical device (safety lancets) used for capillary blood sampling. Therefore, many of the requested fields related to AI/ML device studies (such as MRMC studies, standalone algorithm performance, training set details, and expert ground truth establishment for AI) are not applicable.

However, I can extract the relevant information regarding the acceptance criteria and the studies performed for this physical device.

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

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

• Simulated Clinical Use Study: 300 device samples each for the Safety Lancet (various models).
• Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective/prospective). This was a bench test and simulated use study, not a human data study.

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)

Not applicable. The "ground truth" for this physical device was based on objective physical measurements and established biological safety standards from ISO 10993 and FDA guidance, not expert interpretation of data.

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

Not applicable. This was a non-clinical bench and simulated use study, not a study requiring adjudication of expert opinions.

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. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

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

For bench testing: Objective physical measurements and adherence to functional specifications.
For biocompatibility testing: Laboratory results following ISO 10993 standards.
For simulated clinical use: Evaluation of the safety mechanism against pre-established criteria defined by FDA Guidance (Medical Device with Sharps Injury Prevention Feature) and ISO 23908.

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

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