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It is intended for capillary blood sampling.

Promosemed Blood Lancet is a sterile, handheld, sharply-pointed, nonmechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.

VeriFine Safety lancet and VeriFine Mini-Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets 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 first spring releases the needle into the skin and the second withdraws the needle back into the shield.

Both single-use Promisemed Blood Lancet and VeriFine Safety Lancet/VeriFine Mini-Safety Lancet offers different gauge (needle diameter) options, to allow to choose the lancet which meets blood volume needs.

The provided text is a 510(k) Summary for medical devices (blood lancets) and does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way described in the request (e.g., performance metrics, sample sizes for test sets, expert ground truth, MRMC studies, standalone algorithm performance).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It outlines a comparison of technical characteristics and performance testing that confirms the devices are comparable, not a study designed to establish quantitative performance against defined acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot, based on the input:

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

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

• Sample Size for Test Set: Not specified. The document states "The bench testing performed verifies that the performance of the subject devices are substantially equivalent..." but does not provide specific sample sizes for these tests.
• Data Provenance: Not specified.

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. This is a medical device submission focused on physical and chemical performance, not diagnostic accuracy requiring expert interpretation or ground truth.

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

• Not applicable. This is not a study requiring adjudication of interpretations.

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 document pertains to blood lancets, which are physical medical devices, not AI-powered diagnostic tools.

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

• Not applicable. This document pertains to blood lancets, not algorithms.

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

• Not applicable in the context of diagnostic performance. For device characteristics, the "ground truth" would be established by physical/chemical measurement standards (e.g., ISO, ASTM standards for dimensions, sterility, biocompatibility).

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-based device that requires a training set.

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

• Not applicable. This is not an AI/algorithm-based device.

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