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The safety lancet is intended for capillary blood sampling.

Sterile safety lancet consists of outer shell, middle sleeve, needle holder, spring, upper shell, back cover, small cover, needle. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use and single person use only. The shelf-life of the product is 5 years. The device is for medical professionals and lay person use as an OTC use.

This document is a 510(k) Summary for a medical device called "MedtFine Safety Lancet". It details the device's characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the provided text for acceptance criteria and the study proving the device meets them:

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

The document provides a "Characters comparison" table (Table 2) that includes performance parameters for both the proposed "MedtFine Safety Lancet" and the predicate device "Safety Lancet (K220370)". This table effectively serves as a comparison against acceptance criteria. The acceptance criterion for each performance characteristic is generally implied to be "same" or within the range of the predicate device, or "meet requirements."

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

The document does not specify the sample size used for the non-clinical performance test set. It lists the types of tests performed (e.g., appearance, needle size, firmness, puncture force, safety performance, limits for acidity or alkalinity, resistance to corrosion, sharps injury protection, simulated clinical use study).

The data provenance (country of origin, retrospective/prospective) is also not mentioned. These studies are typically conducted by the manufacturer or a contracted testing lab.

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)

This information is not applicable as the device is a medical lancet. The ground truth for its performance characteristics (like puncture force, needle exposure length, etc.) is established through objective measurements against defined engineering and biological standards, not through expert consensus or clinical interpretation of images.

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

This information is not applicable as the device relies on objective non-clinical performance testing rather than subjective interpretation requiring adjudication among experts.

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

An MRMC study is not applicable for this device. This type of study is relevant for diagnostic imaging AI devices, whereas the MedtFine Safety Lancet is a mechanical medical device for blood sampling.

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

This concept is not applicable to a mechanical blood lancet. Standalone performance refers to the accuracy of an AI algorithm operating without human intervention.

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

The ground truth for the MedtFine Safety Lancet's performance is established through adherence to recognized international standards and validated testing methodologies. For example:

• Physical and performance characteristics: Measured values compared against specifications (e.g., needle size compared to stated gauge, puncture force measured against a defined range, exposure length measured).
• Sterility: Validated according to ISO 11137-2:2013, with a Sterility Assurance Level (SAL) of 10-6.
• Biocompatibility: Demonstrated by testing in compliance with ISO 10993-1.
• Sharps Injury Protection: Tested per ISO 23908 and an FDA Guidance document.
• Shelf-life: Validated under accelerated aging conditions per ASTM F1980-16.
• Package integrity: Tested against ASTM F4169-22, ASTM F88/F88-15, and ASTM F1929-23.
• Sterility (packaging): USP <71>

8. The sample size for the training set

This information is not applicable. The MedtFine Safety Lancet is a mechanical medical device, not an AI/ML-based device that requires a "training set." Its design and manufacturing are based on engineering principles and material science, not data-driven learning.

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

This information is not applicable for the reasons stated above (not an AI/ML device). The design and development process for such a device relies on established engineering specifications, material selection, and manufacturing processes, which are then validated through the performance and biocompatibility testing outlined.

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