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MedtFine Blood Lancet is intended for use together with a lancing device of skin to obtain a drop of capillary blood from fingertip or from alternative sites.

MedtFine Blood Lancet is a small medical device used for capillary blood sampling. It is similar to a small scalpel with a double-edged needle used to make punctures, such as a fingerstick, to obtain small blood specimens. The device consists of a needle sheath, a hub, and a needle and provided sterility that is sterilized by gamma radiation. The device has three types listed in table 1 with recognized color. The device is an over-the-counter instrument equipped with a lancing device that patients mostly use during blood monitoring. However, in this case, it doesn't contain a lancing device, only the lancet. The proposed device is a universal device that can be fitted with most common marked lancing devices.

This document is a 510(k) Pre-market Notification for a medical device called "MedtFine Blood Lancet." It aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from various ISO standards. The reported device performance is presented in comparison to these standards and the predicate devices.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each individual non-clinical test conducted for the MedtFine Blood Lancet. It generally states that "all proposed device types' performance testing is run" for the different gauge sizes.

The data provenance is from non-clinical testing conducted by the manufacturer, Shanghai Carelife International Trading Co. Ltd. (China). The data is prospective in the sense that these tests were performed specifically for this 510(k) submission to demonstrate compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This detailed information is not provided in the document. The non-clinical testing appears to be primarily laboratory-based measurements and evaluations against established ISO standards and internal requirements, rather than relying on expert consensus for "ground truth" in the way a clinical study might for image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable in the context of this 510(k) submission. The non-clinical tests described are objective measurements against predefined standards, which do not typically involve human adjudication or consensus methods like those used in clinical studies for diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing is available for this device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as this describes a physical medical device (blood lancet), not a software algorithm or AI-driven system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by:

• International Standards: Primarily ISO standards (e.g., ISO 9626, ISO 7864, ISO 10993, ISO 11137, ISO 11607, ISO 11737).
• National Standards/Pharmacopoeias: ASTM standards (e.g., ASTM F1980, ASTM F1929, ASTM D4169) and USP (United States Pharmacopeia) tests (e.g., USP , USP , USP , USP ).
• Internal Requirements: For visual checking, additional internal requirements "derived from the visual checking sections of ISO 9626 and ISO 78664" were used.

These standards define the acceptable range or qualitative outcome for each test (e.g., "no corrosion," "meets requirements," specific numerical limits).

8. The Sample Size for the Training Set

This question is not applicable. This is a submission for a physical medical device. The concepts of "training set" and "validation set" are relevant to machine learning/AI models, which are not involved here. The manufacturer performed a series of tests on the device itself to demonstrate its inherent properties and safety.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8.

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