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Lancet is intended for capillary blood sampling.

The Sterile Lancets for Single Use is composed two components: needle and needle holder. Needle holder is plastic part that enclosed the needle. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The lancet is together with a lancing device to puncture the skin to obtain a drop of capillary blood from fingertip or from alternative sites. The shelf-life of the product is 5 years.

The provided document is a 510(k) premarket notification for a medical device (Sterile Lancets for Single Use). It describes the device, its intended use, a comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

Here's an analysis 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 document does not explicitly list "acceptance criteria" with numerical targets in a formal table corresponding to performance. Instead, it refers to "Performance testing is conducted according to Inspection Specification" and states that "the test sample has undergone accelerated aging for 5.5 years" and "passed all tests." The performance attributes tested are listed.

Here's an interpretation of the performance attributes and the implied acceptance criteria from the text:

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

• Sample Size for Test Set: The document does not specify the numerical sample size used for performance testing. It generally refers to "the test sample."
• Data Provenance: The document indicates that the testing was conducted by Ningbo Caremed Medical Products Co., Ltd., based in China. The data would be retrospective in the sense that the tests were completed before the 510(k) submission.

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

This information is not applicable as the device is a medical lancet and the testing involves objective physical, chemical, and biological performance tests, not subjective interpretation by experts to establish a "ground truth" like in imaging or diagnostic AI. The "ground truth" for these tests would be the established scientific and engineering standards and methods.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods are typically used when subjective expert opinion is involved in ground truth establishment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. An MRMC study is relevant for diagnostic devices, especially those involving human interpretation (e.g., radiologists interpreting images). This device is a sterile lancet for single-use capillary blood sampling, a physical instrument, and does not involve human readers interpreting output that would be improved by AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This information is not applicable. This device is a physical medical instrument, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance testing of the lancet is based on:

• Established scientific and engineering standards: For dimensions, firmness, puncture performance, matching, launch performance.
• Specific ISO standards: For biocompatibility (ISO 10993 series) and sterilization (SAL of 10-6).
• Bacterial endotoxin limits: Established regulatory or compendial limits.
• Accelerated aging protocols: To simulate real-time shelf-life.

8. Sample Size for the Training Set

This information is not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable as there is no training set for this device.

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