Search Results

The safety lancet is intended for capillary blood sampling.

The safety lancet consists of needle core, protective cap, plug, trigger, spring, outer case and end cap. 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. The safety lancet is intended for capillary blood sampling. The device was designed to minimize the risk from accidental needle sticks with a used needle by application of a sharp injury prevention feature. The needle tip back into the safety lancet body automatically after launch and cannot be reused. The safety lancet can be disposed safely.

This document is a 510(k) summary for a "Safety Lancet" (K223208). It aims to demonstrate substantial equivalence to a predicate device (Tianjin Huahong Safety Lancet – K220370).

Here's an analysis of the acceptance criteria and study information provided and what's missing, structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a single table of "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might expect for a diagnostic or AI device. Instead, it discusses various performance tests and compliance with standards. The "acceptance criteria" are implied by the standards and internal requirements, and "reported device performance" is summarized as meeting these requirements.

Here's a best effort to extract and present this information based on the provided text, recognizing that specific numerical results or direct comparisons to predicate device values (beyond "same" or "similar") are often not included in 510(k) summaries unless there's a significant difference to justify.

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

• Test Set Description: The document refers to "non-clinical testing results" primarily for physical performance, sterility, shelf-life, and biocompatibility. Additionally, a "simulated clinical use study" was conducted.
• Sample Size for Simulated Clinical Use Study: 500 device samples.
• Data Provenance for Simulated Clinical Use Study: Not explicitly stated, but it's a "simulated clinical use study," implying it wasn't conducted on actual patients. The company is based in China, so it's likely conducted there. It is a prospective study in the sense that the testing was performed on new samples according to a protocol.
• Other Testing Sample Sizes: For other physical, sterility, and biocompatibility tests, specific sample sizes are not provided in this summary, but implied by adherence to the referenced ISO and ASTM standards.

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

This information is not provided in the document. For a medical device like a safety lancet, "ground truth" (as typically thought of in AI/diagnostic studies) isn't directly applicable in the same way. The "truth" is established by adherence to engineering standards and safety requirements (e.g., "is the needle exposed after drop test?"). The "experts" would be the engineers, quality control personnel, and lab technicians conducting the tests and interpreting results against the objective standards. Their qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (physical, sterility, biocompatibility), results are typically objective measurements against a standard, rather than subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a mechanical safety lancet and does not involve AI or "human readers" in the context of interpretation of diagnostic images or data.

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

No, a standalone algorithm performance study was not done. This device is a mechanical safety lancet and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Adherence to recognized international and national standards: ISO standards (e.g., for needle tubing, sterility, biocompatibility), ASTM standards (e.g., for packaging), and USP standards (e.g., for sterility, endotoxins).
• Manufacturer's internal requirements: For specific features like cap removal force (3-9 N).
• FDA Guidance Documents: Particularly for sharps injury prevention features.
• Objective measurements and observations: Such as force measurements, visual inspections after drop tests, biological test results (e.g., "no cytotoxicity").

Essentially, the ground truth is defined by the fulfillment of these established safety and performance benchmarks.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a physical medical device, 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 and therefore not provided. As above, there is no "training set" for a physical medical device.

Ask a specific question about this device