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The safety lancet is intended for capillary blood sampling.

The safety lancet is single use medical device, which is designed to collect capillary blood sample. The intended users include Healthcare personnel, patients and lay persons. According to surface difference or structure, the Safety lancets have 8 models: XIII, XVII, XXI, XXIII, XXIV, XXV, XXVI. XVII model have sub model according to surface difference. For Model XIII, XVII, XXI, XXII, XXV, the safety lancets consist of needle core, button, housing, bottom, spring and protective cap. For Model XXIII, the safety lancets consist of needle core, button, housing, and spring. For Model XXIV, the safety lancets consist of needle core, button, housing, spring and ring, And for Model XXVI, the safety lancets consist of needle core, button, housing, small lid and spring. 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° by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

The provided text describes the 510(k) summary for a Safety Lancet device, specifically K220370. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and simulated clinical use. It is a regulatory submission for a medical device rather than a report detailing a clinical trial or an AI/software as a medical device (SaMD) study. Therefore, many of the requested details, such as the use of AI, human reader studies, and sophisticated ground truth establishment, are not applicable to this type of device submission.

However, I can extract the relevant information from the provided text regarding acceptance criteria and the studies performed for this specific medical device.

Acceptance Criteria and Device Performance (Non-Clinical Testing)

Here's a table summarizing the acceptance criteria and reported device performance based on the "Non-Clinical Testing" section:

Summary of Device Performance Study Information:

The provided document describes physical and biological tests for a medical device (Safety Lancet), not an AI/Software as a Medical Device (SaMD). Therefore, many of the questions related to AI performance, human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for AI models are not applicable.

Here's the information that is extractable from the provided text:

1. Sample size used for the test set and data provenance:

   • Simulated Clinical Use: 500 device samples were used for the simulated clinical use study.
   • Non-Clinical Testing: The sample sizes for the individual bench tests (e.g., appearance, dimension, firmness) are not explicitly stated, but it's implied that sufficient samples were tested to "Meet the requirement."
   • Data Provenance: Not specified in terms of country of origin. The studies are described as "bench testing" and "simulated clinical use," implying lab-based testing rather than clinical patient data. The document is a 510(k) submission to the FDA, from a company in Tianjin, China.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the context of this device's testing. Ground truth for physical characteristics (e.g., dimensions, corrosion) is established by measurement against predefined specifications, not by expert consensus in this specific case.
   • For biocompatibility testing, compliance with ISO 10993 series standards is the "ground truth," evaluated by laboratory tests performed by qualified personnel, but not "experts" in the sense of radiologists.

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

   • Not applicable as this is not a study requiring adjudication of interpretations (e.g., imaging reads). The tests are objective measurements or categorical observations (e.g., "no burr," "no corrosion").

4. 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. This is a physical medical device (Safety Lancet), not an AI/software. Therefore, no MRMC study with human readers was conducted or is applicable.

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

   • Not applicable. This is not an algorithm or AI device. The testing described is for the physical performance and safety features of the lancet itself.

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

   • For Non-Clinical Testing (bench tests): The ground truth is based on engineering specifications, industry standards (e.g., ISO 9626 Annex A for pH, specific limits for extractable metals), and established physical or visual inspection criteria (e.g., "free of burr," "no dust," "no evidence of corrosion").
   • For Biocompatibility Testing: Ground truth is established by adherence to and passing results from tests specified in ISO 10993 series standards (e.g., "No Cytotoxicity," "No Skin Sensitization").
   • For Simulated Clinical Use: The ground truth is whether the device "met the pre-established criteria" for its safety mechanism, evaluated according to FDA Guidance and ISO 23908.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. As noted above, there is no AI training set for this device.

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