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Heel Incision Safety Lancet is intended for capillary blood sampling from the heel of newborns, preemies and toddlers.

Heel Incision Safety Lancet is comprised of Outer cover, Press carrier and Blade holder (include the blade). The press carrier provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired after press the press carrier. The blade holder is to protect the blade from triggering before use and form a sterile barrier to maintain the blade sterile. The device was sterilized by Radiation.

The SteriLance Medical (Suzhou) Inc. Heel Incision Safety Lancet (SteriHeel 2) underwent various performance tests to demonstrate substantial equivalence to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in quantitative terms for each test. Instead, it lists the types of tests performed to verify substantial equivalence. The reported device performance is that the device verifies or demonstrates performance characteristics and compliance.

2. Sample Size and Data Provenance

The document does not specify the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "bench testing performed" for non-clinical data and "biocompatibility evaluation" without detailing the number of units tested.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. The device is a medical lancet, not an AI or diagnostic imaging device that requires expert review for establishing ground truth. The performance criteria are objective physical and biological properties.

4. Adjudication Method

This information is not applicable, as no expert adjudication was involved in establishing ground truth for the physical and biological performance tests of a medical lancet.

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

No MRMC comparative effectiveness study was mentioned or performed, as this device is a physical medical instrument, not a diagnostic AI system requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithm performance study was mentioned or performed, as the device is a physical medical instrument and does not incorporate an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established through objective physical measurements, chemical analyses, and biological assays based on recognized international standards and bench testing methods. These include:

• Physical measurements (dimensions, hardness, surface roughness, sharpness)
• Functional tests (puncture function, safety, single-use, cutting depth/width)
• Biocompatibility tests (cytotoxicity, sensitization, systemic toxicity)
• Sterility validation.

8. Sample Size for the Training Set

No training set is referenced or relevant, as this is a physical medical device and not an AI or machine learning model.

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

Not applicable, as there is no training set for this device.

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