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Unistik® Heelstik: The Unistik® Heelstik heel incision safety lancets are single use devices used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers. Unistik® TinyTouch: The Unistik® TinyTouch heel incision safety lancets are single used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers.

The submission devices are sterile single-use devices with integral sharps protection whereby the lancet blade or needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. The devices automatically self-disable after a single use, thus preventing any hazards of re-use. The submission devices are intended for use by healthcare professionals only, for performing heel incisions on newborns, preemies, and toddlers to obtain capillary blood specimens for IVD assays. The product is intended for prescription (Rx) only use.

This document describes the performance testing conducted for the Unistik® TinyTouch and Unistik® Heelstik sterile single-use heel incision safety lancets.

1. Table of Acceptance Criteria and Reported Device Performance

Because this is a 510(k) summary for a medical device that appears to be a blood lancet, the "acceptance criteria" are implied to be established specifications and standards for similar devices, ensuring safety and effectiveness. The reported device performance is consistently listed as "Meets acceptance criteria/ Pass" for all tests. Specific numerical acceptance criteria are not provided in this summary.

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

The document does not explicitly state the sample sizes used for each specific bench test (e.g., number of devices tested for button actuation force). However, it indicates that "Design verification testing... has been carried out to evaluate the performance of the devices against defined acceptance criteria." The tests appear to be laboratory-based bench evaluations.

The data provenance is not explicitly stated in terms of country of origin, but Owen Mumford Ltd is based in the United Kingdom. The data is retrospective in the sense that the tests were completed prior to the 510(k) submission.

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

For bench testing of a physical medical device like a lancet, the "ground truth" is typically established by engineering specifications, validated test methods, and compliance with recognized standards. This generally does not involve expert consensus in the same way as, for example, image interpretation. The testing would have been performed by qualified technicians and engineers following established protocols. The document does not specify human experts for establishing ground truth for these types of tests.

4. Adjudication Method for the Test Set

Not applicable for this type of bench testing. The results are objective measurements against predefined engineering specifications and pass/fail criteria.

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

No. This is a 510(k) submission for a blood lancet, not an AI or imaging device that would typically undergo an MRMC study.

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

Yes, in a sense. The performance data presented refers to the standalone performance of the physical devices themselves through various bench tests (e.g., incision profile, button actuation force, drop test). There is no "algorithm" in the context of an AI device.

7. The Type of Ground Truth Used

The ground truth for the performance tests is based on engineering specifications, predefined acceptance criteria, and compliance with international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11137 for sterilization). For example, "incision profile - depth of cut" would have a specific numerical range as an acceptance criterion.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would require a training set.

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

Not applicable, as there is no training set.

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