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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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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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Heel Incision Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.

Heel Incision Safety Lancet is comprised of top upper cover, bottom cover, button, safety plug, slider, rod, holder, spring, blade. The spring provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired when the spring is under pressure. The safety plug is to protect the blade from triggering before use. Heel Incision Safety Lancet is single use, sterile medical devices designed to be used in collecting the blood sample. Heel Incision Safety Lancet is intended to be used by professionals. Heel Incision Safety Lancets are sterile and non-toxic. The product is intended for prescription (Rx) only.

The provided document is a 510(k) Premarket Notification for a medical device (Heel Incision Safety Lancet) and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a study proving a device meets acceptance criteria for an AI/ML-based medical device.

Therefore, many of the requested details regarding acceptance criteria, AI/ML study design, sample sizes, expert involvement, and ground truth establishment (especially for AI/ML models) are not applicable and not present in this document. This document describes a traditional medical device (a lancet) and its non-clinical performance testing.

However, I can extract the closest analogous information available from the document regarding acceptance criteria and performance for this non-AI/ML device:

1. A table of acceptance criteria and the reported device performance

The document provides a "Summary of non-clinical testing" with "Items" (which can be interpreted as the performance characteristics for which acceptance was sought) and "Results" (the performance shown). While explicit "acceptance criteria" values (e.g., "must be > X N Force") are not always stated, the "Results" implicitly demonstrate acceptance where they state "No failures observed", "Meet the requirement", or "Compared with equivalent devices, there was no statistical difference."

Biocompatibility Testing:

2. Sample sizes used for the test set and the data provenance

• Test Set Sample Sizes: For key functional tests like "Safety self-locking," "Safety plug pullout," "Shooting performance," and "Accidental access to sharp once in safe mode," a test run of 500 devices was used, with "no failures observed." For other physical property and material tests, specific sample sizes are not explicitly stated, but are implied to be sufficient for meeting the standard/requirement (e.g., "All models have been tested within tolerances").
• Data Provenance: The tests are "bench testing" and "biocompatibility evaluations" conducted by the manufacturer, SteriLance Medical (Suzhou) Inc., based in Suzhou, Jiangsu, P.R.China. The data is prospective, generated specifically for this 510(k) submission.

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

This is not applicable as this is not an AI/ML device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for this device's performance is established by direct measurement of physical properties (e.g., dimensions, forces) and standard laboratory tests (e.g., material analysis, sterility, biocompatibility).

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI/ML ground truth establishment where human readers might disagree. For bench testing of a physical device, results are typically objective measurements or pass/fail outcomes against defined specifications.

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

This is not applicable as this is a physical medical device, not an AI/ML-based diagnostic or assistive technology. No MRMC study was performed.

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

This is not applicable as this is a physical medical device, not an AI/ML algorithm.

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

As explained, for this physical device, the "ground truth" for performance is established by:

• Direct physical measurements (e.g., dimensions, force values).
• Standardized analytical tests (e.g., material composition, sterility).
• Biocompatibility tests according to ISO standards.
• Pass/fail criteria based on safety and functional requirements.

8. The sample size for the training set

This is not applicable as this 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 is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set and associated ground truth establishment.

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