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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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Heel Stick 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.

The heel stick safety lancet is offered in various depth size (0.65mm, 0.85mm, 1.00mm, 1.50mm) and width size (1.50 mm, 1.75mm, 2.50 mm, 2.80 mm). It consists of blade base, blade, which is welded with the blade base, spring, top head, bottom, and pushing button. The top head and bottom are intended to provide physical protection to the blade, and PET blister along with the tyvek paper cover the primary sterile barrier system for the device. The product is individually primarily packaged 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. Heel stick safety lancet is intended to be used by professionals. The product is intended for prescription (Rx) only.

This document describes the premarket notification (510(k)) for the "Heel Stick Safety Lancet (HHZ-II, HHZ-III)" and does not involve an AI or Machine Learning (ML) enabled device. Therefore, many of the typical acceptance criteria and study components requested in the prompt, such as data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and training set details, are not applicable.

The acceptance criteria provided for this device concern its physical and performance characteristics as a manual surgical instrument, not an AI model.

Here's an attempt to answer the prompt based on the provided document, highlighting where the requested information is not relevant due to the nature of the device:

Device: Heel Stick Safety Lancet (HHZ-II, HHZ-III)
Device Type: Manual Surgical Instrument For General Use (Lancet)

1. Table of Acceptance Criteria and Reported Device Performance

Biocompatibility Testing Acceptance and Results:

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

For the Simulated Clinical Use study to evaluate the safety mechanism:

• Sample Size: 600 device samples each for the HHZ-II and HHZ-III models (implicitly, 1200 samples total, though not explicitly stated as combined).
• Data Provenance: Not specified, but generally, bench testing and simulated clinical use for a medical device cleared via 510(k) are conducted by the manufacturer or their contracted laboratories to demonstrate compliance with standards. It's a prospective test of the device. Country of origin not specified for the test data, but the manufacturer is in China.

For the Non-Clinical (Bench) Testing (Appearance, Cleanness, Dimension, etc.):

• Sample Size: Not explicitly stated for each test, but standard quality control and performance testing typically involve a defined sample size from production batches.
• Data Provenance: Not specified, likely internal testing by the manufacturer.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable as the device is a manual lancet and the studies are performance/bench/biocompatibility tests, not studies involving expert adjudication of AI outputs or clinical interpretations. The "ground truth" for these tests is based on measurable physical properties and specified standards (e.g., ISO standards).

4. Adjudication Method for the Test Set

This is not applicable for the type of device and testing performed. Adjudication methods like "2+1" or "3+1" are typical for clinical studies involving human interpretation (e.g., for image reading in AI studies), not for mechanical device performance or biocompatibility testing. The "ground truth" (acceptance criteria) for the bench tests are against physical measurements and functional performance as per engineering specifications and relevant ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted image interpretation or diagnostic tools to assess the impact of AI on human reader performance. The Heel Stick Safety Lancet is a manual instrument.

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 is not an AI/algorithm-based device. The "simulated clinical use" mentioned is a physical test of the device's safety mechanism, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted on the Heel Stick Safety Lancet consisted of:

• Pre-defined engineering specifications and measurable physical properties: For criteria like appearance, cleanness, dimensions, firmness, launch performance, launch depth/width, activating force, and sharp access in safe mode.
• Compliance with international standards: Specifically, ISO 23908 for evaluating the safety mechanism and ISO 10993 series for biocompatibility.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical, manual medical device, not an AI/ML product that requires a training set.

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

This information is not applicable as there is no AI/ML training set for this device.

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