Search Results

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.

Ask a specific question about this device