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It is intended for collection of capillary blood from the heel of newborn and premature babies. The lancet has equipped with safety protection features.

Promisemed Heel Blood 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. Promisemed Heel Blood Lancet is single use, sterile, medical devices designed to be used in collecting the blood sample. Heel Blood Lancet is intended to be used by professionals. They are offered in various lengths (0.65mm, 0.85mm, 1.50mm). The heel blood lancets are sterile (EO sterilization) and non-toxic. The product is intended for prescription (Rx) only.

The provided text is a 510(k) summary for the Promisemed Heel Blood Lancet. This document primarily focuses on establishing substantial equivalence to a predicate device based on common intended use, technological characteristics, and performance testing. It does not describe an acceptance criteria table filled with specific performance metrics and reported device performance values for a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system.

The document discusses performance testing (bench testing) to verify that the subject device's performance is substantially equivalent to the predicate device in terms of critical performance characteristics. However, it lists these tests as general categories (e.g., "Material of blade," "Appearance," "Dimensions of product," "Cutting width and depth," "Safety self-locking," "Shooting performance," "Sterility," "Biocompatibility," etc.) rather than specific quantitative acceptance criteria with corresponding numerical results.

Therefore, I cannot directly extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance: The document only lists the types of tests performed, not specific quantitative criteria or results.
2. Sample sizes used for the test set and the data provenance: Not mentioned. The testing described is bench testing, not a clinical study with a "test set" in the sense of patient data.
3. Number of experts used to establish the ground truth... and their qualifications: Not applicable. This device is a mechanical lancet, not an AI or image-based diagnostic tool requiring expert ground truth establishment for a test set.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is a physical medical device, not an AI system.
6. Standalone (i.e., algorithm only without human-in-the-loop performance): Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The ground truth for this device's performance is likely based on engineering specifications and physical properties.
8. The sample size for the training set: Not applicable. This is a manufactured device; there's no "training set" in the machine learning sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes the regulatory clearance process for a physical medical device (a blood lancet) based on substantial equivalence to a predicate device, focusing on material, design, and general performance characteristics, rather than a clinical study of an AI-driven or diagnostic device.

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It is intended for collection of capillary blood from the heel of newborn and premature babies. The lancet has equipped with safety protection features.

Promisemed Heel Blood 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.

Promisemed Heel Blood Lancet is single use, sterile, medical devices designed to be used in collecting the blood sample. Heel Blood Lancet is intended to be used by professionals. They are offered in various lengths (0.65mm, 0.85mm, 1.50mm). The heel blood lancets are sterile (EO sterilization) and non-toxic. The product is intended for prescription (Rx) only.

The provided text describes a 510(k) premarket notification for a medical device called the "Promisemed Heel Blood Lancet." This document focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the information you're requesting regarding acceptance criteria, a study that proves the device meets them, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details are not explicitly present in this type of FDA submission for a Class I device seeking substantial equivalence.

Instead, the document details bench testing to show the new device performs comparably to the predicate device.

Here's a breakdown of what can be extracted and the limitations:

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

No such table is provided. The acceptance criteria for Class I devices like this are generally based on meeting recognized consensus standards and performance characteristics comparable to predicates, primarily through bench testing.

The document lists performance characteristics tested:

• Material of blade
• Appearance
• Dimensions of product
• Blade corrosion resistance
• Bond between blade and shank
• Cutting width and depth
• Safety self-locking
• Safety plug pullout
• Shooting performance
• Sterility
• Limits acidity and alkalinity
• Total heavy Metal
• Accidental access to sharp once in safe mode
• Safety mechanism activation
• Safety overriding and unlocking force after activation
• Biocompatibility (based on ISO 10993)

The "reported device performance" is broadly stated as "the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device" and that "Test results demonstrate that the subject device meets its intended use and performs as well as or better than the legally marketed predicate device." No quantitative results or comparative data are provided in this summary.

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

• Sample Size for Test Set: Not specified. For bench testing, samples are usually a specific number of units, but this detail is not included in the summary.
• Data Provenance: The tests were "bench testing performed" internally or by a contracted lab. There is no mention of geographical data provenance (e.g., country of origin) or whether it was retrospective or prospective, as these are typically considerations for clinical data, not bench tests.

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

This concept of "experts establishing ground truth" is not applicable here. Ground truth is typically established in clinical studies (e.g., for diagnostic AI where an expert's diagnosis is the truth). For a mechanical device like a lancet, the "truth" is whether it functions according to its specifications and relevant standards. This is evaluated through engineering and quality control tests, not by expert consensus on clinical findings.

4. Adjudication method for the test set:

Not applicable, as it's not a clinical study involving human interpretation.

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:

Not applicable. This device is a manual surgical instrument (a lancet), not an AI-powered diagnostic tool requiring human-in-the-loop studies.

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

Not applicable, as it's not an AI algorithm.

7. The type of ground truth used:

The "ground truth" for this device would be its adherence to engineering specifications, performance standards, and regulatory requirements (e.g., sterility, precise dimensions, safety features functioning as intended). This is verified through objective measurements and validated test methods (bench testing).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/machine learning device.

In summary:

This 510(k) summary focuses on demonstrating that the Promisemed Heel Blood Lancet is substantially equivalent to a predicate device (K130132 BabyLance Heel Incision Device) based on shared technology, intended use, and materials, validated by bench testing for critical performance characteristics and biocompatibility. It does not present clinical trial data or performance metrics in the way one would for a novel diagnostic or AI-powered device.

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