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Lancet: Lancet is intended for capillary blood sampling.
Lancing Device: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared.

Lancet: The Lancet (use with lancing device) is a single use, sterile medical device, which is designed for use of micro blood sampling puncture to obtain capillary blood samples from the fingertip. The Lancet is composed three components: needle (made of stainless steel and silicone oil), main body and protective cap (both made of PE, EVA and calcium powder). Main body and protective cap is plastic part that enclosed the needle. The Lancet is intended to be single use and the needle tip is sterilized by Radiation. The shelf-life of the product is 5 years.
Lancing Device: Along with a lancet, the lancing device is used to collect a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM and PC Resin. And the spring is made of carbon steel. The service life of lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) is no more than 3000 times or 3 years. The service life of lancing device (HH-XVII-T) is no more than 5000 times or 5 years. The Lancing Device is provided non-sterile.

The provided text describes the non-clinical testing performed to demonstrate that the proposed Lancet and Lancing devices meet acceptance criteria.

Here's the breakdown of the information requested:

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

Biocompatibility Testing:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

For the simulated clinical use study, 500 device samples each for the Lancet and Lancing Device were used. The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature, but it is a "simulated clinical use study," implying it was conducted as part of the device's development/testing process. The manufacturer is Tianjin Huahong Technology Co., Ltd. in Tianjin, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The studies described are non-clinical bench testing and simulated clinical use for safety mechanisms, which typically do not involve expert-established ground truth in the same way imaging or diagnostic algorithms would.

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

This information is not applicable/not provided for the types of non-clinical bench tests and simulated clinical use study described. Adjudication methods are more pertinent to studies involving human interpretation or subjective assessments.

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

No MRMC comparative effectiveness study was done. The submission explicitely states: "No clinical study is included in this submission." The device being described is a physical medical device (lancet and lancing device), not an AI-powered diagnostic or interpretive system that would typically undergo an MRMC study.

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

Not applicable. This device is a physical medical device (lancet and lancing device), not an algorithm or AI system.

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

For the non-clinical tests (appearance, dimension, needle diameter, cleanness, firmness, corrosion resistance, acidity/alkalinity, extractable metals, puncture force, lubricant, matching) and biocompatibility tests, the "ground truth" is defined by the pre-established physical, chemical, and biological requirements and standards (e.g., drawings, ISO standards, specific chemical limits). For the simulated clinical use, the ground truth is whether the device "met the pre-established criteria" for its safety mechanism, as evaluated against FDA guidance and ISO 23908.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI or algorithm that requires a training set.

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

Not applicable. No training set was used as this is not an AI/algorithm device.

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