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Lancet: The 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. (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII- T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T)
The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T)

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, main body and protective cap. 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 obtain a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM, PC and PS Resin. And the spring is made of carbon steel. The service life of the Lancing Device is 5 years or 5000 times of normal use, whichever comes first. For Model HH-XIII-T, the service life of the Lancing Device is 10 years or 5000 times of normal use, whichever comes first. The Lancing Device is provided non-sterile.

The provided text is a 510(k) summary for a medical device (Lancet and Lancing Device). This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than extensive clinical studies or AI/software performance evaluations. Therefore, many of the requested details related to "AI performance," "expert ground truth," "MRMC studies," and "training sets" are not applicable to this document.

However, I can extract the relevant acceptance criteria and study information provided for this medical device based on the document's content.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of quantitative acceptance criteria and corresponding performance metrics for the device in the format common for AI/software devices. Instead, it generally states that the device "met the performance criteria outlined" and that "all verification and validation tests passed without deviations." The performance evaluation for this device category (lancets and lancing devices) would typically involve mechanical, sterilization, biocompatibility, and functional tests.

Here's an interpretation of the implied acceptance criteria and reported performance based on the "Non-Clinical Testing" section:

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

• Test Set Sample Size: For the Simulated Clinical Use study, 640 device samples were used for both the Lancet and the Lancing Device. Other performance and biocompatibility tests would have their own sample sizes, but these are not explicitly stated in this summary for each specific test (e.g., mechanical tests, needle integrity, etc.).
• Data Provenance: The studies were conducted by Tianjin Huahong Technology Co., Ltd. (China). The data origin is thus China. The studies described are prospective tests performed on the new device, not retrospective data analysis.

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

Not applicable. This device is a mechanical medical device, not an AI/software device that requires expert radiological or clinical interpretation to establish ground truth for performance evaluation in the way AI algorithms do. The "ground truth" for this device's acceptance is based on engineering specifications, physical measurements, biological safety tests (biocompatibility), and functional performance tests against established standards.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/software performance study relying on human interpretation, there is no "adjudication" in the sense of reconciling expert opinions. Performance is assessed against quantitative engineering specifications and standard test methods.

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 document is for a mechanical medical device (lancet and lancing device), not an Artificial Intelligence (AI) or software device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant or discussed.

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

Not applicable. This is not an algorithmic device. Performance is evaluated through physical and functional testing of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for showing the device meets acceptance criteria is based on:

• Engineering Specifications/Standards: Performance criteria outlined in internal specifications and relevant international standards (e.g., ISO 23908 for sharps injury prevention, ISO 10993-1 for biocompatibility).
• Physical Measurements: E.g., needle length range, gauge range.
• Functional Testing: Demonstrating the device performs its intended action (capillary blood sampling, proper retraction).
• Biocompatibility Testing: Laboratory results confirming non-toxicity and safety of materials.
• Safety Mechanism Testing: Verification that sharps injury prevention features work as intended.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.

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

Not applicable. As there is no training set, there is no ground truth establishment for a training set.

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It is intended for capillary blood sampling.

The propose device, Lancet, which is intended for capillary blood sampling. The safety protection mechanism is to prevent the reuse of products and protection against needle stick injury. The proposed devices are provided sterile, single use. The proposed devices are divided into several models. In addition, the proposed devices are available in different specifications of needle gauge (21G, 28G and 30G) to allow to collect capillary blood sample.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests. The "acceptance criteria" are generally implied to be compliance with relevant international standards and FDA guidance, as well as performance comparable to the predicate device. Specific numerical acceptance criteria are not explicitly stated for all tests, but rather the outcome of "met the requirements" or "complies with."

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

• Simulated Clinical Use: 600 device samples.
• Biocompatibility and Bench Tests: Specific sample sizes for individual tests are not detailed beyond "the lancet" or "the proposed device."
• Data Provenance: The document does not specify the country of origin of the data for these studies. The studies are non-clinical (laboratory/bench) and simulated clinical use, not clinical trials on human subjects. They are prospective tests conducted for the purpose of this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not applicable. This submission describes a medical device (Lancet) and its performance under various non-clinical and simulated clinical conditions. The "ground truth" for these tests relates to objective measurements, standard compliance, and device functionality, not expert interpretation of clinical data. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is not relevant here.

4. Adjudication Method for the Test Set:

• Not applicable. As the tests are objective measurements and compliance assessments (e.g., dimensions, force, cytotoxicity), there is no mention or need for an adjudication method like 2+1 or 3+1. The results are directly measured against predefined standards or specifications.

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

• No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret cases. This document pertains to a blood lancet, and no such study was conducted or is relevant for its substantial equivalence claim.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device is a manual blood lancet, a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

• Objective Test Results and Compliance with International Standards/Guidance: The "ground truth" for the performance tests consists of objective measurements (e.g., dimension records, force measurements, chemical analysis results) and direct compliance with the requirements outlined in recognized international standards (ISO 7864, ISO 9626, ISO 10993 series, ISO 23908, ASTM F756-17, ASTM D4169-16, USP , USP-NF, USP-NF) and FDA guidance documents.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

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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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