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The product is used to obtain capillary blood samples from fingertip in a home. The lancet is assembled with lancing device, once the lancing device is launched, the needle of lancet can prick the skin.

The Disposable Blood Lancets consists of a needle, a body and a cap. The models of the Disposable Blood Lancets are 21G; 23G; 26G; 30G. Disposable Blood Lancets are used to obtain blood samples for testing purposes. It is sterilized by Irradiation and is a single-use product. The device is compatible with the reusable lancing device which met the specification and size requirements of the following figure in the market.

The document provided is a 510(k) summary for a medical device called "Disposable Blood Lancets". It outlines the device's technical characteristics and compares them to a predicate device to establish substantial equivalence.

Based on the provided text, the device is a medical lancet and not an AI/ML powered device. Therefore, a study proving the device meets acceptance criteria related to AI/ML performance (such as MRMC studies, standalone algorithm performance, ground truth establishment methods for AI, or training set sizes) would not be applicable and is not present in this document.

However, I can extract information regarding the acceptance criteria and the studies performed to demonstrate the device's physical performance, biocompatibility, and sterilization for this specific medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., how many lancets were tested for sharpness, bioburden, etc.). It generally states that "The following performance data were provided in support of the substantial equivalence determination."

The data provenance is not specified in terms of country of origin of the data or whether it was retrospective or prospective. It is implied to be internal testing conducted by the manufacturer, Huaian Hening Medical Instruments Co., Ltd.

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

Not applicable for this type of medical device's performance testing. The "ground truth" for these tests is based on objective, measurable physical and biological parameters defined by established standards and internal specifications, not expert consensus on interpretations.

4. Adjudication Method

Not applicable. The tests are objective measurements against predefined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML powered device, so MRMC studies are not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance tests outlined in the table consists of objective physical and biological measurements against predefined specifications and established international standards (e.g., ISO for biocompatibility and sterilization). This is not expert consensus, pathology, or outcomes data in the context of an AI/ML diagnostic device.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model.

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

Not applicable. This is a physical device, not an AI/ML model.

Additional Information on Studies Conducted:

The document also details other non-clinical tests performed:

• Biocompatibility Testing: Evaluated in accordance with ISO 10993-1:2018 for the body contact category. Specific tests performed include:
  • Cytotoxic test (ISO 10993-5:2009)
  • Skin sensitization test (ISO 10993-23:2021)
  • Intracutaneous test (ISO 10993-10:2021)
  • Acute systemic toxicity test (ISO 10993-11:2017)
  • Hemolysis test (ISO 10993-4:2017)
  • Pyrogen Test (ISO 10993-11:2017)
• Sterilization and Shelf Life Testing:
  • Irradiation sterilization validation per ISO 11137-1 and ISO 11137-3.
  • Pyrogen testing per ISO 10993-11:2017.
  • Transportation test per ISTA 2A:2011.
  • Shelf life of 5 years determined based on stability study which includes aging test.

These studies support the substantial equivalence claim by demonstrating that the device meets safety and effectiveness requirements through validated physical, chemical, and biological testing, rather than complex AI/ML performance evaluations.

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The product is used to obtain capillary blood samples from fingertip in a home. The device contains a sharp injury protection feature.

The Disposable Safety Lancets consists 7 parts, include a trigger, plastic handle, out shell, back cover, spring, protective cap and needle. The models of the Disposable Safety Lancets are 21G; 23G; 26G; 28G; 30G. The product is used to obtain capillary blood samples from fingertip in a hospital or at home. The device contains a sharp injury feature. The lancet is hit by pressure, and once the device strikes, the lancet needle can puncture the skin. And once activated, the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. Used Gamma sterilization, and are products for single use.

The provided text describes the 510(k) summary for a medical device (Disposable Safety Lancets) and focuses on demonstrating substantial equivalence to a predicate device, rather than the acceptance criteria and study data for an AI/algorithm-driven device.

Therefore, most of the requested information regarding AI/algorithm performance (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) cannot be extracted from this document, as it pertains to a physical medical device (blood lancet) and not an AI-powered diagnostic or assistive tool.

However, I can extract the acceptance criteria and performance results for the physical device's non-clinical testing.

Here's the information that can be extracted from the document:

1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical Testing for a Physical Device)

Information that cannot be extracted from the provided text (as it's not relevant to this type of device submission):

• Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI models.
• The sample size for the training set (for AI models).
• How the ground truth for the training set was established (for AI models).

Ask a specific question about this device