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The product is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The lancet is intended to be assembled with a lancing device, such that once the lancing device is launched, the needle of the 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 18G; 21G; 23G; 26G; 28G; 30G; 32G; 33G. Disposable Blood Lancets are used to collect blood samples for hospital clinic test. It is sterilized by Irradiation and is a single-use product.

The provided document (K220387 510(k) summary for Disposable Blood Lancets) details acceptance criteria and the results of a study to demonstrate substantial equivalence to a predicate device, rather than a study proving significant improvement over human readers or standalone performance. The document focuses on performance testing against defined specifications for the device itself.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

In addition to these direct performance tests, biocompatibility, sterilization validation, and shelf life testing were also performed, with implied "Pass" results for substantial equivalence:

Biocompatibility Testing (Evaluated in accordance with ISO 10993-1:2018):

• Cytotoxic test (ISO 10993-5:2009)
• Skin sensitization test (ISO 10993-10:2010)
• Intracutaneous test (ISO 10993-10:2010)
• Acute systemic toxicity test (ISO 10993-11:2017)
• Hemolysis test (ISO 10993-4:2017)
• Pyrogen Test (USP <151>)

Sterilization and Shelf Life Testing:

• Irradiation sterilization validation per ISO 11173-1 and ISO 11173-3.
• Pyrogen testing per USP <151>.
• Simulated shipping per ASTM D4169.
• Stability study (including aging test) for a 5-year shelf life.

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 test (e.g., how many lancets were tested for sharpness or appearance). It only reports "Pass" for each criterion.

The data provenance is from non-clinical testing performed by the manufacturer, Suzhou Kyuan Medical Apparatus Co., Ltd., in China. The study is a retrospective evaluation of the device's adherence to established performance and safety standards, typical for a 510(k) submission.

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

This type of information is not applicable to the provided document. The "ground truth" for this device's performance is based on objective, quantifiable engineering and biological test standards (e.g., penetration force of 1.00N, bioburden < 100CFU/g, ISO and USP standards). Experts would be involved in designing and conducting these tests, but not in establishing a subjective "ground truth" through consensus, as might be the case for image interpretation AI.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in studies involving subjective human interpretations (e.g., radiology reads) to establish a consensus ground truth. For the objective performance tests of a blood lancet, the results are typically binary (Pass/Fail) against a defined specification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study would compare human performance with and without AI assistance, which is irrelevant for a physical medical device like a blood lancet. The study focuses on the device's intrinsic physical and biological properties.

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

Not applicable. This question pertains to AI/algorithm performance. The device is a physical blood lancet, not an algorithm. The "standalone performance" here refers to the device's ability to meet its specifications independently, which is what the non-clinical testing demonstrated.

7. The Type of Ground Truth Used

The "ground truth" for the Disposable Blood Lancets is established by:

• Engineering specifications: Quantifiable physical parameters (e.g., launch length, penetration force, connection firmness).
• Biological/Chemical standards: Bioburden levels, sterility test results, biocompatibility test results (cytotoxicity, sensitization, etc.) as defined by international standards (ISO, ASTM) and pharmacopeial standards (USP).
• Regulatory compliance: Adherence to predicate device characteristics and general safety/effectiveness principles as required for 510(k) clearance.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" applies to machine learning or AI models. This submission is for a physical medical device, not an AI product. The assessment is based on physical and biological testing of the manufactured device.

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

Not applicable. As a physical medical device, there is no "training set" or corresponding ground truth established in the context of machine learning. The device's design and manufacturing process are validated against established engineering and biological standards.

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