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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 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 )

Sterilization and Shelf Life Testing:

• Irradiation sterilization validation per ISO 11173-1 and ISO 11173-3.
• Pyrogen testing per USP .
• 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

Ask a specific question about this device