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Disposable Blood Lancet is used for capillary blood sampling.

Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood sampling. The device comprises a stainless needle encapsulated with a plastic needle body and protective cap, the protective cap is twisted off to expose the needle for use. The device was sterilized by Radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.

The provided document is a 510(k) summary for the SteriLance Medical (Suzhou) Inc. Disposable Blood Lancet. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.

The document discusses:

• Regulatory classification: Class II, product code QRK/QRL (Blood Lancets)
• Device description: Single-use, sterile device for capillary blood sampling.
• Comparison to predicate device: Highlights similarities in intended use, sterilization, gauges, components, and materials, with a noted difference in exposed needle length for one model.
• Performance data: Mentions biocompatibility testing (cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity) and non-clinical bench testing (appearance, dimensions, sharpness, binding strength, double needles, empty needle, reverse needle, and compatibility with lancing device).

Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets them for an AI/ML perspective as this document describes a physical medical device (blood lancet) and not an AI/ML-driven device.

If you have a document pertaining to an AI/ML medical device, please provide it, and I will be happy to extract the relevant information.

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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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Disposable Blood Lancet is used for capillary blood collection.

Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood collection. The device comprises a stainless needle encapsulated with a plastic needle body and protective cap, the protective cap is twisted off to expose the needle for use.

The device was sterilized by Radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.

The provided text describes the regulatory clearance of a medical device, the "Disposable Blood Lancet," and details its non-clinical testing for substantial equivalence to a predicate device. It does not involve AI or algorithms, and therefore, the requested information regarding AI-specific criteria, such as MRMC studies, training/test set details, and expert adjudication, is not applicable.

Here's an analysis based on the information provided regarding the non-AI device:

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

The acceptance criteria are implicitly derived from the non-clinical tests performed to demonstrate substantial equivalence to the predicate device. The "reported device performance" is the result of these tests.

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes used for each non-clinical performance test. It only states that "bench testing performed verifies that the performance of the proposed device is substantially equivalent." For biocompatibility, it states "biocompatibility evaluations were conducted." The provenance of the data is from non-clinical lab testing conducted by the manufacturer, SteriLance Medical (Suzhou) Inc., likely in China. The nature of these tests is retrospective in the context of the 510(k) submission, as they were completed prior to the review.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the device is a physical medical device, not an AI/algorithm-driven one. Ground truth is established through standardized laboratory testing and measurement procedures defined by the relevant ISO and ASTM standards. Experts in laboratory testing and quality assurance would perform and evaluate these tests, but their qualifications are not detailed beyond their adherence to the standards.

4. Adjudication method for the test set

This question is not applicable for a non-AI physical device. The testing described involves objective measurements and standardized biological evaluations.

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

This question is not applicable as the device is a physical "Disposable Blood Lancet" and does not involve AI assistance or human readers in an interpretive capacity.

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

This question is not applicable as the device is a physical "Disposable Blood Lancet" and does not contain an algorithm.

7. The type of ground truth used

For the performance tests (e.g., appearance, dimensions, sharpness, binding strength, etc.), the "ground truth" is established by engineering specifications, design requirements, and applicable international standards (e.g., ISO 9626 for needle size). For biocompatibility, the ground truth is established by standardized biological evaluation methods and criteria outlined in ISO 10993 series.

8. The sample size for the training set

This question is not applicable as the device is a physical "Disposable Blood Lancet" and does not involve an AI training set.

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

This question is not applicable as the device is a physical "Disposable Blood Lancet" and does not involve an AI training set.

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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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