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Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

Medipoint Blood Lancets are single-use only and are discarded into a sharps container immediately after use.

The Medipoint Blood Lancet is constructed from a single piece of stainless steel with a sharp, beveled tip for piercing the skin and a knurled grip for maintaining a secure grip on the lancet. Each Medipoint Blood Lancet is individually packaged in a paper package and sterilized in the package via a validated moist heat sterilization process.

The provided document is a 510(k) summary for the Medipoint Blood Lancets. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria in the same way a new device with novel claims would. The "acceptance criteria" here implicitly refer to the performance and safety characteristics established by the predicate devices and relevant standards.

However, I can extract the information related to the device's performance based on the non-clinical testing sections to address your questions as best as possible within the context of this document.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary, the "acceptance criteria" are implied by the performance of the predicate devices and relevant standards (e.g., ISO 10993 for biocompatibility, and expectations for a blood lancet's physical integrity). The study aims to show the subject device performs equivalently.

Study Proving Device Meets Acceptance Criteria

The study described is a series of non-clinical tests performed to demonstrate that the Medipoint Blood Lancets perform equivalently to their predicate devices and meet relevant safety standards.

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

• Performance Testing (Mechanical Integrity): Not explicitly stated, but typically involves a representative sample of devices.
• Biocompatibility Testing: Not explicitly stated, but typically involves a sufficient number of samples as per ISO 10993 guidelines to perform the required tests.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. These are typically bench and lab tests conducted by the manufacturer or contracted labs.

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

• This is not applicable as the studies described are non-clinical bench tests and biocompatibility assessments, not diagnostic performance studies requiring expert interpretation or ground truth establishment in the traditional sense (e.g., imaging interpretation). The "ground truth" for these tests are objective measurements and standardized biological responses.

4. Adjudication Method for the Test Set:

• Not applicable, as these are objective non-clinical tests, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, a MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI or diagnostic tools on human reader performance, which is not relevant for a blood lancet device.

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

• Not applicable. This device is a physical blood lancet, not an algorithm or AI. The "standalone performance" here refers to the device's physical and biological performance characteristics as a medical device.

7. Type of Ground Truth Used:

• Performance Testing (Mechanical Integrity): The "ground truth" is adherence to predefined engineering specifications and the ability to withstand forces without damage, often compared against predicate device performance.
• Biocompatibility Testing: The "ground truth" is established by standard biological assays (e.g., cell viability for cytotoxicity, immune response for sensitization) and regulatory thresholds for acceptable biological reactions as defined in ISO 10993.
• Sterility: The "ground truth" is a Sterility Assurance Level (SAL) validated through a microbial challenge and sterility testing as per ISO 11135 or similar standards.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical product and does not involve AI or machine learning models that require a training set.

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

• Not applicable, as there is no training set for this device.

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