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Lancing device is used with disposable blood lancet to obtain capillary blood samples.

Lancing device is used with disposable blood lancet to obtain capillary blood samples. It has multiple penetration depth levels, normally 6 or 9. Lancing device is for single patient use only.

This document describes the FDA 510(k) clearance for a lancing device (K221970). As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study that proves the device meets specific acceptance criteria in the context of an AI/ML-based medical device (which this lancing device is not).

Therefore, many of the requested elements for an AI/ML device study (like MRMC studies, effect sizes of AI assistance, expert adjudication for ground truth of an AI model, or sample sizes for training sets) are not applicable to this submission.

However, I can extract the relevant information regarding the performance data provided for this specific medical device (a lancing device) and present it in a similar structured format, adapting the questions where necessary.

Device: Lancing device (SteriLance Medical (Suzhou) Inc.)
FDA 510(k) Number: K221970
Predicate Device: ACON Laboratories, Inc., On call® Lancing device (K113332)

1. Acceptance Criteria and Reported Device Performance

For this medical device (a lancing device), the "acceptance criteria" are implied by the non-clinical bench testing conducted to demonstrate substantial equivalence to the predicate device. The performance data is reported as successful completion of these tests.

Note on Puncture Depth: The specific depth values for each gear setting (e.g., LDE model: 1-gear 0.60±0.30mm, 2-gear 0.90±0.30mm, etc.) serve as the specific functional performance criteria for this device, and the testing verified that these were met.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact number of units or repetitions for each non-clinical bench test (e.g., how many lancing devices were tested for bounce performance, or how many punctures were performed). It only lists the types of tests conducted.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This type of data typically comes from in-house lab testing, not patient data in the sense of AI/ML models.

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

• Applicability: Not applicable in the context of this device and testing. "Ground truth" in this context refers to engineering specifications, physical measurements, and standard biocompatibility test results, not expert interpretation of medical images or data.

4. Adjudication Method for the Test Set

• Applicability: Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. Test results are based on objective measurement or established lab protocols (e.g., passing ISO 10993 tests).

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

• Applicability: Not applicable. This is a physical medical device (lancing device), not an AI/ML-based diagnostic or assistive technology for human readers.

6. Standalone (Algorithm Only) Performance

• Applicability: Not applicable. This device does not contain an algorithm in the sense of AI/ML. Its performance is determined by its mechanical and material properties.

7. Type of Ground Truth Used

• Ground Truth: For biocompatibility, the ground truth is established by adherence to the FDA guidance on ISO 10993-1 and the results of standardized biological tests (Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity).
• For non-clinical bench testing, the ground truth is the device's design specifications for dimensions, performance characteristics (e.g., puncture depth tolerance), and comparison to the known performance of the predicate device.

8. Sample Size for the Training Set

• Applicability: Not applicable. This device is not an AI/ML model, so there is no "training set" in the computational sense. The device is manufactured based on design specifications and then tested.

9. How Ground Truth for the Training Set Was Established

• Applicability: Not applicable. As there is no AI/ML training set, there is no corresponding ground truth establishment process required.

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