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The On Call® Lancing Device is used with On Call® disposable sterile lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for blood glucose testing or other testing utilizing small amounts of blood. The On Call® Lancing Device is intended to be used by a single patient and should not be shared.

The On Call "Lancing Device is a mechanical device holding and firing the lancet for collecting capillary whole blood sampled from the fingertip, palm, and forearm in conjunction with On Call® Chosen Blood Glucose Monitoring System for testing glucose in blood.

The provided text describes a lancing device and its comparison to a predicate device, focusing on substantial equivalence for regulatory purposes. It reports on laboratory testing for disinfection efficacy but does NOT contain specific acceptance criteria or a study proving the device meets those criteria in terms of clinical performance or accuracy for drawing blood samples.

Therefore, most of the requested information cannot be extracted directly from the provided document.

Here's what can be extracted and what cannot:

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

The document does not explicitly state acceptance criteria for device performance (e.g., depth of puncture, amount of blood drawn, pain level). It primarily focuses on the physical specifications of the device and its virucidal efficacy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Virucidal Efficacy Validation Testing: The document states this testing was performed in a "Laboratory." It does not specify the sample size (e.g., number of lancing devices tested), country of origin, or if it was retrospective or prospective. It only mentions "all components listed above from the Lancing Device."
• Clinical Tests: The document states: "Discussion of Clinical Tests Performed: On Call® lancing device is a class I device exempt. On Call® Chosen Blood Glucose Monitoring system clinical tests report please refers to K111371." This means clinical tests for the lancing device itself were not performed for this submission; rather, it refers to a separate submission for the companion glucose monitoring system (K111371) for broader clinical context, not specifically for the lancing device's blood drawing performance. Therefore, no sample size or data provenance details for clinical performance of the lancing device are available in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document does not describe a study involving expert assessment or ground truth establishment for clinical performance of the lancing device. The virucidal efficacy testing would have been conducted by laboratory personnel according to established protocols, but no expert "ground truth" establishment in the sense of clinical interpretation is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical study requiring adjudication is described for the lancing device's performance.

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

Not applicable. This device is a mechanical lancing device, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a mechanical lancing device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Virucidal Efficacy Validation Testing: The "ground truth" for this test would be the successful inactivation of the specified virus (duck Hepatitis B as a surrogate for human Hepatitis B) as confirmed by laboratory assays.
• Clinical Performance: No ground truth for clinical performance (e.g., successful blood draw, adequate blood volume, pain assessment) is directly addressed for the lancing device in this document, as it refers to a separate submission for the glucose monitoring system.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it's a mechanical device, not a machine learning algorithm.

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

Not applicable. This device does not involve a training set.

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