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The HumaPen and the HumaPen Ergo are two versions of a reusable pen-injector designed for use by diabetics for the self-injection of a desired dose of insulin. The peninjector uses 3.0 mL cartridges of insulin (Humalog® or Humulin®) and a single use, detachable and disposable pen needle (supplied separately). The pen-injector allows the user to dial the desired dose one unit at a time up to 60 units.

HumaPen and HumaPen Ergo are two versions of a reusable pen-injector designed for use by diabetics for the self-injection of a desired dose of insulin. The pen-injector uses 3.0 mL cartridges of insulin (Humalog® (human insulin[rDNA origin]) or Humulin® (insulin lispro injection [rDNA origin]) and a single use, detachable and disposable pen needle (supplied separately). The peninjector allows the user to dial the desired dose one unit at a time up to 60 units.

The provided document is a 510(k) summary for the HumaPen and HumaPen Ergo insulin pen-injectors. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner requested. The document does mention "Delivery accuracy meets ISO/DIS 11608-1.2 requirements" as a similarity between the new and predicate devices, which implies an acceptance criterion, but it doesn't provide the study details.

Therefore, many of the requested items cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not provide a specific study that proves the device meets these criteria. It only states that it does meet them.

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

Not provided in the 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 provided in the document, as this type of expert review is not generally applicable to the evaluation of an insulin pen's mechanical accuracy.

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

Not provided in the document.

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 is a medical device (insulin pen) and not an AI-assisted diagnostic tool for human readers.

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

This concept is not applicable to a mechanical insulin pen.

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

For delivery accuracy, the ground truth would typically be established based on precise measurements against a standard, often using specialized equipment to measure dispensed volume or mass. However, the document does not elaborate on this.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI model that requires a training set.

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

Not applicable.

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