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The RapiSeal Patch is intended to provide a temporary matrix during the natural tissue repair process, resulting in the additional benefit of hemostatic tamponade.

The Patch is a bioresorbable film containing gelatin. Each Patch is supplied sterile and non-pyrogenic in a single-use package.

This document describes the RapiSeal™ Patch, a surgical patch intended to provide a temporary matrix and hemostatic tamponade.

Here's an analysis of the acceptance criteria and supporting studies as presented in the document:

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

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding performance metrics. However, we can infer the desired performance characteristics (effectiveness and biocompatibility) and extract the reported findings from the "Performance Data" section.

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

• Nonclinical Effectiveness (Splenic Injury Study):
  • Sample Size: 12 pigs (6 untreated control animals, 6 Patch treated animals).
  • Data Provenance: Not explicitly stated, but likely prospective animal study conducted in a controlled lab environment. The country of origin is not specified.
• Clinical Effectiveness (Air Leaks - Lung Study):
  • Sample Size: 48 patients.
  • Data Provenance: "pre-commercial phase of the product." This indicates a prospective human clinical evaluation. The country of origin is not specified.

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

• Nonclinical Effectiveness (Splenic Injury Study): The document mentions "Gross and histological examination." This implies evaluation by experts, likely veterinary pathologists or similar. However, the exact number of experts and their specific qualifications (e.g., years of experience) are not specified.
• Clinical Effectiveness (Air Leaks - Lung Study): The document states "no Patch-related complications were reported" and the study "demonstrated that the Patch was capable of successfully reducing or sealing air leaks intraoperatively." This suggests clinical observation and assessment by surgeons or other medical professionals involved in the procedures. The number and qualifications of these experts are not specified.

4. Adjudication method for the test set

• Nonclinical Effectiveness (Splenic Injury Study): The document does not describe an explicit adjudication method (e.g., 2+1). Assessment was likely based on the findings of gross and histological examinations, presumably by a single or a team of pathologists without a formal adjudication process described for discordance.
• Clinical Effectiveness (Air Leaks - Lung Study): No specific adjudication method is described. Clinical observations and outcomes were reported.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a physical surgical patch, not an AI-powered diagnostic or assistive technology for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

Not Applicable. The RapiSeal™ Patch is a medical device, not an algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept for this product.

7. The type of ground truth used

• Nonclinical Effectiveness (Splenic Injury Study): The ground truth for effectiveness was established through direct surgical observation of bleeding cessation and wound approximation, followed by histopathology (gross and histological examination) at specific time points.
• Clinical Effectiveness (Air Leaks - Lung Study): The ground truth for effectiveness was established through intraoperative clinical observation of the reduction or sealing of air leaks and the absence of reported Patch-related complications.

8. The sample size for the training set

Not Applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The development of the device likely involved iterative design, testing, and refinement, but this is not analogous to a training set for an algorithm.

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

Not Applicable. (See point 8). The "ground truth" for the device's design and manufacturing would be based on established engineering principles, material science, and pre-clinical physiological understanding.

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