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The PeriBeam® Pericardial Membrane is indicated for the reconstruction or repair of the pericardium.

PeriBeam® is an ion-irradiated, expanded polytetrafluoroethylene (ePTFE) membrane used for reconstruction or repair of the pericardium. This device is intended for use as a temporary or permanent prosthesis for repair of pericardium

The provided FDA 510(k) clearance letter for the PeriBeam® Pericardial Membrane does not contain the detailed acceptance criteria and study results typically required to fully answer your request.

The document primarily focuses on the regulatory clearance process, device description, indications for use, and a general overview of the performance, animal, and biological/toxicological safety testing conducted. It does not provide the specific quantitative acceptance criteria or the reported performance data against those criteria. It also doesn't present an MRMC study or details on ground truth establishment for a standalone algorithm performance test, as this type of device (a physical membrane) would not involve AI or image analysis.

Therefore, I cannot create a table of acceptance criteria and reported device performance, nor can I elaborate on sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, or training set details as these are not relevant for the type of device described.

However, I can extract the information that is present:

Summary of Information Available in the Provided Text:

Device Type: The PeriBeam® Pericardial Membrane is a physical medical device (an ion-irradiated, expanded polytetrafluoroethylene (ePTFE) implant) for reconstruction or repair of the pericardium. It is not an AI algorithm, diagnostic imaging software, or a device that would typically involve acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC) or human reader performance.

Therefore, questions pertaining to AI/software performance (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone algorithm performance," "number of experts for ground truth," "adjudication method," "sample size for training set," "how ground truth for training set was established") are not applicable to this device.

The "Performance Testing" section describes types of tests conducted, but not the acceptance criteria or specific results.

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Available in the provided text. The document lists types of performance tests (Tensile Strength, Suture Strength, Accelerated Fatigue, Fibrin Glue, Burst Strength) but does not provide the specific quantitative acceptance criteria for each or the measured performance values.

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

• Nonclinical Performance Testing: The specific sample sizes for tests like Tensile Strength, Suture Strength, Fibrin Glue, and Burst Strength are not explicitly stated, although ISO 2859-1 (Sampling procedures for inspection by attributes) is referenced. This standard relates to sampling plans for quality control, not necessarily the sample size of unique test cases (e.g., patient data).
• Animal Study:
  • Sample Size: "Ten (10) pigs divided into three (3) groups for eight (8) weeks."
  • Data Provenance: Not explicitly stated (e.g., country of origin), assumed to be a controlled laboratory animal study (prospective).

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

• Not Applicable. This is a physical implant device, not an AI or diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for its performance relates to its physical, mechanical, and biological properties, which are assessed through laboratory tests and animal studies.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3.

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. This is a physical implant device, not a diagnostic or AI-powered device. MRMC studies are not relevant for this product.

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

• No. This is a physical implant device. Standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

• For nonclinical performance testing, the "ground truth" is established through standardized engineering and materials testing methods (e.g., ISO, JIS, ASTM standards for tensile strength, burst strength, etc.).
• For the animal study, "ground truth" was established through direct observation (health condition, feeding, respiration, feces), weight measurement, ultrasonography, macroscopic observations at autopsy (adhesions, effusions, infection, discharge), and histopathology (cellular infiltration, fibroblast amount, fibrosis, bacteria). These are direct biological and pathological assessments.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical device, not an AI model that requires a training set.

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

• Not Applicable. See point 8.

In conclusion, while the document provides evidence of various tests performed, it does not include the detailed quantitative acceptance criteria and the corresponding measured performance data within the provided sections. The nature of the device (a physical pericardial membrane) means that many of the AI/software-related questions are not applicable.

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