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The SIS Inguinal Hernia Repair Graft is intended for implantation to reinforce soft tissues where weakness exists, including the repair of inguinal hernias. The graft is supplied sterile and is intended for one-time use.

The SIS Inguinal Hernia Repair Graft is a flat sheet constructed of an animal sourced bioabsorbable, extracellular matrix collagen membrane derived from porcine Small Intestinal Submucosa, (SIS). It is intended for soft tissue repair with sizes and shapes appropriate for the repair of inguinal hernias. SIS Inguinal Hernia Repair Graft contains collagens I, III, IV and VI. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.

The provided document describes the Cook Biotech Incorporated's SIS Inguinal Hernia Repair Graft (K142887) and its substantial equivalence to predicate devices, supported by biocompatibility, mechanical, and clinical testing. The document does not describe the conventional acceptance criteria and device performance in the way typically seen for AI/ML-enabled devices, but rather focuses on demonstrating the device's safety and effectiveness compared to existing market devices.

However, I can extract the relevant performance data from the clinical studies to present it in a similar structure:

1. Table of "Acceptance Criteria" (represented by clinical outcomes) and Reported Device Performance:

Since this is a traditional medical device (surgical mesh) and not an AI/ML device, the concept of "acceptance criteria" is not defined as specific performance metrics and thresholds like sensitivity/specificity for a diagnostic AI. Instead, substantial equivalence is established through demonstrating that the device is as safe and effective as predicate devices, often using clinical outcomes like recurrence rates and adverse events. Below, I've summarized the key clinical outcomes from the provided studies.

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

• US Randomized Clinical Trial (Bochicchio GV, et al., 2014):

  • Sample Size: 95 male patients (45 SIHRG, 50 Polypropylene). Originally 100 randomized, but 5 in SIHM group withdrawn.
  • Data Provenance: United States (one center, Baltimore VA hospital).
  • Retrospective/Prospective: Prospective (randomized double-blinded trial).

• OUS Randomized Clinical Investigation 1 (Puccio F, et al., 2005):

  • Sample Size: 45 patients (randomized into Polypropylene, Polyglactin, and SIHRG groups, specific breakdown for SIHRG not explicitly stated, but outcomes for SIHRG are reported).
  • Data Provenance: Outside US (1 OUS Center).
  • Retrospective/Prospective: Prospective (randomized clinical investigation).

• OUS Randomized Clinical Investigation 2 (Ansaloni L, et al., 2009):

  • Sample Size: 70 patients (randomized to Polypropylene or SIHRG).
  • Data Provenance: Outside US (1 OUS Center).
  • Retrospective/Prospective: Prospective (randomized controlled trial).

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

• For surgical mesh devices, "ground truth" for clinical outcomes (like recurrence) is established through medical diagnosis during patient follow-up, which involves surgeons, physicians, and possibly imaging specialists evaluating patients post-surgery.
• Bochicchio GV, et al. (US Study): "7 investigators including 4 surgeons." The qualifications of these specific surgeons (e.g., years of experience, subspecialty) are not detailed beyond their role.
• Puccio F, et al. (OUS Study 1): "5 investigators." No specific qualifications provided.
• Ansaloni L, et al. (OUS Study 2): "2 investigators." No specific qualifications provided.

4. Adjudication Method:

The document does not explicitly state an "adjudication method" in the context of resolving discrepancies in diagnoses, as would be common for image-based AI studies. Instead, clinical outcomes (recurrence, pain, adverse events) were recorded by investigators as part of the study protocol. The double-blinded nature of the US study (Bochicchio et al.) for a year could imply a degree of objective assessment, but details on how conflicting diagnoses of recurrence were handled are not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic systems, particularly AI-enabled ones, where multiple readers interpret cases with and without AI assistance. The studies presented here are clinical trials comparing a medical device (surgical mesh) with a comparator (another mesh) for treatment effectiveness and safety outcomes in patients.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. The device is a surgical implant (mesh), not an algorithm or diagnostic software. Therefore, there is no "standalone performance" in the context of AI. The performance is the device's clinical outcome when implanted in patients by surgeons.

7. The Type of Ground Truth Used:

The ground truth for the clinical outcomes (e.g., hernia recurrence, pain, adverse events) was established by clinical assessment and follow-up data from the patients in the respective studies. This includes:

• Physical examination by clinicians.
• Patient-reported outcomes (e.g., pain surveys).
• Diagnostic imaging (e.g., ultrasound in Puccio F, et al. study for prosthesis visibility).
• Medical records and direct observation of adverse events.

8. The Sample Size for the Training Set:

• Not applicable for a traditional medical device. The SIS Inguinal Hernia Repair Graft is a physical implant, not an AI/ML model that requires a training set. Its development and testing involve engineering, biocompatibility, and clinical studies, rather than machine learning training.

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

• Not applicable. As stated above, this is not an AI/ML device, so there is no training set or ground truth in that context.

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