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The subject device is indicated for: For implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.

The subject device is a fish skin medical device indicated for physical reinforcement of a soft tissue defect or weakness. The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular solid sizes: 4x7 cm, 7x10 cm, 7x20 cm. The subject device is biocompatible, non-crosslinked, and therefore resorbable, strong, flexible, and supports fixation.

The provided document is a 510(k) summary for a medical device called "Kerecis Reconstruct," which is a surgical mesh. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical effectiveness studies with explicit acceptance criteria for performance metrics like sensitivity, specificity, or reader improvement. Therefore, the information requested in the prompt, which is typical for AI/ML-based diagnostic devices, is not directly available in this document for the Kerecis Reconstruct device.

However, I can extract the information that is present, particularly regarding the studies and comparisons performed to demonstrate substantial equivalence, which serves a similar purpose to meeting "acceptance criteria" in the context of a 510(k) submission for this type of device.

Here's an analysis based on the provided text, structured to address your points where possible, and noting where the information is not applicable or not provided.

Device: Kerecis Reconstruct (Surgical Mesh)

1. Table of Acceptance Criteria and Reported Device Performance

For a surgical mesh, the "acceptance criteria" for 510(k) clearance are primarily focused on demonstrating that the new device is as safe and effective as a predicate device, based on similar technological characteristics and performance. Formal quantitative performance metrics (like sensitivity/specificity for AI, or specific effect sizes for human reader improvement) are not typically applicable or reported for this type of device in a 510(k) summary in the same way they would be for an AI diagnostic algorithm.

Instead, the "acceptance criteria" implicitly relate to meeting similar material properties, functional performance (e.g., tensile strength, suturability), and biocompatibility as the predicate device. The "reported device performance" is demonstrated through bench testing and animal studies, showing equivalence.

• Veterinarian's assessment of animal health (safety) was equivalent.
• Pathologist's assessment of tissue response (safety and efficacy) was equivalent. |
  | Material Properties: Similar physical and mechanical properties to predicate (e.g., non-crosslinked, resorbable, strong, flexible). | Described as biocompatible, non-crosslinked, resorbable, strong, and flexible. Derived from cod fish skin (similar to predicate being porcine). |
  | Mechanical Performance: Equivalent functional characteristics (e.g., tensile strength, suturability, stiffness, hydration). | Bench testing (tensile strength, suturability, hydration time, thickness, weight, stiffness/bend test, microscopic structure) performed on hydrated, sterile, ready-for-market devices confirmed performance as expected.
• Specific quantitative values for these tests are not provided in the summary.
• In-vitro performance data tensile strength testing of the test and control explants side-by-side (efficacy) showed equivalence. |
  | Intended Use Compatibility: Works for reinforcing soft tissue in plastic/reconstructive surgery. | Predicate device's intended use is identical: "to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery." Subject device claims identical intended use. |
  | Sterility & Shelf Life: Meets established standards. | Sterilization Method: Ethylene Oxide (identical to predicate/references).
  Shelf-Life: 3 years. Predicate was 1.5 years, but reference devices were 3 years. This seems to be accepted. |

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

• Test Set Sample Size: Not explicitly stated numerically for the bench testing. The animal study involved at least one "test device" (Kerecis Reconstruct) and a "control device," but the number of animals/samples is not specified in this summary.
• Data Provenance:
  • Bench testing: Performed internally or by a testing laboratory as part of the submission per FDA guidance.
  • Animal testing: Performed in a "GLP laboratory" (Good Laboratory Practice). The origin (country/retrospective/prospective) is not specified, but GLP implies a prospective, controlled study.

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

This information is not applicable in the context of this 510(k) submission for a non-diagnostic medical device. "Ground truth" in this case is established through objective physical measurements (bench testing) and histological/veterinary assessments in the animal model. The animal study mentions a "veterinarian's assessment" and a "pathologist's assessment," but the number and specific qualifications (beyond "veterinarian" and "pathologist") are not provided.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers/interpreters needing adjudication. The evaluation relies on objective physical/mechanical tests and expert animal health and pathology assessments.

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 surgical mesh, not an AI diagnostic tool or an imaging product that would involve human readers or AI assistance.

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

Not applicable. This device is a surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

• For bench testing: Established by validated testing methods against industry standards or direct comparison to the predicate device. This is essentially objective physical and mechanical property measurement.
• For animal study: Established by GLP-compliant veterinary examination and histopathological analysis. This can be considered a form of "pathology" ground truth for tissue response and "outcomes data" for animal health.

8. The Sample Size for the Training Set

Not applicable. This is a manufactured medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary of what the document does provide regarding the "study that proves the device meets the acceptance criteria" (i.e., demonstrates substantial equivalence):

The submission for Kerecis Reconstruct justifies substantial equivalence to the predicate device (Biodesign Plastic Surgery Matrix, K191696) and reference devices (Kerecis SecureMesh K153364, Biodesign Hernia Graft K133306) through:

• Analysis of 510(k) Substantial Equivalence Decision-Making Process: Following FDA's guidance document.
• Bench Testing: Performed according to FDA guidance "Preparation of a Premarket Notification Application for a Surgical Mesh" (1999). Tests included: tensile strength, suturability, hydration time, thickness, weight, stiffness (bend test), and microscopic structure analysis. These tests were performed on hydrated, sterile, ready-for-market devices. The summary states these tests "confirmed that the devices perform as expected under clinical conditions, and there were no negative effects on the mechanical properties."
• Animal Testing: Performed in a GLP laboratory using the subject device and a control device. The results demonstrated "equivalence in safety and efficacy" to the control device, based on:
  • Veterinarian's assessment of animal health (safety).
  • Pathologist's assessment of the tissue response to the device (safety and efficacy).
  • Histology.
  • In-vitro performance data (tensile strength testing of the test and control explants side-by-side) (efficacy).

The document concludes that the "data provided within this submission support substantial equivalence of the subject device to the predicate device with regards to intended use, technological characteristics including principles of operation, performance characteristics, and device safety."

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