(116 days)
The COOK® Urological Graft is for implantation to reinforce soft tissues where weakness exists in the urological anatomy, including temporary wound or solid organ support in the kidney. The Urological Graft is supplied sterile and intended for one-time use.
The COOK® Urological Graft is a bioabsorbable, extracellular collagen matrix that is identical to the predicates SURGIS Mesh (K980431) and SURGISIS® Sling (K992159), also manufactured by COOK Biotech Incorporated, and to Vicryl Mesh bag (K051701), manufactured by Ethicon. The device is manufactured from porcine small intestinal submucosa (SIS), packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.
The provided text describes a 510(k) submission for the COOK® Urological Graft and does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically found for AI/ML medical devices (e.g., performance metrics like sensitivity, specificity, AUC).
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the cornerstone of the 510(k) pathway. The study mentioned refers to the type of testing performed to prove this equivalence, rather than a performance study against specific acceptance criteria for a novel AI/ML algorithm.
Therefore, the requested information cannot be fully provided as the context is different from what the prompt anticipates for AI/ML device studies.
However, I can extract what is relevant to the prompt, even if it's not a direct match to the AI/ML framework:
1. A table of acceptance criteria and the reported device performance
This document does not define specific "acceptance criteria" in terms of quantitative performance metrics (like sensitivity, specificity, or AUC) that an AI/ML model would need to meet. For a 510(k) submission of a traditional medical device like the COOK® Urological Graft, the primary "acceptance criterion" is substantial equivalence to predicate devices.
Reported Device Performance (as it relates to substantial equivalence):
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence to Predicate Devices | The COOK® Urological Graft is similar with respect to intended use, and identical with respect to materials and technological characteristics to the predicate devices (SURGIS Mesh (K980431), SURGISIS® Sling (K992159), and Vicryl Mesh bag (K051701)). Demonstrated through "bench, animal, biocompatibility and clinical testing." |
| Intended Use Equivalence | "for implantation to reinforce soft tissues where weakness exists in the urological anatomy, including temporary wound or solid organ support in the kidney." This matches the general intended use of surgical meshes and slings. |
| Materials and Technological Characteristics Equivalence | "bioabsorbable, extracellular collagen matrix... manufactured from porcine small intestinal submucosa (SIS), packaged in a lyophilized (dried) state and supplied sterile." This is stated to be "identical" to the predicates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench, animal, biocompatibility and clinical testing" to establish equivalence. However, it does not provide details on:
- The specific sample sizes used for these tests.
- The data provenance (e.g., country of origin, retrospective/prospective nature) for any clinical data.
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)
This is not applicable as the device is a physical surgical graft, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth on a test set. The "ground truth" for demonstrating equivalence would be derived from the performance and characteristics of the predicate devices and the results of the specific engineering, animal, and clinical tests performed on the COOK® Urological Graft itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical medical device submission demonstrating substantial equivalence. Adjudication methods are typically relevant for human interpretation or AI/ML output assessment where discrepancies might arise.
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 graft, not an AI-assisted diagnostic tool, so MRMC studies or human reader improvement with AI are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical surgical graft, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for demonstrating substantial equivalence would be based on:
- Material properties data: Bench testing results on tensile strength, bioabsorption rates, pore size, etc.
- Biocompatibility data: Standardized tests for cytotoxicity, sensitization, irritation, etc., according to ISO standards.
- Animal study data: In vivo performance in terms of tissue integration, host response, strength, and degradation over time.
- Clinical safety and performance data (if collected): Surgical outcomes, adverse event rates, and efficacy in repairing or reinforcing tissues, compared to predicates. This data would be against established clinical endpoints and observations from healthcare professionals and patient outcomes.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that uses a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no training set or ground truth in that context.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.