(93 days)
Cook® Biodesign® Surgisis® Anterior Pelvic Floor Graft is indicated for tissue reinforcement in women with pelvic organ prolapse, for transvaginal repair of anterior and anterior/apical vaginal vault prolapse.
Cook® Biodesign® Surgisis® Posterior Pelvic Floor Graft is indicated for tissue reinforcement in women with pelvic organ prolapse, for transvaginal repair of posterior and posterior/apical vaginal vault prolapse.
The Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts are non-synthetic, non-woven, resorbable layered sheets of natural Extracellular Matrix (ECM) collagen that are pre-configured and can be cut and further shaped by a surgeon to the desired size and shape. The grafts are manufactured from multiple layers of porcine Small Intestinal Submucosa (SIS), an acellular collagenous ECM material derived from porcine small intestine where the serosal. mucosal and muscle lavers have been removed. The collagenous material is not cross-linked and is designed to be eventually replaced by the patient's tissue. The shapes of the Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts are specifically designed to meet the clinical needs associated with the device's intended use. The Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts consist of 3 individual grafts: J-PF-ANT-USL, J-PF-ANT-SSL and J-PF-4-POST. J-PF-ANT-USL and J-PF-ANT-SSL are indicated for anterior prolapse repair and J-PF-4-POST is indicated for posterior prolapse repair. The Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts are all supplied sterile and are intended for one time use.
The provided text is a 510(k) Summary for the Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts. This document details the regulatory submission for a medical device and primarily focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the information required for a study that proves the device meets specific acceptance criteria (as would be typical for an AI/software device or a novel device requiring efficacy demonstration) is largely not present in the provided text. The submission is for a surgical mesh, and its approval hinges on demonstrating it is as safe and effective as a legally marketed predicate device, not on meeting predefined performance metrics from a study with acceptance criteria.
However, I can extract the available information and highlight what is missing based on your request:
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not list specific numerical acceptance criteria for a "device performance" metric in the way an AI algorithm's sensitivity/specificity would be evaluated. Instead, the "performance" here refers to physical and biological properties being comparable to predicate devices. The acceptance criteria for this type of device are generally qualitative in demonstrating substantial equivalence in the specified tests.
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Qualitative, inferred) | Reported Device Performance (as stated) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Pass | "undergone and passed all relevant biocompatibility testing" |
| Sensitization | Pass | "undergone and passed all relevant biocompatibility testing" | |
| Acute Intracutaneous Reactivity | Pass | "undergone and passed all relevant biocompatibility testing" | |
| Acute Systemic Toxicity | Pass | "undergone and passed all relevant biocompatibility testing" | |
| Subchronic Toxicity | Pass | "undergone and passed all relevant biocompatibility testing" | |
| Mechanical Performance | Suture Retention Strength | Comparable to predicate | "passed all relevant...performance testing" |
| Probe Burst Strength | Comparable to predicate | "passed all relevant...performance testing" | |
| Tensile Strength | Comparable to predicate | "passed all relevant...performance testing" | |
| Stiffness | Comparable to predicate | "passed all relevant...performance testing" | |
| Tear Resistance | Comparable to predicate | "passed all relevant...performance testing" | |
| Delamination | Comparable to predicate | "passed all relevant...performance testing" | |
| Material/Processing | Impurities Removal | No adverse effect | "additional processing to remove impurities from the SIS material" (implication is successful) |
| Delamination Prevention | Successful | "include resorbable suture to improve handling and prevent delamination" (implication is successful) | |
| Shelf Life | Maintain properties over time | Successful | "shelf life testing was also completed to support substantial equivalence." |
| Clinical Equivalence | Safety and Effectiveness in Use | Equivalent to predicate | "clinical evidence including published clinical data, reinforces the conclusion that the Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts are substantially equivalent to the predicate devices." |
Study Information (Based on the provided text)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: The text refers to "clinical evidence including published clinical data" and "performance data." This implies a compilation of existing data rather than a single, dedicated randomized control trial or a specific "test set" for a novel algorithm. The country of origin is not specified, and it appears to be retrospective ("published clinical data").
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Given the nature of a surgical mesh submission based on substantial equivalence, "ground truth" in the context of expert consensus similar to an AI study wouldn't typically apply. The "ground truth" here is the established safety and effectiveness of the existing predicate devices and the physical/biological properties measured.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided and is not applicable to the type of device and study described (demonstration of substantial equivalence to a physical predicate device).
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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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those involving human interpretation of images with AI assistance. This device is a surgical implant.
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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.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth," in a broad sense for this submission, appears to be:
- Biocompatibility Standards: Established regulatory standards for biocompatibility.
- Mechanical Property Measurement Standards: ASTM/ISO standards for testing material strength, etc.
- Clinical Outcomes/Safety Profiles of Predicate Devices: The established safety and effectiveness of the Surgisis Sling™ (K992159) and Surgisis (K062696) in relevant clinical applications, informed by "published clinical data."
- The "ground truth," in a broad sense for this submission, appears to be:
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The sample size for the training set:
- Not applicable. This device is a surgical mesh, not an AI algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for an algorithm is involved.
Summary of Study Context:
This 510(k) submission primarily relies on non-clinical performance testing (biocompatibility, mechanical tests, shelf life) and reference to existing clinical data (published clinical data) related to the predicate devices and similar materials (SIS). The purpose is to demonstrate that the new device, despite some technological differences (pre-configured shape, perforations, resorbable suture), is substantially equivalent in safety and effectiveness to the legally marketed predicate devices. It is not a study designed to validate a novel performance claim against specific, pre-defined numerical acceptance criteria through a prospective clinical trial.
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.