(25 days)
The Avaulta™ Support System is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.
The Avaulta™ Support System includes a sterile, single use, permanent implant that provides long term reinforcement to support structures in the correction of anterior or posterior vaginal wall prolapse. The central soft knit section provides compliant organ support while the strong knit arms provide improved strength for tension free fixation of the implant.
The Avaulta™ Plus Biosynthetic Support System and Avaulta™ Solo support system both utilize a nonabsorbable monofilament, polypropylene mesh to provide long-term reinforcement for support structures. The Avaulta™ Plus Biosynthetic Support System adds a porous, acellular, ultrathin sheet of crosslinked collagen attached to the polypropylene mesh which serves to establish a protective barrier between mucosal tissue and the polypropylene mesh and contains apertures uniformly sized to allow for ingrowth of host tissue and capillary vessels.
The provided text is a 510(k) summary for the Avaulta™ Solo Support System and Avaulta™ Plus Biosynthetic Support System (K082571). It describes a surgical mesh device for vaginal wall prolapse.
However, the document does not contain any information regarding acceptance criteria or the study that proves the device meets specific performance criteria through an AI/algorithm-based evaluation. The entire submission is focused on establishing substantial equivalence to a predicate device based on similar intended use, general design, fundamental scientific technology, and performance data from physical testing in accordance with guidance for surgical mesh.
Therefore, I cannot provide the requested information. The document details the device's description, intended use, and substantial equivalence to a predicate device, but it lacks any mention of an AI or algorithm-based system, its performance metrics, or related studies.
To illustrate what a comprehensive response would look like if the information were present, I'll use placeholders for each section, emphasizing that this information is missing from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Hypothetical) | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|
| [Specific AI Performance Metric 1] | [Target Value or Range] | [Achieved Value] |
| [Specific AI Performance Metric 2] | [Target Value or Range] | [Achieved Value] |
| ... | ... | ... |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size: Not provided (no AI/algorithm study described).
- Data Provenance: Not provided (no AI/algorithm study described).
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- Number of Experts: Not provided (no AI/algorithm study described).
- Qualifications of Experts: Not provided (no AI/algorithm study described).
4. Adjudication Method for Test Set
- Adjudication Method: Not provided (no AI/algorithm study described).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC study is not mentioned as part of this 510(k) submission.
- Effect Size of Human Readers with vs. without AI assistance: Not applicable, as no AI-assisted study is described.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No, a standalone algorithm performance study is not mentioned. The submission focuses on the performance of the physical surgical mesh itself.
7. Type of Ground Truth Used
- Type of Ground Truth: Not provided (no AI/algorithm study described). For the physical device, "substantial equivalence" to a predicate device is the primary "ground truth" for regulatory approval, supported by physical testing data, not clinical ground truth in the AI sense.
8. Sample Size for Training Set
- Training Set Sample Size: Not applicable, as no AI/algorithm is described.
9. How Ground Truth for Training Set Was Established
- Ground Truth Establishment (Training Set): Not applicable, as no AI/algorithm is described.
Conclusion based on provided text:
The provided 510(k) summary for the Avaulta™ Solo Support System and Avaulta™ Plus Biosynthetic Support System does not describe an AI/algorithm-based device nor any studies related to its performance against acceptance criteria typically associated with AI systems. The document focuses on the mechanical and biological properties of a surgical mesh and its substantial equivalence to a predicate device, as per the requirements for surgical mesh products. Therefore, all the requested information pertaining to AI/algorithm performance studies is absent.
§ 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.