(23 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™ Support System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance through clinical trials and specific acceptance criteria. Therefore, the document does not contain the detailed information requested in the prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Here's a breakdown of what can be extracted and why the other information is missing:
1. A table of acceptance criteria and the reported device performance
- Not Available. The 510(k) summary states, "The appropriate testing to determine substantial equivalence was completed. This includes testing in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999)." This refers to non-clinical testing (e.g., biocompatibility, mechanical properties) to show the new device is similar to the predicate. It does not include performance metrics against pre-defined clinical acceptance criteria like sensitivity/specificity or other efficacy measures expected for AI or diagnostic devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Available. There is no mention of a "test set" in the context of clinical performance evaluation, as this 510(k) focuses on substantial equivalence rather than a new clinical claim. The testing mentioned is for substantial equivalence, likely bench or animal studies, not human clinical data with a test set in the conventional sense.
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)
- Not Applicable/Available. No clinical test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Available. No clinical test set requiring adjudication is described.
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 is a medical device (surgical mesh), not an AI-based diagnostic tool. Therefore, MRMC studies involving AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Available. No clinical ground truth is discussed in this regulatory summary. The "ground truth" for a 510(k) is typically the established safety and effectiveness profile of the predicate device, against which the new device is compared regarding its material, design, and intended use.
8. The sample size for the training set
- Not Applicable/Available. No "training set" in the context of machine learning is discussed.
9. How the ground truth for the training set was established
- Not Applicable/Available. No "training set" or corresponding ground truth establishment is discussed.
Summary of available relevant information from the document:
- Device Name: Avaulta™ Solo Support System, Avaulta™ Plus Biosynthetic Support System; Common Name: Surgical Mesh
- Predicate Device: Avaulta Solo™ Support System, Avaulta Plus™ Biosynthetic Support System (K063712 and K082571) - Note: The document lists the predicate devices with very similar names, suggesting this 510(k) might be an updated version or specific modification of previously cleared devices, or a consolidation.
- Intended Use: "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."
- Performance Data Summary: "The appropriate testing to determine substantial equivalence was completed. This includes testing in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999)." This indicates that the device underwent non-clinical testing (e.g., biocompatibility per ISO standards, mechanical strength, material characterization) to demonstrate similar performance and safety characteristics to its predicate device, as required for a 510(k) submission for a surgical mesh. It does not involve clinical performance criteria or studies in the sense of AI or diagnostic device evaluation.
§ 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.