(88 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.
This 510(k) premarket notification describes a surgical mesh device, the Avaulta™ Solo Support System and Avaulta™ Plus Biosynthetic Support System. The notification focuses on establishing substantial equivalence to predicate devices and provides limited information regarding detailed acceptance criteria and a specific study proving the device meets those criteria.
Based on the provided document, here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific acceptance criteria (e.g., tensile strength, pore size, biocompatibility metrics with defined thresholds) and corresponding reported performance metrics for the Avaulta™ Support System.
Instead, the document 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 implies that the acceptance criteria were based on the guidance document for surgical mesh and that the device performance met the requirements outlined in that guidance, thereby demonstrating substantial equivalence to the predicate devices. The specific numerical values for these criteria are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The 510(k) summary does not detail specific sample sizes for particular tests or the provenance of any data (e.g., country of origin, retrospective/prospective). It generally refers to "appropriate testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable and therefore not provided in the context of this device. The Avaulta™ Support System is a physical surgical mesh, not an AI or diagnostic device that requires expert-established ground truth for its performance evaluation in the way a medical imaging AI would. Its performance is evaluated through material testing and clinical equivalence to predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used in studies involving human readers and AI for diagnostic tasks, not for evaluating a physical medical device like surgical mesh.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not applicable and therefore not provided. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. The Avaulta™ Support System is a surgical implant, not a diagnostic tool assisted by AI, so such a study would not be performed for this device.
6. If a Standalone Study (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable and therefore not provided. This concept is relevant to AI algorithms. The Avaulta™ Support System is a physical medical device.
7. The Type of Ground Truth Used
The concept of "ground truth" in the way it's used for AI or diagnostic studies (e.g., pathology, outcomes data) is not directly applicable to the primary performance evaluation documented here for a surgical mesh.
Instead, the "truth" for this device's performance evaluation would be established through:
- Material properties testing: Adherence to established mechanical, physical, and chemical standards (e.g., tensile strength, burst strength, pore size, biocompatibility using ISO standards).
- Clinical equivalence: Demonstrating that the device performs as intended for tissue reinforcement in vaginal wall prolapse, comparable to the predicate devices, which have a known safety and effectiveness profile. This "ground truth" would be established through clinical experience with the predicate devices and the understanding that the new device's materials and design are substantially equivalent.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. "Training set" is a concept used in machine learning for AI model development. This device is a physical product, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. As explained above, the concept of a training set and its ground truth does not apply to the development and evaluation of this surgical mesh.
Summary of Device Performance and Study Information (Based on the document):
The document functions as a 510(k) summary, aiming to demonstrate substantial equivalence to legally marketed predicate devices. The "study" mentioned is the "appropriate testing to determine substantial equivalence" which "includes testing in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999)." This implies that standard material science, biocompatibility, and potentially preclinical testing (as dictated by the guidance) were conducted, and the results demonstrated that the Avaulta™ Support System met the requirements of the guidance and was comparable to the predicate devices. Specific quantitative data, sample sizes for these tests, or detailed expert reviews (beyond regulatory review) are not typically presented in this condensed form of a 510(k) summary.
§ 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.