(106 days)
Ascend AC (anterior compartment) and Ascend PC (posterior compartment) are indicated for repair of pelvic organ prolapse, including anterior, posterior, vaginal vault and uterine prolapse.
The Ascend Pelvic Floor Repair System consists of macroporous, monofilament, polypropylene mesh implants and a set of reusable introducers to facilitate mesh implant placement. The reusable introducers are available separately.
The provided text is a 510(k) summary for the Ascend Surgical Mesh and does not include a study describing acceptance criteria and device performance in the way a clinical trial or algorithm validation study would.
Instead, the medical device (Ascend Surgical Mesh) demonstrates substantial equivalence to predicate devices (AMS Apogee Vault Suspension System K040537 and AMS Perigee System K040623) based on non-clinical testing.
Here's how this information maps to your requested points, highlighting what is not applicable for this type of submission:
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A table of acceptance criteria and the reported device performance
- Not Applicable in the provided text. The document states: "The mesh used in the Ascend device has been tested in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh and has been shown to be equivalent to the listed predicate devices. In addition, the other components have demonstrated substantial equivalence to the predicate devices in terms of mechanical testing and biocompatibility."
- This implies that the acceptance criteria are regulatory guidelines and established equivalence to predicate devices through mechanical testing and biocompatibility, rather than performance metrics like sensitivity, specificity, or accuracy which would be reported for an AI device. No specific table or numerical performance metrics are given.
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Sample size used for the test set and the data provenance
- Not Applicable. This is a physical medical device (surgical mesh), not an AI/algorithm-based device, so there is no "test set" in the context of data. The "testing" refers to bench testing for mechanical properties and biocompatibility.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth established by experts for a test set, as this is not an AI/diagnostic device.
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Adjudication method for the test set
- Not Applicable. No test set or human adjudication process.
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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
- Not Applicable. This is a surgical mesh, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is not an algorithm.
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The type of ground truth used
- Not Applicable / Inferred: For a physical device like surgical mesh demonstrating equivalence, the "ground truth" for performance would be metrics derived from bench testing (mechanical properties, biocompatibility) and comparison to established predicate devices under regulatory guidelines.
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The sample size for the training set
- Not Applicable. This is not an AI/algorithm-based device using a "training set."
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How the ground truth for the training set was established
- Not Applicable. This is not an AI/algorithm-based device.
§ 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.