(23 days)
The AMS Large Pore Polypropylene Mesh 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 AMS Large Pore Polypropylene Mesh is a knitted mesh of polypropylene fibers. The mesh can be cut to any desired shape or size and resists unraveling.
The provided text is for a 510(k) summary for a medical device (AMS Large Pore Polypropylene Mesh). It details the device's description, indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the other requested particulars related to a study that proves the device meets acceptance criteria.
The summary states: "The new device has been tested in accordance with FDA's 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh' and has been shown to be equivalent to the listed predicate device." This indicates that the regulatory requirements for showing substantial equivalence were met, but it doesn't provide the granular data requested.
Therefore, I cannot populate the table or answer most of the questions based on the provided text.
Here is what can be inferred or explicitly stated from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics. It only states that the device was "shown to be equivalent to the listed predicate device."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Equivalent to predicate device (K033636) per FDA guidance. |
2. Sample sized used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "testing" was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified, as no human expert-based ground truth is mentioned for the testing of a surgical mesh's physical characteristics.
4. Adjudication method for the test set
Not applicable. The testing described appears to be physical/mechanical testing of the mesh, not a clinical assessment requiring expert adjudication.
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 not an AI-enabled device that would involve human readers or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
Not explicitly stated. For a surgical mesh, "ground truth" would typically refer to physical and mechanical properties being measured against established standards or the properties of the predicate device.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device that would involve a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.