(44 days)
PARIETEX™ PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair.
PARIETEX™ PROGRIP™ Mesh will be available in 2 shapes:
Pre-cut, elliptic slit mesh with a self-gripping overlapping flap. Right or left side.
Rectangular simple mesh.
These meshes and the overlapping flaps of the pre-cut versions are made from knitted monofilament polyester with monofilament polylactic acid (PLA) resorbable pins on one side. The PLA pins facilitate placing, positioning and fixation of the overlapping flap and the meshes to the surrounding tissue. A colored yarn marker on the medial edge of the pre-cut mesh helps in orientation.
The acceptance criteria and study proving device performance are not explicitly detailed within the provided text beyond a general statement that "Bench and animal testing has been conducted to evaluate the performance characteristics of PARIETEX™ PROGRIP™ Mesh. Results of mechanical property testing show that PARIETEX™ PROGRIP™ has similar performance characteristics to the predicate PARIETEX™ Mesh."
Therefore, I cannot provide a detailed table of acceptance criteria, reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, or specifics on ground truth establishment for a training set.
Based on the provided information, I can deduce the following:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Mechanical Properties | Similar performance characteristics to the predicate PARIETEX™ Mesh. |
| Material Biocompatibility | Comprised of materials that have been evaluated in accordance with ISO 10993-1 and/or USP standards. |
2. Sample sized used for the test set and the data provenance
- Test set sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "Bench and animal testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study involved bench and animal testing, not human expert evaluations for establishing ground truth in the context of diagnostic performance.
4. Adjudication method for the test set
Not applicable. The study involved bench and animal testing.
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
No. This is a medical mesh device, not an AI-powered diagnostic tool, so an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical mesh device, not an algorithm.
7. The type of ground truth used
For mechanical properties, the "ground truth" would be established by predefined engineering specifications or comparison against the predicate device's measured performance. For material biocompatibility, the "ground truth" is adherence to ISO 10993-1 and/or USP standards.
8. The sample size for the training set
Not applicable. This is a medical mesh device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use a training set in the context of machine learning.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.