(167 days)
Is for the "repair of hemias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result."
ULTRAPRO* Mesh is a sterile partially absorbable composite mesh designed for the repair of hernias and other abdominal fascia deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
ULTRAPRO Mesh is manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non absorbable polypropylene monofilament fiber.
The provided text describes the ULTRAPRO* Mesh device, a sterile, partially absorbable composite mesh for repairing hernias and other abdominal fascia deficiencies. The document is a 510(k) summary for the device, seeking substantial equivalence to predicate devices.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Technological Characteristics of Predicate Devices) | Reported Device Performance (ULTRAPRO* Mesh) |
|---|---|
| Thickness | Similar to predicate devices |
| Burst strength | Similar to predicate devices |
| Flexural rigidity | Similar to predicate devices |
| Tear strength | Similar to predicate devices |
| Tensile strength | Similar to predicate devices |
| Porosity | Similar to predicate devices |
| Suture pull-out strength | Similar to predicate devices |
| Clinical performance (indicated for hernia repair and other fascial deficiencies) | Equivalency in clinical performance to other commercialized surgical meshes; achieved good tissue ingrowth in animal testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a separate "test set" in the context of a clinical study with human patients. The performance data section mentions "Non-clinical laboratory testing" and "animal testing." No details on the sample sizes for these tests (e.g., number of animals, number of mesh samples for lab tests) are provided, nor is the country of origin of the data mentioned. The data is non-clinical and animal-based, not involving human patients in a retrospective or prospective manner as would be typical for medical device performance studies involving patient outcomes.
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)
This information is not applicable and not provided. The study presented is a non-clinical and animal study, not a human clinical trial where expert consensus on "ground truth" for patient outcomes would typically be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As noted above, there is no human "test set" or clinical trial described that would necessitate an adjudication method for establishing ground truth from multiple expert readings.
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
An MRMC comparative effectiveness study was not done. This device is a surgical mesh, not a diagnostic or AI-powered device that involves human "readers" or an AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done. This device is a physical surgical mesh, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical laboratory testing, the "ground truth" would be objective measurements against established engineering and material science standards for surgical meshes.
For the animal testing, the "ground truth" regarding "good tissue ingrowth" would likely be based on histological examination and macroscopic assessment by veterinary pathologists or other trained professionals, comparing the tissue response to existing accepted benchmarks for similar devices. This is a form of biological outcome data.
8. The sample size for the training set
This information is not applicable and not provided. This device is a physical surgical mesh, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
§ 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.