(77 days)
Parietex Progrip™ Mesh is indicated for inguinal and incisional hernia repair.
Parietex Progrip™ TEM2015G and TEM3015G are rectangular meshes made of knitted monofilament polyester with polylactic acid (PLA) resorbable pins on one of the sides. The PLA pins facilitate placement, positioning and fixation of the mesh to the surrounding tissue.
The provided document is a 510(k) summary for the Parietex Progrip™ Mesh, specifically for new sizes TEM2015G and TEM3015G. It states that these new sizes are substantially equivalent to a previously cleared predicate device (K081050).
Based on the provided information, the document does not contain a study that proves the device meets specific acceptance criteria in the traditional sense of a clinical or performance study with defined metrics for the device itself.
Instead, this 510(k) submission relies on the concept of substantial equivalence to a predicate device. This means that the new device sizes are considered safe and effective because they are fundamentally similar to a device already legally marketed.
Here's a breakdown of why a table of acceptance criteria and reported device performance isn't applicable in the way you've requested, and how to address the other points based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not available in the provided document. The 510(k) summary explicitly states:
- "No additional bench testing has been conducted."
- "The materials of the new Parietex Progrip™ references are identical to the predicate Parietex Progrip™ and therefore, the performance data submitted in the predicate Parietex Progrip™ Traditional 510k (K081050) applies to the two additional sizes."
This indicates that specific acceptance criteria and performance data for the new device sizes (TEM2015G and TEM3015G) were not generated independently. Their performance is inferred from the predicate device (K081050), which would have had its own performance data and acceptance criteria at the time of its clearance. Without the K081050 document, we cannot construct such a table for these specific acceptance criteria and performance results directly from this text.
Regarding the requested study information:
Since no new study was conducted for TEM2015G and TEM3015G, most of the following points are not applicable or cannot be determined from the provided text for these specific device sizes. The information below pertains to the absence of such studies for this 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this 510(k). No new test set data was generated. The submission relies on data from the predicate device.
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)
- Not applicable for this 510(k). As no new test set was generated, there was no need for expert ground truth establishment for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this 510(k). No new test set was generated.
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 device is a surgical mesh, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for this 510(k). No new ground truth for performance was established for the new device sizes.
8. The sample size for the training set
- Not applicable. This device is a surgical mesh; the concept of a "training set" is not relevant in this context.
9. How the ground truth for the training set was established
- Not applicable. This device is a surgical mesh.
Summary of what can be derived from the document:
- Device: Parietex Progrip™ Mesh (TEM2015G and TEM3015G)
- Indication: Inguinal and incisional hernia repair.
- Mechanism of Clearance: Substantial Equivalence to predicate device Parietex Progrip™ Mesh (K081050).
- Reason for Substantial Equivalence: The new sizes are comprised of identical materials and share the same intended use and fundamental technology as the predicate device. No new performance or testing data was required or submitted for these specific models, as the performance data from the predicate device's 510(k) (K081050) was deemed applicable.
§ 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.