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510(k) Data Aggregation
(28 days)
PROGRIP™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach.
The PROGRIP™ Laparoscopic Self-Fixating Mesh is available in anatomical and rectangular shapes. The mesh is made of knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and a resorbable collagen film on the other side. The film is made up of collagen from porcine origin and glycerol. The grips allow positioning and fixation of mesh to the surrounding tissue, while the collagen film facilitates mesh handling and deployment. The mesh presents a green band that facilitates mesh orientation No changes to product have been made in this submission.
This 510(k) submission (K123479) for the PROGRIP™ Laparoscopic Self-Fixating Mesh is not a study that proves the device meets specific acceptance criteria through clinical trials or performance testing as would be described for an AI/ML device.
Instead, this submission is a request to the FDA to remove a specific final product specification (lower specification of extractible pH) for an already legally marketed device (PROGRIP™ Laparoscopic Self-Fixating Mesh, K120897). The core assertion is that this change does not impact the device's intended use, does not alter its fundamental scientific technology, and does not require additional performance data.
Therefore, many of the requested elements for an AI/ML device study (like sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) are not applicable and not present in this document.
Here's an breakdown based on the provided text, focusing on what is relevant to a 510(k) submission for a modification to a predicate device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table with typical performance metrics (like sensitivity, specificity, AUC) for a new device. Instead, it discusses the impact of a specification change on the effectiveness for intended use.
| Acceptance Criteria (Conceptual, based on the submission) | Reported Device Performance (Argument for Equivalence) |
|---|---|
| Original Device Performance: Maintained despite specification change. The product must continue to be "effective for intended use" (reinforcement of tissues during surgical repair, specifically inguinal hernia). | The submission argues that "The removal of the collagen film lower specification of extractible pH, as a final product specification, does not affect the product performance." It further states that "The combination of the upper extractible pH and the lot release final product specification (gripping point test) ensure the product effectiveness for intended use." No quantitative performance data is provided as it's a change to a predicate. |
| Technological Characteristics: Remain substantially equivalent to the predicate device. | "The subject PROGRIP™ Laparoscopic Self-Fixating Mesh is identical to the predicate device PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897) in terms of its physical, technological characteristics and performance characteristics." |
| Safety: No new safety concerns introduced by the specification change. | Implied by the lack of new performance data requirement and the assertion that "This change does not impact the intended use and does not alter the fundamental scientific technology of the device." |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is for a modification to a previously cleared medical device, not a new device requiring a clinical performance study with a test set. The justification relies on the existing predicate device's performance and the argument that the change is minor.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No expert review panel or ground truth establishment for a test set is mentioned, as this is not a study evaluating diagnostic or predictive performance.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is described.
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/ML diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this submission.
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 applicable. As there is no "test set" in the context of an AI/ML study, there is no discussion of ground truth derived from pathology, outcomes data, or expert consensus. The "ground truth" for this submission is implicitly the established safety and efficacy profile of the predicate device (K120897), which this modified device claims to be substantially equivalent to, despite a minor change in a manufacturing specification.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set mentioned.
9. How the ground truth for the training set was established:
- Not applicable. No training set exists for this device.
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