(42 days)
Modified PROLENE mesh is intended for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material, to obtain the desired surgical result. Modified PROLENE mesh has the same intended use as the preamendment predicate device PROLENE mesh. Modified PROLENE mesh is intended for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material.
Modified PROLENE mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE suture nonabsorbable surgical sutures, U.S.P. (ETHICON, INC.). The mesh is approximately 0.027 inches thick. This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.
The provided text is a 510(k) summary for a medical device (Modified PROLENE polypropylene mesh nonabsorbable synthetic surgical mesh). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and device performance metrics in the way a diagnostic AI would.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from this document, as it's not a study designed to evaluate an AI diagnostic device.
Here's an analysis based on the provided text, addressing the applicable points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as specific numerical acceptance criteria. The overarching "acceptance criterion" is proving substantial equivalence to the predicate device. | Burst strength testing was conducted to compare the predicate device and the modified device. (No specific numerical results or comparison thresholds provided in this summary). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "burst strength testing was conducted" but does not detail the number of samples used in this testing for either the predicate or the modified device.
- Data Provenance: Not applicable/specified. This is a physical device test, not data from patients or a specific geographic region. The testing would have been performed by the manufacturer, ETHICON, Inc.
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. This summary describes testing of a physical medical device (surgical mesh), not an AI diagnostic system requiring expert interpretation or ground truth establishment based on clinical observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 physical device, not an AI diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the burst strength testing would be the measured physical properties of the material itself, as determined by standardized laboratory methods for mechanical testing.
8. The sample size for the training set
- Not applicable. This is a physical device test, not an AI training process.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of Device and Equivalence Claim (from the document):
- Device Name: Modified PROLENE* polypropylene mesh nonabsorbable synthetic surgical mesh
- Predicate Device Name: PROLENE* polypropylene mesh nonabsorbable synthetic surgical mesh
- Intended Use: Repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material.
- Technological Characteristics: The modified device has the same technological characteristics (chemistry, material, composition) as the predicate device. The only differences are additional sizes and a pre-cut keyhole shape for convenience.
- Performance Data (Study): Burst strength testing was conducted comparing the predicate and modified devices.
- Conclusion: Based on the information, the modified device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act.
§ 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.