(181 days)
The Bard 3DMAX Mesh is a sterile, single use device indicated to reinforce soft tissue where weakness exists e.g. for repair of hernias and chest wall defects.
The modified Bard 3DMAX Mesh is anatomically designed to fit the inguinal anatomy. The device is curve shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 7.5 millimeters in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an M shape with an arrow to facilitate mesh positioning and placement.
The provided text describes a 510(k) premarket notification for a medical device, the Bard 3DMAX Mesh. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, much of the requested information (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable to this type of regulatory submission and is not present in the provided text.
The "study" referenced in the document is a comparison to predicate devices, focusing on technological characteristics, performance, and intended use, rather than a clinical trial with acceptance criteria for a new AI or diagnostic device.
Here's a breakdown of what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific quantitative performance metrics like sensitivity, specificity, or accuracy. The "performance" assessment focuses on demonstrating substantial equivalence to predicate devices.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials must not cause adverse biological reactions. | "Biocompatibility testing was performed on the modified 3DMAX device. Testing performed to date indicates that changes made to the 3DMAX device do not impact its biocompatibility profile." |
| Technological Characteristics: Must be similar to predicate devices. | "laboratory testing was performed to compare the modified 3DMAX Mesh device to the currently marketed 3DMAX Mesh and Bard Mesh devices. The results show that the modified device is substantially equivalent to the currently marketed predicate devices." |
| "The modified 3DMAX Device differs from the currently marketed 3DMAX device in medial marker material only. The main components of the medial marker, polypropylene and Phthalocyaninato(2-) copper dye will remain the same. However, these items will be purchased from a different vendor and extruded to form a dyed polypropylene monofilament." | |
| Intended Use: Must be the same as predicate devices. | "The intended use for the modified device is exactly the same as the predicate devices, 3DMAX Mesh, Bard Mesh and Usher's Marlex Tubular Mesh." |
| Safety and Effectiveness: Must be safe and effective for its intended use. | "Therefore, based on laboratory testing and biocompatibility data, the modified 3DMAX device is safe and effective for its intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "testing" mentioned refers to laboratory and biocompatibility tests, not a clinical test set with human subjects or data provenance in the context of AI.
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 assessment relies on laboratory and biocompatibility testing, not expert-adjudicated ground truth data for a diagnostic algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable and not provided. The Bard 3DMAX Mesh is a surgical mesh, not an AI-powered diagnostic tool, so MRMC studies are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" equivalent for this device is based on biocompatibility testing standards and laboratory tests comparing material properties and performance characteristics to the existing predicate devices.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" in the context of a physical surgical mesh.
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.