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Bard® 3DMax™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias.

The Bard® 3DMax™ Mesh is anatomically designed to fit the inquinal 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.

This submission, K233402, describes a Special 510(k) for the Bard 3DMax Mesh, which focuses solely on labeling changes to align with European medical device regulations and other devices in the Davol Inc. portfolio. The submission explicitly states:

"No non-clinical or clinical testing was provided in support of this Special 510(k)." and "The purpose of this Special 510(k) is to notify FDA of the changes to the Bard® 3DMax™ Mesh labeling. There are no changes to the device itself."

Therefore, based on the provided document, there are no acceptance criteria or studies associated with this specific submission to describe regarding device performance, as the device itself (materials, design, manufacturing, etc.) has not changed from its predicate, K081010.

To provide the requested information, one would need access to the original 510(k) submission (K081010) that established the substantial equivalence of the device itself, rather than just its labeling.

Since the prompt asks for information from the provided input, and the input explicitly states no testing was done, I cannot fulfill the request for acceptance criteria and study details.

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The OptiFix AT Absorbable Fixation System with Articulating Technology is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

The OptiFix™ AT Absorbable Fixation System with Articulating Technology, herein after referred to as "OptiFix™ AT", is a sterile (via gamma) single use device that is comprised of a deployment component and an absorbable fastener component. The device is available in either 15 or 30 preloaded fasteners. The tip of the shaft can be articulated, and the handle of the device can be rotated 360 degrees to facilitate access for fixation during surgery. The fasteners are designed with retention features and are manufactured from Poly (L-lactide and glycolide) and are dyed with D&C Violet No. 2.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantifiable acceptance criteria (e.g., minimum tensile strength, maximum deployment force) or numerical performance metrics for the OptiFix™ AT device. Instead, it uses qualitative statements about the device meeting established requirements.

2. Sample Sizes and Data Provenance

The document does not specify the sample sizes used for the product testing (design verification and validation).

• Test Set Sample Size: Not specified.
• Data Provenance: Not explicitly stated, but given the nature of pre-market submissions in the US, the testing would generally occur in the US or in adherence to US/international standards. It is retrospective in the sense that the testing was completed prior to the submission.

3. Number of Experts and Qualifications for Ground Truth Establishment

This information is not applicable as the device is a physical medical stapling system, not an AI/software device that requires expert-established ground truth for a test set. The performance is assessed through engineering and biological testing.

4. Adjudication Method for the Test Set

This information is not applicable as the device is a physical medical stapling system. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for setting ground truth in imaging/AI studies, which were not conducted for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical studies were not performed for the submission of this device nor were clinical studies performed for the predicate device." MRMC studies are typically for evaluating diagnostic devices where human readers interpret results.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study was not done. This device is a physical medical staple system and does not involve an algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. For this physical device, the "ground truth" for verifying performance relies on:

• Engineering Specifications: The device's design, materials, and functional performance are compared against predetermined engineering specifications and safety standards.
• Biocompatibility Standards: Performance against established international standards (ISO 10993).
• Packaging Standards: Performance against established international standards (ISO 11607).

8. Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI algorithm, so there is no training set in the AI sense. The manufacturing process and quality control would involve internal testing of components and assemblies that could be analogous to "training" in a broader engineering sense, but not for an "AI training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8. The "ground truth" for the design and manufacturing of such a device is established through engineering design principles, material science, applicable regulatory standards, and risk assessments.

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