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Bard® Mesh is indicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects.

Bard® Mesh Pre-shaped is indicated for the repair of inguinal hernia defects.

The Bard® Mesh is a nonabsorbable, sterile mesh designed for the reinforcement of soft tissue where weakness exists, i.e., repair of hernias and chest wall defects. The Bard® Mesh Pre-Shaped is a nonabsorbable, pre-trimmed sterile mesh designed for reinforcement of inguinal hernias. The Bard® Mesh is offered in several sizes of rectangular flat sheets and in several pre-shaped configurations, known as Bard® Mesh Pre-Shaped. Bard® Mesh product family products consist of the standard, rectangular or square sizes which can be trimmed as needed to provide surgeons with more freedom to customize the prosthesis prior to implantation. The Bard® Mesh portfolio currently ranges from 1" x 4" to 10" x 14" rectangle mesh. The Bard® Mesh is comprised of knitted polypropylene monofilaments in a square or rectangular flat sheet with selvage edges. The Bard Mesh Pre-Shaped is comprised of knitted polypropylene monofilaments in a pre-shaped configuration with a pre-cut into a shape commonly used by surgeons to protect the spermatic cord or similar structure as part of an inguinal hernia repair. All clinical, biological, and technical characteristics of the Bard® Mesh and Bard® Mesh Pre-Shaped are identical except that Bard® Mesh Pre-Shaped is only indicated for inguinal hernias due to the pre-cut/pre-shaped nature of the product.

The provided document is an FDA 510(k) clearance letter for a medical device called Bard® Mesh. However, this document does not contain the information typically found in a study demonstrating how an AI/algorithm-driven device meets acceptance criteria.

The Bard® Mesh is a surgical mesh, a physical medical device used to reinforce soft tissue, such as in hernia repair. It is a Class II device, and the clearance is based on its substantial equivalence to a preamendment predicate device (meaning it was marketed before May 28, 1976).

The document specifically mentions:

• "As there are no new or increased risks identified, no verification or validation activities are required for these labeling changes. Design verification testing was conducted to support the performance of the pre-shaped configuration." This indicates that for this type of physical device and the nature of the changes (labeling and a pre-shaped configuration), extensive clinical studies or complex performance evaluations are not required in the same way they would be for a novel diagnostic or AI-powered device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or diagnostic algorithms, is not present in this 510(k) letter. This clearance is based on the device's established technological characteristics and historical use, demonstrating its equivalence to a long-marketed product, rather than proving performance against specific acceptance criteria through a new study as would be done for an AI device.

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Kerecis® Tendon Protect is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Kerecis® Tendon Protect is a medical device made from solid fish skin (North Atlantic Cod) sheets of thickness no less than 0.4 mm. The product is intended to provide a covering around the newly repaired tendon for the management and protection of tendon injuries in which there has been no substantial loss of tissue. The device with natural structure and proteins from fish skin is applied around the newly repaired tendon. The structure of the fish skin provides a supportive environment for new host tissue deposition as part of wound healing while still providing an initial barrier facilitating the sliding of the repaired tendon within the surrounding tissue during tendon use. The biomechanical strength for the tendon itself is provided separately by sutures used to repair the tendon tear and/or by sutures or bone anchors used to attach the tendon tissue to the bone.

The fish skin is fully integrated into the surrounding tissue over time, with corresponding new host tissue deposition. The device is biocompatible, non-crosslinked, bioresorbable, strong, and pliable. Its tensile strength supports fixation by sutures customary for tendon protection surgical procedures. The device is intended for one-time use and supplied sterile in labelled Tyvek® pouch packaging.

The subject device is available in following sizes:

• 3x5 cm size
• 6x9 cm size

Kerecis® Tendon Protect is a standalone, single use medical device made from fish skin that is technologically similar to the predicate device Tendon Wrap Tendon Protector (K053655) (Substantial Equivalence) and identical to the Kerecis® Reconstruct™ (K202430).

The provided text is a 510(k) clearance letter and summary for a medical device called "Tendon Protect." It details the device's characteristics, indications for use, and a summary of the non-clinical performance testing conducted to demonstrate its safety and effectiveness and substantial equivalence to predicate devices. However, it does not contain the specific detailed information typically found in acceptance criteria tables or a comprehensive study report, particularly regarding a multi-reader multi-case (MRMC) study, standalone algorithm performance, or the detailed methodology for ground truth establishment that would be associated with AI/ML-based medical devices.

The document describes a physical medical device (surgical mesh made from fish skin) rather than an AI/ML-based diagnostic or assistive software. Therefore, many of the questions related to AI/ML specific criteria (such as sample size for training set, number of experts for ground truth, adjudication methods, MRMC studies, and standalone algorithm performance) are not applicable to this particular device submission.

Here's a breakdown of the applicable information found in the document:

1. A table of acceptance criteria and the reported device performance:

The document mentions that the device "met all the pre-defined acceptance criteria" for various tests, but it does not provide a table detailing the specific numerical or quantitative acceptance criteria and the corresponding reported performance values. It only states that the tests were "conducted and passed successfully according to the test specifications."

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated for most tests (e.g., biocompatibility bench tests). For the Tendon GLP Chicken Study, it is a chronic model evaluating early, mid-term, and late time points, comparing the subject device to a control and a negative control. The specific number of animals or tendons tested is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical (bench and animal testing), not human clinical data, and are likely prospective given they are part of a regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the device is a physical surgical mesh, not a diagnostic or AI-based device requiring expert interpretation of images or signals for ground truth. Ground truth for the animal study would be based on objective scientific measurements and observations (e.g., histology, biomechanics).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable for the reasons stated above.

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 is not applicable as the device is a physical surgical mesh, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is a physical surgical mesh, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the animal study:

• Histopathology evaluation
• Macroscopic evaluations
• Tendon biomechanical function assessment
• Overall animal health

For bench testing, ground truth would be established by the physical and mechanical properties of the material itself, measured against predefined specifications.

8. The sample size for the training set:

This is not applicable as the device is a physical surgical mesh, not an AI/ML system requiring a training set.

9. How the ground truth for the training set was established:

This is not applicable for the reasons stated above.

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Endoform™ Reconstructive Template – PLGA is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing material to obtain the desired surgical outcome.

Endoform™ Reconstructive Template – PLGA is a surgical mesh comprised of multiple layers of ovine-derived extracellular matrix reinforced with poly(lactic-co-Glycolic) acid (PLGA). The device design includes a range of shapes, sizes, and thicknesses in surface areas up to 400cm², to give a range of strengths as required for a particular implant procedure. Devices are terminally sterilized by ethylene oxide (EO) sterilization.

This FDA 510(k) clearance letter and supporting summary for the Endoform™ Reconstructive Template – PLGA device does not involve artificial intelligence (AI) or machine learning (ML). Therefore, many of the requested elements for AI/ML device validation are not applicable.

The device is a traditional medical device (surgical mesh) and its substantial equivalence is demonstrated through non-clinical performance data and comparison to a predicate device. There is no mention of an algorithm, AI assistance, or human readers.

However, I can extract the information relevant to its acceptance criteria and the study that proves it meets those criteria, based on the provided document.

Acceptance Criteria and Study Proof for Endoform™ Reconstructive Template – PLGA

Since this is a traditional medical device (surgical mesh) and not an AI/ML device, the concept of "acceptance criteria" is related to meeting performance specifications and demonstrating biocompatibility and safety comparable to a predicate device, rather than diagnostic accuracy metrics. The "study" refers to non-clinical testing.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the types of tests conducted and the conclusion that the device meets specifications, rather than providing specific numerical acceptance criteria and results in a table format common for AI/ML.

For this device, the "acceptance criteria" are implied by the performance characteristics demonstrated to be "substantially equivalent" to the predicate device and meeting recognized standards.

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