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The DePuy Restore® Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. In addition, the implant is intended for use in the specific application of reinforcement of the soft tissues, which are repaired by suture or suture anchors, during rotator cuff repair surgery.

The Restore® Implant is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures to repair the tear and suture or bone anchors to reattach the tissue to the bone provide mechanical strength for the rotator cuff repair. The Restore® Implant reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

The Restore® Orthobiologic Soft Tissue Implant is a round device, manufactured from 10 plys of Small Intestine Submucosa (SIS). SIS is a biomaterial derived from porcine small intestine. SIS is composed predominately of water and collagen.

The document provided is a 510(k) summary for the DePuy Restore® Orthobiologic Soft Tissue Implant, indicating an expanded intended use for rotator cuff repair. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and performance study results as would be found in a clinical trial report for novel technologies.

Therefore, many of the requested details regarding acceptance criteria, study design elements such as sample sizes, expert qualifications, adjudication methods, ground truth establishment, and specific performance metrics for the device are not available in this summary. The 510(k) process is primarily a comparison to existing devices.

However, I can extract the following information based on the provided text:

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

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

• Not specified in this 510(k) summary. The document states that the expanded indication is "evidenced by clinical data," but does not provide details on the study design, sample size, or data provenance.

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

• Not specified in this 510(k) summary.

4. Adjudication method for the test set:

• Not specified in this 510(k) summary.

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/Not mentioned. This device is a surgical mesh, not an AI-assisted diagnostic tool.

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

• Not applicable/Not mentioned. This is a medical device (surgical mesh), not an algorithm.

7. The type of ground truth used:

• The basis for substantial equivalence for the expanded indication is stated as "safety and effectiveness considerations and evidenced by clinical data." However, the nature of this clinical data (e.g., specific outcome measures, pathological findings, etc.) is not detailed in this summary. For a mesh, ground truth for effectiveness would likely relate to successful tissue reinforcement, integration, and lack of adverse events, typically demonstrated through clinical outcomes.

8. The sample size for the training set:

• Not applicable/Not specified. This is a manufactured medical device, not a machine learning model requiring a training set.

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

• Not applicable/Not specified. This is a manufactured medical device.

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The DePuy Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. In addition, the implant is intended for use in the specific application of reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.

The Restore Orthobiologic Soft Tissue Implant is a round device, manufactured from 10 plys of Small Intestine Submucosa, (SIS). SIS is a biomaterial derived from porcine small intestine. SIS is composed predominately of water and collagen. This material is identical to the material approved K982330 for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample size, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

The document is a 510(k) summary for a surgical mesh device, focusing on its substantial equivalence to previously marketed devices. It describes the device, its intended use, and the basis for substantial equivalence but does not include any performance studies or validation data against specific acceptance criteria.

Ask a specific question about this device