Search Results

The DePuy Restore Orthobiologic Soft Tissue Implant is intended to reinforce soft tissue where weakness exists, specifically for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, and other tendons. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. The DePuy Restore Orthobiologic Soft Tissue Implant is also intended for use during general tissue reconstruction of the periosteum. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

The DePuy Restore Orthobiologic Soft Tissue Implant is manufactured from porcine small intestinal submucosa (SIS), comprised predominantly of water and collagen, and will be supplied in a sheet or strand configuration in sterile form in a sealed double pouch system.

The DePuy Restore Orthobiologic Soft Tissue Implant (K071016) is a surgical mesh made from porcine small intestinal submucosa (SIS), intended to reinforce soft tissue during tendon repair surgery and general tissue reconstruction of the periosteum. It is not intended to replace normal body structure or provide full mechanical strength, but rather to serve as a resorbable scaffold.

Here's an analysis of its acceptance criteria and the supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device's characteristics and the types of tests performed rather than specific quantitative acceptance criteria or detailed performance metrics. The stated "acceptance criteria" appear to be meeting the requirements of the conducted tests to demonstrate suitability for use.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "extensive biocompatibility testing," "viral inactivation testing," and "mechanical testing." These tests were likely conducted on the device material itself rather than human clinical subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided. The testing described (biocompatibility, viral inactivation, mechanical) is typically laboratory-based and does not involve expert readers establishing ground truth in the same way as, for example, diagnostic imaging studies.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the nature of the tests described.

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 MRMC comparative effectiveness study was mentioned. This device is a surgical implant, not an AI-assisted diagnostic tool, so such a study would not be relevant.

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 and not an algorithm or software.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the specific tests mentioned:

• Biocompatibility: Ground truth would be established by standardized toxicological and biological response assays, often with reference materials.
• Viral Inactivation: Ground truth would be established through virological assays and controls.
• Mechanical Testing: Ground truth would be established by standardized mechanical testing methods and material properties specifications.

These are objective, laboratory-derived ground truths rather than clinical ground truths requiring expert consensus or pathology.

8. The Sample Size for the Training Set

This information is not provided and is not applicable, as this is a physical medical device, not an AI model requiring a training set.

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

This information is not provided and is not applicable, as this is a physical medical device, not an AI model.

Summary of the Study:

The "study" referenced in the 510(k) submission is a series of laboratory-based tests. The device underwent:

• Extensive biocompatibility testing: This likely involved in vitro and/or in vivo tests to ensure the material does not cause adverse biological reactions.
• Viral inactivation testing: This would have assessed the effectiveness of the manufacturing process in neutralising potential viral contaminants from the porcine source material.
• Mechanical testing: This would have evaluated the physical strength and properties of the mesh to ensure it can perform its intended function of reinforcing soft tissue without providing full mechanical strength.

The conclusion drawn from these tests was that the device met the requirements, providing evidence of its suitability for use and substantial equivalence to legally marketed predicate devices (DePuy Restore Orthobiologic Soft Tissue Implant (K031969), CryoLife ProPatch Soft Tissue Repair Matrix (K061892), W.L. Gore Absorbable Mesh (K033671)). The basis for substantial equivalence primarily relies on its similar material (porcine SIS) to K031969 and similar intended use and indications to all listed predicate devices. No new safety or effectiveness questions were raised.

Ask a specific question about this device

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.

Ask a specific question about this device

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