(147 days)
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.
| Acceptance Criteria Category | Reported Device Performance (as per submission) |
|---|---|
| Biocompatibility | Met the requirements of extensive biocompatibility testing. |
| Viral Inactivation | Met the requirements of viral inactivation testing. |
| Mechanical Strength | Met the requirements of mechanical testing. |
| Suitability for Use | Evidence of suitability for use in soft tissue repair. |
| Substantial Equivalence | Found substantially equivalent to predicate devices (K031969, K061892, K033671) in terms of intended use and technological characteristics, raising no new types of safety and effectiveness questions. |
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.
§ 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.