(73 days)
OrthoMend is intended for surgical implantation to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes. In addition, the device is intended to reinforce soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff surgery.
OrthoMend is a remodelable collagen matrix used to reinforce soft tissues where weakness exists. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs.
The provided text describes a 510(k) premarket notification for the OrthoMend™ device, a remodelable collagen matrix used to reinforce soft tissues. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for the device itself in a clinical setting.
Therefore, many of the requested categories related to acceptance criteria, device performance, ground truth, and human reader studies are not applicable to this type of regulatory submission. The document primarily highlights biocompatibility testing and shared technological characteristics with existing devices to claim substantial equivalence.
Here's an breakdown of the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The submission is for substantial equivalence to legally marketed predicate devices, not for demonstrating performance against specific clinical acceptance criteria. The document lists biocompatibility tests as an assessment performed, but doesn't define "acceptance criteria" or report specific "device performance" in a quantitative clinical sense.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) submission does not describe a clinical study with a test set of data for performance evaluation. It mentions biocompatibility testing and viral inactivation testing, which are typically conducted on material samples in a laboratory setting, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. There is no discussion of a test set with ground truth established by experts in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no test set or adjudication method 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
- Not Applicable. This document pertains to a medical device (collagen matrix), not an AI-assisted diagnostic or treatment system, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth for an algorithm or diagnostic performance is discussed. The "ground truth" in this context would be the successful demonstration of biocompatibility and manufacturing safety, which were assessed by an independent certified laboratory.
8. The sample size for the training set
- Not Applicable. There is no training set mentioned, as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set.
Summary of Relevant Information from the Document:
Device Description: OrthoMend™ is a remodelable collagen matrix used to reinforce soft tissues where weakness exists. It is supplied sterile in sheet form to be trimmed and sutured by the surgeon.
Intended Use: For surgical implantation to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes. Additionally, it is intended to reinforce soft tissues (limited to the supraspinatus) repaired by suture or suture anchors during rotator cuff surgery.
Predicated Devices:
- TissueMend Soft Tissue Repair Matrix (TEI Biosciences, K020455)
- Restore Orthobiologic Soft Tissue Implant (DePuy, K001738)
Biocompatibility Assessment:
- A "rigorous biocompatibility assessment" was performed by an independent certified laboratory.
- Tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity.
- Manufacturing Safety: The manufacturing methods for OrthoMend™ were also tested by an independent laboratory to assure safe levels of viral inactivation.
Basis for Equivalence: OrthoMend™ is claimed to be substantially equivalent to other surgical meshes with respect to its design as a thin, flexible, polymeric sheet that can be sutured, and its full resorbability over months.
Conclusion: The 510(k) notification for OrthoMend™ relies on demonstrating substantial equivalence to existing legally marketed devices, supported by biocompatibility and viral inactivation testing, rather than an independent clinical study with predefined acceptance criteria and performance metrics.
§ 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.