(42 days)
OrthoMend Soft Tissue Repair Matrix is intended for reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
OrthoMend Soft Tissue Repair Matrix is not intended to replace normal body structure or provide the 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. OrthoMend Soft Tissue Repair Matrix reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient's own soft tissues.
OrthoMend is a remodelable collagen matrix used to reinforce soft tissues. OrthoMend 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.
This 510(k) premarket notification for OrthoMend does not contain acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics and biocompatibility.
Here's what the document does provide, and what it does not:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not provided. This document is a 510(k) summary for a Class II surgical mesh, which typically relies on substantial equivalence to predicate devices rather than direct clinical performance studies with acceptance criteria in the same way a novel device might. The submission focuses on equivalence in technological characteristics and biocompatibility.
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. No performance test set or clinical study data is presented for OrthoMend itself in this summary. The assessment is based on the characteristics of the device and its predicates, and a biocompatibility assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No clinical performance study is detailed, so there's no ground truth establishment by experts for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No clinical performance study involving adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- No. An MRMC study was not conducted or reported in this 510(k) summary. This type of study is more common for diagnostic imaging devices where human interpretation is a key component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. OrthoMend is a physical surgical mesh and does not involve an algorithm or AI.
7. The type of ground truth used:
- Not applicable/Not provided. No clinical performance ground truth is established for OrthoMend in this summary. The basis for approval is substantial equivalence and biocompatibility.
8. The sample size for the training set:
- Not applicable. OrthoMend is a physical medical device, not a machine learning algorithm, so there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an algorithm is involved.
Summary of Information Provided Related to Equivalence (instead of acceptance criteria):
The submission highlights the following aspects to support substantial equivalence:
- Technological Characteristics: OrthoMend is described as "substantially equivalent to other surgical meshes with respect to its design as a thin, homogenous sheet which can be sutured to hold it in place. In addition, the device is fully resorbable over a period of months." This compares its physical form, method of use, and biological fate to predicate devices.
- Biocompatibility: "A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of OrthoMend. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, intramuscular toxicity, hemolysis, and acute systemic toxicity, genotoxicity." The methods for viral inactivation were also tested by a certified laboratory. While specific results are not tabulated, the statement indicates that a standard set of biocompatibility tests were passed.
- Intended Use: The intended use statement for OrthoMend is aligned with its predicate devices for reinforcement of soft tissues during tendon repair surgery.
In essence, the "study" for this 510(k) is the demonstration that OrthoMend is "substantially equivalent" to already legally marketed devices, primarily the OrthoMend (K031188), CuffPatch Surgical Mesh (K042809), and Fortaflex Surgical Mesh (K020049), through similar design, materials, intended use, and acceptable biocompatibility. This type of submission does not typically involve setting specific performance acceptance criteria for a novel clinical outcome in the same way a drug or a new diagnostic device might.
§ 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.