(239 days)
The OrthADAPT® Bioimplant (Surgical Mesh) is intended to be used for implantation to reinforce soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures. The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar. Achilles, biceps, quadriceps, or other tendons.
OrthADAPT® 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.
OrthADAPT® is intended for one-time use only.
The OrthADAPT Bioimplant is a decellularized equine pericardium. The OrthADAPT Bioimplant has been crosslinked and exposed to a liquid chemical sterillant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.
The provided text is a 510(k) summary for the OrthADAPT® Bioimplant, a surgical mesh. It describes the device, its intended use, and its substantial equivalence to predicate devices based on biocompatibility and performance testing. However, it does not contain the detailed acceptance criteria for a study, nor does it describe a study design that would directly assess and prove the device meets specific performance criteria.
The 510(k) summary states: "The results of biocompatibility and performance testing demonstrate that OrthADAPT is comparable to the predicate devices." This implies that some testing was done to establish substantial equivalence, but the specifics of that testing, including acceptance criteria, sample sizes, ground truth establishment, or any AI-related components, are not provided in this document.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: The document does not list specific acceptance criteria or quantitative performance metrics for the OrthADAPT® Bioimplant.
- Sample sizes used for the test set and the data provenance: No sample sizes for a test set are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method: Not applicable as no such study is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not mention any MRMC studies, nor does it involve AI assistance for human readers.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: The device is a physical surgical mesh, not an algorithm. Therefore, a standalone algorithm performance study is not relevant here.
- The type of ground truth used: Not specified for any performance testing described.
- The sample size for the training set: Not applicable as this is not an AI/algorithm-based device.
- How the ground truth for the training set was established: Not applicable.
Summary:
The provided document describes a medical device (surgical mesh) and its regulatory clearance based on substantial equivalence. It does not provide the information typically associated with the performance evaluation of a diagnostic or AI-driven device, such as specific acceptance criteria and detailed study results. The "performance testing" mentioned is in the context of demonstrating comparability to existing predicate devices, rather than meeting predefined, quantitative acceptance criteria for a novel performance claim beyond what is typical for a surgical mesh.
§ 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.