(226 days)
The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during soft tissue repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons .
The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the bone, provide mechanical strength for the repair.
The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is a woven tape made from Polyethylene Terephthalate (PET) also referred to as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market. These devices are permanent implants for the reinforcement of soft tissues that are repaired by suture or other fixation devices during soft tissue repair surgery.
I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device, the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device, and discusses its substantial equivalence to other predicate devices for FDA clearance.
It details:
- Acceptance criteria: Not explicitly stated in terms of clinical performance metrics, but the document implies that "adequate mechanical properties for its use in soft tissue reinforcement" are criteria demonstrated through various tests.
- Device performance: The text states that "The results demonstrate that the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device provide adequate mechanical properties for its use in soft tissue reinforcement." However, specific numerical performance results are not provided.
- Type of study: "Performance Data" section lists several types of tests conducted: Suture Retention Testing, Ultimate Strength Testing, Cyclic Testing, Packaging Testing, and Biocompatibility Testing, along with routine endotoxin (LAL) batch testing. These appear to be laboratory and material science tests, not clinical studies.
The document does not provide information on:
- A table of acceptance criteria and reported device performance with numerical values.
- Sample size used for a test set, data provenance, or whether it was retrospective/prospective.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
- Standalone algorithm performance (as this is a physical medical device, not an AI/software device).
- The type of ground truth used (expert consensus, pathology, outcomes data).
- The sample size for the training set or how ground truth for the training set was established.
Therefore, I cannot generate the requested table or answer most of the questions based on the provided text.
§ 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.