(82 days)
The Pitch-Patch Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons.
The Pitch -Patch 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 tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.
The Pitch-Patch is a permanent implantable device for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon. It is constructed from a warp knitted fabric with integral eyelets. It is reinforced around its perimeter and around each eyelet to increase the security of suture attachment. The Pitch-Patch is available in two sizes, to cover different tear sizes without trimming (30 x 20 mm and 35 x 25 mm). It should not be cut to size. The device is supplied sterile, by Gamma Irradiation to an SAL of 10-6.
The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a non-absorbable material that has a long history of use in the orthopedic market.
The provided text describes a medical device called the "Pitch-Patch Tissue Reinforcement Device" and its FDA 510(k) clearance application. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The document is a 510(k) summary for a physical surgical mesh device, not an AI software or system. Therefore, details like AI performance metrics (sensitivity, specificity, AUC), test set characteristics, expert ground truth establishment, MRMC studies, or training set details are not applicable to the information given.
The "Performance Data" section lists various mechanical and biological tests for the Pitch-Patch (e.g., Suture Retention, Ultimate Strength, Biocompatibility). These are typical for surgical mesh devices to demonstrate safety and effectiveness for their intended physical function, but they are not the type of acceptance criteria or studies relevant to AI/ML device performance.
Therefore, I cannot provide the requested information for an AI/ML device based on the input 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.