(85 days)
The Pitch-Patch is a single use device intended to be used for reinforcement of the rotator cuff following or during repair by suture or suture anchors, where weakness exists in the soft tissue.
The Pitch-Patch is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, 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 rotator cuff tears. 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.
The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market.
The provided text describes the 510(k) clearance for the Pitch-Patch Tissue Reinforcement Device. This device is a surgical mesh intended to reinforce the rotator cuff during or after repair.
The information provided focuses on the performance testing conducted to demonstrate the device's substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving the device meets them in the context of an AI/software device. The document describes a medical device, not an AI/software device. Therefore, many of the requested points related to AI/software performance criteria (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone algorithm performance) are not applicable or extractable from this document.
However, I can extract information related to the performance studies done for this physical medical device.
Here's an analysis based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in the typical sense for an AI/software device (e.g., minimum sensitivity, specificity). Instead, it lists the types of performance tests conducted and concludes that the results demonstrate the device's mechanical properties are appropriate and that differences from predicates do not affect safety and efficacy.
| Type of Performance Test | Reported Device Performance and Conclusion |
|---|---|
| Bench Testing: | |
| - Simple Stitch Pull-Out Testing | • Successfully completed in accordance with FDA Guidance for Surgical Mesh. |
| - Burst Testing | • Successfully completed in accordance with FDA Guidance for Surgical Mesh. |
| - Tensile Testing of base material | • Successfully completed in accordance with FDA Guidance for Surgical Mesh. |
| - Tear Testing | • Successfully completed in accordance with FDA Guidance for Surgical Mesh. |
| - Density and Pore Size Testing | • Successfully completed in accordance with FDA Guidance for Surgical Mesh. |
| - Biocompatibility | • Successfully completed in accordance with FDA Guidance for Surgical Mesh. |
| Overall Bench Testing Conclusion | "The results demonstrate that the Pitch-Patch provides appropriate mechanical properties for its use in soft tissue repair." "The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficacy of the new device in relation to the predicate." |
| Clinical Performance (Cohort Study): | |
| - Constant-Murley Score | • Increased significantly from 36.5 (pre-op) to 81.2 (midterm, P |
§ 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.