(36 days)
The MTA Protective Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and endoscopic procedures. MTA Protective Sheet is intended for one-time use.
MTA Protective Sheet is composed of microbial-derived cellulose. The non-resorbable surgical mesh is used for the management and protection of tendon injuries. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The implantable device is presented in a sterile double-pouched package for appropriate removal in preparation for surgery.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Biologically and chemically identical to Securian Tissue Reinforcement Matrix (K083823) and very similarly manufactured. |
| Biomechanical Equivalence | Met test requirements in material property and suture pull-out testing, demonstrating biomechanical equivalence to MAST Biosurgery Ortho-Wrap Bioresorbable Sheet. |
| Intended Use | Provides reasonable assurance of device performance for its intended use. |
| Minimizes Tissue Attachment | Minimizes tissue attachment to the device in case of direct contact with the tissues (stated in device description and indications). |
| Management & Protection of Tendon Injuries | Indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. |
| Open and Endoscopic Procedures | Indicated for open and endoscopic procedures. |
| Single Use | Intended for one-time use. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "various performance tests typical for its product code such as material property and suture pull out testing." However, it does not specify the sample size used for these tests.
The data provenance is from bench testing, meaning it was conducted in a laboratory setting, not on human or animal subjects, and is neither retrospective nor prospective in the typical clinical sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The studies conducted were bench tests on material properties, not clinical studies requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set:
An adjudication method is not applicable as the studies were bench tests focused on material properties and biomechanical equivalence, not on interpreting images or clinical outcomes that typically require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The document primarily focuses on demonstrating substantial equivalence through material and biomechanical testing against predicate devices.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical surgical mesh, not a software algorithm, so the concept of standalone performance does not apply in this context.
7. Type of Ground Truth Used:
The ground truth for the performance testing was based on objective measurements from material property and suture pull-out tests, and comparison against the known characteristics and performance of the predicate devices (Securian Tissue Reinforcement Matrix for biocompatibility, and MAST Biosurgery Ortho-Wrap Bioresorbable Sheet for biomechanical properties).
8. Sample Size for the Training Set:
The document does not mention a "training set" as this is not a machine learning or AI-based device. The testing described is for performance validation, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set," this information is not applicable.
§ 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.