(121 days)
The MectaLock Ti Suture Anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in shoulder in the following procedure:
· Shoulder: cuff rotator repair and biceps tenodesis.
The MectaLock TI Suture anchor is an implantable device used for the soft tissues refixation (i.e.: muscles, tendons, ligaments..) composed of an anchoring component (titanium alloy anchor) and two Ultra High Molecular Weight PolyEthylene non-absorbable braided sutures. This assembly, which stays within the patient during all its lifetime, is provided mounted on a dedicated disposable driver which allows the surgeon to insert and place the MectaLock TI Suture anchor into the patient. The driver can be disposed immediately after the implant is been placed. The MectaLock TI Suture anchor comes in two different sizes: ø5.0 and ø6.5mm with a fixed length of 15mm, to cover the intended population and bone quality.
The provided text describes a 510(k) premarket notification for a medical device called the "MectaLock Ti Suture Anchor." This document primarily focuses on demonstrating substantial equivalence to predicate devices based on design comparisons and non-clinical performance data, rather than AI-based performance metrics.
Therefore, the requested details regarding acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training set information are not applicable (N/A) in the context of this traditional medical device submission. The device described is a physical implant (suture anchor), not an AI/ML-driven diagnostic or treatment algorithm.
Here's a breakdown of why each point is N/A for this specific submission:
- 1. A table of acceptance criteria and the reported device performance: N/A. The submission refers to "design validation" and "characterization testing" for physical properties of a suture anchor, not performance metrics for an AI system. The acceptance criteria for such a device would relate to mechanical strength, material compatibility, and sterilization efficacy, which are confirmed through the non-clinical studies listed.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A. There isn't a "test set" in the sense of data for an AI algorithm. The studies mentioned are primarily bench testing (e.g., cyclic and load-to-failure properties) and cadaver workshops.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): N/A. This is a physical device, not an AI system requiring expert-adjudicated ground truth for a test set.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. See point 3.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A. This is not an AI-assisted device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A. The "ground truth" for this device relates to engineering specifications and biological safety standards (e.g., material properties, sterility, biocompatibility).
- 8. The sample size for the training set: N/A. This is not an AI system; there is no training set.
- 9. How the ground truth for the training set was established: N/A. See point 8.
Summary of the study conducted (Non-Clinical Studies):
The submission relies on a series of non-clinical studies to demonstrate substantial equivalence and safety/effectiveness. These included:
- Design Validation:
- A Cadaver Workshop (Protocol A1, M07.85.003) with an Evaluation form Titanium anchor.
- MR compatibility and safety evaluation for the Titanium Anchor.
- Characterization Testing:
- Cyclic and load-to-failure properties of suture anchors (Empa Test report No. 18-06-25 5214019237 1e Anchor-test final.pdf, according to Medacta Protocol IL 07.09.488 rev.0).
- Pyrogenicity:
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter ).
- Pyrogen test according to USP chapter .
- Sterilization:
- Compliance with ISO 11135:2014 (Ethylene Oxide Sterilization).
- Compliance with ISO 10993-7:2008 (Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals).
Clinical Studies:
- No clinical studies were conducted.
The "acceptance criteria" for this device are implicit in the performance standards and regulatory guidelines against which these non-clinical tests are performed (e.g., ASTM, ISO standards for materials, mechanical strength, biocompatibility, and sterilization). The reported "device performance" is confirming that the device meets these established engineering and safety standards through the described tests.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.