(219 days)
The MectaTap 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 MectaTap TI - Suture anchor is an implantable knotted device used for the soft tissues refixation (i.e.: muscles, tendons, ligaments...) composed of a titanium alloy anchoring component preloaded with two Ultra High Molecular Weight PolyEthylene non-absorbable braided sutures and assembled on a disposable inserter.
Due to its specific design, the MectaTap TI - Suture anchor is implanted by tapping on the plastic handle of the inserter: the modularity between the internal eyelet and the external sleeve translates the axial movement of tapping into rotation of the anchor's body into the bone.
The MectaTap TI Suture anchor comes in two different sizes: ø5.0 and ø6.5mm (maximum external diameter) with a fixed length of 15mm, to cover the intended population and bone quality.
The document provided is a 510(k) Premarket Notification from the FDA for a medical device called "MectaTap TI Suture Anchor." This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting detailed performance criteria and studies for AI/ML-driven devices or clinical trials that establish detailed efficacy.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for AI/ML systems is not present in this document.
Instead, the document details physical performance tests (non-clinical studies) to show the device is safe and effective compared to predicate devices. Here's what can be extracted:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with reported device performance in terms of specific quantitative metrics for AI/ML performance. Instead, it lists non-clinical studies conducted to support substantial equivalence. The "acceptance criteria" are implied to be that the device performs comparably or acceptably based on these physical tests to existing marketed devices.
The reported "performance" is that these tests were conducted according to written protocols and found satisfactory to support the substantial equivalence claim.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary) |
|---|---|
| Design Validation | Confirmed through Medacta Design Validation Protocol A1 (Wetlab) M07.85.003 and Evaluation form. Impaction Test satisfactory. |
| MR Compatibility | MR Safety Evaluation confirmed. |
| Mechanical Characterization | Cyclic and load-to-failure testing conducted according to Empa Test report and Medacta Protocol. Hitting force assessment Workshop conducted. Finite Element Study on Mechanical Evaluation During Assembly completed. |
| Biocompatibility | Deemed unnecessary due to extensive history of use of materials in marketed medical devices. |
| Pyrogenicity | Bacterial endotoxin test (LAL test) and Pyrogen test conducted according to European Pharmacopoeia and USP chapter. |
| Sterilization | Compliance with ISO 11135:2014 and ISO 10993-7:2008 for Ethylene Oxide sterilization confirmed. |
| Shelf-life | Labelled with a 5-year shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of AI/ML or clinical data. The performance claims rely on non-clinical engineering and biological safety tests.
- Design Validation (Wetlab): The protocol A1 (Wetlab) M07.85.003 was used; however, the sample size (number of devices or tests performed) is not specified.
- Impaction Test, Hitting force assessment Workshop, Cyclic and load-to-failure testing, Mechanical Evaluation (FEA): No sample sizes are provided for these tests, nor is the provenance of any data (e.g., country of origin, retrospective/prospective) relevant here as these are physical device tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the provided document. The document pertains to physical device performance and safety, not diagnostic performance where expert ground truth is typically established.
4. Adjudication Method for the Test Set
This information is not applicable to the provided document. Adjudication methods are typically used in clinical or image-based studies to resolve discrepancies in ground truth, which is not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or conducted. The document explicitly states: "No clinical studies were conducted." The device is a physical medical implant, not an AI/ML diagnostic or assistive tool.
6. If a Standalone Study Was Done
The term "standalone" typically refers to the performance of an algorithm without human intervention in AI/ML contexts. In this case, the studies conducted (Design Validation, Mechanical Characterization, Biocompatibility, etc.) assess the physical device's intrinsic properties and performance. These studies are "standalone" in the sense that they evaluate the device itself, not in combination with another technology like AI.
7. The Type of Ground Truth Used
The concept of "ground truth" as it applies to AI/ML or clinical outcomes is not applicable here. The "ground truth" in this context is based on:
- Engineering standards: Device materials conforming to ASTM and ISO standards.
- Biocompatibility standards: Confirmation that materials have a history of safe use, and specific tests like bacterial endotoxin and pyrogen tests meeting Pharmacopoeia/USP standards.
- Mechanical testing results: Outcomes of cyclic loading, load-to-failure, and impaction tests are compared against established engineering expectations or predicate device performance.
- Sterilization standards: Compliance with ISO standards.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical implant, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As no training set is involved, there is no ground truth establishment for it.
§ 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.