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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.

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.

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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.

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