(57 days)
The Arthrex TightRope II is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACL/PCL Repair and Reconstruction.
The Arthrex TightRope II is suture and button construct comprised of a titanium button and nonabsorable suture intended to be used for the purpose ACL/PCL repair and reconstruction.
This is a 510(k) summary for a medical device, which means it describes the device and its equivalence to a predicate device, but it does not contain information about an AI/ML-driven medical device or a clinical study proving its performance against acceptance criteria in the way a diagnostic AI would.
The document describes the Arthrex TightRope II, which is a mechanical device (suture and button construct) for bone and soft tissue fixation, specifically for ACL/PCL repair and reconstruction.
Therefore, many of the requested categories for AI/ML device studies (like sample size for test set, data provenance, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this document.
However, I can extract the relevant information regarding acceptance criteria and performance for this type of mechanical device:
1. Table of Acceptance Criteria and Reported Device Performance
For the Arthrex TightRope II, the "acceptance criteria" are implied by demonstrating that modifications to the device (compared to its predicate) do not negatively impact its mechanical strength and that it meets pyrogen limits and MR compatibility standards.
| Performance Metric | Acceptance Criteria (Implied/Standard) | Reported Device Performance and Method |
|---|---|---|
| Mechanical Strength | Modifications do not negatively impact mechanical strength compared to predicate device K112990. | Ultimate load testing and cyclic displacement were performed on the subject device and compared to the predicate device to demonstrate that the modifications do not negatively impact mechanical strength. (Specific quantitative results are not provided in this summary but are implied to meet equivalence.) |
| Pyrogenicity | Meets pyrogen limit specifications (per EP 2.6.14/USP ). | Bacterial endotoxin testing per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications. (Specific quantitative results are not provided but are implied to meet the standard.) |
| MR Safety & Compatibility | Meets FDA guidance and ASTM standards for MR compatibility (i.e., safe for use in MR environment). | MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" and specific ASTM standards: |
- ASTM F2052 (Magnetically Induced Displacement Force)
- ASTM F2119 (MR Image Artifacts)
- ASTM F2182 (Radio Frequency Induced Heating)
- ASTM F2213 (Magnetically Induced Torque)
(Results are not quantified but are implied to show MR conditional labeling is appropriate and safe.) |
Explanation of the Study Proving Device Meets Acceptance Criteria:
The study involved various bench tests and laboratory analyses comparing the Arthrex TightRope II to its predicate device (K112990) and assessing its compliance with relevant regulatory standards. These tests covered:
- Mechanical Performance: Ultimate load testing and cyclic displacement testing to ensure the device's structural integrity and durability were not compromised by design modifications.
- Biocompatibility/Pyrogenicity: Bacterial endotoxin testing to confirm the device is non-pyrogenic.
- MR Compatibility: A series of tests adhering to FDA guidance and ASTM standards (F2052, F2119, F2182, F2213) to evaluate magnetic force, torque, radiofrequency-induced heating, and image artifacts, leading to an "MR conditional" label.
The conclusion states that these "performance data" demonstrate that the device modifications are minor and "do not raise different questions concerning safety or effectiveness," thereby supporting its substantial equivalence to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This document does not specify the number of individual devices or test runs for each mechanical or biological test. These are typically standard laboratory tests, not clinical studies with patient data.
- Data Provenance: The data would originate from laboratory bench testing and analysis conducted by the manufacturer (Arthrex Inc.) or a contracted testing facility, likely in the US, as Arthrex Inc. is based in Naples, FL, USA. It is essentially prospective testing against predefined engineering and material standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a mechanical fixation device, "ground truth" is established by adherence to engineering specifications, material science principles, and regulatory standards, not by expert medical review of patient data. The "experts" involved would be engineers, material scientists, and quality assurance specialists performing the tests and comparing results to established benchmarks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is not a diagnostic AI study requiring adjudication of expert opinions. Device performance is determined by quantitative measurements against objective criteria.
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
- Not Applicable. This is a mechanical surgical device, not an AI-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a mechanical construct, not an algorithm. Its performance is inherent in its physical and material properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth Type: For mechanical performance, the "ground truth" is defined by engineering specifications, material properties, and established industry standards (e.g., maximum load, displacement limits, pyrogen limits, MR safety thresholds from ASTM standards).
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this mechanical device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question does not apply.
§ 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.