(28 days)
The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure
• Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
The Arthrex FiberTak Suture Anchor is an all-suture knotless anchor intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.
The anchor is constructed from a hollow braid sheath made of polyester yarns with Arthrex suture components assembled to the sheath. The suture components include a repair suture and a passing suture which are braided polyester sutures made of ultra-high molecular weight polyethylene (UHMWPE) where the suture may also include nylon yarns. The anchor is preloaded on a disposable inserter and is provided sterile (Ethylene Oxide), single-use, and is packaged in a 5-pack.
The provided document is a 510(k) premarket notification for a medical device, the Arthrex FiberTak Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based diagnostic or prognostic tool.
Therefore, many of the requested elements regarding acceptance criteria, training/test sets, expert adjudication, MRMC studies, and standalone performance for an AI/algorithm are not applicable to this document. This document details the physical characteristics of a mechanical medical device and its performance through mechanical testing and biocompatibility assessment.
However, I can extract information related to the performance data and the comparison to the predicate device, which serves a similar function to demonstrating "acceptance criteria" in the context of a 510(k) submission for a physical device.
Here's the information that can be extracted from the provided text, and where gaps exist due to the nature of the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Measured Performance) | Reported Device Performance (Arthrex FiberTak Suture Anchor) |
|---|---|
| Mechanical Strength (Cyclic Pull-out Testing) | Statistically equivalent to the primary predicate device (K221396) |
| Pyrogenicity (Bacterial Endotoxin per EP 2.6.14/USP ) | Meets pyrogen limit specifications |
| Biocompatibility | Identical biocompatibility profile to the primary predicate device (K221396) |
| Sterility (Ethylene Oxide) | Provided sterile, single-use, packaged in a 5-pack |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample size used for the cyclic pull-out testing. It only mentions that "Cyclic pull-out testing was conducted."
- Data Provenance: The data was generated by Arthrex Inc. in the context of demonstrating substantial equivalence for their new device. There is no mention of country of origin of the data or whether it was retrospective or prospective in the context of a clinical study, as this is a device performance test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device, and "ground truth" is established through physical testing standards and specifications (e.g., measured pull-out strength, endotoxin levels), not expert interpretation of diagnostic images or data.
4. Adjudication method for the test set:
- Not Applicable. As above, mechanical tests do not involve adjudication by multiple human experts.
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 document pertains to a physical medical device (suture anchor), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/algorithm device.
7. The type of ground truth used:
- The "ground truth" for this device's performance is established by engineering and material science standards and specifications. For example:
- Mechanical strength: Measured values from cyclic pull-out tests that are compared against predefined performance benchmarks or the performance of a legally marketed predicate device.
- Biocompatibility: Demonstrated through adherence to established biocompatibility testing standards (e.g., ISO 10993) and comparison to a predicate device with a known biocompatibility profile.
- Sterility: Demonstrated through validated sterilization processes and testing to ensure compliance with sterility assurance levels.
- Pyrogenicity: Demonstrated by a bacterial endotoxin test meeting specified limits.
8. The sample size for the training set:
- Not Applicable. This is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/algorithm device.
Summary of the study proving the device meets the "acceptance criteria" (i.e., substantial equivalence):
The study described is a performance testing study primarily focused on cyclic pull-out testing and bacterial endotoxin testing.
- Purpose: To demonstrate that the new Arthrex FiberTak Suture Anchor performs equivalently to its primary predicate device (K221396) and meets safety specifications.
- Methodology:
- Cyclic Pull-out Testing: Performed on the new device. The results were then compared statistically to the performance of the predicate device (K221396). The document states the new device "performs statistically equivalent to the primary predicate device."
- Bacterial Endotoxin Testing: Conducted per EP 2.6.14/USP to ensure the device meets pyrogen limit specifications.
- Technological Comparison: The submission also relies on a detailed technological comparison, stating that the subject device is a line extension with "identical basic design, indications for use, intended use, packaging, shelf-life, biocompatibility profile, overall manufacturing, and sterilization processes" to the predicate. The only stated modification is to the pre-loaded sutures, and this difference is considered minor, not raising new questions of safety or effectiveness.
- Conclusion: Based on the performance data and technological comparison, Arthrex determined that the subject device is substantially equivalent to the currently marketed primary predicate device, implying it meets the necessary performance and safety criteria for its intended use.
§ 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.