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510(k) Data Aggregation
(21 days)
Arthrex Knotless FiberTak Suture Anchor
The Arthrex Double Loaded Knotless FiberTak® Suture Anchor is intended to be used for suture (soft tissue) fixation 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 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 (Except Canada)
· Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair (Except Canada)
The Arthrex Double Loaded Knotless 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 Arthrex Double Loaded Knotless FiberTak Suture Anchor is a sterile, single use implant device constructed from a hollow braid of polyester (sheath) preloaded on an inserter with a double loaded suture component composed of UHMWPE and polyester.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device: the "Arthrex Double Loaded Knotless FiberTak® Suture Anchor." This document describes a surgical implant and its intended uses, asserting its substantial equivalence to a previously cleared device. It does not describe an AI/machine learning device, nor does it contain information about acceptance criteria or a study that proves an AI device meets acceptance criteria.
The information you are requesting, such as ground truth, sample sizes for training/test sets, expert adjudication methods, or MRMC studies, are concepts applicable to AI/ML device evaluations, particularly for diagnostic imaging or assistive technologies. Since this document describes a physical surgical implant (a suture anchor), these concepts are not relevant to its regulatory submission.
Therefore, I cannot extract the requested information from the provided text for an AI/ML device. The document explicitly states the "Performance Data" is "Cyclic pull-out testing was conducted on the proposed devices submitted in this Special 510(k). The test data demonstrates that the proposed devices perform statistically equivalent to the predicate device. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications." This type of testing is standard for mechanical implants, not AI.
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(70 days)
KNOTLESS FIBERTAK SUTURE ANCHOR
The Arthrex Knotless FiberTak Suture Anchor is intended for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers
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
Hip: Acetabular Labral repair
The Arthrex Knotless FiberTak Suture Anchor is an "all-suture" soft-tissue fixation device with an expandable push-in design. It is constructed from a hollow braid of polyester. An UHMWPE suture construct is assembled through the hollow braid coupled with a nitinol passing wire. The device comes preloaded on a disposable inserter.
Here's an analysis of the provided text regarding the Arthrex Knotless FiberTak Suture Anchor, focusing on the acceptance criteria and the study that proves the device meets those criteria:
Device: Arthrex Knotless FiberTak Suture Anchor
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary indicates that the primary acceptance criterion is substantial equivalence to predicate devices. This means the new device must perform comparably to existing, legally marketed devices for its intended use.
Specifically, the document states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Basic Design Features are the same as predicate devices. | "The Arthrex Knotless FiberTak Suture Anchor is substantially equivalent to the predicate devices, in which the basic design features and intended uses are the same." |
| Intended Uses are the same as predicate devices. | "The Arthrex Knotless FiberTak Suture Anchor is substantially equivalent to the predicate devices, in which the basic design features and intended uses are the same." (Specific intended uses for various anatomical locations are listed in detail for the device itself, implying they align with the uses of the predicate devices). |
| Material Composition is substantially equivalent to predicate devices. | "The proposed devices are comprised of polyester and UHMWPE. These materials are substantially equivalent to the materials found in the predicate devices." |
| Tensile Strength (pull-out) is substantially equivalent to predicate devices for the desired indications. | "The submitted mechanical testing data demonstrates that the tensile strength (pull-out) of the proposed devices are substantially equivalent to the predicates for the desired indications." |
| Safety and Effectiveness are not compromised by any minor differences. | "Any differences between the Arthrex Knotless FiberTak and the predicates are considered minor and do not raise questions concerning safety and effectiveness." This is a general statement that encompasses the overall assessment of the device's performance relative to the predicates. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly mentions "mechanical testing data" to demonstrate tensile strength (pull-out). However, it does not specify the sample size used for this mechanical testing.
The data provenance is implied to be from laboratory-based mechanical testing, likely conducted by Arthrex, Inc. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective. Given the nature of mechanical testing for a medical device, it would inherently be prospective in its execution (i.e., tests were performed specifically for this submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" established by experts, as typically applied in AI/ML studies, is not applicable here. This document describes the premarket notification for a physical medical device (suture anchor), not a diagnostic algorithm or AI system. The "truth" or performance is established through direct mechanical testing, not through expert interpretation of data.
4. Adjudication Method for the Test Set
Since ground truth as per AI/ML context is not applicable, an adjudication method in that sense is not relevant for this mechanical device submission. The results of the mechanical tests themselves would be the "data" that are then compared against the predicate device's performance.
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 done. This type of study is relevant for evaluating the performance of diagnostic tools or AI systems, particularly how human readers perform with or without AI assistance. This submission is for a physical surgical anchor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance study (in the context of an algorithm) was not done. This is not an AI/ML device. The "standalone performance" here would be the tensile strength and other mechanical properties of the device itself, which were indeed tested.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on objective mechanical testing data, specifically "tensile strength (pull-out)." This is a direct physical measurement, not expert consensus, pathology, or outcomes data. The comparison is made against documented performance characteristics of legally marketed predicate devices.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. This is not an AI/ML device that requires a training set for model development. The device itself is being tested, not an algorithm.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an AI/ML model, this question is not applicable.
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