(181 days)
The FiberTak Button 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 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
• Hip: Acetabular labral repair
The FiberTak Button is also 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 in the knee, shoulder, and elbow and may include the following indications; ACL/PCL repair (minor/major), biceps tendon repar and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The FiberTak Button is an 'all-suture' soft-tissue device constructed from a hollow braid of polyester and two shuttling sutures made of a polyblend of UHMWPE and polyester. The FiberTak Button is preloaded on a disposable inserter and will be sold sterile for single use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the FiberTak Button, structured according to your request.
Please note: The provided document is a 510(k) summary for a medical device (FiberTak Button), not a clinical study report for an AI/CADe device. Therefore, many of your requested points related to AI/CADe studies (like multi-reader multi-case studies, expert consensus on images, training sets, etc.) are not applicable to this type of submission. The information below focuses on mechanical and biological performance rather than diagnostic accuracy.
Acceptance Criteria and Device Performance for FiberTak Button (K191426)
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Testing | Met criteria established by predicate devices. | Demonstrated pull-out strength, including post-cyclic loading, met the criteria established by the predicate devices. |
| Biocompatibility | Passing results per ISO 10993-1:2009. | Demonstrated passing results per ISO 10993-1:2009. |
| Bacterial Endotoxin | Met pyrogen limit specifications per EP 2.6.14 / USP . | Conducted to demonstrate that the device meets pyrogen limit specifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for the tensile testing, biocompatibility testing, or bacterial endotoxin testing. It refers to these as performance data that demonstrate equivalence.
Regarding data provenance: This clinical and regulatory document does not cover the country of origin or whether data was retrospective or prospective in the context of typical AI/CADe studies. These are laboratory and material tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to the type of device and testing described. "Ground truth" in this context refers to established standards for material properties and biological response, not expert interpretation of diagnostic images. The ground truth is defined by the specified international standards (ISO 10993-1:2009, EP 2.6.14 / USP ) and comparison to predicate devices, which are themselves held to certain performance levels.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in diagnostic imaging studies. The tests described are objective laboratory measurements, not subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for assessing the diagnostic performance of AI-assisted systems in interpreting medical images, which is not the function of the FiberTak Button.
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 or AI system was not done. The FiberTak Button is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance tests relies on:
- Established standards and specifications: ISO 10993-1:2009 for biocompatibility, EP 2.6.14 / USP for bacterial endotoxin/pyrogen limits.
- Performance of legally marketed predicate devices: For tensile strength, the proposed device's performance was compared to the criteria established by its predicate devices (K181769: Arthrex FiberTak Suture Anchor, K123341: Arthrex Proximal Biceps Button). This establishes a benchmark for clinical safety and effectiveness based on prior device performance.
8. The Sample Size for the Training Set
This question is not applicable. There is no AI algorithm being trained for this device. The term "training set" is typically used in machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for an AI algorithm for this device.
§ 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.