(41 days)
The Q-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for:
Shoulder: Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular shift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; biceps tenodesis
Foot & Ankle: Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux valgus reconstruction; Metatarsal ligament/tendon repair or reconstruction; Achilles tendon repair
Elbow: Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon reattachment
Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure
Hand & Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in phalanx; Volar plate reconstruction
Hip: Acetabular labral repair
The purpose of this subnission is to seek clearance for modifications and additions to the accessory instrumentation used with the previously cleared Q-Fix Suture Anchor System (K132513). There are no changes to the previously cleared indications for use, materials, design, technology, method of anchor insertion and or tissue attachment.
The Q-Fix Suture Anchor System (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures.
The Q-Fix consists of two primary parts: a bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.
The entire product is packaged in a tray with a Tyvek® Iid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
The O-Fix Suture Anchor System consists of the bone anchor and associated instruments for implanting the bone anchor.
The Q-Fix™ Suture Anchor System is a medical device designed for soft tissue to bone fixation. The device underwent mechanical testing to demonstrate its safety and effectiveness.
1. Acceptance Criteria and Reported Device Performance:
The acceptance criteria are not explicitly quantifiable performance metrics in the provided text, but rather a demonstration of substantial equivalence to the predicate device and adherence to design, performance, and safety specifications based on mechanical testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets design, performance, and safety specifications | "The test results demonstrate that the Q-Fix meets its design, performance, and safety specifications." |
| Performs as intended | "Based on the test results, the proposed device performs as intended..." |
| Mechanical properties are substantially equivalent to the predicate device (ArthroCare Q-Fix™ Suture Anchor: K132513) | "...mechanical properties are substantially equivalent to the predicate devices when used in accordance with labeling." Also, "All testing demonstrates that the Q-Fix performs as intended and has acceptable mechanical properties..." |
| Testing performed in accordance with FDA Guidance Document, Testing Bone Anchors, April 1996 | "Mechanical testing was performed in accordance with the requirements of the FDA Guidance Document, Testing Bone Anchor Devices, April 1996." |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: Not explicitly stated. The text mentions "Bench testing was performed on both the proposed and predicate devices," implying multiple units were tested, but the exact number is not provided.
- Data Provenance: The testing was "in vitro," involving insertion of anchors into a "simulated human bone substrate." This indicates the data is from laboratory bench testing, rather than from human or animal subjects. The origin (country) is not specified beyond "ArthroCare Corporation" which is located in Austin, Texas, USA. The testing is prospective as it was conducted specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This device is a mechanical implant, and its performance was assessed through bench testing, not through expert interpretation of data or images. Therefore, clinical experts were not required to establish ground truth for the device's mechanical performance.
4. Adjudication Method:
Not applicable, as no expert adjudication was involved for this type of mechanical bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The Q-Fix™ Suture Anchor System is a surgical implant, and its performance is evaluated mechanically rather than through human interpretation.
6. Standalone (Algorithm Only) Performance:
Not applicable. The Q-Fix™ Suture Anchor System is a medical implant, not an AI algorithm. Its performance is inherent to its physical design and mechanical properties, not an algorithm.
7. Type of Ground Truth Used:
The ground truth for evaluating the device's performance was established through mechanical testing against predefined specifications and comparison to the predicate device. This involved "static and cyclic fatigue testing" in a "simulated human bone substrate."
8. Sample Size for Training Set:
Not applicable. As a medical implant, there is no "training set" in the context of machine learning or AI. The design and manufacturing process would involve internal testing and validation, but not a training set as understood in AI/ML.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no training set. The "ground truth" for the device's design and manufacturing would be based on engineering principles, material science, and regulatory standards.
§ 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.