(38 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 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® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
The Q-Fix Suture Anchor System consists of the bone anchor and associated instruments for implanting the bone anchor.
Here's an analysis of the provided text regarding the ArthroCare Q-Fix Suture Anchor System, focusing on acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative-only acceptance criteria in a dedicated table format. Instead, it describes acceptance based on the device performing as intended and its mechanical properties being "substantially equivalent" to a predicate device. The "Comparison of Technological Characteristics" table serves as a form of acceptance criteria by showing that the proposed device is largely identical or very similar to the predicate device.
Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (based on Predicate Device K122336) | Reported Device Performance (Proposed Device ArthroCare Q-Fix) |
|---|---|---|
| Intended Use | Fixation of soft tissue to bone | Same |
| Delivery Method | Arthroscopic and Limited Access | Same |
| How Supplied | Packaged in pouch, Sterile (EtO), Single Use | Packaged in thermoform tray with Tyvek® lid, Sterile (EtO), Single Use (minor packaging difference) |
| Suture Material | No. 2 UHMWPE Suture | Same |
| Anchor Material | Braided Polyester | Same |
| Inserter Handle Materials | Medical Grade Plastics and Surgical Grade Stainless Steels | Same |
| Method of Anchor Insertion | Inserted into a predrilled hole | Same |
| Bone Locking Mechanism | Expandable Compression Fit | Same |
| Suture Locking Mechanism | Manually tied suture knot | Same |
| # of Suture Legs | Two (1.8mm) & Four (2.8mm) | Same |
| Sizes Offered | 1.8mm & 2.8mm | Same |
| Deployed Length | 15mm for 1.8mm anchor, 20mm for 2.8mm anchor | Same |
| Bone Hole Size | 2.1mm (0.083") for 1.8mm anchor, 3.1mm (0.121") for 2.8mm anchor | 2.2mm (0.085") for 1.8mm anchor, 3.1mm (0.123") for 2.8mm anchor (minor dimensional difference) |
| Accessory Instruments | Drill, Drill Guide, Obturator | Same (with additional listed instruments: Bone Punch, Knot Pusher, FirstPass* Suture Punch) |
| Overall Performance | Adherence to "design, performance, and safety specifications" and "substantially equivalent" to predicate based on FDA Guidance Document, Testing Bone Anchors, April 1996. | "meets its design, performance, and safety specifications" and "mechanical properties are substantially equivalent to the predicate devices." |
Study Information
-
Sample Size used for the test set and data provenance:
- The document states: "Bench testing was performed on both the proposed and predicate devices in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996."
- It mentions "insertion of the anchors into a simulated human bone substrate followed by both static and cyclic fatigue testing."
- Sample Size: The exact sample size (number of anchors tested) for the bench testing is not specified in the provided text.
- Data Provenance: The data is from in vitro bench testing using a "simulated human bone substrate." There is no mention of country of origin as it's not human data. The study is inherently prospective in its design as laboratory testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- There is no mention of human experts being used to establish ground truth for this mechanical/bench test. The "ground truth" here is objective mechanical performance measured against predefined standards or comparison to a predicate device.
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Adjudication method for the test set:
- No adjudication method (like 2+1, 3+1, none) is applicable or mentioned, as this involves mechanical testing, not expert review of subjective data.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a mechanical medical implant (suture anchor), not an AI diagnostic or assistance system. Therefore, the concept of "human readers improve with AI" is not applicable.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm-only performance study was not done. As mentioned, this is a mechanical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" used for this submission is based on objective mechanical test results (static and cyclic fatigue testing) against established FDA guidance for bone anchors, and direct comparison of technological characteristics to a legally marketed predicate device to establish substantial equivalence.
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The sample size for the training set:
- This is not an AI/machine learning device, so there is no training set in the traditional sense.
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How the ground truth for the training set was established:
- Not applicable as there is no training set.
§ 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.