(29 days)
The MultiFIX S Ultra Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
The MultiFIX S Ultra Knotless Fixation System (MultiFIX S Ultra) is an implantable bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S Ultra is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The MultiFIX S Ultra consists of two primary parts: an implantable bone anchor and an 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 irradiation. Both the anchor and inserter are designed for single use only.
The provided text describes the MultiFIX® S Ultra Knotless Fixation System, a bone anchor device, and its substantial equivalence to a predicate device. This submission is for a medical device that requires mechanical and functional testing, not an AI/ML powered device, therefore some of the requested information (such as reader studies, ground truth for AI, training set size) is not applicable.
Here's the relevant information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical values for performance. Instead, it states that "The test results demonstrate that the proposed MultiFIX S Ultra meets its design, performance, and safety specifications." and "All testing demonstrates that the proposed MultiFIX S Ultra performs as intended and has acceptable mechanical properties when used in accordance with the labeling."
The bench testing was performed "in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996." This guidance likely outlines the types of tests and expected performance metrics for bone anchors, which would serve as the acceptance criteria. The performance is reported as meeting these implied specifications.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet design, performance, and safety specifications (per FDA Guidance Document, Testing Bone Anchors, April 1996) | "The test results demonstrate that the proposed MultiFIX S Ultra meets its design, performance, and safety specifications." |
| Acceptable mechanical properties | "All testing demonstrates that the proposed MultiFIX S Ultra performs as intended and has acceptable mechanical properties..." |
| Substantially equivalent mechanical properties to predicate device | "...mechanical properties are substantially equivalent to the predicate device when used in accordance with labeling." |
2. Sample size used for the test set and the data provenance
The document states that "Bench testing was performed on both the proposed and predicate devices" for static and cyclic fatigue testing, and also "Design Verification testing" and "Simulated use testing." However, the exact sample sizes for these tests are not explicitly provided in the document.
Data provenance:
The data is from non-clinical bench testing. The tests simulate human bone substrate. No specific country of origin for the data is mentioned, but it's part of a submission to the U.S. FDA.
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 submission for a physical medical device, not an AI/ML powered device where expert consensus for ground truth is typically required. The "ground truth" for this type of device is established through engineering and material science principles, against defined performance specifications and physical testing methods.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations. The testing involves objective physical measurements and comparisons to engineering specifications and predicate device performance.
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 device is a bone anchor, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical bone anchor, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on engineering specifications and comparative mechanical testing results against a predicate device, as well as adherence to the principles outlined in the "FDA Guidance Document, Testing Bone Anchors, April 1996."
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.