(94 days)
The MultiFIX S 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 Knotless Fixation Device (MultiFIX S) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The MultiFIX S consists of two primary parts: a PEEK 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 irradiation. Both the anchor and inserter are designed for single use only.
The MultiFIX S Knotless Fixation System consists of the bone anchor and associated instruments for implanting the bone anchor.
The provided document describes the MultiFIX® S Knotless Fixation Device and its 510(k) submission, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert qualifications for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this submission.
However, I can extract information regarding the device's acceptance criteria and the study that proves it meets them, based on the document's content.
Acceptance Criteria and Device Performance for MultiFIX® S Knotless Fixation Device
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Metric) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Properties | Deemed substantially equivalent to predicate devices. Meets design, performance, and safety specifications. Performs as intended. |
| Design Specifications | Met |
| Performance Specifications | Met |
| Safety Specifications | Met |
| Substantial Equivalence | Demonstrated across intended use, operating principle, materials, and technological characteristics when compared to predicate devices. Minor differences do not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the mechanical tests. It mentions that "Bench testing was performed on both the proposed and predicate devices," indicating that multiple units of each were tested.
- Data Provenance: The testing was "in vitro," using a "simulated human bone substrate." This indicates the data is from a controlled lab environment (bench testing), not from human or animal subjects. The country of origin is not explicitly stated but implies the US, given the submission to the FDA. The testing is prospective as it's part of the premarket submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the study involves mechanical bench testing of a device, not an AI/ML algorithm requiring expert ground truth for classification or diagnosis. The "ground truth" here is the physical performance measured against engineering specifications.
4. Adjudication method for the test set
- This question is not applicable for the same reasons as above. No expert adjudication method (like 2+1 or 3+1) is relevant for mechanical bench testing.
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
- This question is not applicable. This submission is for a medical device (bone anchor), not an AI/ML software. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. This involves a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the mechanical testing was based on pre-defined design, performance, and safety specifications, and comparison to the mechanical properties of legally marketed predicate devices. This is an engineering/design-based ground truth, not clinical or diagnostic.
8. The sample size for the training set
- This question is not applicable as there is no AI/ML algorithm involved. The device underwent bench testing, not a training process.
9. How the ground truth for the training set was established
- This question is not applicable as there is no AI/ML algorithm involved.
§ 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.