(29 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 System (MultiFIX S) is an implantable 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: an implantable 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 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 text describes the MultiFIX® S Knotless Fixation System and its substantial equivalence to a predicate device (K131182). The submission focuses on non-clinical data (bench testing) to demonstrate performance and safety, rather than clinical studies with human participants. Therefore, many of the requested categories related to clinical study design, expert evaluation, and ground truth in a medical imaging context are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text states that "Bench testing was performed on both the proposed and predicate devices. The test results demonstrate that the MultiFIX S meets its design, performance, and safety specifications." However, specific quantitative acceptance criteria or detailed numerical performance results were not provided in the summary. The comparison table focuses on characteristics and features, not quantitative performance metrics.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Meets design specifications | "The test results demonstrate that the MultiFIX S meets its design, performance, and safety specifications." |
| Meets performance specifications | "The test results demonstrate that the MultiFIX S meets its design, performance, and safety specifications." |
| Meets safety specifications | "The test results demonstrate that the MultiFIX S meets its design, performance, and safety specifications." |
| Performs as intended | "Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate devices when used in accordance with labeling." |
| Mechanical properties substantially equivalent to predicate device | "Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate devices when used in accordance with labeling." |
2. Sample Size Used for the Test Set and Data Provenance
The study was bench testing of a medical device, not a human clinical study. The text does not specify the sample size (e.g., number of anchors tested) for the "bench testing" performed on the proposed and predicate devices.
- Sample Size for Test Set: Not specified for the bench testing.
- Data Provenance: The study was non-clinical bench testing. No country of origin or retrospective/prospective distinction applies in the context of human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was bench testing of a mechanical device, not a study evaluating human data requiring expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. This was bench testing of a mechanical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This was bench testing of a mechanical device, not a study involving human readers or cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a bone anchor, not an algorithm. The assessment was of the device's mechanical properties.
7. The Type of Ground Truth Used
The "ground truth" for the bench testing would be the objective measurements of the device's mechanical properties (e.g., pull-out strength, fatigue life) compared against established engineering standards or the performance of the predicate device. The text implies comparison to "design, performance, and safety specifications" and "mechanical properties" of the predicate.
8. The Sample Size for the Training Set
Not applicable. This was bench testing, not a machine learning study involving a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set was involved in this non-clinical bench testing.
§ 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.