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510(k) Data Aggregation
(75 days)
MULTIFIX P KNOTLESS FIXATION DEVICE
The MultiFIX P 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 attachment.
- 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 P Knotless Fixation Device (MultiFIX P) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX P is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue. The MultiFIX P 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 P Knotless Fixation System consists of the 4.5 mm MultiFIX P and associated instruments for implanting the bone anchor.
The MultiFIX™ P Knotless Fixation Device is a bone anchor designed for the fixation of soft tissue to bone.
1. Acceptance Criteria and Reported Device Performance:
The document states that mechanical testing was performed in accordance with the FDA Guidance Document, "Testing Bone Anchor Devices, April 1996." The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to the predicate device, the ArthroCare LabraLock® P Knotless Fixation Device (K061349).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (ArthroCare LabraLock® P Knotless Fixation Device K061349) based on mechanical testing. | "Results indicated substantial equivalence for the proposed device." |
| "The test results demonstrate that the MultiFIX P meets all design, performance, and safety specifications." | |
| "All testing demonstrates that the MultiFIX P performs as intended and has acceptable mechanical properties when used in accordance with its labeling." | |
| Meet all design, performance, and safety specifications. | "The test results demonstrate that the MultiFIX P meets all design, performance, and safety specifications." |
| Acceptable mechanical properties. | "All testing demonstrates that the MultiFIX P performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size for the test set used in the bench testing. It only states that "side by side bench testing was performed on both the proposed and predicate device."
- Data Provenance: The data is from in vitro testing, specifically "in a simulated human bone substrate." The country of origin is not explicitly stated but is implied to be within the scope of the submitting company, ArthroCare Corporation. This was a retrospective evaluation of the device's mechanical properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the study involved mechanical bench testing, not expert-based assessment of medical images or patient outcomes. The "ground truth" was established by objective mechanical measurements against established engineering principles and the performance of a predicate device.
4. Adjudication Method for the Test Set:
This information is not applicable for mechanical bench testing. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used for evaluating human reader performance, typically with medical imaging, and is not applicable to the mechanical testing of a bone anchor.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The bench testing evaluated the mechanical performance of the MultiFIX P Knotless Fixation Device (algorithm only, if considering the device's function as an "unassisted" component) against predetermined criteria and the predicate device, independent of human interaction beyond implantation during the test.
7. Type of Ground Truth Used:
The ground truth used was mechanical performance data obtained from laboratory bench testing. This included measurements of static and cyclic fatigue performance against a simulated human bone substrate, with the predicate device serving as a comparative benchmark for substantial equivalence.
8. Sample Size for the Training Set:
This information is not applicable. The device is a mechanical medical device, not an AI/ML algorithm that requires a training set. The "training" in this context would refer to the design and refinement of the physical device, which isn't described in terms of a data-driven training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as in point 8. The device's "ground truth" for its design would be engineering specifications, material properties, and clinical needs, rather than a labeled dataset used for training an algorithm.
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