(27 days)
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 an implantable 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: 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® lid, and the finished product is sterilized by irradiation. Both the anchor and inserter are designed for single use only.
This document describes the MultiFIX® P Knotless Fixation Device, a medical device for soft tissue to bone fixation. The provided text is a 510(k) submission for FDA clearance, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics for a new device's efficacy or diagnostic accuracy.
Therefore, the requested information regarding acceptance criteria and performance data as typically found in studies proving diagnostic or therapeutic effectiveness is not explicitly present in the provided document. The document primarily addresses the substantial equivalence of the proposed device to a previously cleared predicate device based on design, materials, and mechanical properties.
However, I can extract information related to the "study" that was conducted to support the 510(k) submission and the "acceptance criteria" as implied by the comparison to the predicate device.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the proposed device performs "as intended" and has "acceptable mechanical properties" that are "substantially equivalent" to the predicate device. The "reported device performance" is that it met these criteria through bench testing.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (Bench Testing) |
|---|---|
| Performs as intended | Met |
| Acceptable mechanical properties | Met |
| Substantially equivalent to the predicate device | Met |
| (Specific mechanical test results are not detailed in this summary, only the conclusion) | (Specific mechanical test results are not detailed in this summary, only the conclusion) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document states "Bench testing was performed on both the proposed and predicate devices," but does not specify the sample size (e.g., number of devices tested) for the bench tests.
- Data Provenance: The data is from non-clinical bench testing. The country of origin is not specified, but the applicant, ArthroCare Corporation, is located in Irvine, California, USA, suggesting the testing likely occurred in the US or a facility affiliated with the company. The data is prospective in the sense that the tests were conducted specifically to support this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" for demonstrating substantial equivalence of a bone fixation device in a 510(k) context is typically based on engineering standards, material specifications, and mechanical testing protocols, not expert clinical interpretation of results like in diagnostic imaging studies. The evaluation of mechanical properties is objective.
4. Adjudication method for the test set:
- Not applicable for bench testing of mechanical properties. The assessment is based on quantitative measurements and comparison to predefined 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:
- No, this is not applicable. The document describes a traditional medical device (bone anchor) and its mechanical testing, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study was performed, and there's no mention of AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. As mentioned above, this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used:
- For the bench testing, the "ground truth" for comparison effectively comes from established engineering principles, material science, and the performance characteristics of the legally marketed predicate device (K120096). The tests are designed to confirm that the proposed device behaves within expected mechanical parameters and equivalently to the predicate.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth established for it.
§ 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.