(83 days)
The RC Multi-Suture Anchor is intended for soft tissue to bone fixation for the following indications: SHOULDER Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair KNEE Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair
The RC Multi-Suture Anchor is intended for fixation of soft tissue to bone in the shoulder, knee, and ankle. The device consists of a three-piece polymer implant assembled onto a delivery shaft. The implant is delivered manually using a delivery handle. The RC Multi-Suture Anchor is a sterile, single use device offered in one size, 4.5mm.
This document describes the performance data for the RC Multi-Suture Anchor, which is a bone anchor device. The study is a comparison of the RC Multi-Suture Anchor to a predicate device, the ROC EZ Suture Bone Fastener, to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Objective: Demonstrate substantial equivalence in holding strength to the predicate device. | The ultimate holding strength of the proposed RC Multi-Suture Anchor was compared to the currently marketed ROC EZ Suture Bone Fastener. The holding strength of the proposed RC Multi-Suture Anchor was greater than that of the predicate device, demonstrating substantially equivalent performance between the devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document mentions "Bone Model Testing" and compares the "ultimate holding strength" of the proposed device to the predicate device, implying a quantitative test, but the number of samples or tests performed is not provided.
- Data Provenance: Not explicitly stated. The study appears to be a laboratory-based performance test rather than involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This information is not applicable to the type of study conducted. The ground truth for device performance in this context is the measured "ultimate holding strength" in a bone model, not expert interpretation of clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not applicable. The study involves direct physical measurement of device performance, not expert adjudication of subjective outcomes.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the mechanical performance of a medical device, not on the effectiveness of human readers with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a physical bone anchor, not an algorithm. The study assesses the standalone performance of the physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth used is the measured ultimate holding strength of the devices in a bone model. This is a direct physical measurement of performance.
8. The sample size for the training set
- This information is not applicable. There is no mention of a "training set" as this is a physical device performance study, not an AI/machine learning study.
9. How the ground truth for the training set was established
- This information is not applicable, as there is no training set involved in this type of device performance study.
§ 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.