(113 days)
The RoG 5.5mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
- Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
- Wrist/Hand indications:- Ulnar/Radial collateral ligament reconstruction, . scapholunate ligament reconstruction.
- Foot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
- Elbow indications : Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair.
- Knee indications:- Lateral collateral ligament repair, medial collateral ligament ● repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in diameter of 5.5mm lengths of 17mm. It is supplied non-sterile and is intended for sterilization by the user facility. It allows the user to secure a suture of his/her selection to the top of the anchor. The anchor is supplied with reusable taps and guides of corresponding size.
Here's an analysis of the acceptance criteria and study information for the RoGTM Sports Medicine Knotless Suture Anchor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study to Prove Performance |
|---|---|---|---|
| Mechanical Performance | Pull Testing | Equivalent to predicate device | Comparative study with K070389 |
| Fatigue Testing | Equivalent to predicate device | Comparative study with K070389 | |
| Material Safety | Biocompatibility | Compliance to ISO 10993 | Master File from PEEK supplier |
| Sterilization | Sterility | Sterility following autoclave sterilization validataed | Validation testing for autoclave sterility |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify exact sample sizes for the pull testing or fatigue testing. It only states "Testing consisted of pull testing and fatigue testing with comparison to the predicate device." The data provenance is not explicitly mentioned (e.g., country of origin), and it implies a prospective experimental design since it's a comparison of a new device against a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" for this device's performance is established through objective mechanical testing (pull force, fatigue cycles) and material safety standards rather than expert clinical consensus or interpretation.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the "ground truth" for this device is objective testing, not expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The RoGTM Sports Medicine Knotless Suture Anchor is a surgical implant, and its performance is evaluated through mechanical bench testing and material safety.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical surgical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth used for this device's performance evaluation is based on:
- Objective Mechanical Test Results: Tensile strength/pull-out force and fatigue resistance from controlled laboratory experiments.
- Material Science Standards: Compliance with ISO 10993 for biocompatibility.
- Sterilization Validation: Demonstrated effectiveness of the sterilization process.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.