(97 days)
This device (Polymer Threaded Anchor and Cinch Polymer Threaded Anchor) is intended for use only for the fixation of non-absorbable synthetic sutures.
The Polymer Threaded Series Anchor is intended for the fixation of surgical suture material for the following indications:
Shoulder:
- し、 Bankhart Repair
- SLAP Lesion Repair vi
- Acromio-clavicular separation 3.
- Rotator Cuff Repair 4.
- Capsule and Capsulolabral Reconstruction ર.
-
- Biceps Tenodesis
-
- Deltoid Repair
Hand, Wrist, Elbow:
- Scapholunate ligament reconstruction し、
-
- Ulnar Collateral Ligament Reconstruction
-
- Lateral Collateral Ligament Reconstruction
-
- Biceps Tendon Reattachment
- Elbow Medial/Lateral Repair of Tendons in the Elbow న్.
Foot:
-
- Hallux Valgus Reconstruction
- Mid and Forefoot Reconstruction 2.
Knee:
- medial collateral ligament l .
- lateral collateral ligament 2.
- posterior oblique ligament 3.
-
- Joint capsule closure
- Illiotibial band tendonesis
- VMO Advancement 6.
The Cinch Polymer Threaded Anchor is intended only for the fixation of surgical material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.
The proposed device, Polymer Threaded Anchor, is a pre-packaged, sterile polyacetal implant. The device is used to secure soft tissue to bone. The device is to be used with reusable insertion devices including a drill, tap, drill/tap combination, and inserter. Surgeons may loop suture of his/her choice through the eyelet of the anchor for the attachment of soft tissue. The device is single use. The device can be used for open and arthroscopic procedures. The anchor is packaged sterile in double mylar/tyvek pouches or formed trays.
The Polymer Threaded Anchor is a polyacetal screw designed to be screwed into a hole in bone chosen by the surgeon as a site for anchoring soft tissue to bone. The anchor constists of a threaded portion to engage bone, an eyelet to retain suture, and a drive means to couple the device to the inserter. The anchor is referred to by it's major diameter of the largest thread). The sizes included in this submission are 2.8 mm, 4.0 mm, 5.0 mm, and 6.5 mm. Please see the drawings on page 9 for shape and dimensions of the device.
The Insertion Device is a manual surgical instrument comprised of a handle and shaft. The handle is constructed from polypropylene and serves as the interface between the surgeon's hand and the device. The shaft serves the functions of transferring the torque from the surgeon's hand to the anchor.
Materials Polyacetal
Use
To implant the Anchor, the surgeon must first create an implantation site in bone. OBL supplies accessory drills, taps and drill/tap combinations to prepare these sites. The inserter is used to screw the anchor into the implantation site. After the anchor is fully seated, the inserter is removed from the implantation site, leaving the anchor in the bone and suture through the anchor. The suture can then be used to attach soft tissue.
The Polymer Threaded Anchor is a medical device designed to secure soft tissue to bone. The acceptance criteria and the study proving the device meets these criteria are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pullout Strength | Higher than predicate ROC device in cancellous bone model (8 lbs/cft polyurethane foam). | "All four of the proposed devices provide higher pullout strength than the predicate ROC device." |
| Anchor/Suture Interface | Higher suture break strength than USP listed Knot Break Strength. | "The Polymer OBL 2.8 mm Anchor provides higher suture break strength than USP listed Knot Break Strength for." (Specifically for the 2.8 mm anchor, considered the worst-case due to smallest head). |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the exact sample size for either the pullout strength or anchor/suture interface tests. It refers to "All four of the proposed devices" for pullout strength (2.8 mm, 4.0 mm, 5.0 mm, and 6.5 mm anchors) and the "2.8 mm anchor" for interface testing, implying multiple units of each size were tested.
- Data Provenance: The tests were conducted using a "cancellous bone model made from polyurethane foam." This is an in vitro (laboratory) test, not originating from a country in terms of patient data. The study is prospective in nature, as it involves testing the device under controlled conditions to gather performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable to this type of performance study. The "ground truth" here is the physical measurement of pullout strength and suture break strength, determined by mechanical testing, not by expert interpretation.
4. Adjudication Method for the Test Set:
- Not applicable. As the ground truth is established through objective mechanical testing, there is no need for expert adjudication. The results are quantitative measurements.
5. Multi-Reader-Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is a performance study of a physical medical device (an anchor) measuring its mechanical properties. MRMC studies are typically used for diagnostic or imaging devices where human readers interpret results, and the effectiveness of AI assistance for these readers is being evaluated. This device's function does not involve human interpretation in a diagnostic context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, in essence. The performance tests described (pullout strength and anchor/suture interface) assess the inherent mechanical properties of the device itself, without any human interaction or algorithm involvement during the measurement of these properties. The device's "performance" is its intrinsic mechanical behavior.
7. Type of Ground Truth Used:
- Objective Mechanical Measurements: The ground truth for pullout strength was the force required to liberate the anchor from the foam model, and for the anchor/suture interface, it was the force at which the suture failed. These are direct, quantifiable physical measurements.
8. Sample Size for the Training Set:
- Not applicable. This study does not involve a "training set" in the context of machine learning or AI. The device's performance is evaluated based on its physical and mechanical properties, not on learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set was used.
§ 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.