(112 days)
The Acu-Sinch Repair System is intended to be used in conjunction with a clavicle plate of the Congruent Bone Plate System to provide fixation during the healing of clavicle fractures.
The Acu-Sinch Repair System also may be used as a stand-alone system for treatment of acromioclavicular and/or coracoclavicular ligament disruption.
The Acumed Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures:
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Acumed's Locking Clavicle Plating System is designed to provide fixation during fractures, fusions, or osteotomies of the clavicle.
The Acu-Sinch Repair System consists of several components (Suture Anchor, Clavicle Fracture Plate, Acu-Sinch plate, Suture Retainer, Screws, and Suture) which can be combined to create various device constructs to treat the indications listed above. The Suture Anchor can be used for fixation of suture to bone in the anatomic locations listed above.
The acceptance criteria and study proving the device meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Load to Failure | Substantially equivalent to predicate device components | Components demonstrated substantial equivalence to predicate |
| Fatigue Testing | Substantially equivalent to predicate device components | Components demonstrated substantial equivalence to predicate |
| Pull-out Comparison | Substantially equivalent to predicate device components (for 2.3mm screws with Distal Clavicle Plates) | Demonstrated substantial equivalence to predicate |
| Engineering Analysis | Substantially equivalent to predicate device plates | Demonstrated substantial equivalence to predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact "sample sizes" in terms of number of devices or iterations for the preclinical testing. The testing described is preclinical (laboratory-based mechanical testing), not a clinical study involving human or animal subjects, so data provenance such as "country of origin" or "retrospective/prospective" is not applicable in the typical sense. The testing was performed on the device components themselves.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the "ground truth" for the preclinical mechanical tests is based on the physical properties and performance of the device components compared to established predicate devices, rather than expert interpretation of medical data.
4. Adjudication Method for the Test Set
This information is not applicable as the preclinical tests involve objective mechanical measurements and comparison to predicate devices, not expert adjudication of clinical outcomes or images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The study conducted was preclinical mechanical testing.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a surgical repair system, not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the preclinical testing was established by the performance of legally marketed predicate devices. The acceptance criterion for the Acu-Sinch Repair System was that its mechanical performance (load to failure, fatigue, pull-out strength, and general engineering analysis) was "substantially equivalent" to these predicates.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this is a medical device subject to preclinical mechanical testing, not an algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated above.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.