(98 days)
The CC-Clip® device is intended as an adjunct in coracoclavicular ligament disruption repair.
Specifically, the CC-Clip® device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
CC-Clip® is an implantable device for an arthroscopic coracoclavicular (CC) ligament reconstruction and acromioclavicular (AC) ligament reconstruction technique. The original ligaments fail due to an AC joint separation and cause superior and posterior translation of the clavicle.
CC-Clip® device consists of a titanium implant on the clavicle, a titanium counterpart under the coracoid, and non-resorbable suture between the implants. A USP size 5 suture is not provided with CC-Clip®, but the Arthrex #5 FiberWire is recommended with the CC-Clip® device.
Instrumentation included with the CC-Clip® system includes two instruments: the CC-Clip® Straight Lasso guide and CC-Clip® Curved Lasso guide. Additional general-use, readily available instrumentation required for the CC-Clip® procedure includes lasso wire, guide pins, and drill bits which are to be supplied by the end user per the surgical technique. Both CC-Clip® guides are re-usable surgical instruments provided non-sterile to the user. The CC-Clip® implants are supplied sterile to the user and are single use.
This is an orthopedic device, not an AI/ML device. Therefore, the request for information on "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as effect size of human readers improving with AI, standalone performance, ground truth establishment for training, etc.) is not applicable.
The provided document describes the CC-Clip® Implant System, a medical device intended for coracoclavicular ligament disruption repair and acromioclavicular separations. The regulatory submission (K232780) establishes its substantial equivalence to a predicate device (Arthrex TightRope® Acromioclavicular (AC) device, K052776) based on mechanical testing and comparison of technological characteristics.
Here's the relevant information based on the provided text, adapted for a non-AI/ML medical device:
Acceptance Criteria and Study Proving Device Meets Criteria
The acceptance criteria for this non-AI/ML device are primarily demonstrated through mechanical testing to ensure safety and effectiveness, and by showing substantial equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Static Testing (Ultimate Load) | Acceptable |
| Dynamic Testing | Acceptable |
- Study: Mechanical Testing Program for CC-Clip® Implant System (Table 6.1)
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each mechanical test. The nature of mechanical testing usually involves multiple samples per test condition to achieve statistical significance.
- Data Provenance: The tests are non-clinical (laboratory-based mechanical testing), not derived from patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable as this is a mechanical device without "ground truth" established by human experts in the context of AI. The "ground truth" for mechanical testing is defined by engineering specifications, material properties, and regulatory standards for device performance.
4. Adjudication Method for the Test Set
- Not applicable, as this refers to expert review in AI/ML performance evaluation. Mechanical tests are governed by standardized protocols and objective measurements.
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
- Not applicable. This is a surgical implant, not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a surgical implant.
7. The Type of Ground Truth Used
- Ground Truth (for mechanical testing): Established through engineering specifications, material standards (e.g., ASTM F136 for titanium alloy), and performance requirements derived from the intended use and comparison to the predicate device. These are objective, measurable physical properties and forces.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the AI/ML sense. Design and manufacturing processes are iterative and based on engineering principles and material science.
9. How the Ground Truth for the Training Set was Established
- Not applicable for the same reason as above. The "ground truth" for the development of such a device stems from established biomechanical principles, material science, and the performance characteristics of predicate devices.
§ 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.