(140 days)
The Instratek CMC Cable FIX is a suture button implant designed to stabilize the thumb metacarpal following removal or partial resection of the trapezium. The CMC Cable FIX is an adjunct in the healing process when used in conjunction with a biologic reconstruction of the ligament at the base of the thumb metacarpal for treatment of carpometacarpal (CMC) arthritis and instability.
The Instratek CMC Cable FIX is a suture button implant designed to stabilize the thumb metacarpal following removal or partial resection of the trapezium. The CMC Cable FIX is an adjunct in the healing process when used in conjunction with a biologic reconstruction of the ligament at the base of the thumb metacarpal for treatment of carpometacarpal (CMC) arthritis and instability. The implanted device consists of three (3) components: Plate - 2-hole round - Ti-6Al-4v Plate - 2-hole oblong w/break away guide wire - Ti-6AL-4v #2 Suture - Ultra High Molecular Weight Polyethylene There are 3 accessories required to implant the device: Cannulated Drill Bit - 17-4 Stainless Steel K-wire - 316L Stainless Steel Suture Passer - PTFE tubing
This is a 510(k) premarket notification for a medical device called the "Instratek CMC Cable FIX," a suture button implant. The submission aims to establish substantial equivalence to predicate devices and does not describe a study involving AI or complex statistical analyses of diagnostic performance.
Here's a breakdown of the requested information based on the provided text, outlining why certain sections cannot be completely filled:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Suture Tensile Force (N) | "Comparative Suture Tensile Force (N) vs. Displacement (mm)." was performed. No specific numerical acceptance criteria or performance values are provided in the summary. The "Conclusions" state: "There are no significant differences between the proposed and predicate device; therefore, the proposed device does not raise any questions regarding safety and effectiveness." |
| Displacement (mm) | "Comparative Suture Tensile Force (N) vs. Displacement (mm)." was performed. No specific numerical acceptance criteria or performance values are provided in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. The submission describes "Comparative Suture Tensile Force (N) vs. Displacement (mm)" testing, which is likely mechanical testing of the device components, not a study on a "test set" of patients or data in the typical sense applied to diagnostic algorithms. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable/not provided. The "test set" described is mechanical testing, not a dataset requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving human judgment for ground truth establishment. This submission describes mechanical device testing.
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. This submission is for a medical device (suture button implant) and focuses on demonstrating substantial equivalence through technological characteristics and mechanical testing, not on comparative effectiveness with human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This submission is for a physical medical implant, not an algorithm or AI-powered device.
7. The Type of Ground Truth Used
The "ground truth" for the testing performed appears to be measured physical properties (suture tensile force and displacement) of the device components under various conditions, likely compared against established benchmarks or the predicate device's performance. It is not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This submission is for a physical medical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. As no training set for an algorithm is involved, no ground truth establishment for it is relevant.
§ 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.