(14 days)
The CSS Cannulated Screw System will be indicated for use in long and small bone fracture fixation, which includes the following;
- Fractures of the tarsals and metatarsals
- Fractures of the olecranon, distal humerous
- Fractures of the radius and ulna
- Patella fractures
- Distal tibia and pilon fractures
- Fractures of the fibula, medial malleolus, os calcis
- Tarso-metatarsal and metatarsal phalangeal arthrodesis
- Metatarsal and phalangeal osteotomies
- Osteochondritis dissecans
- Ligament fixation
- Other small fragment, cancellous bone fractures and osteotomies
The CSS Cannulated Screw System consists of cannulated screws of various diameters, lengths and thread configurations. The system also includes correspondingly sized washers, the use of which are optional, as well as guide wire and various instruments.
The cannulated screws are self tapping. They are made from made from Titanium Ti-6Al-4V ELI Alloy in conformance with ASTM F-136 Standard Specification for Wrought Titanium 6Al-4V ELI Alloy for Surgical Implant Applications.
The CSS System includes (4) different types of washers. These are; Flat Washers, Contoured Washers, Partial Contoured Washers, and Domed Washers. The various styles are intended to offer the surgeon a variety of anatomical fit to the bone in certain applications.
The provided text describes the CSS Cannulated Screw System and its substantial equivalence to a predicate device, the Howmedica Asnis III Cannulated Screw System (K000080).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Measure) | Reported Device Performance (CSS Cannulated Screw System) |
|---|---|
| Substantial Equivalence to Predicate Device (Howmedica Asnis III) in terms of mechanical performance. | Results clearly demonstrate that the CSS System is substantially equivalent to its' predicate based on Finite Element Analysis (FEA) and performance testing. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a separate "test set" in the context of clinical data for the device's performance. The performance evaluation was primarily mechanical and computational.
- Sample size for test set: Not applicable in the context of human data. For the mechanical and computational analysis, the "samples" would refer to the designs modeled and tested. The document implies a comparison of the CSS Cannulated Screw System against the predicate device.
- Data provenance: Not applicable. The data is from in-vitro mechanical testing and computational modeling (Finite Element Analysis) performed by the manufacturer, OrthoHelix Surgical Designs, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. Ground truth in this context refers to mechanical properties and substantial equivalence, not clinical diagnostic accuracy or efficacy requiring expert consensus for a test set.
4. Adjudication Method for the Test Set:
Not applicable. This concept pertains to resolving discrepancies in expert interpretations of clinical data, which is not relevant to this type of device submission.
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. The CSS Cannulated Screw System is a physical medical device (cannulated screws) for orthopedic fixation, not a software or AI-driven diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. As noted above, this device is not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for demonstrating substantial equivalence was the known mechanical performance and design specifications of the legally marketed predicate device, the Howmedica Asnis III Cannulated Screw System. This served as the benchmark against which the CSS Cannulated Screw System's performance (via FEA and performance testing) was compared.
8. The Sample Size for the Training Set:
Not applicable. The concept of a "training set" typically refers to data used to train machine learning models and is not relevant to the evaluation of this physical medical device. The design and materials are based on established engineering principles and materials science for medical implants.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set in the context of machine learning, no ground truth was established for it. The design and manufacturing process would adhere to established standards (e.g., ASTM F-136) and engineering best practices for orthopedic implants.
§ 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.