(115 days)
The Medical Facet Bone Fixation Screws and Pins are intended to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices
Medical Facets Bone Screws are available in thread diameters ranging from 1.5mm to 7.3mm, lengths ranging from 6mm to 180mm, and either solid or cannulated, and made of stainless steel or titanium.
Medical Facets External Fixation Screws are available in thread diameters ranging from 4mm to 6mm, lengths ranging from 60mm to 250mm, and thread lengths ranging from 18mm to 80mm, and made of stainless steel or titanium.
Medical Facets Kirschner Wires are available in wire diameters ranging from 1.0mm to 2.5mm, in lengths ranging from 100mm to 150mm. 0.028 inches to 0.062 inches, in lengths ranging from 4.0 inches to 12.0 inches and are partially or completely threaded. or smooth. Made of stainless steel or titanium.
Medical Facets Guide Wires are available in wire diameters ranging from 0.8mm to 2.8mm, in lengths ranging from 100mm to 450mm, are partially threaded or smooth. Made of stainless steel, titanium, or cobalt.
Medical Facets Steinmann Pins are available in wire diameters ranging from 0.078 inches to 0.187 inches, in lengths ranging from 9.0 inches to 12.0 inches, are completely threaded, or smooth. Made of stainless steel or titanium.
The provided text describes the acceptance criteria and a study for Medical Facets Bone Fixation Screws and Pins.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| ASTM F543 (Metallic Medical Bone Screws) | Substantial performance of the worse case in side-by-side testing with the predicate device. |
| ASTM F2193 (Components Used in the Surgical Fixation of the Spinal Skeletal System) | Substantial performance of the worse case in side-by-side testing with the predicate device. |
| ASTM F1264 (Intramedullary Fixation Devices) | Substantial performance of the worse case in side-by-side testing with the predicate device. |
| ASTM F1541 (External Skeletal Fixation Devices) | Substantial performance of the worse case in side-by-side testing with the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" in the context of clinical trials or AI/algorithm performance. Instead, it refers to "Non-Clinical Testing (worse case)" where the device was mechanically tested according to the listed ASTM standards. The specific sample size for these mechanical tests is not provided, nor is the data provenance in terms of country of origin or retrospective/prospective nature, as these are typically associated with clinical studies involving human or animal subjects, which is not the type of study described here.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This is a mechanical testing study, not a study involving expert assessment of images or clinical outcomes to establish a ground truth.
4. Adjudication Method for the Test Set:
Not applicable. This is a mechanical testing study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. An MRMC comparative effectiveness study was not done. The study described is a non-clinical mechanical testing comparison between the subject device and predicate devices. There is no mention of human readers or AI assistance.
6. Standalone (Algorithm Only) Performance:
No. This is a medical device, specifically bone fixation screws and pins, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used:
The "ground truth" in this context is defined by the mechanical performance requirements specified in the ASTM standards (F543, F2193, F1264, F1541). The device's performance was compared to the performance of "predicate devices" during "side-by-side testing," implicitly meaning it met or exceeded the established mechanical properties and stability criteria for similar devices on the market.
8. Sample Size for the Training Set:
Not applicable. This is a mechanical testing study of a physical device, not an AI or algorithm that requires a training set.
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.