(83 days)
The ARIX Cannulated Screw System is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid-and hind foot and ankle. Also, the ARIX Cannulated Screw System is internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.
The ARIX Cannulated Screw System consists of cannulated screw with diameters raging from 2.3mm to 6.0mm. The cannulate screws are made of Titanium Alloy(Ti-6AI-4V), ASTM F136, which are widely used for surgical implants with well-known biocompatibility and provided nonsterile. This submission is to reclassify the previously approved device and to add 4.0mm diameter screws.
It also includes washer various manual surgical instruments, such as drill bit, screwdriver shaft, countersink, screwdriver handle, depth gauge, guide pin, cleaning stylet, dispenser, forceps and drill guide.
The ARIX Cannulated Screw System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The sterilization method is presented in the instruction, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
The provided text is a 510(k) summary for the ARIX Cannulated Screw System, which is a medical device. This type of document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria and proving performance through a study with the detailed elements you've requested.
Therefore, much of the information you've asked for, particularly regarding acceptance criteria, specific performance metrics, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and training set details, is not available in this document.
However, I can extract the relevant information from the document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't define specific "acceptance criteria" in terms of performance thresholds for the device itself against clinical outcomes or diagnostic accuracy. Instead, it relies on demonstrating compliance with recognized standards and equivalence to predicate devices. The "reported device performance" is primarily the successful passing of these non-clinical tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ASTM F543: Standard Specification and Test Method for Metallic Medical Bone Screws | The subject device complies with ASTM F543. |
| - Driving Torque Test | Test results demonstrated compliance. |
| - Torsion Test | Test results demonstrated compliance. |
| - Axial Pull-out Test | Test results demonstrated compliance. |
| Substantial Equivalence to Predicate Devices (K131311, K131566) | Found to be substantially equivalent in design, function, materials, operational principles, indications for use, technological characteristics, operating principle, design features, performance, biocompatibility, materials, and method of sterilization. |
| Sterilization validation per ISO 17665-1:2006 | Sterilization method validated per ISO 17665-1: 2006. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document describes non-clinical laboratory testing of bone screws, not a study involving a test set of data or patient samples.
- Data Provenance: Not applicable. The testing was non-clinical and conducted in a laboratory setting. There is no mention of country of origin for data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. There was no "ground truth" to establish in the context of diagnostic accuracy or clinical outcomes for this device.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. There was no test set requiring expert adjudication.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a bone screw, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable. The "ground truth" for this device involved engineering specifications and biomechanical performance standards (ASTM F543).
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- How Ground Truth for Training Set was Established: Not applicable.
§ 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.