(158 days)
The ARIX Hand System is intended for use in 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 Hand System is designed to 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 Hand System consists of the ARIX Hand System Plate and the ARIX Hand System Screw. The ARIX Hand System Plate is made of Pure Titanium (ASTM F67) and the ARIX Hand System Screw is made of the Titanium Alloy (ASTM F136). This device performance is not adversely affected by aging or storage conditions since this device is to be sterilized at the hospital before use and also to be single use.
The provided text describes the ARIX Hand System, a device for internal fixation of hand and wrist bones, and its 510(k) submission for substantial equivalence to a predicate device. The submission primarily focuses on comparing the ARIX Hand System to the Profyle System, K062498, based on materials, design, intended use, and mechanical properties.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for the ARIX Hand System itself. Instead, it states that "the ARIX Hand System has the similar device characteristics as the predicate device" and that "Only the technical specifications - bending stiffness, tensile strength, driving torque, torsion and pullout - are slightly different." The study performed for the ARIX Hand System involved comparing its mechanical performance to the predicate device. The implicit acceptance criterion is that the ARIX Hand System's performance for these tests should be comparable to or better than the predicate device to establish substantial equivalence. However, specific numerical thresholds for "acceptance" are not provided for either the predicate or the new device, nor are the reported performance values for each.
| Test Parameter | Acceptance Criteria (Implicitly: Comparable to Predicate) | Reported Device Performance (ARIX Hand System) |
|---|---|---|
| Plate Bending Strength (ASTM F382) | Should be similar to predicate device (Profyle System) | Not explicitly reported numerically |
| Plate Tensile Strength | Should be similar to predicate device (Profyle System) | Not explicitly reported numerically |
| Screw Driving Torque (ASTM F543) | Should be similar to predicate device (Profyle System) | Not explicitly reported numerically |
| Screw Torsion (ASTM F543) | Should be similar to predicate device (Profyle System) | Not explicitly reported numerically |
| Screw Axial Pullout Strength (ASTM F543) | Should be similar to predicate device (Profyle System) | Not explicitly reported numerically |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the mechanical tests. The data provenance is not explicitly stated in terms of country of origin of the data or if it was retrospective or prospective. It describes laboratory mechanical tests (e.g., Bending Strength, Tensile Strength, Driving Torque, Torsion, Axial Pullout Strength) which are typically conducted in a controlled environment, not on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable in this context. The "test set" consists of mechanical tests on the device components (plates and screws), not on clinical data requiring expert human review to establish ground truth.
4. Adjudication Method for the Test Set
This question is not applicable as the "test set" involves objective mechanical property measurements, not subjective evaluations that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes mechanical bench tests to demonstrate substantial equivalence, not a clinical study involving human readers or cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a physical implant (bone plate and screw system), not an algorithm or software. Therefore, human-in-the-loop or standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on objective mechanical performance metrics obtained from standardized tests (e.g., ASTM F382, ASTM F543). The comparison is made against the mechanical properties of a legally marketed predicate device.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical implant, not an AI/ML algorithm that requires a training set. The evaluation focuses on its mechanical properties.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. As stated above, the device is not an AI/ML algorithm requiring a training set.
§ 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.