(89 days)
The ARIX Hand System is intended for use in internal fixation of thand 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 document describes a 510(k) premarket notification for the ARIX Hand System, a bone plate and screw system. The submission aims to demonstrate substantial equivalence to a predicate device (K131566) also named ARIX Hand System. The information provided is primarily focused on the non-clinical testing performed to establish this equivalence.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific numerical thresholds that the device must meet for each test. Instead, it states that the tests were performed to "verify that the proposed device met all design specifications" and that the results "indicate that the ARIX Hand System is equivalent to predicate device." Therefore, the implied acceptance criterion is that the device's performance in these non-clinical tests is comparable or superior to the predicate device.
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Plate Tensile Strength Test | Comparable to or better than the predicate device (ASTM F382-99) | Results indicate equivalence to the predicate device. |
| Plate Bending Strength Test | Comparable to or better than the predicate device (ASTM F382-99) | Results indicate equivalence to the predicate device. |
| Screw Driving Torque Test | Comparable to or better than the predicate device (ASTM F543-07) | Results indicate equivalence to the predicate device. |
| Screw Axial Pull-out Test | Comparable to or better than the predicate device (ASTM F543-07) | Results indicate equivalence to the predicate device. |
| Screw Torsion Test | Comparable to or better than the predicate device (ASTM F543-07) | Results indicate equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of plates or screws tested for each non-clinical test.
- Data Provenance: The tests are "Bench tests," which implies they were conducted in a laboratory setting. The country of origin of the data is not explicitly stated, but the submitter (Jeil Medical Corporation) is based in Korea. The studies are retrospective in the sense that they are laboratory tests on manufactured devices, not prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the study is a non-clinical bench testing study, not a clinical study involving diagnosis or interpretation by experts. Ground truth is established by the physical testing results against standard specifications.
4. Adjudication Method for the Test Set
This section is not applicable for a non-clinical bench testing study. Adjudication typically refers to expert review in clinical trials or diagnostic studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were considered necessary and performed."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This section is not applicable. The device is a physical medical implant (bone plate and screw), not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth used for these non-clinical mechanical tests is based on engineering standards and specifications (ASTM F382-99 for plates and ASTM F543-07 for screws). The performance of the subject device is compared against these standards and against the predicate device's performance.
8. Sample Size for the Training Set
This section is not applicable. There is no "training set" as this is a physical medical device undergoing mechanical testing, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as above.
§ 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.