(248 days)
The INTEGRA® Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The INTEGRA® Freedom Wrist Arthroplasty System is intended for cemented use.
The INTEGRA® Freedom Wrist Arthroplasty (IFW) System three part semi-constrained implant system designed to replace the radiocarpal joint (distal radius and proximal row of carpal bones) and is intended to alleviate pain while restoring functionality and mobility of the joint. IFW is intended for patients with intractable pain and loss function due to traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis. The system consists of three major components:
- Radial implant made from Cobalt Chromium Molybdenum Alloy (CrCoMo) .
- . Carpal plate - (includes two variable angle screws with locking caps) - made from Titanium Alloy
- . Carpal Poly bearing - made from Ultra-High-Molecular-Weight Polyethylene (UHMWPe)
Portions of the radial implant and carpal plate have a titanium plasma sprayed coating. The implant system is provided with instrumentation necessary to complete the procedures for which the system is indicated. The components are intended to be implanted together as a system, not individually as hemi-arthroplasty components and are intended for cemented fixation.
The Integra® Freedom Wrist Arthroplasty System is a medical device, and the provided document is a 510(k) summary for its clearance. This summary details non-clinical tests performed to demonstrate substantial equivalence to previously cleared devices. It does not describe a study involving human subjects, AI systems, or the specific criteria typically associated with clinical performance evaluation of an AI/ML device.
Therefore, the requested information components related to AI/ML device studies (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable to this document. This document focuses on the mechanical and material performance of the implant itself.
Here's a breakdown of the available information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The results of these performance tests met their respective acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test, only that the device met them.
| Test | Reported Device Performance |
|---|---|
| Fatigue Life Test | Met acceptance criteria |
| Carpal Poly Bearing Removal | Met acceptance criteria |
| Movement to Instability | Met acceptance criteria |
| Axial Screw Pull-out (ASTM F543) | Met acceptance criteria |
| Insertion Torque (ASTM F543) | Met acceptance criteria |
| Breaking Torque (ASTM F543) | Met acceptance criteria |
| Breaking Angle (ASTM F543) | Met acceptance criteria |
| Shear Fatigue Strength (ASTM F1160) | Met acceptance criteria |
| Static Shear Strength (ASTM F1044) | Met acceptance criteria |
| Static Tensile (ASTM F1147) | Met acceptance criteria |
| Abrasion (ASTM F1978) | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The tests mentioned are non-clinical (mechanical/material performance) rather than studies on a "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or outcomes. These are non-clinical engineering tests.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are used in clinical trials or expert review processes for diagnostic accuracy, not physical device testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This is a non-clinical device clearance for a physical implant, not an AI/ML diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This refers to the performance of an AI/ML algorithm without human intervention, which is not relevant to this physical implant.
7. The Type of Ground Truth Used
Not applicable in the AI/ML context. For these non-clinical tests, "ground truth" would be the objectively measured physical properties/performance of the device under specific test conditions (e.g., maximum load bearing before failure, precise wear rates). The standards referenced (ASTM F543, F1160, F1044, F1147, F1978) define the methods for establishing these objective measurements.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML "training set" for this physical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no AI/ML "training set" for this physical device.
§ 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.