(179 days)
Avanta Orthopaedics Wrist implant is intended for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.
The wrist implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the wrist.
Here's an analysis of the provided text regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria or quantifiable performance metrics for the Avanta Orthopaedics Wrist implant. Instead, the "study" demonstrating the device meets "acceptance criteria" is a comparison to a predicate device and a general statement about fatigue and wear testing.
Therefore, the table would look like this:
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly defined as quantitative criteria, but implied by substantial equivalence to the predicate device. | - "Fatigue and wear testing have been performed" |
| - "Similar design characteristics and intended use" to predicate. | |
| - "Substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" or provide details about data provenance (e.g., country of origin, retrospective/prospective). The "study" mentioned is not a clinical trial with human subjects or a defined test set in the traditional sense of evaluating a diagnostic algorithm. It refers to non-clinical fatigue and wear testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes a medical device (wrist implant) for surgical replacement, not a diagnostic device or algorithm that requires a "ground truth" established by experts in a test set. The validation is based on engineering principles (fatigue, wear) and comparison to an existing predicate device.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. There is no mention of a test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not performed, or at least not mentioned. This type of study is typically used for diagnostic imaging devices or algorithms where human readers' performance is evaluated with and without AI assistance. The Avanta Orthopaedics Wrist implant is a physical implant.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not performed, or not applicable. This device is a physical implant, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device's functionality is established by engineering tests (fatigue and wear) and comparison to the established performance and safety of the predicate device. There is no mention of pathology, outcomes data, or expert consensus in relation to a "ground truth" for a diagnostic evaluation.
8. Sample Size for the Training Set
There is no mention of a training set. This concept applies to machine learning algorithms. The development of the wrist implant would involve engineering design and material science, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no mention of a training set.
Summary of the Study:
The "study" referenced in the document is a regulatory submission process to demonstrate substantial equivalence to an already legally marketed predicate device (Universal Total Wrist System, KMI, K961051). The core of this demonstration relies on:
- Design Characteristics Comparison: Highlighting similarities in product name, use (single use), fixation method (stem in intramedullary canal, screw fixation distally), constraint (semi-constrained), material (Co-Cr/UHMWPE/CPTi), and sizes.
- Indications for Use Comparison: Showing that the Avanta implant has the same indications as the predicate: replacement of the painful wrist joint due to rheumatoid arthritis, osteoarthritis, or post-traumatic arthritis.
- Non-Clinical Testing: A general statement about "Fatigue and wear testing have been performed on this devices to demonstrate substantial equivalence."
Essentially, the "acceptance criteria" appear to be met by demonstrating that the new device is functionally, materially, and geometrically similar to a device already deemed safe and effective, and that it has undergone basic engineering tests (fatigue and wear) to support its durability. The document does not describe a typical clinical trial or a study evaluating diagnostic performance.
§ 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.