(71 days)
The Maestro™ Total Wrist System is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by:
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis
- Rheumatoid arthritis
- Revision where other devices or treatments have failed
- Scapholunate Advanced Collapse (SLAC) and other functional deformities
- Trauma, including fractures of the distal radius and/or carpal bones
The device is intended to be implanted with bone cement.
The Maestro™ Total Wrist System consists of a two piece radial component with a molded bearing and a three-piece carpal component. The radial component is composed of a distal body with a modular stem. The distal bodies come in three sizes and have a molded polyethylene bearing surface. The stem is modular, assembled in the operating room by a screw assembly. The carpal component consists of a carpal head, a carpal plate and a capitate stem. The carpal head comes in 3 heights, standard, +2 and +4. This allows the surgeon to adjust for soft tissue laxity. Two lengths of carpal plates give the surgeon options of screw placement. Like the radial stems, the capitate stems screw to the plate and head.
The provided text is a 510(k) summary for the Maestro™ Total Wrist System, which is a medical device. This type of document is for premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not typically a report of a study proving a device meets acceptance criteria in the way a clinical trial or performance study for an AI/software device would.
Therefore, many of the requested details, particularly those related to AI/software performance studies, ground truth establishment, sample sizes for test and training sets, expert adjudication, and MRMC studies, are not applicable to this 510(k) submission for a non-AI/software medical device.
However, I can extract the relevant information regarding the non-clinical testing and general acceptance criteria as much as possible from the provided text.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and effectiveness similar to predicate devices | N/A - Demonstrated substantial equivalence to Ten (DePuy Orthopedics, Inc.) – K031203 and Blax™ A.F. Wrist System (Biomet Orthopaedics) - K020554 & K030037. This is the primary "acceptance criterion" for a 510(k). |
| Ability to function under expected clinical conditions | "Mechanical testing has demonstrated the device's ability to [perform] under expected clinical conditions." |
| Overall design, materials, surface finishes, and processing | "The overall design, materials, surface finishes and processing of the Maestro™ Total Wrist are similar or identical to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No "test set" in the context of a clinical performance study for an AI/software device is mentioned. The submission relies on substantial equivalence to existing devices and mechanical testing.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No "ground truth" establishment in this context is described.
4. Adjudication method for the test set
- Not applicable.
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
- Not applicable. This is not an AI/software device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/software device.
7. The type of ground truth used
- Not applicable in the context of AI/software performance. For this non-AI device, the "ground truth" for acceptance is essentially the safety and effectiveness profile demonstrated by the predicate devices and confirmed by non-clinical (mechanical) testing, not by expert consensus on clinical data for the new device.
8. The sample size for the training set
- Not applicable. This is not an AI/software device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/software device.
Study Proving Device Meets Acceptance Criteria
The study that "proves" the device meets the acceptance criteria (in the context of a 510(k) for this type of device) is Non-Clinical Mechanical Testing.
- Description of the Study: "Mechanical testing has demonstrated the device's ability to [perform] under expected clinical conditions." The document does not provide details of the mechanical testing protocols, specific acceptance values (e.g., fatigue cycles, load limits), or results beyond this summary statement.
- Conclusion: The results of this mechanical testing, along with the demonstration of substantial equivalence in design, materials, and processing to the predicate devices, were sufficient for the FDA to determine substantial equivalence and clear the device for marketing.
Note: This 510(k) summary explicitly states: "Clinical Testing: None provided." This further confirms that no human clinical trials or performance studies were conducted to support this specific submission.
§ 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.