(56 days)
The RHS is intended for:
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
a. Joint destruction and/or subluxation visible on x-ray
b. Resistance to conservative treatment - Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection
- Revision following failed radial head arthroplasty
The long stem is for single cemented use only. The short stem coated with titanium plasma-spray is for single use with or without cement.
The RHS has been designed in order to provide surgeons and patients with a joint prosthesis to restore function and relieve pain of the radial part of the elbow joint. The RHS has an anatomical design, which reproduces the kinematics of the radial joint. The RHS consists of two components: a metal radial stern and a metal-polyethylene radial head.
This is a radial head prosthesis submission, not an AI/ML device, therefore, the requested information about acceptance criteria, study details, and AI/ML specific metrics (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable.
The provided document is a 510(k) Premarket Notification for the "RHS" radial head prosthesis. The purpose of this type of submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not to prove performance against specific acceptance criteria in the manner of an AI/ML diagnostic device study.
The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
However, based on the general information provided for medical devices, I can extract information relevant to "claims" and "indications for use" as they relate to what a device is designed to do, which can be seen as a form of "acceptance criteria" in a broader sense for a non-AI/ML device.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from Indications for Use and Device Description)
Since this is a prosthesis and not a diagnostic device, "performance" is largely demonstrated through substantial equivalence to predicate devices and the physical properties of the materials, rather than metrics like sensitivity or specificity. "Acceptance criteria" in this context refer to the conditions under which the device is intended to be used and the clinical problems it aims to address.
| Acceptance Criteria (Indications for Use) | Reported Device Performance (Implicitly met by S.E. to predicates and device design) |
|---|---|
| Purpose: Restore function and relieve pain of the radial part of the elbow joint. | Achieved by anatomical design and material properties. |
| For replacement of radial head for degenerative or post-traumatic disabilities with: | |
| - Pain, crepitation, and decreased motion at radio-humeral and/or proximal radio-ulnar joint | |
| - Joint destruction and/or subluxation visible on x-ray | |
| - Resistance to conservative treatment | |
| Primary replacement after fracture of radial head | |
| Symptomatic sequelae after radial head resection | |
| Revision following failed radial head arthroplasty | |
| Material Composition: Radial head: UHMWPE with CoCr shell. Stem: CoCr, some with Ti plasma-spray. | Confirmed via material specification. |
| Stem Usage: Long stem for single cemented use only. Short stem (Ti plasma-spray) for single use with or without cement. | Confirmed via design specification. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is a 510(k) for a physical implant, not an AI/ML diagnostic device requiring a "test set" in the computational sense. Substantial equivalence is typically demonstrated through comparison of design, materials, manufacturing processes, intended use, and sometimes non-clinical testing (e.g., mechanical testing, biocompatibility) to predicate devices, rather than a clinical study with a "test set" of patient data for performance evaluation against specific metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. See point 2.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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 a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable directly for performance evaluation in the AI/ML sense. For a prosthesis, "ground truth" might pertain to established biomechanical principles, material standards (e.g., ASTM, ISO), and historical clinical outcomes of predicate devices that establish the safety and effectiveness of the type of device. Formal "ground truth" to evaluate diagnostic accuracy is not relevant here.
8. The sample size for the training set:
- Not Applicable. See point 2.
9. How the ground truth for the training set was established:
- Not Applicable. See point 2.
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow 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 consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.