(340 days)
The Synthes Radial Head Prosthesis System is intended for:
- The replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, 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 Synthes Radial Head Prosthesis is a two-piece modular system comprised of titanium alloy stem and cobalt chrome head components with an integral screw and side-loading application to allow for in situ assembly. The system consists of a range of lengths and diameters for the stem in both straight and curved configurations as well as heads in a range of diameters and heights to accommodate the surgical need.
This document is a 510(k) Summary for the Synthes Radial Head Prosthesis System. It is focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way one might for a novel diagnostic or AI device.
Therefore, many of the specific questions regarding acceptance criteria, device performance metrics (e.g., sensitivity, specificity), sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not directly applicable or explicitly detailed in this type of submission for a medical implant device.
However, I can extract the relevant information regarding the performance testing and the approach to demonstrating substantial equivalence.
Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:
Context: The Synthes Radial Head Prosthesis System is a medical implant (a modular radial head prosthesis) intended for the replacement of the radial head in specific orthopaedic conditions. The 510(k) submission aims to demonstrate that this new device is "substantially equivalent" to existing, legally marketed predicate devices. This means it has the same intended use, fundamental technological characteristics, and similar materials, and that performance testing shows it is as safe and effective as the predicates.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria for performance metrics typical of, for example, diagnostic accuracy (like sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices through various tests and analyses.
| Acceptance Criteria (Implied) | Reported (Demonstrated) Device Performance |
|---|---|
| Withstand clinical loads of the radiocapitellar joint (similar to predicates) | In vitro performance testing demonstrates the ability of the proposed device to withstand the same clinical loads of the radiocapitellar joint. (Specific numerical thresholds or comparative data against predicates are not provided in this summary but would have been part of the full 510(k) submission). |
| Similar surface characteristics to predicate devices (for stems) | Macro Surface Analysis (roughness, pore size, pore depth, etc.), Scanning Electron Microscopy (SEM), and X-Ray Photoelectron Spectroscopy (XPS) have been conducted to demonstrate similar macro- and micro-surface characteristics in comparison to existing devices (Titan Endoskeleton Interbody Fusion Devices, Rhausler Plage Anterior Cervical Fusion System, Straumann Dental Implant System, Synthes Epoca Titanium Humeral Stem, Synthes Epoca Titanium Humeral Stem w/ (HA) Coating). The literature review also relates these device surface characteristics to physiological responses. Specific quantitative comparisons are not provided in this summary. |
| Same indications for use as predicates | The proposed Synthes Radial Head Prosthesis has the same indications for use as the predicate Biomet ExploR™ (K051385) and Ascension® (K032686) Modular Radial Head Devices. |
| Same fundamental technological characteristics as predicates | The proposed Synthes Radial Head Prosthesis has the same fundamental technological characteristics as the predicate Biomet ExploR™ (K051385) and Ascension® (K032686) Modular Radial Head Devices. This refers to the two-piece modular system with a titanium alloy stem and cobalt chrome head components with integral screw and side-loading application. |
| Similar materials as predicates | The proposed Synthes Radial Head Prosthesis has similar materials as the predicate Biomet ExploR™ (K051385) and Ascension® (K032686) Modular Radial Head Devices (titanium alloy and cobalt chrome). |
| No new issues of safety and effectiveness | Based on the discussed similarities in conjunction with performance testing, physical macro and micro surface analysis, surface chemistry analysis, and literature review the proposed Synthes Radial Head Prosthesis System does not raise any new issues of safety and effectiveness in comparison to the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a "sample size" in terms of patients or anatomical specimens as one would for a clinical trial or diagnostic study. The "test set" here refers to the actual physical devices (or components thereof) that underwent in vitro performance testing and surface analysis. The number of such devices or samples tested is not disclosed in this summary.
- Data Provenance: The tests are described as "in vitro performance testing," "Macro Surface Analysis," "Scanning Electron Microscopy (SEM)," and "X-Ray Photoelectron Spectroscopy (XPS)." These are laboratory-based studies, not clinical studies involving patient data from specific countries or populations. The data provenance is controlled laboratory conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable to this type of device submission. The "ground truth" for a mechanical implant is its physical and mechanical properties, not expert-derived diagnostic labels. The performance is assessed through engineering and materials science testing, not clinical diagnosis by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretations of clinical data or images. This submission focuses on the objective physical and mechanical properties of an implant.
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
- This question is not applicable. The device is a physical implant, not a diagnostic imaging or AI algorithm that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by engineering and materials science standards and measurements. This includes:
- Mechanical properties: The ability to withstand clinical loads.
- Material properties: Chemical composition and physical and macro/micro surface characteristics.
- Peer-reviewed literature: Used to demonstrate how these material and surface characteristics relate to physiological responses.
8. The sample size for the training set
- This question is not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a physical implant. The design and manufacturing processes are based on engineering principles and prior knowledge from predicate devices, rather than machine learning training.
9. How the ground truth for the training set was established
- This question is not applicable, as there is no training set. The "ground truth" for the device's design and material selection would be established through established engineering principles, materials science, and conformity to relevant ASTM/ISO standards (though specific standards are not named in this summary).
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.