Search Results
Found 1 results
510(k) Data Aggregation
(129 days)
DePuy Synthes Radial Head Replacement System
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: joint destruction and/or subluxation visible on x-ray; and/or resistance to conservative treatment. Primary replacement after fracture of the radial head. Symptomatic sequelae after radial head resection. Revision following failed radial head arthroplasty.
This document is regarding the DePuy Synthes Radial Head Replacement System-MR Conditional. The Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 –24mm in length. The Radial Head is manufactured from wrought CoCrMo alloy. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone. The devices in scope of the subject submission are being reviewed for MR Conditional labeling in addition to the previously cleared indications for use.
Please find the information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria below:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Magnetically Induced Displacement Force (ASTM F2052-15) | Not explicitly stated, but generally implies forces should be within safe limits for patient use. | The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no different questions of safety or effectiveness. |
| Magnetically Induced Torque (ASTM F2213-17) | Not explicitly stated, but generally implies torque should be within safe limits for patient use. | The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no different questions of safety or effectiveness. |
| Radio Frequency (RF) Heating (ASTM F2182-11a) | Not explicitly stated, but generally implies heating should be within safe limits for patient use. | The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no different questions of safety or effectiveness. |
| Image Artifacts (ASTM F2119-07 (2013)) | Not explicitly stated, but generally implies artifacts should be acceptable and not obscure critical information for diagnosis. | The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no different questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set or the data provenance for the non-clinical performance data. It refers to "non-clinical testing" conducted to support the conditional safety of the implants in the MR environment. This type of testing typically involves testing physical samples of the device and not human patient data.
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)
This information is not applicable. The studies conducted were non-clinical performance tests on the device itself, not studies involving human subjects with clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The studies conducted were non-clinical performance tests on the device itself, not studies involving human subjects requiring adjudication.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical implant (Radial Head Replacement System), not an algorithm or AI system. The testing performed was related to its performance in an MR environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance data, the "ground truth" would be the established safety standards and measurement methodologies outlined in the ASTM standards (F2052-15, F2213-17, F2182-11a, F2119-07 (2013)). These standards define the acceptable limits and procedures for testing device performance under specific conditions.
8. The sample size for the training set
This information is not applicable as the device is a physical medical implant, not an AI or algorithm-based system that requires training data.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical medical implant, not an AI or algorithm-based system that requires training data and ground truth establishment for a training set.
Ask a specific question about this device
Page 1 of 1