(101 days)
The Acumed Anatomic Radial Head System, the Acumed Anatomic Radial Head Long Stems, the Acumed ARH Slide-Loc™ System, and accessories are designed specifically for:
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation, 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 device is intended to be press fit or cemented.
The Acumed Anatomic Radial Head Long Stems and the Acumed ARH Slide-Loc "" System include modular heads and stems with accessories to anatomically replace the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitulum of the distal humerus.
The provided document (K131845) is a 510(k) summary for the Acumed Anatomic Radial Head Long Stems and ARH Slide-Loc™ System, which are elbow hemi-prostheses. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way one might see for a diagnostic AI device.
Therefore, many of the requested elements regarding acceptance criteria, study design, ground truth, and expert involvement are not applicable or cannot be extracted from this type of regulatory submission. This document describes non-clinical (bench) testing to characterize the strength of the device.
Here's an attempt to answer the questions based on the provided text, indicating where information is not applicable (N/A) or not provided (NP):
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or specific numerical performance results from the non-clinical tests. It broadly states that the devices "underwent static and cyclic load testing to characterize their strength." The comparison table focuses on material, dimensions, and design features, not performance metrics related to acceptance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical criteria. The implicit acceptance criterion for a 510(k) is that the device is "substantially equivalent" to a legally marketed predicate device, ensuring similar safety and effectiveness. This is assessed through design, material, and in this case, non-clinical (mechanical) testing. | The devices "underwent static and cyclic load testing to characterize their strength." The results were presumably sufficient to demonstrate substantial equivalence to the predicate device, but no specific performance data (e.g., load sustained, cycles to failure) is provided. |
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 for Test Set: Not specified. This refers to the number of devices or components tested in the static and cyclic load assessments.
- Data Provenance: Not applicable in the context of device mechanical testing. These tests are typically performed in a laboratory setting by the manufacturer or a contract testing facility. It's not clinical data from patients.
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)
- Number of Experts: Not applicable. For mechanical testing of an elbow prosthesis, "ground truth" is not established by medical experts interpreting images or patient outcomes. It's determined by engineering standards and measurements.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant interpretations in clinical studies or for establishing ground truth from multiple human readers. This is mechanical bench testing.
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
- MRMC Study: No. This document describes a medical device (prosthesis), not an AI diagnostic tool.
- Effect size of AI improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: No. This device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For mechanical testing, the "ground truth" would be established by the physical properties of the materials and the mechanical performance of the device as measured against engineering standards (e.g., ASTM standards for implants). The document refers to "static and cyclic load testing to characterize their strength," implying that the measured mechanical properties are the "ground truth" for evaluating the physical integrity of the device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning study requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
§ 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.