(90 days)
The OSCAR Orthosonics System for Cemented Arthroplasty Revision is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.
The OSCAR Orthosonics Ultrasonic Cement Removal System consists of a power module which generates the ultrasonic energy and provides overall control of the device, a handpiece, a set of cement removal probes, and an ultrasonic cleaning system for part of the reprocessing procedures for reuse of the probes. Three independent power modules are included in each device and these are mounted in a cart for ease of use.
The provided 510(k) summary for the OSCAR Orthosonics System for Cemented Arthroplasty Revision does not detail acceptance criteria or a study proving the device meets specific performance metrics in the way modern AI/ML device submissions do. This document is from 1996, and the regulatory requirements and types of evidence presented were different.
However, based on the information provided, we can infer the "acceptance criteria" were related to safety and effectiveness, and the "study" was a series of engineering tests and a comparison to predicate devices, rather than a clinical trial with a defined test set and ground truth in the AI/ML context.
Here's an attempt to structure the information based on your request, highlighting what is present and what is absent, given the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from "Issues Addressed") | Reported Device Performance (Summary from E. Testing) |
|---|---|---|
| Safety - Thermal Effects | No significant or harmful temperature rise in bone. | Testing confirmed acceptable temperature rise in bone during OSCAR procedures. |
| Safety - Bone Damage | No significant or harmful damage to bone from direct contact. | Testing confirmed that direct contact with the device did not cause unacceptable bone damage. |
| Clinical Efficacy/Experience | Safe and effective performance in a clinical setting. | Clinical experience supported the safety and effectiveness. (No specific metrics or patient numbers provided in this summary). |
| Reprocessing/Reuse | Probes can be effectively reprocessed for safe reuse. | Testing validated the reprocessing procedures for probes. |
| Electromagnetic Compatibility (EMC) | Meets relevant EMC standards. | Testing demonstrated compliance with electromagnetic compatibility requirements. |
| Electrical Safety | Meets relevant electrical safety standards. | Testing demonstrated compliance with electrical safety requirements. |
| Sterilization Validation | Sterilization recommendations are effective. | Validation confirmed the effectiveness of sterilization recommendations. |
| Substantial Equivalence (Overall) | Device is substantially equivalent to predicate devices. | "The results from all of these tests supported the safety and effectiveness of the Orthosonics OSCAR device and demonstrate that the Orthosonics OSCAR is substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the individual tests (temperature rise, bone damage, clinical experience, etc.).
- Data Provenance: The tests were carried out by Orthosonics. The provenance of clinical experience data (e.g., country of origin, retrospective/prospective) is not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
- Not applicable in the AI/ML sense. Ground truth was not established by experts reviewing data for device performance. Instead, ground truth was implicitly defined by the physical or biological outcomes observed during the engineering and validation tests (e.g., measured temperature, observed bone damage, successful sterilization). Clinical experience would have involved medical professionals, but their role in establishing a "ground truth" for a test set is not described, nor are their qualifications.
4. Adjudication Method for the Test Set
- Not applicable. There was no "test set" in the context of human interpretation of data requiring adjudication. The tests were direct measurements or observations of the device's physical and biological interactions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No such study was conducted. This device is a surgical instrument, not an AI/ML diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. There is no "algorithm" in this device. Performance was measured directly during operation or through validation studies.
7. The Type of Ground Truth Used
- Engineering/Biological Measures: For aspects like temperature rise, bone damage, EMC, electrical safety, and sterilization, the "ground truth" was established by direct measurement against predetermined safe limits or validated protocols.
- Clinical Observation: For "clinical experience," the ground truth would have been derived from observed patient outcomes and surgeon feedback, but no specific methodology is detailed.
- Predicate Device Comparison: A significant part of the "ground truth" for substantial equivalence was the established safety and effectiveness of the legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a training set as it is not an AI/ML product.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
§ 888.4580 Sonic surgical instrument and accessories/attachments.
(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.