(115 days)
Reprocessed soft tissue ablators are to be used in patients requiring arthroscopic surgery of the knee, shoulder, ankle, hip, wrist and elbow to resect, ablate and excise soft tissue.
Soft tissue ablators are radiofrequency (RF) surgical tools designed for removal and dissection of tissue in arthroscopic surgeries. A generator or controller serves as the power unit. Soft tissue ablators are available in a wide range of sizes and angles; some models include thermal or suction functions.
This document describes the reprocessing of soft tissue ablators, not an AI device. Therefore, the specific questions regarding AI device performance metrics, such as ground truth establishment with experts, multi-reader multi-case studies, and training set sample sizes, are not applicable.
The acceptance criteria and device performance for the Reprocessed Soft Tissue Ablators are based on the principle of substantial equivalence to predicate devices, ensuring safety and effectiveness are maintained after reprocessing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Validation of reprocessing procedures confirms biocompatibility of the reprocessed devices. |
| Functionality | Performance testing demonstrates that Reprocessed Soft Tissue Ablators perform as originally intended by the manufacturer. |
| Intended Use | The reprocessed devices maintain the same intended use: to remove soft tissue and control bleeding using high-frequency electrical current in arthroscopic surgeries. |
| Materials | The reprocessed devices are identical in materials to the predicate devices. |
| Design | The reprocessed devices are identical in design (standard mechanical design, shapes, and sizes) to the predicate devices. |
| Performance Specifications | The reprocessed devices maintain the same performance specifications as the predicate devices. |
| Clinical Applications | No changes to clinical applications compared to predicate devices. |
| Patient Population | No changes to the patient population compared to predicate devices. |
| Method of Operation | No changes to the method of operation compared to predicate devices. |
Study Proving Device Meets Acceptance Criteria:
A study involving bench and laboratory testing was conducted to demonstrate the performance (safety and effectiveness) of the Reprocessed Soft Tissue Ablators.
2. Sample Size for Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of AI development. Instead, the performance was validated through bench and laboratory testing. The sample size for these tests is not explicitly stated in the provided text.
Data provenance: Not applicable in the context of AI. The tests were conducted on reprocessed physical devices.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The "ground truth" for this device relates to its physical and functional integrity after reprocessing, not diagnostic accuracy requiring expert consensus on medical images or patient data. The standard for ground truth is equivalence to the original manufacturer's specifications.
4. Adjudication Method for Test Set
Not applicable. Adjudication methods are typically relevant for human interpretation of data, particularly in clinical effectiveness studies or for establishing ground truth in AI. The performance validation here involves objective engineering and biological tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is not an AI diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a reprocessed physical medical device, not an algorithm or software.
7. Type of Ground Truth Used
The ground truth used for this study is implicitly the original manufacturer's specifications and performance standards for the single-use devices. The reprocessed devices must perform "as originally intended" and be "substantially equivalent" to these new devices. This includes biocompatibility, functional performance, and maintaining the original design, materials, and intended use.
8. Sample Size for Training Set
Not applicable. There is no training set as this is not an AI device.
9. How Ground Truth for Training Set Was Established
Not applicable. As this is not an AI device, there is no training set or ground truth establishment method for a training data set.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.