(52 days)
The Reprocessed SERFAS Energy Probe is a disposable, radio-frequency probe used in electrosurgical procedures for resection, ablation, and coagulation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery for the knee, shoulder, ankle, hip, elbow and wrist.
The Reprocessed SERFAS Energy Probe includes an energy-transferring cable as well as several different tip configurations and suction probes which are capable of providing simultaneous fluid aspirations.
The provided text describes the 510(k) summary for the Reprocessed SERFAS Energy Probe (K121855). This submission is for a reprocessed device, and as such, the performance data focuses on demonstrating that the reprocessed device performs as originally intended, rather than establishing novel clinical efficacy or accuracy for a new AI algorithm.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a reprocessed device, the "acceptance criteria" are generally that the reprocessed device functions identically to the original predicate device and meets safety standards for reprocessing. The "reported device performance" reflects tests done to ensure this equivalence.
| Acceptance Criteria Category | Specific Test/Performance Goal | Reported Device Performance |
|---|---|---|
| Safety & Biocompatibility | Biocompatibility (cytotoxicity, sensitization, irritation, etc.) | Testing conducted to demonstrate performance. |
| Reprocessing Effectiveness | Validation of Reprocessing (cleaning, decontamination, integrity) | Testing conducted to demonstrate performance. |
| Sterilization Assurance | Sterilization Validation (achieve sterility assurance level) | Testing conducted to demonstrate performance. |
| Functional Equivalence | Function Test(s) (mechanical, electrical, energy transfer capabilities) | Testing conducted to demonstrate performance; each individual probe tested for appropriate function. |
| Packaging Integrity | Packaging Validation (maintain sterility and device integrity) | Testing conducted to demonstrate performance. |
| Overall Equivalence | "Perform as originally intended" | Performance testing demonstrates that Reprocessed SERFAS Energy Probes perform as originally intended. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for an AI algorithm. Instead, it refers to performance testing on the reprocessed devices.
- Test Set Sample Size: Not specified. The document states "Each individual Probe is tested for appropriate function of its components prior to packaging and labeling operations," implying a form of 100% inspection for functional integrity during reprocessing. However, for validation studies (biocompatibility, sterilization, reprocessing validation), the specific sample sizes used are not detailed in this summary.
- Data Provenance: Not applicable in the context of clinical data. The performance data is derived from bench and laboratory testing of the reprocessed devices themselves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The device is a reprocessed electrosurgical probe, not an AI diagnostic device that requires expert consensus for establishing ground truth on medical images or patient conditions. Ground truth for its performance is based on established engineering and biological standards for device function, material integrity, sterility, and biocompatibility.
4. Adjudication Method for the Test Set
This information is not applicable. There is no "adjudication method" in the context of expert review for this type of device. Performance is assessed against predefined technical specifications and regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not applicable to a reprocessed electrosurgical probe.
6. If a Standalone Performance Study Was Done
Yes, in a sense, a "standalone" performance evaluation was done for the reprocessed device. The "Bench and laboratory testing" described, which includes biocompatibility, reprocessing validation, sterilization validation, function tests, and packaging validation, assesses the performance of the reprocessed probe itself against established safety and functional standards, independent of human interaction or a clinical trial. This is a standalone evaluation of the device's physical and functional properties.
7. The Type of Ground Truth Used
The "ground truth" for the Reprocessed SERFAS Energy Probe's performance is based on a combination of:
- Engineering Specifications: The original design and functional specifications of the predicate device.
- Regulatory Standards: ISO standards for biocompatibility (e.g., ISO 10993), sterilization (e.g., ISO 11135/11137), and reprocessing (e.g., AAMI TIR12, AAMI ST79).
- Established Test Methods: Standardized laboratory assays and bench tests to evaluate material properties, electrical performance, and mechanical integrity.
8. The Sample Size for the Training Set
This information is not applicable. This device does not use an "AI algorithm" in the conventional sense, and therefore, there is no "training set" of data for machine learning. The "training" for this device involved the development and validation of the reprocessing procedures.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8. The "ground truth" for the reprocessing process itself would have been established through extensive validation studies demonstrating the efficacy and safety of each step (cleaning, disinfection, sterilization, functional testing) in restoring the device to its "as-new" state, adhering to design specifications and regulatory guidelines.
§ 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.