(268 days)
The SIRA™ RFA Electrosurgical Device supplies energy for use in electrosurgery and is indicated for use in intraoperative coaqulation and ablation of soft tissue. The SIRA™ RFA Device is to be used in conjunction with a radiofrequency (RF) electrosurgical generator for use in open abdominal surgical procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The SIRA™ RFA Electrosurqical Device is used for the simultaneous administration of RF energy and saline for the coagulation and ablation of soft tissue in open intraoperative procedures. The SIRA™ RFA Electrosurgical Device is comprised of a 4cm diameter electrode array, a handle (shaft), a co-extruded cable, an integrated electrical RF switch and timer, a main cable, and a fluid administration set.
The provided text describes a 510(k) summary for the SIRA™ RFA Electrosurgical Device, which demonstrates substantial equivalence to a predicate device. This type of submission relies on comparisons to an already legally marketed device rather than establishing new acceptance criteria based on independent clinical trials for novel devices. Therefore, the information typically found in a clinical study report for a new device's acceptance criteria, such as specific performance metrics like sensitivity, specificity, or AUC, and detailed study designs (sample size, ground truth methodology, expert qualifications, adjudication methods, MRMC studies, standalone performance), is not explicitly stated in this document.
However, based on the provided text, we can infer and summarize the "acceptance criteria" through the lens of performance testing and substantial equivalence, and describe the studies conducted to support these claims.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device and the successful completion of various performance tests as part of the overall safety and effectiveness evaluation. The reported device performance aligns with these successful test outcomes.
| Acceptance Criteria (Implied by Substantial Equivalence and Testing) | Reported Device Performance (Summary from Text) |
|---|---|
| Technological Equivalence: Similar electrosurgical function (RF energy + saline for coagulation/ablation), sterile, single-use, disposable, integrated cable, electrical insulation, user control of RF energy/duration, similar accessories. | Demonstrated through comparative analysis and testing that minor differences in saline flow control and working end size do not raise new questions of safety or effectiveness. The depth of treatment created by both devices is equivalent when energy is applied at similar durations and levels. |
| Software Performance: Software performs as intended. | Software verification and validation demonstrated that the software performs as intended. |
| Electrical Safety: Compliance with IEC 60601-1 and IEC 60601-2-2. | Electrical safety testing (IEC 60601-1 and IEC 60601-2-2) was conducted and results were passing. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. | Electromagnetic compatibility (IEC 60601-1-2) testing was conducted and results were passing. |
| Biocompatibility: Patient-contacting components are biocompatible. | Biocompatibility of the patient-contacting components of the device was established. |
| Sterility: All required components are sterile. | Sterility validation was established for all required components. |
| Mechanical Performance: Device functions mechanically as intended. | Performance bench testing, including mechanical testing, demonstrated the device functioned as intended. |
| Dimensional Conformance: Dimensions are within acceptable ranges. | Dimensional testing was performed and the device functioned as intended. |
| Functional Performance: Device performs its intended functions (e.g., coagulation/ablation). | Functional tests and performance bench testing confirmed the device functioned as intended. |
| Safety and Effectiveness (In Vivo): Safe and effective in an animal model. | In vivo testing in an animal model was performed to evaluate and establish the safety and effectiveness of the subject device. |
| Usability: Intended users can use the device as intended without significant errors or difficulty leading to harm. | Usability testing demonstrated that intended users can use the device as intended to coagulate/ablate soft tissues without patterns of perceptible use errors or difficulty that could result in serious harm to the user or patient. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test set (e.g., how many devices for mechanical testing, how many animals for in vivo testing, how many users for usability testing). It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, though generally, performance testing for 510(k) devices (especially bench and animal studies) are prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" in the way it would for an AI/algorithm-based diagnostic device (e.g., radiologists interpreting images). The "ground truth" for the performance tests would be established by the physical and biological outcomes measured in the lab or animal models by qualified researchers/technicians following established scientific protocols. For usability testing, "experts" would be the intended users (e.g., surgeons) whose ability to use the device safely and effectively is observed. No specific number or qualifications are given beyond "intended users."
4. Adjudication Method for the Test Set
Not applicable in the context of this 510(k) submission and the types of performance tests described. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical evaluations involving subjective interpretations, such as image analysis by multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned. This type of study is usually relevant for AI-powered diagnostic tools to assess the impact of AI assistance on human reader performance. The SIRA™ RFA device is an electrosurgical tool, not a diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not directly applicable as the SIRA™ RFA device is a physical electrosurgical tool, not a standalone AI algorithm. Its performance is inherent in its design and function, tested both in bench and in vivo settings, with human interaction being a fundamental part of its intended use. The "software verification and validation" would be the closest analogue to a standalone evaluation of its control system.
7. The Type of Ground Truth Used
The "ground truth" for the various performance tests consists of:
- Engineering/Physical Measurements: Established standards and measurements for electrical safety, EMC, mechanical properties, and dimensions.
- Biological Outcomes: In vivo testing in an animal model to evaluate safety and effectiveness (e.g., extent of coagulation/ablation, absence of adverse events).
- Biocompatibility Standards: Established criteria for material safety in contact with biological tissues.
- Sterility Assurance Levels: Defined standards for ensuring device sterility.
- Usability Observations: Direct observation and assessment of intended users performing tasks with the device to identify errors or difficulties.
8. The Sample Size for the Training Set
Not applicable. The SIRA™ RFA Device is not an AI/machine learning algorithm that requires a "training set" of data. Its design and manufacturing process are validated through engineering and biological testing, not by learning from labeled datasets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
§ 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.