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The SIRA™ RFA Electrosurgical Device supplies energy for use in electrosurgery and is indicated for use in intraoperative coagulation and ablation of soft tissue. The SIRATM RFA Electrosurgical 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 coaqulation (permanent female sterilization).

The SIRA™ RFA Electrosurgical Device, model number SIRA-1000, is a sterile, single-use electrosurgical device, which is for use in the intraoperative coagulation and ablation of soft tissue. The SIRA-1000 is supplied STERILE using an ethylene oxide (EO) process. The device is a single-use device that can be used for multiple applications in one operative site. The SIRA-1000 is to be used in conjunction with a bipolar electrosurgical generator (e.g., Medtronic ForceTriad Generator). The SIRA-1000 is a prescription Class II device. The SIRA-1000, shown in Figure 1 below, consists of an electrode array with an internal irrigation chamber, a cable assembly, and an integrated switch and timer.

The provided text is a 510(k) Summary for the SIRA™ RFA Electrosurgical Device, model number SIRA-1000. It describes a modification to an already cleared predicate device (K181071). This document focuses on demonstrating substantial equivalence to the predicate device, rather than proving a novel device's effectiveness through clinical studies involving human readers, AI assistance, or complex diagnostic accuracy metrics.

Therefore, the information typically required to fill in the requested table and details about acceptance criteria, ground truth, and comprehensive clinical studies (like MRMC studies) for an AI/ML device is not present in this document. This device is an electrosurgical tool, and its performance is evaluated through nonclinical bench testing for safety and basic functionality, not through diagnostic accuracy studies.

Here's a breakdown of why the requested information cannot be found in the provided text and what information is available:

• Acceptance Criteria and Reported Device Performance (Table): The document does not specify quantitative acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, AUC) or human reader improvement. Instead, the acceptance criteria are implicit in the "passing results" for the nonclinical tests.

  • Acceptance Criteria (Implied):
    • Software performs as intended.
    • Electrical safety (IEC 60601-1) requirements met.
    • Electromagnetic compatibility (IEC 60601-1-2) requirements met.
    • Biocompatibility of patient-contacting components established.
    • Mechanical, dimensional, and functional performance as intended.
    • Packaging integrity maintained.
  • Reported Device Performance: "In all instances, the subject device functioned as intended." and "results were passing."

• Sample size used for the test set and the data provenance: Not applicable in the context of diagnostic accuracy. The "test set" here refers to the units of the device subjected to nonclinical bench testing. The document states "Performance bench testing was conducted," implying multiple units were tested, but does not specify the sample size of devices or the origin of the data. This is typically a laboratory environment, not data from patients.

• 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): Not applicable. "Ground truth" for this device is established by engineering specifications, safety standards, and functional requirements, not by expert medical interpretation of images or patient outcomes.

• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is relevant for ambiguous cases in diagnostic accuracy studies.

• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this type of study was not done. The document explicitly states "nonclinical performance testing has been conducted to support the substantial equivalence." MRMC studies are for diagnostic devices, particularly those involving human interpretation.

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrosurgical tool, not an AI algorithm.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is based on engineering specifications, established safety standards (IEC 60601-1, IEC 60601-1-2), and demonstrating the desired functional outcome during bench testing (e.g., effective coagulation/ablation in a controlled environment, proper electrical operation). It does not involve medical ground truth derived from pathology or patient outcomes for diagnostic purposes.

• The sample size for the training set: Not applicable. There is no AI/ML algorithm being "trained" for this device.

• How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML algorithm.

In summary, the provided document details the nonclinical testing performed to demonstrate the safety and functional equivalence of a modified electrosurgical device to its predicate. It does not contain information related to clinical studies, human reader performance, or AI/ML algorithm validation, which are typically the focus of the requested questions.

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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.

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.

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