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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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