(23 days)
The Sonata® Transcervical Fibroid Ablation System 2.2 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue.
The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece.
The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. The change associated with this submission regards a change to materials, labeling artwork, and cable length of the Sonata Dispersive Electrode.
A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. Dispersive Electrodes are placed on the patient's thighs and connected to the RF Generator to complete the electrical circuit. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. When the Needle Electrodes are anchored within tissue, the physician is able to pivot the IUUS Probe transducer around the Needle Electrodes in order to confirm safety of the uterine serosa through multiple ultrasound planes.
The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery.
Sonata Graphical Guidance Software (GGS) includes the SMART Guide and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.
Two main elements of the SMART Guide are the Ablation Zone and the Thermal Safety Border.
- Ablation Zone (red inner ellipse) – a two-dimensional representation of the outer boundary of the average region of tissue ablation for the selected ablation size
- Thermal Safety Border (green outer ellipse) – the distance at which tissue outside of the Ablation Zone is safe from the potential of thermal damage.
The provided text is an FDA 510(k) clearance letter for the Gynesonics Sonata® Transcervical Fibroid Ablation System 2.2. It details the device's indications for use, technological comparison to a predicate device, and a summary of non-clinical and/or clinical tests performed.
Crucially, this document states that the changes made to the device (materials, labeling artwork, and cable length of the Dispersive Electrode) were minor and did not raise new questions of safety and effectiveness. For such minor modifications, the FDA typically does not require extensive new clinical studies comparing the modified device's performance against detailed acceptance criteria in the manner of an AI/ML algorithm. Instead, the focus is on demonstrating that the modified device still meets existing design requirements and is as safe and effective as its predicate.
Therefore, the information required to answer most of your specific questions regarding acceptance criteria and a study proving the device meets them (especially in the context of an AI/ML algorithm with detailed performance metrics) is not present in this regulatory document. The document describes a modification to an existing, already cleared device, not an initial clearance that would require a new, comprehensive clinical study with detailed performance outcomes.
The "study that proves the device meets the acceptance criteria" in this context refers to the verification and validation testing of the modified components to ensure they still meet the established safety and performance characteristics of the original cleared device. This is primarily non-clinical testing.
Here's how to address your points based on the provided text:
Acceptance Criteria and Device Performance
As this document describes a modification to an already cleared device, not a new device requiring novel clinical performance acceptance criteria, the detailed table you requested is not explicitly provided in the text. The acceptance criteria referenced are for the modified components to ensure they don't negatively impact the established safety and effectiveness of the predicate device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Met acceptance criteria |
| Mechanical Performance | Met acceptance criteria |
| Product Life | Met acceptance criteria |
| Basic Electrical Safety | Met acceptance criteria |
| Essential Performance (including Electromagnetic Compatibility) | Met acceptance criteria |
Note: The document states, "In all cases, the verification and validation testing met acceptance criteria with and without justification." This implies that the tests confirmed the modified components did not degrade the performance or safety of the system, aligning with the predicate device's established levels.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" sample size in terms of patient data for a clinical study. The testing described (biocompatibility, mechanical performance, etc.) refers to non-clinical, in-vitro, or bench testing of the modified device components.
- Data Provenance: Not applicable as this is primarily non-clinical testing of device components, not a clinical study on patient populations with geographical data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This is not applicable to the type of testing described in the document. Ground truth establishment by experts (e.g., radiologists for imaging studies) is relevant for clinical studies, particularly those involving AI/ML algorithms, which is not the primary focus of this 510(k) for a device modification. The "ground truth" here is the established safety and performance of the predicate device, against which the modified device's components were evaluated.
4. Adjudication Method for the Test Set
- Not applicable for the non-clinical component testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
- Not applicable. This device is a surgical ablation system, not an AI/ML diagnostic or assistive imaging tool that would undergo MRMC studies. The document describes a physical medical device and its modifications.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device. While it has "Graphical Guidance Software (GGS)" with "SMART Guide," the focus of this 510(k) is a modification to a physical component (Dispersive Electrode), not a new AI algorithm requiring standalone performance evaluation. The software functionality (SMART Guide) is part of the established predicate device.
7. The Type of Ground Truth Used
- For the non-clinical tests conducted on the modified device, the "ground truth" would be engineering specifications, regulatory standards (like FDA recognized standards), and the established performance characteristics of the predicate device. The goal was to demonstrate that modifications did not compromise these established criteria.
8. The Sample Size for the Training Set
- Not applicable. Training sets are relevant for AI/ML model development. This document is about a physical device modification.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See #8)
In summary: The provided FDA 510(k) letter pertains to a minor modification of an already cleared medical device (Sonata® Transcervical Fibroid Ablation System 2.2). The "study" described is a series of non-clinical verification and validation tests (biocompatibility, mechanical, electrical safety, etc.) on the modified components to ensure the device remains as safe and effective as its predicate. It does not involve a new clinical trial with human subjects or the evaluation of an AI/ML algorithm's performance, which would necessitate the detailed information requested in your questions related to ground truth, expert adjudication, or MRMC studies.
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).