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510(k) Data Aggregation
(254 days)
The Sonata® Sonography-Guided Transcervical Fibroid Ablation System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
The Sonata System 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 provided text describes the acceptance criteria and the clinical study results for the Gynesonics Sonata® Sonography-Guided Transcervical Fibroid Ablation System.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Sonata System) |
|---|---|
| Co-primary Efficacy Endpoint: Reduction in Menstrual Blood Loss (MBL) at 12 months Success criterion: Lower Confidence Limit (LCL) ≥ 45% (referring to ≥ 50% Reduction in PBAC and PBAC <250) | 64.8% of subjects achieved ≥ 50% reduction in PBAC and PBAC <250 at 12-Month Visit. 95% CI (LCL, UCL): 56.3%, 72.6%. Outcome: Met Endpoint Success Criteria. (LCL of 56.3% is ≥ 45%) |
| Co-primary Efficacy Endpoint: Surgical Reintervention through 12 Months Success criterion: LCL of the percentage of subject success ≥ 75% (meaning rate of no surgical re-intervention) | 99.3% Rate of No Surgical Re-intervention through 12 Months. 95% CI (LCL, UCL): 95.1%, 99.9%. Outcome: Met Endpoint Success Criteria. (LCL of 95.1% is ≥ 75%) |
| Safety Objective: Absence of serious adverse device effect (SADE), adverse device effect (ADE), or unanticipated adverse device effect (UADE). | There was no occurrence of SADE, ADE, or UADE. Two procedure-related serious adverse events (SAEs) in two subjects (one deep venous thrombus, one leukorrhea/pelvic pain managed with antibiotics). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 147 subjects were enrolled, with 142 subjects evaluated for the MBL endpoint and 143 subjects evaluated for the surgical re-intervention endpoint.
- Data Provenance: The data was obtained from a prospective, longitudinal, multicenter, single-arm cohort study named the SONATA Pivotal IDE Clinical Trial. Subjects were enrolled in clinics in the United States and Mexico.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the clinical trial endpoints. For outcomes such as Pictorial Blood Loss Assessment Chart (PBAC) scores, these are typically self-reported by patients or assessed by study coordinators based on patient reporting. Surgical re-intervention is a factual event, often confirmed by medical records. However, the study involved multiple investigational sites (27) with trained personnel who would have been responsible for data collection and assessment as per the study protocol.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1 or 3+1 for the clinical trial endpoints. However, it indicates that the trial was a "single-arm cohort study with each subject serving as her own control," implying comparison of pre- and post-treatment metrics within the same subject. The endpoints were assessed at 12 months post-procedure, and data collection continued for 3 years for select measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The clinical study was a single-arm trial evaluating the device's performance against pre-defined success criteria.
6. Standalone (Algorithm Only) Performance Study
While the software component (SMART Guide) underwent extensive bench testing including volumetric ablation registration, development and confirmation of ablation dimensions, and effect of parameter variations on ablation dimensions, this was not presented as a standalone clinical performance study but rather as verification and validation of the software's ability to accurately guide the ablation. The study focused on the performance of the integrated Sonata System with human users.
7. Type of Ground Truth Used
The ground truth for the clinical study was based on:
- Patient-reported outcomes: Menstrual Blood Loss (MBL) was quantified using the Pictorial Blood Loss Assessment Chart (PBAC) score. Subject satisfaction, symptom improvement, and likelihood to recommend were also patient-reported outcomes.
- Observed clinical outcomes: Surgical re-intervention rates were direct clinical events.
- Objective measurements: Reduction in fibroid volumes (measured at 3 months post-procedure in the FAST-EU trial).
- Adverse events: Clinically observed and reported events.
8. Sample Size for the Training Set
The document specifies the sample size for the pivotal clinical trial (test set) as 147 subjects. It does not explicitly state a separate sample size for a training set for the software or algorithm. The software (SMART Guide) development involved "ex vivo testing with non-perfused bovine tissue model" and "in vivo peri- and pre-Hysterectomy studies data" to set the final SMART Guide dimensions, but a specific "training set sample size" for an AI/ML algorithm in the conventional sense is not provided.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, a specific "training set" for an AI/ML algorithm is not explicitly detailed. However, the "ground truth" for the development of the SMART Guide, which is a key software component providing graphical guidance, was established through:
- Ex vivo testing: Using bovine tissue models to measure volumetric registration offset and develop the initial dimensions of the Ablation Zone (AZ) and Thermal Safety Border (TSB).
- In vivo studies: Peri- and pre-Hysterectomy studies provided data used to establish the final dimensions of the AZ and TSB.
- Computational modeling: Finite Element Method (FEM) was used to determine the sensitivity of ablation dimensions to variations in tissue parameters.
These methods were used to define and validate the graphical representations (AZ and TSB) within the SMART Guide, ensuring they accurately predict the ablation effect.
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