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510(k) Data Aggregation
(132 days)
The Acessa System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.
The Acessa System includes the following system components: Generator (Model Number 1000): Provides RF energy to the Handpiece through the Handpiece Cable. Handpiece (Model Number 2000): Consisting of a disposable handle with a trocar-pointed shaft and 7 deployable needle electrodes. For use only disposable electrosurgical devices provided by Halt Medical, Inc. Handpiece Cable (Model Number 4200): Connects Handpiece to the Generator. This extension cable is provided with the Generator. Pads (Model Number 3000): A disposable set of 2 units, providing the return path for the RF energy applied by the Handpiece. Use only the Pads provided by Halt Medical, Inc. Pad Cable (Model Number 4300): Connects the Pads to the Generator. This extension cable is provided with the RF Generator. Power Cord (Model Number 4110): A medical grade power cord that provides AC power to the Generator. The Power cord is provided with the Generator. Foot Pedal (Model Number 4100): Pneumatic foot pedal with tubing used to turn RF energy on and off. The Foot Pedal with tubing is provided with the Generator. The Acessa System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Manual Control and Coagulation Mode. A touch screen with a graphical user interface (GUI) enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the Handpiece placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the Generator. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal. NOTE: The Acessa System must be used under laparoscopic ultrasound guidance. Laparoscopic ultrasound equipment is not included with the Acessa System.
The provided document describes the Acessa System, a device for laparoscopic coagulation and ablation of soft tissue, specifically for symptomatic uterine fibroids. Here's a breakdown of the acceptance criteria and the studies conducted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabulated format with specific thresholds. Instead, it describes various performance testing and clinical study outcomes that demonstrate the device's safety and effectiveness. Based on the provided information, the closest approximation of acceptance criteria and reported performance is:
| Acceptance Criteria (Inferred) | Reported Device Performance (as demonstrated by studies) |
|---|---|
| Safety - Electrical, Mechanical, Software, and Biocompatibility | The Acessa System passed all electrical, mechanical, and software validation testing, as well as applicable safety requirements (EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-2-2). EMC and safety testing were completed on the entire device and per component. Biocompatibility testing demonstrated materials are safe and in compliance with ISO 10993-1, ISO 10993-5, and ISO 10993-10. Device-related adverse events were less than 4% in the pivotal study, with only 2 serious adverse events (a pelvic abscess and a serosal colon injury) considered related to the device among 10 reported serious events. Only one (1.4%) serious adverse event (abdominal wall hematoma) was considered procedure-related in the Phase II studies. |
| Functional Performance - Ablation Capability & Control | Animal and bench ablation testing successfully demonstrated the Acessa System performs as intended and per specifications. Ablation capability was confirmed, providing a reproducible, discretely demarcated zone of tissue necrosis. The peri-hysterectomy feasibility study showed that ex vivo bench testing ablation results are predictive of ablations in fibroid tissue in vivo, with no device-related adverse events. The system continuously monitors parameters, automatically stops RF energy if outside acceptable limits, and allows user-initiated stops. |
| Effectiveness - Reduction in Menstrual Blood Loss (for symptomatic uterine fibroids) | Phase II Studies: At 12 months post-treatment, 3.5% (p<0.0001) of subjects reported heavy to very heavy bleeding, down from 77% at baseline. Pivotal Study: Mean reduction in menstrual blood flow at 12 months post-treatment was 103.6 ml. 83.9% of subjects experienced a reduction in blood loss. 40.2% (95% CI 31.6% - 48.7%) met the bleeding relief criterion (≥50% reduction in menstrual bleeding at 12 months), though this was below the prespecified study hypothesis of ≥45% lower bound. |
| Effectiveness - Symptom Severity Reduction (for symptomatic uterine fibroids) | Phase II Studies: Mean percent improvement in Symptom Severity Scores (UFS-QOL) was 59.6% at 3 months, 65.0% at 6 months, and 79.0% at 12 months. Overall, 94.2% reported improved Symptom Severity Scores. Pivotal Study: Continuous decrease in Symptom Severity Scores (SSS) from a high 61 at baseline to a low 24 at 24 months post-treatment. At least 94% of subjects responded that the treatment had been somewhat, moderately, and very effective in eliminating their symptoms. |
| Effectiveness - Improvement in Health-Related Quality of Life (for symptomatic uterine fibroids) | Phase II Studies: Mean percent change in HRQL Scores from baseline was 41.6% at 3 months, 39.7% at 6 months, and 42.9% at 12 months. Overall, 88.4% reported improved HRQL Scores. Pivotal Study: Steady improvement in mean Health-Related Quality of Life (HRQL) scores (from a low 37 at baseline to 80 after 24 months post-treatment). Subjects reported a decrease in disease burden and improved health state with mean EQ-5D scores starting at 71 at baseline and rising to 85 after 24 months. |
| Effectiveness - Reduction in Uterine and Fibroid Volume | Phase II Studies: Mean uterine volume significantly reduced to 155.0 cm³ (p=0.012) at 6 months and 151.4 cm³ (p=0.009) at 12 months, from 204.4 cm³ at baseline. 79.3% of subjects showed reduced uterine volume at 12 months. Pivotal Study: At 12 months post-treatment, mean reduction in uterine volume was 25.1%, and mean reduction in fibroid volume was 44.3% (assessed by contrast-enhanced MRI). |
| Effectiveness - Low Reintervention Rate | Pivotal Study: Within 24 months, a cumulative reintervention rate for fibroid-related bleeding was <6% (6 out of 107 subjects). |
| Outpatient Minimally Invasive Option with Rapid Recovery and High Patient Satisfaction | Treatment with this device provides an outpatient minimally invasive option that allows rapid recovery. 96% of subjects in the pivotal study were treated on an outpatient basis. Subjects returned to work in a median of 5 days, and all subjects reported returning to normal in a median of 9 days. 94% of subjects were "very, moderately, or somewhat satisfied" with the treatment. 98% of subjects would "probably or definitely recommend" the procedure to friends with the same health problem at 12 months. |
| Feasibility in Varied Cases (e.g., fibroid types/locations, calcified fibroids) & Predictability of Ablation | The peri-hysterectomy feasibility study encountered various fibroid locations and types. The Phase II and pivotal studies also treated various fibroid types and locations. Seven subjects (5.1%) with calcified fibroids were treated, and calcified fibroids did not appear to impact the physician's ability to insert the Handpiece tip. Bench testing was predictive of in vivo ablation. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document details three main clinical studies that serve as the "test set" for the device's performance:
- Peri-hysterectomy feasibility study:
- Sample Size: Not explicitly stated, but implies a small cohort of patients undergoing hysterectomy where the Acessa System was used.
- Data Provenance: Not explicitly stated, but likely prospective and from a clinical setting where hysterectomies were being performed.
- Prospective, non-randomized, longitudinal Phase II studies:
- Sample Size: A total of 69 subjects (implied from the phrase "sixty-five subjects (94.2%)" and "sixty-one subjects (88.4%)" which point to a denominator around 69).
- Data Provenance: Prospective, non-randomized, conducted at "two separate centers," likely in the US (not explicitly stated country, but common for IDE trials).
- Device pivotal (Phase III) study:
- Sample Size: 137 women with symptomatic fibroids.
- Data Provenance: Prospective, conducted at 11 centers in the United States (9 centers) and Latin America (2 centers).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe a ground truth established by a specific number of experts for image interpretation or diagnosis in the traditional sense of AI studies. Instead, the "ground truth" for the clinical effectiveness studies was derived from:
- Patient-reported outcomes: Validated questionnaires (UFS-QOL, EQ-5D), menstrual pad counts, patient surveys on satisfaction and symptom effectiveness, and self-reported return to normal activities.
- Clinical measurements: Uterine volume, fibroid volume (assessed by contrast-enhanced MRI).
- Pathology reports: From the peri-hysterectomy study, correlated with ablation zones.
- Adverse event reporting: By investigators.
- Investigators: 13 investigators participated in the pivotal study. Their specific qualifications (e.g., number of years of experience) are not detailed but they are presumed to be qualified clinicians (e.g., gynecologists) experienced in treating uterine fibroids.
4. Adjudication Method for the Test Set
The document does not mention an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing a "ground truth" for the test set. The clinical trial data relies on patient reporting, objective clinical measurements, and investigator reporting of adverse events and outcomes based on standard clinical practice.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The Acessa System is a therapeutic device (for ablation), not a diagnostic device that involves "human readers" interpreting images. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. The Acessa System is a physical medical device (generator, handpiece, etc.) used by a physician during a laparoscopic procedure. It is not an algorithm or AI system that operates in a standalone capacity without human interaction for its primary function. While it has internal software for control and monitoring, its performance is inherently tied to human use and guidance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for evaluating the Acessa System's performance was primarily a combination of:
- Clinical Outcomes Data:
- Patient-reported outcomes: From validated questionnaires (Uterine Fibroid Symptom Quality of Life (UFS-QOL), EuroQol 5 Dimensions (EQ-5D)), patient satisfaction surveys, symptom severity scales, and menstrual pad counts.
- Objective clinical measurements: Reduction in uterine and fibroid volume (via contrast-enhanced MRI), reduction in menstrual blood loss, and reintervention rates.
- Adverse event reporting: Clinical events reported by investigators and medical staff.
- Pathology: In the peri-hysterectomy feasibility study, pathology reports of ablation zones were correlated with procedure documentation.
- Device specifications: For electrical, mechanical, and software performance.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an AI/machine learning model. The studies described are clinical trials and engineering validations for a physical medical device. The "training" in this context would be the development and iterative testing of the device during its engineering phase, which is not quantified by a patient sample size but by laboratory and bench testing efforts.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the AI/ML sense, this question is not directly applicable. For the device development itself, "ground truth" for design and engineering was established through:
- Internal specifications and standards: Adherence to regulatory standards (EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-2-2, ISO 10993).
- Bench testing: To qualify and quantify mechanical and functional properties, ablation output, and safety features.
- Animal studies: To demonstrate performance as intended and per specifications prior to human trials.
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