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510(k) Data Aggregation
(191 days)
The TULSA-PRO is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.
The TULSA-PRO system combines real-time Magnetic Resonance (MR) imaging and MR thermometry with transurethral directional ultrasound and closed-loop process control software to deliver precise thermal ablation of physician prescribed prostate tissue. The system consists of both hardware and software components. The subject device includes a modification to the device software that is described below. The hardware components and treatment workflow description are identical to the predicate device.
The physician inserts two catheters, one transurethral and another transrectal, into the patient before he is moved into the MR bore. The transurethral catheter consists of an Ultrasound Applicator (UA) which delivers energy from within the prostate tissue, heating it to thermal coagulation. The transrectal catheter is an Endorectal Cooling Device (ECD) which does not emit any energy and cools the rectal wall adjacent to the prostate. Both catheters have fluid flowing inside throughout the treatment.
The physician uses the TULSA-PRO console to robotically position the Ultrasound Applicator in the prostate and plan the treatment by contouring the prescribed tissue intended for ablation on real-time high-resolution cross-sectional MR images of the prostate. These features provide the physician with the ability and the control to customize the treatment plan to minimize thermal impact to critical structures surrounding the prostate including the external urethral sphincter, rectum and neurovascular bundles.
The treatment begins based upon the physician starting the thermal ablation in the software. The TULSA-PRO closed-loop process control software reads real-time MR thermometry measurements and adjusts automatically and dynamically the frequency and power of ultrasound provided by each ultrasound transducer, and rotation rate of the Ultrasound Applicator, to deliver precise ablation of the prescribed prostate tissue defined by the physician in the treatment plan.
Software Modification: An optional feature called Thermal Boost is available in the software during the treatment delivery phase of the treatment workflow. The Thermal Boost feature is useful when the prostate is large and the treatment radius is >15mm for any active ultrasound element. In such cases, heat may not reach the prostate boundary due to prostate size or if tissue perfusion is preventing the heat from reaching the target boundary. The physician has a choice to use the Thermal Boost feature on the corresponding ultrasound transducer. When this feature is turned on, the treatment boundary temperature can reach ≤63 degrees or ≤65 degrees depending on the treatment radius. Thermal Boost does not change the ablation plan prescribed by the physician. Whether Thermal Boost is turned on or off, the tissue heating and monitoring principle of operation of the TDC software do not change.
Following completion of the ablation process, the two catheters are removed from the natural orifices of the patient.
The provided text describes modifications to the TULSA-PRO System, specifically a software update introducing an optional feature called "Thermal Boost." The document is a 510(k) summary, aimed at demonstrating substantial equivalence to a previously cleared predicate device rather than presenting a novel device that requires a full, de-novo clinical trial with extensive acceptance criteria.
Therefore, the acceptance criteria and study detailed here are focused on demonstrating that the modification (Thermal Boost feature) does not adversely impact the safety and effectiveness of the existing, cleared TULSA-PRO system. It's not a study to establish the device's efficacy from scratch, but rather to show that the new feature maintains the established safety and performance profile.
Here's an analysis based on the provided text:
Key Takeaway: The "acceptance criteria" for this 510(k) submission are implicitly about demonstrating that the software modification (Thermal Boost) does not introduce new safety or effectiveness concerns compared to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, the "acceptance criteria" are not explicitly defined as pass/fail thresholds for specific metrics in a table format for the Thermal Boost feature itself in a clinical comparative study. Instead, the focus is on showing that the modified device's performance, particularly in terms of safety and technical metrics, is consistent with or better than the predicate device.
The document highlights the following evaluation points for the Thermal Boost feature:
| Criteria Category | Specific Metric/Approach | Reported Device Performance (Thermal Boost) | Comparison to Predicate/Acceptance |
|---|---|---|---|
| Safety | Rate of serious adverse events and adverse events | Adverse events reported with Thermal Boost were similar to those previously reported in the pivotal clinical dataset for TULSA-PRO (K191200). (e.g., epididymitis, urinary retention, pain/discomfort, urinary urgency, nocturia, urinary incontinence, ejaculation disorder, erectile dysfunction, urinary tract infection, and hematuria). No new complications were observed. | This implicitly meets the acceptance criteria of not increasing adverse event rates or introducing novel complications compared to the predicate device. The "similarity" indicates acceptance. |
| Technical Performance | Dice Similarity Coefficient (DSC) (Physician-defined ablation plan vs. temperature maps) | Median (IQR) DSC: 0.90 (0.88-0.92) | All technical endpoints met the established performance criteria. (The specific numerical criteria for the predicate are not detailed in this document for direct comparison, but the statement indicates meeting pre-defined thresholds). |
| Technical Performance | Controller overshoot percentage (Physician-defined ablation plan vs. temperature maps) | Median (IQR) Controller overshoot: 6.4% (3.6%-10%) | All technical endpoints met the established performance criteria. (Same as above) |
| Technical Performance | Controller undershoot percentage (Physician-defined ablation plan vs. temperature maps) | Median (IQR) Controller undershoot: 3.9% (1.7%-7.1%) | All technical endpoints met the established performance criteria. (Same as above) |
| Usability | User perception and understanding of Thermal Boost feature; identification of new use errors via questionnaire | Responses indicated that identification of the feature and training material was effective. No new use errors identified. | This meets the criterion of demonstrating that the feature is usable and does not introduce new risks due to user error. |
| Non-clinical (Software V&V) | Performance of modified software compared to predicate software (in tissue-mimicking phantom) | No significant differences in temperature profile with respect to location of peak temperature or rate of change of temperature at the prostate boundary. Rectal cooling and treatment controller targeting statistics were met even in worst-case scenario. | This non-clinical testing directly serves as an "acceptance criterion" that the software modification functions as intended without adverse changes in a controlled environment, validating its equivalence to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Performance (Test Set): 71 adult male patients.
- Data Provenance: Clinical performance data were collected from patients presumably treated with the commercially available TULSA-PRO system with Thermal Boost applied. The location of the clinical study is not explicitly stated, but the company is based in Canada. Given it's a 510(k) for a known device, it's likely a prospective collection of data on patients treated with the modified system in a clinical setting. It is not explicitly stated if it was retrospective or prospective, but the phrasing "Clinical performance data were collected from 71 adult male patients treated..." implies prospective data collection tailored to assess the new feature's impact.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts or their qualifications involved in establishing "ground truth" for the clinical test set concerning the Thermal Boost feature. The assessment appears to rely on:
- Treating Physician's Determination: The area of prostate requiring Thermal Boost was determined by the treating physician.
- Adverse Event Assessment: Adverse events were assessed by the treating physician for a six-month period post-treatment.
- Technical Performance: Evaluation was via comparison of physician-defined ablation plan to temperature maps measured during ablation delivery by the software. This implies the software's ability to monitor and report accurate temperature data serves as a form of "ground truth" for real-time ablation monitoring, validated by physical phantom testing.
- Usability Questionnaire: Administered to physicians who used the system.
Given the nature of the submission (510(k) for a software modification to an already cleared device), the "ground truth" is primarily whether the software controls maintained their accuracy and if clinical outcomes (adverse events, usability) remained comparable to the cleared predicate, as reported by the treating physicians and the device's own monitoring systems.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1 consensus) for the clinical data. Adverse events were assessed by the treating physician. Technical performance was automatically evaluated by the system comparing its plan to measured temperature maps. Usability was through a questionnaire. This implies no external, multi-expert adjudication process beyond the primary treating physicians' reports and the device's internal technical metrics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not explicitly stated or implied for this submission.
- This type of study is more common for AI-driven diagnostic or interpretative tools where human reader performance (with vs. without AI) is a direct measure of the AI's clinical utility.
- The TULSA-PRO System is an ablation device with a software control modification. Its "effectiveness" is primarily a measure of its ability to ablate tissue safely and accurately, not an interpretative aid. The efficacy of the TULSA-PRO system itself was established in previous clearances (K191200 onward). This 510(k) focuses on the safety and performance impact of a new control feature.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
- Yes, in a non-clinical context.
- "Technical performance of the software with Thermal Boost enabled was compared to the predicate software during simulated prostate ablation in a tissue-mimicking gel phantom."
- This phantom study effectively tested the algorithm's performance in a standalone, controlled environment, measuring temperature profiles and confirming its targeting statistics. This demonstrates the algorithm's behavior independent of human intervention, although the "Thermal Boost" is a user-enabled feature.
7. The Type of Ground Truth Used
The "ground truth" depends on the evaluation aspect:
- Safety: The ground truth for safety was based on clinically reported adverse events identified by the treating physicians and classified using MedDRA and Clavien-Dindo.
- Technical Performance: The ground truth was the real-time MR thermometry measurements during ablation delivery, compared against the physician-defined ablation plan. This implies the MR thermometry is considered the benchmark for actual temperature distribution, while the physician's plan is the target.
- Usability: The ground truth for usability was the direct subjective feedback from physicians via a questionnaire.
- Non-clinical (Software V&V): For the phantom study, the ground truth was MR thermometry measurements within the tissue-mimicking gel.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This is because the submission describes a software modification for an existing device, not a de novo AI/ML model that requires a new, explicit training phase for this specific submission. The "Thermal Boost" feature appears to be a modification to the control algorithm of an existing system, likely developed based on engineering principles and potentially internal performance data, rather than a separate, newly trained AI model.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" for a new AI/ML model linked to this specific software feature is mentioned, the method for establishing its ground truth is not detailed. The software verification and validation activities are described as being performed in accordance with FDA guidance, comparing the modified software's performance to the predicate device. This implies that the "ground truth" for verifying the software's behavior would stem from its expected performance parameters, likely established during the original device development (K191200) and confirmed during the modification through non-clinical testing.
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