(90 days)
The Thermoflex system is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia ("BPH"). It is indicated for use in men over the age of 50 years with prostate lengths between 2.0 cm and 6.4 cm who present symptoms of urinary outflow obstruction secondary to BPH.
The Thermoflex system is a catheter based thermal therapy device for the treatment of symptoms due to urinary outflow obstruction secondary to BPH. The Thermoflex system combines a heating console/pump with a sterile, multiple balloon WIT prostatic catheter. Following insertion of the WIT prostatic catheter into the bladder through the urethra, a "locating" balloon is filled with a small volume of air and positioned within the bladder neck to insure proper placement of the treatment balloon within the prostate. A predetermined volume of water is added to the balloon dilation catheter ("treatment balloon"), causeing the treatment balloon to dilate within the prostate, creating pressure and insuring contact of the treatment balloon's surface with the prostatic tissue. Water is heated externally to the body and pumped through the thermally insulated catheter to the treatment site and back to the heating console/pump. At the treatment site, heat from the water is exposed to the urethra and prostatic tissue by means of physical contact of the treatment balloon with the target tissue. Heat from the water is transferred conductively to the tissue, inducing tissue ablation due to coagulation necrosis and tissue devitalization.
Here's a breakdown of the acceptance criteria and study information for the Argomed, Inc.'s Thermoflex system, based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly state formal, quantitative acceptance criteria in a table format with pass/fail thresholds. Instead, it focuses on demonstrating substantial equivalence to predicate devices through a clinical study that assessed improvements in BPH symptoms and signs. The "acceptance" can be inferred from the reported clinical significance and safety.
| Acceptance Criteria (Inferred from Clinical Objectives) | Reported Device Performance (Thermoflex System) |
|---|---|
| Improved urine flow rates | Clinically and statistically significant improvements |
| Reduced prostate volume | Clinically and statistically significant improvements |
| Reduced prostate symptomatology | Clinically and statistically significant improvements |
| Improved quality of life assessments | Clinically and statistically significant improvements |
| Acceptable safety profile | Adverse events observed are typical for devices used to treat BPH or for catheterization in general. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical value for patients in the clinical study. It is described as a "multicenter, nonrandomized, prospective clinical study of a single patient group."
- Data Provenance: The document does not specify the country of origin. It indicates it was a "multicenter" study, which suggests multiple clinical sites, but location is not mentioned. The study was prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide information on the number or qualifications of experts used to establish a "ground truth" for the test set. The study design centers on objective clinical endpoints (urine flow rates, prostate volume, symptom scores, quality of life assessments) rather than expert interpretation of images or data needing a "ground truth" consensus.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for the test set. Given the nature of the clinical endpoints (quantitative measurements and patient-reported symptoms/QOL scores), a traditional adjudication process as seen in imaging or diagnostic studies is unlikely to have been employed.
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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. This was a clinical study evaluating a medical device (Thermoflex system) for BPH treatment. It was not an MRMC study and did not involve AI assistance or human readers in the context of diagnostic interpretation. The comparison was to published safety and effectiveness information of predicate devices (TUNA and VLAP systems).
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. The Thermoflex system is a physical medical device (catheter-based thermal therapy system), not a software algorithm. The study assessed the device's performance in treating BPH in human subjects.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" implicitly used for evaluating the device's effectiveness was based on clinical outcomes data and patient-reported assessments. These include objective measurements like urine flow rates and prostate volume, and subjective assessments of BPH symptoms and quality of life. The document states "changes in severity of BPH symptoms and signs from pretreatment to post-treatment."
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The sample size for the training set:
- The document does not mention a training set. This is a clinical trial for a physical medical device, not a machine learning model, so the concept of a "training set" is not applicable in this context. The study described is the primary clinical evaluation.
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How the ground truth for the training set was established:
- As there was no training set in the context of a machine learning model, this information is not applicable.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).