(134 days)
The Novasys Transurethral RF System is indicated for the transurethral treatment of female stress urinary incontinence due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy.
The Novasys Transurethral RF Generator delivers controlled, low-level radiofrequency energy through the Novasys Transurethral RF Probe for localized collagen denaturation.
The provided text pertains to a 510(k) premarket notification for the Novasys Transurethral RF System. The document focuses on establishing substantial equivalence to predicate devices, rather than a detailed report of a clinical trial designed to explicitly define and meet acceptance criteria with specific performance metrics.
Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide what is available, and note what is not.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided document in the format of a table with specific acceptance criteria and numerical performance values. The document focuses on demonstrating substantial equivalence based on the device functioning "as clinically designed and intended" and improving quality of life and other clinical measures.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document mentions "clinical trials (both the Pilot Clinical Trial and the subsequent U.S. Multicenter Clinical Trial)," but does not specify the sample size for either of these trials.
- Data Provenance:
- Country of Origin: At least one of the clinical trials was a "U.S. Multicenter Clinical Trial." The country of origin for the Pilot Clinical Trial is not specified, though it's likely also US-based given the context of a US submission.
- Retrospective or Prospective: The description of "clinical trials" generally implies prospective studies. The document also states, "Sufficient data has been gathered from clinical investigations to determine..." which supports a prospective approach.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document describes clinical trials but does not detail how specific "ground truth" for patient outcomes or safety was established by experts, nor does it quantify the number or qualifications of such experts if they were involved in this specific capacity.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The device in question is a therapeutic medical device (Transurethral RF System), not an AI-assisted diagnostic tool, so an MRMC study with human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a therapeutic system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context appears to be based on clinical outcomes data from the patients treated in the clinical trials. The document mentions:
- "improvement in quality of life"
- "reduction in number of daily incontinence episodes"
- "reduction in daily incontinence pad use"
- "improvement in Valsalva leak point pressure"
- "no Serious Adverse Events and only limited Anticipated Adverse Events"
These are all clinical outcome measures.
8. The sample size for the training set
This information is not applicable because the Novasys Transurethral RF System is a hardware/software medical device for treatment, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's development would involve design, bench testing, and pre-clinical/clinical validation, but not a "training set" like that used for machine learning.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.