(87 days)
The Somnoplasty™ System is intended for the coagulation (thermal ablation, tissue volume reduction) of soft tissue, including tissue in the uvula/soft palate and may reduce the severity of snoring in some individuals. The system is intended for use by qualified medical personnel trained in the use of RF tissue ablation.
The SomnoplastyTM System is comprised of an Electrosurgical (RF) Generator and Tissue Coagulating Electrodes. The RF Generator has controls for power delivered and time of energy delivery. The unit has readouts for total energy delivered, impedance, number of active channels and temperature for up to 6 thermocouples. Connectors on the front panel include connectors for coagulating and dispersive electrodes and a footpedal. The electrodes are provided with various handpiece configurations to facilitate the placement of the needles in the tissue to be ablated. Accessories included with the generator include a line power cable, single pedal footpedal and an adapter plug to accommodate dispersive electrodes from various manufacturers.
This 510(k) summary for the Somnoplasty™ System primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information regarding specific acceptance criteria for performance, a formal study proving adherence to those criteria, or the methodology of such a study as one would typically find for AI/ML-based device submissions today.
The document discusses "performance validation testing, including a clinical study," but provides minimal details about the clinical study itself beyond its general purpose.
Therefore, much of the requested information cannot be extracted from the provided text.
Here is the information that can be gleaned and the limitations based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states that "Performance validation testing, including a clinical study, has been done to validate the performance of the device," and that "The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use." However, specific quantitative acceptance criteria or their corresponding performance results are not detailed.
2. Sample size used for the test set and the data provenance
The document mentions a "clinical study" but does not specify the sample size used for any test set or provide details on data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not available. This document predates the common requirements for AI/ML device submissions, and the nature of this electrosurgical device means ground truth would likely be established through direct clinical observation, patient outcomes, or pathological assessment rather than expert review of data/images in the context of an AI algorithm.
4. Adjudication method for the test set
Not applicable/Not available.
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
Not applicable. This is not an AI/ML device, hence an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device. The device itself performs the therapeutic action, rather than an algorithm providing diagnostic or therapeutic guidance.
7. The type of ground truth used
The device's intended use is for "coagulation (thermal ablation, tissue volume reduction) of soft tissue... and may reduce the severity of snoring in some individuals." Given this, the "ground truth" for its effectiveness and safety in the clinical study would likely have been established through:
- Clinical observation and patient outcomes: Assessment of tissue coagulation/ablation, reduction in snoring severity reported by patients or bed partners, and absence of adverse events.
- Medical imaging/physical examination: Potentially used to verify tissue changes or volume reduction.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
§ 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.