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The Somnoplasty System is intended for tissue coagulation (thermal ablation) in the inferior turbinates to treat the symptoms of nasal obstruction due to chronic turbinate hypertrophy. The System is intended for use only by qualified medical personnel, trained in the use of radio frequency tissue ablation.

The SomnoplastyTM System is comprised of an Electrosurgical (RF) Generator and Tissue Coagulating Electrodes. The RF Generator has controls for target temperature, 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 3 thermocouples per channel. 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.

The provided text is a 510(k) summary for the SomnoplastyTM System and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting detailed results from a clinical study directly within this document. Therefore, much of the requested information regarding specific acceptance criteria and detailed study results is not present.

However, based on the text, here's what can be inferred and what information is not available:

Acceptance Criteria and Device Performance (Not explicitly stated or defined in this document for the clinical study):

The document states: "Performance validation testing, including a clinical study, has been done to validate the performance of the device." However, it does not specify quantifiable acceptance criteria or reported device performance metrics from this clinical study.

Study Information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in this document.
   • Data Provenance: Not specified (e.g., country of origin). The document mentions a "clinical study" but does not indicate if it was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The clinical study is mentioned in a general sense, but details about its methodology, including ground truth establishment and expert involvement, are not provided.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not specified.

4. 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 versus without AI assistance:

   • No. The SomnoplastyTM System is an electrosurgical device for tissue coagulation, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This is an electrosurgical device that requires direct human operation. The concept of a "standalone algorithm" is not applicable. The device's performance inherently involves human operators ("intended for use only by qualified medical personnel, trained in the use of radio frequency tissue ablation").

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not specified. The clinical study's endpoint or how "performance" was validated is not detailed. Given the intended use (treating symptoms of nasal obstruction due to chronic turbinate hypertrophy), it's likely related to patient outcomes or symptom relief, but this is not explicitly stated.

7. The sample size for the training set:

   • This is an electrosurgical device, not an AI or machine learning model that typically involves "training sets" in the conventional sense. The "training" referred to in the document is for the medical personnel using the device.

8. How the ground truth for the training set was established:

   • As above, the concept of a "training set" for ground truth establishment is not applicable to this type of device.

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