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The Somnoplasty™ System is intended for the reduction of the incidence of airway obstructions in patients suffering from UARS or OSAS.
The Somnoplasty " System is intended for the reduction of the incidence of airway obstructions in patients suffering from UARS or OSAS.
The Somnoplasty®" System is intended for the reduction of the incidence of airway obstructions in patients suffering from UARS (Upper Airway Resistance Syndrome) or OSAS (Obstructive Sleep Apnea Syndrome).

The Somnoplasty™ System is comprised of an Electrosurgical (RF) Generator and Tissue Coagulating Electrodes. The RF Generator has controls for target temperature, target energy, 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 and single pedal footpedal.

The provided document does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested. The document is a 510(k) summary and related FDA correspondence, primarily focusing on the device's intended use, comparison to predicate devices, and FDA clearance.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about a test set, its sample size, or data provenance.
• Information on the number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance data.
• The type of ground truth used (e.g., pathology, outcomes data).
• The sample size for the training set.
• How ground truth for the training set was established.

The document mentions that "Performance validation testing, including a clinical study, has been done to validate the performance of the device," but it does not provide any specifics or results from that study. It also states the device "is safe and effective in its intended use" based on comparisons and validation results, but no metrics or criteria are elaborated upon.

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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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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.

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