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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 Somnus™ Tissue Coagulating Electrodes are intended for coagulation of soft tissue.
The Somnus Model RC-1 and RC-2 Reusable Cables are intended to provide an electrical connection between the Somnus Medical Technologies Model 1100, 1110 and 2110 Tissue Coagulating Electrodes and the Somnus Medical Technologies Electrosurgical (RF) Generators

The Somnus™ Tissue Coagulating Electrodes and Reusable Cables provide a reliable means of coagulating soft tissue.

This 510(k) submission (K973701) for the Somnus™ Tissue Coagulating Electrodes and Somnus Reusable Cable generally states that "performance validation testing has been done to validate the performance of the device." However, it does not provide any specific acceptance criteria or detailed study results proving the device meets said criteria. Therefore, most of the requested information cannot be extracted from the provided text.

Here is a breakdown of what can be inferred or determined from the given text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for the test set: Not specified.
• Data provenance: Not specified (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 (e.g. radiologist with 10 years of experience)

• Not specified. The document indicates "performance validation testing," which suggests lab-based or engineering tests rather than human expert evaluation for ground truth in a clinical context.

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

• Not specified. Given the nature of the device (electrosurgical accessories), adjudication methods typically associated with image-based diagnoses or clinical outcomes are unlikely to be relevant here.

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

• MRMC study: No. The device is a physical electrosurgical cable and electrodes, not an AI-powered diagnostic tool requiring human reader studies.
• Effect size of human reader improvement with/without AI: Not applicable, as there is no AI component.

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

• Standalone performance: The concept of "standalone performance" typically applies to AI algorithms. For this physical medical device, performance testing would involve demonstrating that the cable and electrodes transmit electrical energy effectively and safely to coagulate tissue as intended, which would be an "algorithm only" equivalent in the sense that it's the device's inherent function without human interpretive input. However, no details on such testing are provided.

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

• Not specified. For a device like this, ground truth would likely be based on engineering specifications, electrical performance metrics (e.g., impedance, power delivery), and possibly histological assessment of tissue coagulation in preclinical models or animal studies.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a "training set." Performance validation for a physical device focuses on its functional characteristics.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for this type of device.

Summary of what is present:

The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics. It generally states that "performance validation testing has been done to validate the performance of the device," but it does not elaborate on the specific tests, acceptance criteria, methodologies, or results of this testing. The submission is a regulatory filing for a physical electrosurgical device and accessories, not a software or AI-based diagnostic tool, thus many of the requested categories (e.g., MRMC, AI assistance, training/test sets, expert adjudication) are not relevant to this specific device or the information provided.

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The Somnus Model 30xx Disposable Tri-Needle Coagulating Electrode is indicated for use in the coagulation of tissue. This device is intended for use by qualified medical personnel trained in the use of Somnus Tissue Coagulating Electrodes.

The Somnus™ Model 30xx Disposable Tri-Needle Coagulating Electrode is a modification of the Model 3000 Disposable Tri-Needle Coagulating Electrode cleared under 510(k) #K963884. Both devices provide a reliable method of performing coagulation on target areas of tissue using a handle grip for ease of placement. The configuration of the handle grip of the Model 30xx is identical to the Model 3000 handle grip.

This 510(k) summary does not contain information on acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device. The document states:

"The Somnus has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, performance validation testing has been done to validate the performance of the device. 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, it does not provide details about the specific 'performance validation testing,' including the acceptance criteria, study design, sample sizes, or ground truth establishment.

Therefore, I cannot populate the requested table or answer the specific questions about the study design, sample size, expert qualifications, or comparative effectiveness. The information is not present in the provided text.

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The Somnus™ Model 6000 Disposable Tissue Coagulating Electrode is intended for use in the coagulation of tissue.

The Somnus™ Model 6000 Disposable Tissue Coagulating Electrode is a modification of the Model 3000 Disposable Tri-Needle Coagulating Electrode cleared for commercial distribution under 510(k) #K963884. The Model 6000 device has a maximum of six needles configured in two rows of three needles each. The Model 3000 has a maximum of 3 needles in a single row. Both devices provide a reliable method of performing coagulation on target areas of tissue using a handle grip for ease of placement. The configuration of the handle grip of the Model 6000 and Model 3000 are identical.

The provided text, a 510(k) summary for the Somnus Model 6000 Disposable Tissue Coagulating Electrode, lacks detailed information regarding specific acceptance criteria, study designs, sample sizes for training/test sets, expert qualifications, or adjudication methods typically found in comprehensive performance studies for medical devices.

The primary focus of this document is to establish substantial equivalence to a predicate device (Somnus Model 3000 Disposable Tri-Needle Coagulating Electrode) rather than presenting a standalone clinical performance study with defined acceptance criteria and detailed results.

However, based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics like accuracy, sensitivity, or specificity. The "performance validation testing" mentioned is generalized, and its results are summarized as supporting "substantial equivalence."

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified. The document mentions "performance validation testing" but does not provide details on the number of subjects, cases, or specific tests conducted for this validation.
• Data Provenance: Not specified. There is no mention of the country of origin of any data, nor whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is an electrosurgical tool, not an AI diagnostic or interpretive device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable as this is not an AI algorithm. The device is a physical electrosurgical electrode and its performance is inherently human-in-the-loop (qualified medical personnel).

7. The Type of Ground Truth Used

• Type of Ground Truth: Not specified. For a device like this, ground truth would typically relate to observed physical effects (e.g., successful tissue coagulation, absence of unintended damage) during testing. The document refers generally to "performance validation testing," which would have established this through experimental observation, but specifics are missing.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not specified. As this is a physical medical device (an electrosurgical electrode) and not an AI/machine learning system, the concept of a "training set" in the context of data-driven model development does not apply.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set Establishment: Not applicable. See point 8.

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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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The Somnus™ Model 215 Electrosurgical Generator and Accessories are intended for use with the Somnus Tissue Coagulating Electrodes for the coagulation of tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The Somnus Model 215 Electrosurgical Generator, in combination with various Somnus electrodes, is indicated for the coagulation of tissue.

This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

The SomnusTM Model 215 Electrosurgical Generator is an electrosurgical generator with controls for power delivered, time of energy delivery and in the automatic mode, maximum temperature. 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 electrodes and a footpedal.

Accessories included with the generator include a line power cable, single pedal footpedal an adapter for a dispersive electrode.

The provided text is a 510(k) summary for the Somnus Model 215 Electrosurgical Generator and Accessories.

Based on the provided document, here's an analysis regarding acceptance criteria and a study proving the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document does not provide specific, quantifiable acceptance criteria or reported device performance in the format of a table. It states:

"In addition, performance validation testing has been done to validate the performance of the device. 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."

This indicates that internal testing was performed, and the results were deemed satisfactory for substantial equivalence, but the details of those tests, including specific performance metrics and acceptance thresholds, are not included in this publicly available summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the sample size used for any test set or the data provenance. It only mentions "performance validation testing."

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 device is an electrosurgical generator, which typically involves objective performance measurements (e.g., power output, impedance, temperature control) rather than subjective interpretation by experts for ground truth establishment.

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

This information is not provided. Given the nature of the device (electrosurgical generator), an adjudication method in the context of expert consensus is unlikely to be relevant in the same way it would be for AI-driven diagnostic imaging devices.

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 is not applicable to this device. The Somnus Model 215 Electrosurgical Generator is a medical device for tissue coagulation, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC comparative effectiveness study would not be performed for this type of product.

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

This is not applicable to this device. This is a hardware electrosurgical generator, not an algorithm. The phrase "standalone performance" typically refers to the performance of an AI algorithm independent of human interaction.

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

The document does not explicitly state the type of ground truth used. For an electrosurgical generator, "ground truth" would likely relate to objective measurements of electrical output, thermal profiles, and perhaps tissue effects in an experimental setting, rather than pathology or outcomes data in the context of a diagnostic test.

8. The sample size for the training set:

This information is not provided in the document. As an electrosurgical generator, it is a hardware device and does not involve a "training set" in the context of machine learning. Its design and performance are based on engineering principles and validated through physical and electrical testing.

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

This information is not provided, and the concept of a "training set" is not applicable to this type of device.

In summary:

The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics, along with "performance validation testing." However, it does not detail the specific acceptance criteria, test methodologies, sample sizes, or expert involvement that would be typically found in a study demonstrating how a device meets specific, quantifiable acceptance criteria, especially for AI or diagnostic devices. The document is typical for a hardware medical device submission where the focus is on safety, effectiveness, and comparison to existing technology.

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