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The SomnoDent ALPHA is temporarily intended as an aid in the reduction of simple night time snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older.

The SomnoDent ALPHA is a device that functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device consists of two generic splints, which fit over the upper and lower teeth. The lower splint is held in a protrusive position by an advancement mechanism. The device advances the mandible in the sagittal plane to increase the patient's pharyngeal space during sleep and reduce the apnea symptoms.

This document is a 510(k) summary for the SomnoDent ALPHA® device, which is an intraoral device for snoring and obstructive sleep apnea. The document asserts the device's substantial equivalence to predicate devices based on technological characteristics, intended use, and performance testing.

There is no detailed study described in this document that proves the device meets specific acceptance criteria with quantifiable results. Instead, the document relies on comparisons to predicate devices and general statements about performance and safety testing.

Here's a breakdown of the requested information based on the provided text, highlighting the absence of specific study details where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. It relies on the concept of "substantial equivalence" to predicate devices. However, we can infer some "performance specifications" from the comparison table (Section 7.0) and the discussion in Section 8.0.

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

This information is not provided in the document. The document refers to "performance testing" and "simulated in-use testing" but does not specify the sample size for these tests (e.g., number of devices tested, number of cycles for mechanical testing). Data provenance is also not mentioned.

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

This information is not provided in the document. The document does not describe any human-involved assessment of the device's performance that would require establishing a ground truth by experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. No adjudication method is mentioned as there's no description of a study involving multiple interpretations needing reconciliation.

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

There is no MRMC comparative effectiveness study described. This device is a physical intraoral device, not an AI-powered diagnostic or assistive tool, so this type of study is not relevant.

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

This is not applicable as the device is a physical intraoral device, not an algorithm.

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

The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. The document describes performance testing based on engineering principles (e.g., ability to withstand forces, biocompatibility testing against ISO standards) rather than clinical diagnostic accuracy against a definitive truth.

8. The sample size for the training set

This information is not provided and is not applicable as this is a physical device, not a machine learning model requiring a training set.

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

This information is not provided and is not applicable as this is a physical device, not a machine learning model.

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To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).

The TAP III Anti-Snoring device is comprised of:

• Lower tray fitted over the lower teeth.
• Upper tray fitted over the upper teeth.
• Impression material
• Hook and Base mechanism to attach lower tray to upper tray.

The provided text is a summary of safety and effectiveness for a medical device (TAP III), not a study. It compares the TAP III to predicate devices but does not describe acceptance criteria for studies or report device performance against such criteria in the way a clinical study would. The document states "Non applicable under Section 514" for "Performance Testing," indicating that a new performance study was not required for this 510(k) submission.

Therefore, the following information cannot be extracted from the provided text:

• Acceptance criteria and reported device performance (as these relate to a study's outcomes)
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study details
• Standalone performance details
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The only performance-related information mentioned is a "Reduced AHI in patients" of "72%" for the TAP III, which is also listed for all predicate devices. This appears to be a characteristic of the device type rather than a specific result from a study conducted on the TAP III itself for this submission. The document explicitly states "Non applicable under Section 514" for Performance Testing, suggesting that the substantial equivalence of the TAP III to existing devices means a new performance study was not deemed necessary by the FDA for this particular submission.

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To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).

The TAP T Anti -- snoring device is comprised of -- - 트 Lower tray fitted over the lower teeth. - . Upper tray fitted over the upper teeth. - 트 Impression material - . Hook mechanism to attach to lower tray to upper tray

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any specific criteria. The document is a 510(k) premarket notification summary for the TAP T device, outlining its description, intended use, and substantial equivalence to predicate devices, but it does not contain details of any performance studies or acceptance criteria.

Therefore, I cannot provide the requested information.

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To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).

The TAP II Anti-Snoring device is comprised of:

• & Lower tray fitted over the lower teeth.
• Upper tray fitted over the upper teeth.
• Impression material
• Hook and Base mechanism to attach lower tray to upper tray.

The provided text does not contain detailed information about specific acceptance criteria for device performance, nor does it describe a study that explicitly proves the device meets such criteria using metrics like sensitivity, specificity, or accuracy. The document is a 510(k) premarket notification summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance thresholds in a clinical study.

Therefore, many of the requested details related to acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not present in the provided text.

However, based on the available information, here's what can be inferred or directly stated:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document's purpose is to establish substantial equivalence to predicate devices, not to report on specific performance metrics against defined acceptance criteria.

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

This information is not provided in the document. The text does not describe a clinical study with a test set.

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

This information is not provided in the document.

4. Adjudication method 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, and 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, TAP II, is an oral appliance (anti-snoring device), not an AI-assisted diagnostic tool for which an MRMC study would typically be conducted.

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

This information is not applicable/not provided in the context of an oral appliance. The TAP II is a physical medical device, not an algorithm.

7. The type of ground truth used:

This information is not provided in the document as no specific clinical study with ground truth establishment is detailed. The basis for substantial equivalence is comparison to legally marketed predicate devices.

8. The sample size for the training set:

This information is not provided in the document. The text does not detail the development of an algorithm that would typically involve a training set.

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

This information is not provided in the document.

Summary based on the provided text:

The provided documents, a Non-Confidential Summary of Safety and Effectiveness and an FDA clearance letter for the TAP II oral appliance, primarily focus on demonstrating substantial equivalence to predicate devices. This process does not typically involve the detailed performance studies, acceptance criteria, test sets, or expert ground truth adjudication that would be requested in the prompt. The clearance is based on the device having the same intended use, similar technological characteristics, and being as safe and effective as devices already on the market (listed as Nellcor Puritan Bennett - TAP-K962516, Thornton Oral Appliance - TOA-K972061, OASYS Oral Airway System - K030440).

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The Breathe EZ Anti-Snoring Device is intended to reduce or alleviate snoring and to prevent bruxing, clenching and grinding of the teeth while sleeping.
The Breath EZ Anti-Snoring Device is intended to reduce or alleviate snoring by maintaining an open air way and to prevent bruxing, clenching and grinding of the teeth while sleeping.

The Breathe EZ Anti-Snoring/Anti-Grinding Device is composed of:

• · An oval plate fitted in front of and between the upper and lower teeth and gums.
• A port to facilitate normal breathing

The provided text is a 510(k) premarket notification for "The Breathe EZ" anti-snoring device. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics. Therefore, the document does not contain specific acceptance criteria for device performance or a study that rigorously proves the device meets such criteria in the way a clinical trial would.

Instead, the submission focuses on comparing the new device's features and intended use to those of legally marketed predicate devices. The "acceptance" in this context refers to the FDA's acceptance of the claim of substantial equivalence.

Here's an analysis based on the information provided, highlighting why many aspects of your request cannot be fulfilled by this type of regulatory document:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) premarket notification for "The Breathe EZ" anti-snoring device does not present traditional acceptance criteria for performance metrics (e.g., a specific reduction in AHI, a percentage of patients achieving a certain snoring reduction). Instead, the "acceptance criteria" are implied by the FDA's criteria for substantial equivalence to legally marketed predicate devices. The device 'meets' these criteria if the FDA determines it is as safe and effective as a predicate device.

The "study" or justification for meeting these criteria is a comparative analysis against predicate devices, rather than a clinical trial demonstrating new performance.

1. Table of Acceptance Criteria and Reported Device Performance:

• Reduce or alleviate snoring
• Prevent bruxing, clenching, and grinding of teeth while sleeping
• Target Population: Adult patients
• Environment of Use: Home and sleep laboratories | The BREATHE EZ has the same intended use as predicate devices. The presence of an anti-tongue and lip obstruction component (a port/tube) facilitates an open airway, supporting the anti-snoring claim. |
  | Technological Characteristics:
• Intraoral device
• Heat-sensitive impressible material for fitting
• Custom fit
• Adjustable/refittable
• Placed in mouth each evening, cleaned daily, easily removed
• Permits user to breathe through mouth
• Non-sterile | The BREATHE EZ shares these characteristics with predicate devices (Dr. B's Mouthpiece, Marketing Technologies Inc., Nellcor Puritan Bennett Inc./Dr. Kieth Thornton). The primary difference is the design (addition of an anti-tongue/lip obstruction component: one port). |
  | Material Safety:
• Made of heat-sensitive impression material | Materials are implied to be similar to legally marketed predicate devices, none of which are sterile. |
  | No new questions of safety or effectiveness raised. | The design difference (the port for an open airway) is presented as a modification that doesn't raise new safety or effectiveness concerns, but rather enhances the function. The FDA's letter of substantial equivalence confirms this. |

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

• Sample Size for Test Set: Not applicable. This submission is a 510(k) premarket notification, which typically relies on demonstrating substantial equivalence to existing devices rather than new clinical testing with a "test set" of patients. No clinical study data with a test set is presented.
• Data Provenance: Not applicable, as no new clinical data from human subjects is provided. The provenance of information comes from comparisons to predicate devices (Dr. B's Mouthpiece – K991948, Marketing Technologies, Inc. – K963063, Nellcor Puritan Bennett Inc. – K972061, Dr. Kieth Thornton – K972061).

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

• Not applicable. No ground truth was established by experts for a test set in this submission. The "ground truth" for regulatory clearance is based on the established safety and effectiveness of the predicate devices as determined by the FDA.

4. Adjudication Method for the Test Set:

• Not applicable. There was no test set or clinical data requiring adjudication by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. No MRMC study was performed or described. This type of study demonstrates human reader performance with and without AI, which is not applicable to a physical anti-snoring device being cleared via substantial equivalence.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. This device is an oral appliance, not an algorithm. Therefore, no standalone performance study in the context of AI algorithms was performed.

7. Type of Ground Truth Used:

• The "ground truth" for the purpose of this 510(k) clearance is the established safety and effectiveness of legally marketed predicate devices as previously determined by the FDA. The submission argues that "The Breathe EZ" shares the same intended use and similar technological characteristics, thereby making it as safe and effective.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical medical device, not an AI model. Therefore, no training set for an algorithm was used.

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

• Not applicable, as there was no training set for an algorithm.

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