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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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The O'Brien MPA is intended to reduce snoring and to treat mild to moderate obstructive sleep apnea. This individually fabricated, non-sterile prescription device is a single patient, multi-use product for use at home or in a sleep laboratory.

The O'Brien MPA is made of thermal plastic material (ADA approved materials). It is a very simple device that fits snugly over the upper and lower anterior teeth in such a way as to keep the mandible in a stationary, anterior protrusive position. The reason for this is to physically open the airway and thus potentially reduce the occurrence of snoring and sleep apnea. (This theory of airway management is common, standard operating procedures in the emergency medical field for airway management purposes.) The device also includes air channels to allow breathing through the mouth.

The provided 510(k) summary for the O'Brien MPA (Mandibular Positioning Appliance, K060744) does not contain information regarding acceptance criteria, a study proving the device meets acceptance criteria, or any details about a clinical study's methodology.

This 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices (SUAD - K023836, TAP - K962516, OASYS - Oral Airway System - K030440) based on similar design principles, materials, and intended use. The document describes the device, its intended use (reducing snoring and treating mild to moderate obstructive sleep apnea), and the regulatory classification.

Therefore, I cannot populate the table or answer the subsequent questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth. These types of details are typically found in a clinical study report, which is not part of this 510(k) summary.

Summary of what is NOT in the provided document:

• Acceptance Criteria for Device Performance: The document does not define specific metrics (e.g., percentage reduction in AHI, success rate for snoring reduction) that the O'Brien MPA must achieve.
• Study Proving Acceptance Criteria: No study is described that was designed to demonstrate the device meets any performance criteria.
• Device Performance Data: There are no reported numerical results or performance statistics for the O'Brien MPA regarding its effectiveness in reducing snoring or treating sleep apnea.
• Sample Size for Test Set: Not applicable as no clinical study is detailed.
• Data Provenance: Not applicable.
• Number of Experts for Ground Truth: Not applicable.
• Qualifications of Experts: Not applicable.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No such study is mentioned.
• Standalone Performance Study: No details of any performance study are provided.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• Ground Truth for Training Set: Not applicable.

The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials for every submission, particularly if the technology is well-understood and the risks are manageable. In this case, the FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This indicates that the approval was based on equivalence, not necessarily on a new clinical study demonstrating specific performance against predefined acceptance criteria for the O'Brien MPA itself.

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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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