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The myTAP2 is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

The myTAP2 is an oral appliance design concept based upon the use of a standard set of upper and lower travs filled with an impression material. A screw is used to advance the lower tray. The myTAP2 is of a design often referred to as a "Boil and Bite" and the concept of advancement is commonly referred to as a Mandibular Repositioning Device (MRD).

Based on the provided text, the device in question is the myTAP2, an intraoral device intended for the reduction of snoring. The document is a 510(k) summary for its premarket notification to the FDA.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

No specific acceptance criteria table or quantitative performance data is provided in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (SnoreRx - K170825) rather than presenting a detailed clinical study with pre-defined acceptance metrics for efficacy (e.g., percentage reduction in AHI, or snore count).

The "study" in this context is the non-clinical performance testing and biocompatibility testing conducted to show the myTAP2 is as safe and effective as its predicate.

Non-Clinical Performance Testing and Biocompatibility (The "Study")

The provided text describes the non-clinical and biocompatibility tests conducted to support the substantial equivalence of the myTAP2 to the predicate device, SnoreRx (K170825). It does not describe a clinical study of human performance or a multi-reader multi-case (MRMC) study.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide a quantitative table of acceptance criteria or performance results like sensitivity, specificity, or AUC for snoring reduction. The "acceptance" here is demonstrated by meeting the safety and basic functional requirements through non-clinical testing and by being substantially equivalent to a legally marketed predicate.

The table below summarizes the types of testing performed and the general conclusion regarding their success in supporting substantial equivalence.

• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity

Conclusion: Tests appear to have been passed, as the claim of substantial equivalence is made with these tests as supporting evidence, indicating the device materials are safe for their intended use and contact duration. Specific numerical results are not provided. |
| Operational Principle | Uses a screw adjustment mechanism to advance the lower jaw, similar to the predicate's principle of mandibular repositioning.
Conclusion: The document asserts, "The difference in advancement means does not raise different concerns of safety or effectiveness from the predicate." |
| Indications for Use | Intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.
Conclusion: "Similar to predicate - SnoreRx - K170825 - indicated as an aid for the reduction of snoring." |
| Patient Population | Adult patients 18 years and older.
Conclusion: "Similar to predicate - SnoreRx - K170825 - 18 years and older." |
| Contraindications/Warnings | Contraindications and warnings are similar to the predicate device.
Conclusion: "The contraindications are similar for both devices." Changes were made to labeling deemed "applicable and appropriate." |
| OTC Designation | Over-The-Counter (OTC) designation.
Conclusion: "Both are OTC designation and thus similar" to the predicate, which was also cleared for OTC. |

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

• Test Set Sample Size: Not applicable in the context of a clinical test set for AI performance. The studies performed were non-clinical (durability, mechanical, biocompatibility). For these tests, sample sizes would refer to the number of devices or material samples tested, but these specific numbers are not provided in the summary.
• Data Provenance: Not applicable for non-clinical testing. The tests would have been performed in a lab setting, likely by the manufacturer or a contracted testing facility.

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

• Not applicable. This is a medical device for snoring, and the submission is based on substantial equivalence demonstrated through non-clinical performance and biocompatibility testing, not on a clinical AI performance study requiring expert ground truth for image interpretation or diagnosis.

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication process is described as part of non-clinical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on non-clinical performance and similarity in design and indications to a predicate device. This type of study would typically be conducted for diagnostic AI devices, not for a physical intraoral device for snoring.

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

• Not applicable. This device is a physical intraoral appliance, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For Non-Clinical Testing: The "ground truth" for the non-clinical tests (durability, strength, biocompatibility) is established by adherence to industry standards (e.g., ISO 10993-1 for biocompatibility) and engineering specifications. The "truth" is whether the device materials and construction meet the predefined physical, chemical, and biological safety parameters.
• For Efficacy (Snoring Reduction): The document does not present a clinical study for efficacy with ground truth data (e.g., from polysomnography or snore monitors). The efficacy claim is based on the substantial equivalence to the predicate device, which itself is cleared as "an aid for the reduction of snoring," implying a known mechanism of action.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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The TAP(r) family of intra-oral appliances are intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea in patients 18 years or age or older.

The DentiTrac(t) micro-recorder is completely embedded into the TAP(r) intra-oral appliance, the micro-recorder is intended to measure patient compliance to oral device / appliance therapy when used in combination with the DentiTrac(t) System.

Airway Management, Inc. has a family of intra-oral appliances known and referred to as the Thornton Appliance Positioner ("TAP®") family.

There have been a number of 510(k) clearances and the TAP® versions are all fundamentally the same. They are:

• Separate upper and lower trays
• Contain trays custom fitted to each patient
• Have a coupling mechanism (single point midline) that allows adjustment by way of incremental advancement of the mandible
• Allows the sleep specialists to titrate the advancement for optimum treatment effect
• Both Customized trays and Standard sized trays
• Mandibular advancement acts to increase the patient's pharyngeal space during sleep.

This submission is to offer the option of an embedded micro-recorder, DentiTrac® which will record and track a patient's compliance to the prescribed oral appliance therapy.

The DentiTrac® can be incorporated into any of the TAP® family of intraoral appliances.

The DentiTrac® micro-recorder monitors the wear time through oral temperature, tracks movements, and head position. The DentiTrac® provided information when used with the DentiTrac® System. During scheduled visits, the DentiTrac® data can be transferred to a cloudbased web application for reporting and tracking.

The addition of the DentiTrac® does not alter the principle of operation, technological characteristics, or safety of the TAP® family of intraoral appliances, which are the reference devices.

The provided text is a 510(k) summary for the TAP® 1 and TAP® 3 intra-oral appliances with an embedded DentiTrac® micro-recorder. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed study with acceptance criteria for device performance.

Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in your request.

Instead, it relies on demonstrating that the modified device (TAP® with DentiTrac®) is substantially equivalent to a predicate device (SomnoMed SomnoDent® with micro-recorder) and reference devices (TAP® 1 and TAP® 3 without the micro-recorder). The rationale is that the DentiTrac® micro-recorder has already been cleared under K150369, and its embedding does not alter the performance of the TAP® device as an intra-oral appliance, thus requiring no additional performance testing.

Here's a breakdown of what is and isn't present in the document based on your request:

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

   • Not present. The document focuses on comparing the proposed device's characteristics (indications for use, technology, materials, environment of use, patient population) with predicate and reference devices, not on quantifiable performance metrics against specific acceptance criteria.

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

   • Not present. No new performance study or test set is described for the combined device. The reliance is on existing clearances for the components.

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 present. No new study requiring expert ground truth establishment is detailed.

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

   • Not present. No new study requiring adjudication is detailed.

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 present. This device is an intra-oral appliance with a compliance micro-recorder, not an AI-assisted diagnostic tool for human readers.

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

   • Not present. While the DentiTrac® micro-recorder likely has internal algorithmic functions for data collection (temperature, movement, head position), the document doesn't detail its standalone performance or validation studies. It states that "data is available under MAF2557" for the DentiTrac® micro-recorder, implying its individual performance was assessed previously.

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

   • Not present for the combined device. For the original clearance of the DentiTrac® micro-recorder (K150369), there would have been ground truth for its compliance measurement function (e.g., actual wear time compared to recorded wear time), but this is not discussed here.

8. The sample size for the training set:

   • Not present. This is not a machine learning or AI device that typically involves a training set in the conventional sense.

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

   • Not present. Follows from point 8.

In summary, the document serves as a regulatory submission demonstrating substantial equivalence based on the concept that embedding an already cleared component (DentiTrac® micro-recorder) into an already cleared device (TAP® intra-oral appliance) does not introduce new safety or effectiveness concerns, and therefore, no new performance data or acceptance criteria for the combined device are required to be presented in this 510(k) summary.

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The TAP PAP Nasal Pillow Mask is intended to be used by individuals who have been diagnosed by a Physician as requiring CPAP or Bi-Level ventilator treatment. The TAP PAP Nasal Pillow Mask is intended for single patient adult (>66lb/30kg) use in the home, hospital or other clinical setting.

The TAP PAP Nasal Pillow Mask consists of a boil & bite type dental appliance. A small bracket that extends beyond the lips to attach the mask frame (Mask - Upper Mouth Piece Adjustment Joint). Two soft silicone nasal pillows are located on the mask frame to seal against the nostrils. The nasal pillows come in three sizes and can be individually rotated to align with the user's nares. A corrugated flexible tube extends upwards from the mask frame to a 22 mm connector which connects to a breathing tube of a CPAP or bi-level device. The mask frame has exhalation vents (bias holes) that allow exhaled gases to be continually flushed.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: TAP PAP Nasal Pillow Mask

1. Table of Acceptance Criteria and Reported Device Performance

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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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