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1. An oral appliance to be used for the treatment of mild and moderate Obstructive Sleep Apnea.
2. For the treatment of snoring.
3. For the prevention of bruxism.

The Full Breath Sleep Appliance PB & PBB is a custom device fabricated typically by a Professional dental laboratory and delivered by a dentist. This is a simple enhancement to the design of the Quiet Night & Quiet Night MA (K032410). It incorporates the Quiet Night function of control of vertical dimension and mandibular advancement for reduction/elimination of snoring. It also incorporates the posterior trans-palatal bar of the Quiet Night and Quiet Night MA to prevent the tongue from sealing against the palate and thus reduce snoring. It also restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping.

This 510(k) premarket notification for the Full Breath Sleep Appliance (PB and PBB) does not contain a study that establishes acceptance criteria or demonstrates device performance against those criteria. The submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices.

Here's a breakdown of what can be inferred from the provided text regarding a study, and what information is missing:

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

• Acceptance Criteria: Not explicitly stated or defined in the provided document. The 510(k) relies on substantial equivalence to predicate devices, implying that acceptable performance is generally aligned with those devices.
• Reported Device Performance: The document only makes a qualitative claim: "The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping." No quantitative data or metrics are provided to support this claim. Therefore, a table comparing acceptance criteria to reported performance cannot be constructed from this document.

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

• This information is not provided in the document. The statement "The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping" is a general claim without details of a specific study, sample size, or data provenance.

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 because no specific study with a "test set" and "ground truth" establishment is detailed.

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

• This information is not provided as no specific study or test set is described.

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 the Full Breath Sleep Appliance. This device is a physical intraoral appliance, not an AI or imaging diagnostic tool that would involve "human readers" or AI assistance in interpretation.

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

• This is not applicable to the Full Breath Sleep Appliance, for the same reasons as point 5.

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

• This information is not provided as no specific study with established ground truth is detailed.

8. The sample size for the training set

• This information is not provided. This device is not an AI/machine learning model, and thus does not have a "training set" in that context. If a clinical study was undertaken, it would involve participants to evaluate clinical outcomes, but details of such a study are absent.

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

• This information is not provided as there is no "training set" in the context of an AI/machine learning model.

Summary of Study Information in the K053065 510(k):

The provided 510(k) summary for the Full Breath Sleep Appliance is focused on demonstrating substantial equivalence to predicate devices (Quiet Night & Quiet Night MA, Breathe EZ Anti-Snoring Device, Sleepbite, The Silencer) that have already been cleared for similar indications. It does not include detailed clinical study data or a statistical analysis of performance against specific acceptance criteria.

The only statement related to performance is: "The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping." This is a general claim about the device's effect, but no supporting data (e.g., from a clinical trial, sample size, methodology, statistical significance) are presented in the provided text. For a 510(k) submission, particularly for Class II devices, clinical data demonstrating safety and effectiveness may not always be required if substantial equivalence to a predicate device can be established through technological characteristics and indications for use.

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1. AN ORA/ Appliance to be used for the theatment of mild And Moderate Obstructive Sleep ApNCA
2. For the treatment of SNORING
3. For the prevENTION OF DRUKIEM.

The Full Breath Sleep Appliance is a custom fabricated device typically by a professional dental laboratory and delivered by a dentist. This is a simple enhancement to the design of the Quiet Night & Quiet Night MA (K032410). It incorporates the Quiet Night and the NTI (K010867) anterior discluding element for bruxism and control of vertical dimension and anterior mandibular advancerient for reduction/elimination of snoring. It also has the posterior trans-palatal bar to prevent the tongue from sealing against the palate and reducing snoring, and restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's and reduction of ODI's.

This document is a 510(k) summary for the Full Breath Sleep Appliance. The device is intended for the treatment of mild and moderate Obstructive Sleep Apnea, the treatment of snoring, and the prevention of bruxism.

The key information provided includes:

• Acceptance Criteria and Device Performance: Not explicitly stated as acceptance criteria in the prompt's sense. However, the device is considered substantially equivalent to predicate devices, implying it meets similar performance expectations. The efficacy is based on its design incorporating features from existing devices known to achieve these indications.
• Sample Size and Data Provenance: No specific study data, sample size, or provenance (country of origin, retrospective/prospective) is provided in this 510(k) summary. The submission focuses on substantial equivalence to predicate devices rather than new clinical trials.
• Ground Truth Establishment: Not applicable as no new clinical study validating performance against a ground truth is presented.
• Expert and Adjudication Methods: Not applicable as no new clinical study validating performance against a ground truth is presented.
• MRMC Comparative Effectiveness Study: Not performed or reported in this document. The submission is not related to assessing AI assistance.
• Standalone Performance: Not applicable as this is not a standalone algorithm, but a physical medical device.
• Type of Ground Truth: Not applicable, as detailed above.
• Training Set Sample Size and Ground Truth: Not applicable, as this is not an AI/algorithm-based device requiring a training set.

Summary of Device Performance (Implied by Substantial Equivalence):

The Full Breath Sleep Appliance (AB and ABB) is described as a simple enhancement to existing predicate devices (Quiet Night & Quiet Night MA - K032410, and NTI - K010867). Its design incorporates the anterior discluding element for bruxism and control of vertical dimension and anterior mandibular advancement for reduction/elimination of snoring, similar to the NTI. It also includes a posterior trans-palatal bar, which is stated to prevent tongue sealing against the palate, reduce snoring, and restrain the tongue from up and back movement, leading to "reduced AHI/RDI's and reduction of ODI's."

Predicate Device Comparison Table:

Note: The FDA's 510(k) clearance process involves demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials that explicitly define acceptance criteria and studies to meet them in the manner described in the prompt for AI/algorithm-based devices. The "study" in this context is the comparison to existing, approved devices and the rationale for how the new device's design achieves similar intended effects.

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OASYS Oral Airway System is intended for use to reduce or eleviate snoring and obstructive sleep apnea.

The OASYS ORAL AIRWAY SYSTEM Anti-Snoring Device is composed of:

• Lower tray fitted over the lower teeth.
• Upper shield fitting in front of upper anterior teeth.
• Upper molded splint fitted over upper teeth.
• Connecting mechanism joining upper shield and lower tray.
• Extensions off shield which act as nasal dilators.

The provided document for the "OASYS-ORAL AIRWAY SYSTEM" (K030440) does not contain detailed acceptance criteria or a specific study proving the device meets quantitative performance metrics. This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel safety and effectiveness through extensive clinical trials with predefined acceptance criteria.

The document primarily highlights the device's technical characteristics and intended use, comparing them qualitatively to predicate devices. There are no quantifiable performance metrics, sample sizes, expert ground truth details, or statistical analyses typically associated with proving acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions quantitatively based on the information provided. The document specifically states: "Literature supports the historical significance of oral devices that reposition the mandible and reduce and manage snoring as well as sleep apnea." This implies reliance on existing knowledge and predicate device performance rather than dedicated efficacy studies for this specific device in this submission.

However, I can extract information related to the device's intended use and the comparison to predicate devices, which implicitly serves as the "acceptance criteria" in a 510(k) context – demonstrating that the new device is as safe and effective as existing legally marketed devices.

Summary of Information from the Provided Document (K030440):

Since no specific acceptance criteria with quantifiable metrics and associated study data are presented in this 510(k) summary, I will interpret "acceptance criteria" in the context of a 510(k) submission as the attributes and intended uses for which the device needs to demonstrate substantial equivalence to its predicates. The "reported device performance" would then be its conformance to these attributes and uses as stated in the comparison.

1. Table of Acceptance Criteria and 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)

The provided document does not mention any specific test set, sample size, or data provenance from a study conducted for this device. The submission relies on demonstrating substantial equivalence to predicate devices and general literature support for oral appliances.

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)

No test set is described, and therefore, no information is provided regarding experts or their qualifications for establishing ground truth.

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

No test set is described, and therefore, no information on adjudication methods is provided.

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

No MRMC study was conducted or reported in this 510(k) submission. This is not an AI-assisted device.

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

No standalone algorithm performance study was conducted or reported. This device is a mechanical oral appliance, not an algorithm.

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

No specific ground truth type is mentioned as no dedicated study data is presented for this device's performance. The submission relies on the established safety and effectiveness of predicate devices and general scientific literature on oral appliances for snoring and sleep apnea.

8. The sample size for the training set

No training set is described, as this is a mechanical device submission and not an AI/algorithm submission.

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

No training set is described, and therefore, no information on how ground truth was established for a training set is provided.

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