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The SleepRight Snore Aid is intended for use on adults 18 years of age or older as an aid for the reduction in mild to moderate obstructive sleep apnea (OSA) and/or snoring.
The SleepRight Snore Aid is intended for use on adults 18 years of age or older as an aid for the reduction of snoring.

The SleepRight Snore Aid is a customizable adjustable, in 1mm increments up to 6mm total, intraoral mandibular advancement device (MAD). An adjustable stop moves the lower tray, which moves the mandible, to the desired user setting of a position that increases (opens) the pharyngeal space (airway), which aids in minimizing air obstruction and aids in the reduction of snoring during sleep.

The SleepRight Snore Aid consists of two independent, customizable moldable, via hot (not boiling) water and bite method, removable, thermoplastic resin injection molded trays, fitted into the user's mouth, that fit separately over the upper (maxillary) and lower (mandibular) dental arches. The upper tray is provided with an adjustable advancement stop mechanism, one on each side of the rear of the upper tray, that provides the incremental 1mm up to 6mm total adjustment. The lower tray is provided with a fin, one on each side of the tray. As the adjustable advancement stop mechanism on each side of the upper tray is incrementally adjusted, the adjustable advancement stop mechanism on each side of the upper tray engages the fin, in a mating position on each side of the lower tray, stabilizing the mandible in a neutral posture or advances the mandible forward until the desired position that opens the airway and aids in a reduction of snoring during sleep is obtained by the user. Because the mandible is attached to the Oropharynx airway tissues (throat), and its posterior movement collapses the airway, stabilizing the mandible in a neutral or advanced forward position opens the airway for improved breathing. Having two independent dental arch trays allows for freedom of movement of the jaw musculature resulting in more user comfort, compliance and efficacy. Necessary Inspiratory and expiratory rapid expulsion of air is also improved.

Based on the FDA 510(k) Clearance Letter for the SleepRight Snore Aid (K250122), here's an analysis of the acceptance criteria and the study proving the device meets them:

Overall Conclusion: The provided text does not describe a study involving device performance, efficacy, or AI assistance. Instead, the clearance for the SleepRight Snore Aid is based on demonstrating substantial equivalence to previously cleared predicate and reference devices. This means the manufacturer did not conduct new clinical efficacy studies to prove the device meets performance criteria, but rather demonstrated that its design, materials, and intended use are sufficiently similar to devices already recognized as safe and effective.

Therefore, many of the requested criteria regarding performance studies, sample sizes, expert involvement, and ground truth establishment are not applicable in this specific context, as these types of studies were not performed for this 510(k) submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative performance acceptance criteria (e.g., a certain percentage reduction in AHI score or snore events) or measured device performance data. The "acceptance criteria" for this 510(k) appear to be based on demonstrating equivalence to predicate devices, particularly in terms of design, materials, manufacturing, intended use, labeling, and a general understanding of safety and efficacy derived from the predicates.

The Study that Proves the Device Meets the Acceptance Criteria

The study described is primarily a non-clinical bench testing and material characterization study in conjunction with a comparative analysis for substantial equivalence.

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

• Test Set Sample Size: Not applicable in the context of a clinical performance study. For non-clinical testing, it would refer to material samples.
• Data Provenance:
  • Material Biocompatibility: Data derived from previous testing on the same materials used in other Splintek products (SleepRight Pro Rx, SleepRight Advance Dental Mouthguard) and predicate/reference devices. This suggests a mix of historical data and potentially some internal material identification (Fourier Transform Infrared Spectroscopy).
  • Physical Properties: Data primarily from manufacturer-supplied technical data sheets (TDS) for the raw materials. This data is likely from materials suppliers rather than specific testing of final device components by Splintek for this submission, although the phrasing "These tests were conducted by the material manufacturers" supports this. The provenance would be the material manufacturers' laboratories.
  • Retrospective/Prospective: The use of existing data (prior test results, TDS) suggests a retrospective approach to assembling the non-clinical evidence. No prospective clinical data was generated for this 510(k).

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

• Not applicable. This was not a human-in-the-loop or clinical performance study requiring expert consensus for ground truth. The "ground truth" for material properties is established by standardized test methods (ISO, ASTM) and material specifications from manufacturers.

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication was described or required for the substantial equivalence demonstration using material and physical property data.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not conducted as the SleepRight Snore Aid is substantially equivalent to the predicate and reference devices in relation to design, materials, manufacturing, intended use, labeling and function."
• Effect Size: Not applicable as no such study was performed.

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 a software algorithm.

7. The Type of Ground Truth Used

• For Biocompatibility: The "ground truth" was whether the materials passed the specified ISO 10993 standards (e.g., no cytotoxicity, no sensitization, no irritation). This is a laboratory-based, in vitro and in vivo (for sensitization/irritation) standardized testing ground truth.
• For Physical Properties: The "ground truth" was whether the material properties (e.g., flexural strength, hardness) met or exceeded the established benchmark acceptance criteria for intraoral use, as measured by ASTM standards. This is a laboratory-based, standardized physical property testing ground truth.

8. The Sample Size for the Training Set

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

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 Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older.

The Advanced Anti Snoring Device 4.0 is designed to reduce snoring by gently repositioning the lower jaw forward, which opens the airway and allows for smoother airflow during sleep. By adjusting the position of the lower jaw, the device helps prevent the throat tissues from collapsing and blocking airflow, which is a common cause of snoring. The 4.0 version is customizable, allowing users to set the lower jaw advancement up to 6mm, providing a personalized fit for maximum comfort and effectiveness. This forward positioning also reduces vibrations in the airway, which are often responsible for the snoring sound.

The provided FDA 510(k) clearance letter and summary for the Advanced Anti Snoring Device 4.0 (K250482) explicitly state "Performance Testing - Clinical: Not Applicable." This indicates that no human clinical studies were performed to demonstrate the device's performance in reducing snoring.

Therefore, based solely on the provided document, I cannot fulfill most of your request as the information regarding clinical performance, expert ground truth, sample sizes for test sets, MRMC studies, or training sets is not present. The device's clearance is based on substantial equivalence to a predicate device (K233850) through non-clinical testing.

However, I can extract the information related to acceptance criteria (implied by the comparison to the predicate) and the non-clinical studies performed.

Here's a breakdown of what can be inferred and what cannot be provided from the given text:

What Can Be Inferred/Extracted from the Document:

• Acceptance Criteria (Implied by Predicate Equivalence): The primary "acceptance criteria" here is the demonstration of substantial equivalence to the predicate device (Difiney Anti Snoring Device, K233850) based on shared technological characteristics and non-clinical performance. The device must meet the regulatory requirements for an intraoral device for snoring.
• Reported Device Performance: The device's performance is not reported in terms of clinical efficacy in reducing snoring, but rather in meeting material and mechanical specifications.
• Non-Clinical Studies: Biocompatibility and physical properties testing.

What Cannot Be Provided from the Document (as "Not Applicable" or Not Mentioned):

• A table of acceptance criteria and reported device performance related to snoring reduction (as no clinical performance data is provided).
• Sample sizes used for a test set (no clinical test set described).
• Data provenance for a test set.
• Number of experts used to establish ground truth for a test set.
• Qualifications of those experts.
• Adjudication method for a test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Effect size of human readers improving with AI vs. without AI assistance.
• If a standalone (algorithm only) performance was done.
• The type of ground truth used (clinical outcomes).
• The sample size for the training set (no AI/ML algorithm mentioned requiring a training set).
• How the ground truth for the training set was established.

Summary Based on Provided Document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance:
* N/A. The document explicitly states "Performance Testing - Clinical: Not Applicable." The clearance is based on non-clinical testing and substantial equivalence to a predicate device.
* The non-clinical tests (biocompatibility, physical properties) are typically conducted on material samples or device prototypes, not human subjects, and thus "sample size" in the context of a clinical test set is not relevant here.
* Data Provenance: Not applicable for clinical data. For non-clinical tests, the tests were conducted by the manufacturer, Fissiontech LLC. The country of origin for the device manufacturing is likely China, given the correspondent's location, but this is not explicitly stated for the testing location itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
* N/A. As no clinical performance testing or "test set" for efficacy was conducted or reported, no experts were used to establish ground truth for clinical outcomes in this context.

4. Adjudication Method for the Test Set:
* N/A. No clinical test set or adjudication process for human data was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
* N/A. No clinical studies were reported, and the device is not an imaging AI product that would typically undergo MRMC studies.

6. If a Standalone Performance Study was done (e.g., algorithm only without human-in-the-loop performance):
* N/A. The device is a physical intraoral device, not an algorithm. No standalone performance study related to AI/ML was relevant or conducted.

7. The Type of Ground Truth Used:
* For the non-clinical testing, the "ground truth" was established by standardized test methods and specifications (e.g., ISO 10993 for biocompatibility, and various physical property tests for material characteristics). The device's conformance to these predefined standards served as the "ground truth" for material and manufacturing quality.
* For clinical efficacy in snoring reduction, no ground truth was established or presented in this document.

8. The Sample Size for the Training Set:
* N/A. This device does not incorporate AI/ML, so there is no training set.

9. How the Ground Truth for the Training Set Was Established:
* N/A. No training set exists.

In conclusion, the FDA 510(k) clearance for the Advanced Anti Snoring Device 4.0 was granted based on demonstrably meeting all non-clinical design specifications and showing substantial equivalence to a legally marketed predicate device, rather than through clinical performance testing for snoring reduction.

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Rest Assure is an intraoral device intended to be used in the treatment of snoring and mild to moderate obstructive sleep apnea in patients over 18. Rest Assure has the capability to record and monitor patient compliance to oral device/appliance therapy.

The SomnoDent intraoral devices functions as a mandibular repositioner, which acts to increase the patient's pharvngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to breather during sleep. The devices are patient specific (they are customized for each patient) and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the sleep dentist at the time of fitting the device. The devices can then be adjusted by the sleep dentist to control the treatment to find the best possible adjustment.

This Rest Assure System consists of two appliances, namely the Rest Assure Elite Appliance with (formerly the SomnoDent Herbst commercially distributed under K150369) and the Rest Assure Avant. Both hold current 510(k) clearances from FDA, K150369 for the SomnoDent Herbst Advanced with embedded micro-recorder and K183443 for the SomnoDent Avant.

The provided FDA 510(k) summary for the "Rest Assure System" does not contain the acceptance criteria and the study that proves the device meets those criteria in the format requested.

The document states that "clinical testing was not required or performed." Therefore, there is no clinical study described that would establish acceptance criteria for device performance based on patient outcomes, nor details on a clinical test set, expert adjudication, or MRMC studies.

The performance testing section (8.0) lists various engineering and regulatory compliance tests:

• A. Software Testing per IEC 62304
• B. Safety Testing by UL per 60601-1 series
• C. EMC Testing per 60601-1-2
• D. Risk Analysis per ISO 14971
• E. Cybersecurity Evaluation and Assessment
• F. Co-existence Testing and Assessment
• G. Biocompatibility Assessment
• H. Usability Testing per IEC 62366
• Further, functional and systems testing was performed to demonstrate requirements were successfully completed to demonstrate compliance with the device requirements and specifications.

These tests are primarily focused on safety, electromagnetic compatibility, usability, software quality, and biocompatibility, as per regulatory standards, rather than clinical performance metrics like sensitivity, specificity, or improvement in a medical condition. The document concludes that based on these engineering tests and the device's similarity to predicates, it is "safe and effective for its intended purpose."

Therefore, I cannot populate the table and answer the subsequent questions as the information is not present in the provided text.

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The DNA Appliance is intended to reduce nighttime snoring and to treat moderate and severe obstructive sleep apnea in children, 6- 17 years of age who are diagnosed with snoring and/or moderate or severe obstructive sleep apnea and need orthodontic treatment.

The DNA appliance is an intraoral device that consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. The device is customized to each patient, and features an adjustment mechanism to allow it to be further customized to each patient.

The provided document is a 510(k) summary for the DNA Appliance, intended to reduce snoring and treat obstructive sleep apnea in children. It includes a section on clinical testing which details the study performed to demonstrate the device's efficacy.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a structured table format. However, it reports several metrics of improvement. We can infer the "acceptance" was based on these positive outcomes.

2. Sample Size and Data Provenance

• Sample Size for the Test Set: 48 patients.
• Data Provenance: The study was conducted at 5 sites, specifically "4 U.S. and 1 Canadian." It was a "prospective, clinical trial."

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document states: "Patients were diagnosed with obstructive sleep apnea by a medical physician reading a HSAT, a pediatric questionnaire, and needed orthodontic treatment for dentofacial abnormalities." It does not specify the number of medical physicians (experts) or their detailed qualifications (e.g., years of experience, specific board certifications beyond "medical physician").

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for establishing the ground truth diagnoses. It only mentions that diagnosis was made by a single "medical physician."

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the effectiveness of the device and the improvement in patient metrics, rather than comparing AI-assisted human readers to unassisted human readers.

6. Standalone Performance

The study evaluates the device's performance in patients, not the performance of an algorithm as a standalone diagnostic tool. The "performance" metrics (AHI, PSQ, SRBD improvements, etc.) are clinical outcomes after using the physical device. The text states: "All these results are measured during sleep studies without the appliance in the mouth," indicating that the "performance" reflects the long-term changes induced by using the device, not the immediate effect of wearing it or a diagnostic algorithm's output.

7. Type of Ground Truth Used

The ground truth for diagnosis of obstructive sleep apnea was established by:

• "a medical physician reading a HSAT [Home Sleep Apnea Test]"
• "a pediatric questionnaire"
• The need for "orthodontic treatment for dentofacial abnormalities"

Sleep studies (both baseline and post-treatment) were also used to measure outcomes (e.g., AHI scores), which served as objective measures for evaluating the device's effectiveness against the initial ground truth diagnosis.

8. Sample Size for the Training Set

The document describes a clinical trial (the "test set") but does not mention a separate "training set" for an AI or machine learning algorithm. This suggests the device is a physical appliance, not a software algorithm with a distinct training phase.

9. How Ground Truth for the Training Set Was Established

As there is no mention of an AI/ML algorithm or a training set, this question is not applicable based on the provided text. The device is a physical intraoral appliance.

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The Slow Wave DS8 is indicated for the treatment of sleep bruxism and as an aid in the treatment of associated tension/migraine type headaches in adults over the age of 18.

The Slow Wave DS8 is an intraoral appliance designed to safeguard teeth and restorations from the impacts of bruxism forces. It is a patient-specific device that consists of two trays worn on the maxilla and mandible conforming to the upper or lower teeth. This device acts as a physical divide between upper and lower tooth surfaces, preventing damage induced by bruxism activities such as grinding and clenching. Additionally, it eases discomfort associated with muscle tension and headaches. Multiple tray designs are available for this purpose, each offering distinct levels of functionality and suitability based on the patient's requirements. The device is manufactured using additive manufacturing, specifically on a Formlabs 3D Printer utilizing stereolithography (SLA) using biocompatible material.

The provided document does not contain information about acceptance criteria for device performance or any study conducted to prove the device meets such criteria.

The document is a 510(k) premarket notification for the Slow Wave DS8 device, which is an intraoral appliance indicated for the treatment of sleep bruxism and associated tension/migraine type headaches. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against specific quantitative acceptance criteria through clinical studies.

The document explicitly states in section 1.8.1 "Clinical Studies": "Clinical testing was not necessary for the demonstration of substantial equivalence." This means there was no study conducted to measure and report device performance against acceptance criteria.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone algorithm performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on comparing the Slow Wave DS8 to a predicate device (Luco Hybrid OSA Appliance K160477) and reference devices (Formlabs Dental LT Clear V2 K222061 and Slow Wave DS8 K191320) based on characteristics like classification, product code, indications for use, prescription status, target population, use of device, principle of operation, features, material properties, materials, manufacturing method, and sterility. The "Performance Data" section (1.8) only states that "Performance requirements were determined through an assessment of the physical properties of the device," implying engineering or material testing, not clinical performance data against specific acceptance criteria relevant to the device's therapeutic claims.

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The Hushd Pro Avera device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Hushd Pro Avera device series are a set of removable intraoral patient specific device used for treating snoring and mild to moderate obstructive sleep apnea. The device consists of number of custom made maxillary and mandibular splints fit over the upper and lower teeth. when interfaced together, functions as a mandibular repositioner holding the mandible forward during sleep thus preventing the togue and soft tissues of the throat from collapsing into the airway.

The Hushd Pro Avera device series are patient-specific devices, consisting of one or more maxillary device(s) and one or more mandibular device(s) that mates together. The sequential devices are CAD/CAM designed and manufactured according to the requested mandibular advancements position prescribed by the dentist or physician to provide a selection of gentle advancements according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing current maxillary or mandibular device and inserting the next maxillary or mandibular device in the advancements series. The maximum protrusion of the device is 10mm.The Hushd Pro Avera device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, straps or repositioning elastics.

Based on the provided text, the device in question, Hushd Pro Avera, is an intraoral device for snoring and mild to moderate obstructive sleep apnea. The text does not describe acceptance criteria or a study that proves the device meets those criteria from a clinical performance perspective. Instead, it explicitly states that no clinical performance data was deemed necessary or performed for this submission.

The submission relies on a demonstration of substantial equivalence to predicate and reference devices, supported by non-clinical performance data (material properties and biocompatibility).

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor specific details about sample size, expert ground truth establishment, or MRMC studies, as these types of studies were not conducted or reported in this 510(k) summary.

However, I can extract the information provided regarding the non-clinical testing and the rationale for not performing clinical studies.

Summary regarding Acceptance Criteria and Performance (based on provided text):

The provided 510(k) summary for the Hushd Pro Avera device focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing clinical performance against pre-defined acceptance criteria through a clinical study. The FDA's clearance (K232025) is based on this equivalence, along with successful non-clinical performance data and biocompatibility testing.

Here's an analysis of the requested information based on the document:

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

   • Clinical Performance: No clinical performance acceptance criteria or reported clinical performance data is provided in the document. The submission explicitly states: "The clinical performance of the subject device is deemed not necessary. The Hushd Pro Avera device has equivalent indication and method of use to its predicated and reference devices, therefore there was no clinical testing to support this device."
   • Non-Clinical Performance: The acceptance criteria for non-clinical testing are implied by the successful completion of the tests and the conclusion that the device "meets all design specification." The reported performance is that the tests were conducted and the device passed.

   Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
   Compliance with ISO 14971:2007 (Risk Analysis)	All identified risks have been addressed through device design, biocompatibility, and bench testing or through labeling provided to the consumer.
   Material Mechanical Properties	Tests conducted by the manufacturer for Flexural Modulus, Flexural Strength, and Impact Strength. (Details of specific values or thresholds are not provided, only that tests were done to "evaluate its ability to achieve its intended use.")
   Biocompatibility (ISO 10993-1)	Final finished device tested for: Cytotoxicity, Irritation, Sensitization, System Toxicity, Pyrogen. (Specific results are not provided, but the overall statement implies successful completion: "The subject device is able to achieve its intended use based on the same materials of construction, similar manufactory process and the identical application to the predicate device.")
   Design Specifications	The device "meets all design specification". (Specific design specifications are not enumerated.)

2. Sample sizes used for the test set and the data provenance

   • Clinical Test Set: Not applicable, as no clinical test set was used for performance evaluation (no clinical study was conducted).
   • Non-Clinical Test Set: The sample sizes for the non-clinical materials testing and biocompatibility testing are not specified in the document. However, these are generally standard tests conducted on representative samples of the device and its materials. The provenance is internal testing by the manufacturer.

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

   • Not applicable, as no clinical test set with human-established ground truth was used for performance evaluation.

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

   • Not applicable, as no clinical test set requiring adjudication was used.

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, as this device is a physical intraoral device, not an AI/software product, and no clinical studies (MRMC or otherwise) were conducted.

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

   • Not applicable, as this is a physical device, not an algorithm.

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

   • Clinical Ground Truth: Not applicable, as no clinical studies were performed.
   • Non-Clinical Ground Truth: For mechanical properties and biocompatibility, the ground truth is established by validated laboratory testing methods and compliance with international standards (ISO 10993-1, ISO 14971:2007).

8. The sample size for the training set

   • 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

   • Not applicable, as there was no training set.

In conclusion, the core of this 510(k) submission and FDA clearance is based on the principle of substantial equivalence to existing devices, supported by non-clinical testing, rather than new clinical performance data or studies defining and meeting specific clinical acceptance criteria.

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The EMA 3D is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The EMA 3D device is a simple hardware device. It is an oral appliance and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients. The EMA 3D device is intra-oral device used for treating snoring and mild to moderate Obstructive Sleep Apnea (OSA). It has a patented button hook design with variable elastic band for optimum titration with bitewing if needed. The device consists of two custom fitted trays which fit over the upper and lower dentition of a patient. The trays are standard biocompatible trays that do not reposition teeth. Each tray holds the teeth in their present location not allowing tooth movement. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air. There are four button hooks utilized on the EMA 3D device (two hooks per tray, two trays top and bottom. The hooks must be placed at a distance of 21mm apart from the top tray hook to the bottom tray hook center to center. Though there is no requirement except the opitimum location for hook placement between the top and bottom trays is on the upper bicuspid and the lower first molar. Button hooks and bite blocks for the EMA 3D utilize standard dimensions. These button hooks serve as fastening anchors for Elastic Straps that come in four different color coded strengths: White-Soft, Yellow-Medium, Blue-Firm and Clear- Extra Firm. These straps also come in 9 different lengths such that the Dental Professional can ensure the patient specific correct amount of mandibular advancement the lengths are as follows: 21mm, 20mm, 19mm, 18mm, 17mm, 16mm, 15mm, 14mm, 13mm.

Based on the provided text, the device in question is the EMA 3D, an intraoral device for snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The substance of the application is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical efficacy through a comparative effectiveness study or standalone algorithm performance. Therefore, the information provided focuses on non-clinical performance data and comparison to predicates rather than a clinical study with human readers or AI.

Here's a breakdown of the requested information based on the document:

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

The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds for "Pass" or "Fail" for all tests. Instead, it states that "All testing was considered successful and met identified acceptance criteria" and "The EMA 3D passed all the testing in accordance with internal requirements, applied national standards, and applied international standards." The performance data is primarily qualitative and comparative to predicate devices concerning materials, design, and functionality.

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 refers to "testing" of the device components and materials. It does not specify sample sizes for these tests in terms of number of devices or patients. The data provenance is also not explicitly stated in terms of country of origin or retrospective/prospective nature. The tests mentioned are laboratory-based material and component performance tests, not clinical studies on patient populations.

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 applicable and not provided. The "ground truth" concept usually applies to clinical efficacy or diagnostic accuracy studies (e.g., for AI/image analysis devices). For a hardware device seeking 510(k) clearance based on substantial equivalence, the "ground truth" refers to the adherence to engineering standards and biocompatibility requirements rather than clinical consensus.

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

This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which is not the primary focus of this 510(k) submission as 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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance. This device is a physical intraoral appliance, not an AI or imaging device where such a study would be relevant.

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

There is no mention of a standalone algorithm performance. This is a physical medical device.

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

For this device, the "ground truth" is established through adherence to recognized material and performance standards (e.g., ISO, ASTM for mechanical properties; ISO 10993 for biocompatibility) and demonstrable equivalence to predicate devices in terms of indications for use, technological characteristics, and safety profiles. It is not based on direct clinical outcomes data from new patient studies for this 510(k) submission.

8. The sample size for the training set

This information is not applicable and not provided. This is not a machine learning or AI device that would require a "training set."

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

This information is not applicable and not provided. There is no training set for this type of device.

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The Difiney Anti Snoring Device is intended to help reduce snoring in adults 18 years of age or older.

The Difiney Anti Snoring device is an intraoral device that is composed of an upper and lower intraoral trays with a handle that is used during the process of customizing the trays. The Difiney Anti Shoring device repositions the jaw anteriorly relative to the maxilla in order to increase the patient's pharyngeal space to improve the ability to exchange air and decrease air turbulence, a causative factor in snoring.

The provided text is a 510(k) summary for the Difiney Anti Snoring Device. It outlines the regulatory classification, intended use, and a comparison to a predicate device (SnoreRx). Crucially, the document states "Performance Testing - Clinical: Not Applicable" and "Performance Testing - Animal: Not Applicable."

This means the submission does not include data from a clinical study or animal study to demonstrate the device's performance based on specific acceptance criteria. Instead, the substantial equivalence determination is based on technological characteristics and non-clinical testing (biocompatibility and physical properties).

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, device performance from a study, sample sizes, expert involvement, or MRMC studies, because this information is explicitly stated as "Not Applicable" in the provided document.

The document's conclusion is that the device is substantially equivalent to the predicate based on technological characteristics and non-clinical testing, not on clinical performance metrics.

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Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.

AIO Breathe consists of two separate intraoral trays (upper, lower) that are customized to fit over all the teeth. The device is manufactured at AIOMEGA facilities using additive manufacturing with Stereolithography (SLA) 3D printing technology that builds the device from biocompatible resins. The customized trays are fabricated based on intraoral scans provided by the dentist and the dentist's prescription.

AIO Breathe features right and left protrusive flanges on the buccal sides of the upper tray. These flanges engage with corresponding right and left vertical flanges featured on the buccal sides of the lower tray. This engagement repositions the jaw to reflect the dentist's prescribed anterior mandibular advancement.

Additionally, mandibular plateaus, as prescribed by the dentist, featured on the right, and left occlusal cranial surfaces of lower tray, guide the mandible downward, thus opening the anterior airway. The plateaus and flanges allow vertical opening of the jaw (jaw is not fixed in a single position) and work together to maintain advancement in open and closed mouth positions. This design feature allows more room and creates traction for the tongue to migrate forward. The resulting mechanical protrusion acts to increase the patient's pharyngeal space, improving their ability to exchange air, thereby reducing the tendency to snore and alleviating signs of obstructive sleep apnea.

The provided text is a 510(k) summary for the AIO Breathe device, an intraoral device intended to reduce or alleviate snoring and mild to moderate Obstructive Sleep Apnea (OSA). Crucially, the document explicitly states: "No clinical studies were conducted on AIO Breathe."

Therefore, I cannot provide information regarding acceptance criteria or a study proving the device meets those criteria, as no such study was conducted according to this document. The submission relies on substantial equivalence to a predicate device (Slow Wave DS8 K191320), not on a direct clinical study of AIO Breathe's performance.

If there were a clinical study described, the following information would be extracted and organized as requested:

1. Table of acceptance criteria and reported device performance: This would list specific metrics (e.g., AHI reduction, snoring reduction percentage) with their predefined acceptance thresholds and the results achieved by the AIO Breathe device in the study.

2. Sample size used for the test set and the data provenance: This would state the number of patients/participants in the study and whether the data was collected specifically for this study (prospective) or from existing records (retrospective), and the country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would detail how many independent experts were involved in evaluating patient outcomes and their professional backgrounds (e.g., Board-certified sleep physicians with X years of experience).

4. Adjudication method for the test set: This would describe how discrepancies among experts were resolved (e.g., a third expert reviewed discordant cases).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This would state if human readers were part of the study, and if so, how their performance was measured with and without AI assistance, including the effect size. (Likely not applicable for a physical intraoral device).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This would indicate if the device's performance was evaluated purely by itself, without human intervention in its function or interpretation. (Likely not applicable for a physical intraoral device).

7. The type of ground truth used: This would specify the gold standard against which the device's performance was measured (e.g., polysomnography results, patient-reported outcomes).

8. The sample size for the training set: If machine learning was involved in the device's design or functionality, this would state the size of the dataset used to train any algorithms. (Likely not applicable for this type of device).

9. How the ground truth for the training set was established: This would describe the method used to label or categorize the data in the training set for any machine learning components. (Likely not applicable for this type of device).

In summary, based on the provided document, no clinical studies were performed on the AIO Breathe device, and therefore, no acceptance criteria or study results demonstrating its performance are available within this text. The clearance is based on its substantial equivalence to an existing predicate device.

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The airVata™ sleep appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The airVata™ sleep appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

The airVata™ sleep appliance is a mandibular advancement device. It holds the mandible in a protrusive position as determined by a trained dentist. The device consists of upper and lower splints (trays), which are additive manufactured using a biocompatible light curable resin. Connectors, made of a biocompatible synthetic polymer with injection molding technology attach the upper and lower splints to maintain the forward position of the lower jaw. The device is adjustable in 1.0 mm increments by using different lower trays supplied with the device. The connectors are attached after the upper and lower splints (trays) are manufactured. The Subject device is a single patient, non-sterile, prescription-only device. It is to be used only by the patient for whom it is custom designed. It is to be worn during sleep and may be removed by the patient at any time.

This document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of a new medical device (airVata™) to a legally marketed predicate device (EndSnorZ™ Sleep Appliance). It does not describe a study proving the new device meets acceptance criteria in the way a clinical trial or algorithm performance study would. Instead, it focuses on non-clinical testing and comparison to an existing device to demonstrate similar safety and effectiveness.

Therefore, many of the requested criteria for an AI/algorithm-based device cannot be fully answered or are not applicable to the information provided in this 510(k) summary. The document explicitly states: "No clinical or animal testing data is included in this submission."

However, I can extract information related to the device's characteristics and the non-clinical testing performed to support its substantial equivalence.

Here's an attempt to address your prompts based on the provided text, indicating where information is not available or not applicable:

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

The document does not present acceptance criteria or reported performance in the typical format of an algorithm's diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating that the new device (airVata™) is "substantially equivalent" to a predicate device (EndSnorZ™ Sleep Appliance) based on its intended use, technological characteristics, and non-clinical performance testing.

The "acceptance criteria" here implicitly relate to demonstrating that the airVata™ device functions similarly and is as safe and effective as the predicate device.

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

• Sample Size: Not applicable. This 510(k) submission relies on non-clinical performance testing and comparison to a predicate device, not a clinical test set of patient data. The non-clinical tests would have their own sample sizes (e.g., number of material samples for physical property testing, number of devices for manufacturing validation), but these are not detailed in terms of patient data.
• Data Provenance: Not applicable for patient data. The non-clinical testing data would typically originate from the manufacturer's labs or contracted testing facilities. Given the US-based manufacturer and FDA submission, it's implied the testing would follow international standards recognized by the US, potentially performed in the US or by certified labs elsewhere.
• Retrospective or Prospective: Not applicable for patient data. The non-clinical tests would be prospective in nature, designed and executed for the premarket submission.

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 applicable as this is not an AI/algorithm performance study requiring ground truth derived from expert consensus on patient data.

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

• Not applicable.

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. The document explicitly states: "No clinical or animal testing data is included in this submission."

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

• No. This device is a physical appliance, not an algorithm.

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

• Not applicable. For a physical device, "ground truth" would relate to its physical properties, biocompatibility, and functional performance based on engineering specifications and intended use, rather than a diagnostic 'truth' established from patient data. The "truth" evaluated here is whether the device meets material, manufacturing, and safety standards to be considered equivalent to a legally marketed device.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable.

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