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

The RADx White Night and RADx White Night-p Intraoral Appliance for Snoring and Mild to Moderate Sleep Apnea are removable intraoral devices used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated adjustable rods that fit separately over the upper and lower teeth. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. The device is a prescription device customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The device can be adjusted only by the user and / or the dentist in increments of 0.5 mm.

The custom oral appliance is checked for proper and comfortable fit as well as the appropriate initial progressive arm attachment. The dentist will provide the patient with subsequent progressive arms from 1.0 mm up to 5.0mm in 0.5mm increments.

There are 9 different arms each identified with a number for each side of the jaw. The arms are also identified as either "L" for left or "R" for right.

Variants / Configurations

There are two variants of the device.

The RADx White Night has removable progressive arms with the female housing active as the receptacle for the arms.

The RADx White Night-p was designed with the upper housing and arm as one piece. In this version, the fixed upper tray-arm combination are the progressive parts of the entire apparatus.

The provided document is a 510(k) summary for the RADx Intraoral Appliance for Snoring & Sleep Apnea. It describes the device and its compliance with regulatory standards, focusing on biocompatibility. However, it explicitly states that "Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the subject device." Instead, the substantial equivalence to predicate devices and material biocompatibility testing are the bases for its clearance.

Therefore, many of the requested items related to clinical study performance and ground truth cannot be answered from this document.

Here's what can be extracted based on the provided text:

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

Since no clinical performance study was conducted for this device, a direct comparison of acceptance criteria to reported device performance metrics like sensitivity, specificity, accuracy, etc., is not available in the document. The performance testing focused on biocompatibility.

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

Not applicable. No clinical test set or data provenance from human subjects is mentioned as human clinical studies were not deemed necessary. The biocompatibility tests were likely performed in laboratories using standard animal models or in-vitro methods.

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. No clinical test set requiring expert ground truth establishment was conducted.

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

Not applicable. No clinical test set requiring adjudication was conducted.

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. This device is an intraoral appliance, not an AI-powered diagnostic tool, and no MRMC study was conducted.

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.

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

For biocompatibility testing, the "ground truth" is established by the accepted scientific standards and methodologies defined in the cited ISO and USP standards (e.g., cell viability in cytotoxicity, skin reaction in sensitization, etc.). These are objective laboratory measurements, not expert consensus or clinical outcomes data in the context of device performance for snoring/sleep apnea.

8. The sample size for the training set:

Not applicable. No algorithm or AI model was developed for this device, so there is no training set.

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

Not applicable. There is no training set.

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The Slide is for use to reduce night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Slide™ is a prescribed intraoral device worn while sleeping in order to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA). Snoring and OSA is caused by partial or complete closure of the muscle in the upper airway (pharyngeal space). The device uses two splints joined by two parallel sliding connectors that position the lower iaw forward and open from its normal location. This forward protrusion opens up the upper airway reducing obstructions during sleep. The prescribing dentist determines the exact repositioning of the lower bite. Its simplistic design allows for the forward displacement to be adjusted without the use of specialized tools using different sized spacers. Adjustments are initially made in the prescribing dentist office; further adjustments can be made depending on relief of symptoms and comfort while sleeping.

The provided text is a 510(k) Premarket Notification Summary for "The Slide," an intraoral device for snoring and obstructive sleep apnea. It outlines the device's characteristics, comparison to a predicate device (SomnoDent G2), and performance data.

However, the document does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device for which such detailed performance metrics, ground truth establishment, and clinical study designs (MRMC, standalone) would be highly relevant.

The document makes it clear that clinical testing was NOT required and that substantial equivalence was based upon "benchtop performance testing" and comparison to a predicate device. This is a traditional medical device clearance, not an AI/ML device clearance that would typically involve the kind of rigorous performance evaluation against established ground truth as outlined in your request.

Therefore, many of your requested points cannot be answered from the provided text because the study type (benchtop mechanical testing, not a clinical study assessing diagnostic or therapeutic accuracy in humans based on ground truth data) does not lend itself to those questions.

Here's a breakdown based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance (as per the provided text for a mechanical device):

The "acceptance criteria" detailed in the document primarily revolve around mechanical integrity and biocompatibility, not performance metrics related to diagnostic accuracy or AI assistance.

Study Details (Based on the Provided Text):

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of clinical data for an AI/algorithm. The performance data is primarily benchtop mechanical testing. The document states, "Mechanical testing was performed to verify device functionality by assessing the maximum force the device can withstand..." No human test subjects or clinical data are described.
   • Data Provenance: Not applicable for clinical data. The context is benchtop testing of the device itself.

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

   • Not applicable. Ground truth, in the sense of expert consensus on patient conditions (e.g., diagnosis of sleep apnea from physiological data), was not established for this type of testing. The "truth" here is engineering specifications and material properties.

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

   • Not applicable. There was no clinical test set requiring adjudication.

4. 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. An MRMC study was explicitly not done. The document states: "Clinical testing was not required to demonstrate the safety and effectiveness of The Slide. Instead, substantial equivalence is based upon benchtop performance testing." This device is a physical intraoral device, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is not an algorithm-only device.

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

   • The "ground truth" for this regulatory submission was compliance with engineering standards (ISO 10993-1:2018 for biocompatibility) and achieving specific mechanical properties (withstanding force) that were deemed sufficient compared to the predicate device and expected in-mouth forces. Clinical ground truth was not part of this evaluation.

7. The sample size for the training set:

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

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

   • Not applicable. There was no training set for an AI/ML model.

In summary, the provided document details the regulatory clearance of a physical medical device (intraoral snore/sleep apnea appliance) based on engineering performance and substantial equivalence to a predicate, rather than the performance evaluation of an AI/ML diagnostic or assistive algorithm. Therefore, many of your questions regarding AI-specific criteria are not addressed by this document.

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

DS8 consists of two trays worn on the maxilla and mandible. The device is manufactured at Slow Wave facilities using additive manufacturing, specifically on a Formlabs 3D Printer utilizing stereolithography (SLA) using biocompatible material.
The trays are designed to be an exact custom fit by a trained dental technician, using a 3Shape intraoral scanning device, or comparable intraoral scanner such as the iTero, or Cerec, registering one's full impressions of the upper teeth, lower teeth. A bite scan registration with a gap (typically 8 mm), which is a crucial design feature. The gap results from the design of the lower and upper trays. The upper and lower trays, the molars, premolars, and canines, are covered by the device. However, the lateral or central incisors are not covered, which effectively leaves eight teeth (four maxillary incisors and four mandibular incisors) uncovered. The trays are shaped like arch because the covered portion of the device is connected to each other by two palatal bands one connecting the upper left and upper tray, and the other connecting the lower tray.

Additionally, the trays are built with ramps that guide the mandible forward and downward, thus maintaining advancement, enlarging the airway, allowing more room for the tongue to migrate forward naturally. The vertical opening of the jaw is not fixed in a single position. DS8 is a traction-based mandibular repositioning device that allows nasal and/or oral breathing.

The provided text is a 510(k) Premarket Notification summary for the Slow Wave DS8 device. It evaluates the substantial equivalence of the Slow Wave DS8 to legally marketed predicate devices, specifically the Panthera D-SAD and The NightBlocks Appliance.

However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through empirical testing (e.g., clinical trials or performance assessments with ground truth and expert reviews). This type of detailed study showcasing device performance against defined acceptance criteria, often seen with AI/ML-driven medical devices, is not part of this 510(k) submission.

The 510(k) process for this device relies on demonstrating substantial equivalence to existing predicate devices, meaning it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety and effectiveness. The document primarily focuses on comparing the Slow Wave DS8's features and operating principles to its predicates.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on claims of substantial equivalence rather than quantifying direct device performance against specific metrics.
2. Sample size used for the test set and the data provenance: No "test set" in the context of an AI/ML performance study is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set requiring expert-established ground truth.
4. Adjudication method 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: Not applicable, as this device is a physical intraoral device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document explicitly states:

• "Animal or Human testing: No Animal or Human testing was conducted on DS8 device." This confirms that there were no clinical studies or human/animal trials to generate performance data for this submission. The biocompatibility assessment was performed on the material itself by Formlabs, not on the finished device in biological systems for efficacy.

In summary, this 510(k) submission primarily addresses the substantial equivalence of a physical medical device (intraoral device for snoring/sleep apnea) to predicate devices based on shared intended use and technological similarities, rather than demonstrating performance against specific acceptance criteria through empirical studies with test sets, ground truth, or expert evaluations.

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The NightBlocks™ Appliance is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The NightBlocks™ Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.

The NightBlocks™ appliance consist of two removable, custom fabricated acrylic trays that fit separately over the upper and lower dental arches and engage each other in order to reposition the mandible in a slightly anterior position. They contain stainlesssteel ball clasps for extra retention and stainless-steel orthodontic expansion screws on the buccal portion of the upper tray that engage with the dorsal wings of the lower tray. The trays occlude on the left or right molar and premolar region. Every device is custom prescribed and fabricated for each patient from dental models and is adjustable at the time of delivery and anytime thereafter as it is intended to be used in the home setting.

The principal of operation is jaw repositioning. Worn during sleep, the NightBlocks™ function as a mandibular advancement device which acts to increase the patient's pharyngeal airway space, improving their ability to exchange air during sleep. The anterior repositioning of the mandible prevents the tongue from sliding backward or downward for a prone sleeping individual. Therefore, the airway will be larger, contributing to the reduction in snoring and mild to moderate sleep apnea.

Materials: Polymethylmethacrylate Polymer and Monomer (Lang Orthodontic Acrylic K141439), medical grade stainless steel wire (AJ Wilcock), and orthodontic stainlesssteel expansion screws (Leone).

This document is a 510(k) summary for "The NightBlocks™ Appliance." It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria based on performance metrics.

Therefore, many of the requested details, such as a table of acceptance criteria and reported performance, sample sizes for test sets, expert involvement in ground truth, MRMC studies, or standalone algorithm performance, are not applicable as this submission relies on demonstrating similarity to an already cleared device, not on new clinical performance data.

Here's an analysis of the provided information in the context of your questions:

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

• Not Applicable. This submission is for substantial equivalence. It does not define new clinical performance acceptance criteria or report new clinical device performance data. The device's performance is inferred to be equivalent to 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)

• Not Applicable. No clinical test set data was used. The submission states, "Clinical testing has not been performed."

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. No clinical test set requiring ground truth establishment was conducted.

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

• Not Applicable. No clinical test set requiring adjudication was conducted.

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. This device is a physical intraoral appliance, not an AI or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are irrelevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. No new clinical ground truth was established as no new clinical testing was performed.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not Applicable. As above, this is a physical medical device.

Summary of the document's approach:

The manufacturer, Advanced Facialdontics LLC, is seeking 510(k) clearance for "The NightBlocks™ Appliance." Their strategy is to demonstrate substantial equivalence to existing legally marketed predicate devices, primarily the "ATG/SM-OSA Appliances (K130130)."

The core argument for equivalence is based on the following:

• Identical Indications for Use: Both the proposed device and the predicate are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults, by supporting the lower jaw in a forward position.
• Similar Technological Characteristics:
  • Principle of operation (mandibular repositioning)
  • Prescription device, custom fabricated, intraoral, removable by patient, reusable.
  • Environment of use (home).
  • Non-sterile.
  • Nearly identical raw materials (Polymethylmethacrylate Polymer and Monomer, medical grade stainless steel wire, orthodontic expansion screws).
  • Manufacturing, finishing, and cleaning processes are identical and performed at the same facility (Space Maintainers Laboratory).
• Minor Design Differences: The only noted differences are the location of the occluding surface of the upper and lower trays and the inclusion of additional braided stainless-steel supporting wire within the dorsal wings of the proposed device. The submission states these minor differences "do not affect the substantial equivalence" as they don't change the indication, principle of operation, manufacturing/sterilization process, or elevate risk.
• Non-Clinical Tests: A risk analysis per ISO 14971 was performed, comparing potential risks (soreness, obstruction, tooth movement, TMD, saliva, breakage) to the predicate device, concluding risks were equivalent or less. Biocompatibility and physical properties were leveraged from the predicate device materials.
• Clinical Tests: Explicitly stated that "Clinical testing has not been performed."

In essence, the "study" proving the device meets criteria (or rather, is substantially equivalent) is a comparison and analysis of the device's design, materials, manufacturing, and intended use against a legally marketed predicate device, rather than a novel clinical effectiveness trial. The acceptance criteria are implicitly met if the device is deemed sufficiently similar to a device already cleared by the FDA for the same indications for use.

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The SML OSA2 Appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The SML-OSA2 appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.

The SML-OSA2 APPLIANCES include five device models: Adjustable Sleep Appliance (ASA), Clear Sleep Adjustable Dorsal, Clear Sleep Adjustable Anterior, Quiet Night Appliance (QNA) and V-force.

The SML-OSA2 Appliances are customized, intraoral dental devices designed to reduce snoring and mild to moderate obstructive sleep apnea in adults. The devices fit over the dentition and reposition the mandible in a slightly protrusive position. The SML-OSA2 APPLIANCES consist of 2 arch forms that are linked to advance the mandible, and are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the SML-OSA2 Appliances device:

This document is a 510(k) Premarket Notification for the SML-OSA2 Appliances. In the context of 510(k) submissions, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through de novo performance studies. Therefore, the information provided focuses on comparability and known safety/effectiveness of materials and design.

Acceptance Criteria and Reported Device Performance

The document doesn't present a table of numerical acceptance criteria and a corresponding table of the device's measured performance in the typical sense of a diagnostic or therapeutic device undergoing a detailed performance study. Instead, substantial equivalence to a predicate device (ATG/SM-OSA Appliances, K130130) is the overarching "acceptance criterion" being met.

Here's how the "acceptance criteria" (implicitly, the characteristics of the predicate) and "reported device performance" (characteristics of the subject device) are presented:

Study Information & Data Provenance

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

   • No specific test set or associated sample size is mentioned. This is a 510(k) submission primarily relying on substantial equivalence to a predicate device, not de novo performance testing.
   • The document implies that the "data provenance" for the predicate device's effectiveness would be from its own clearance, but no specific study details are given here for either device.

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

   • Not applicable. There was no specific test set or ground truth established for the SML-OSA2 Appliances regarding clinical performance, as no clinical testing was required or performed for this 510(k). The ground truth for the predicate's effectiveness would have been established during its own clearance.

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

   • Not applicable, as no specific test set or clinical study requiring adjudication was performed for the SML-OSA2 Appliances.

4. 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. This device is a physical intraoral appliance, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

   • Not applicable. This device is a physical intraoral appliance.

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

   • For the purposes of this 510(k) submission, the "ground truth" for the device's safety and effectiveness relies on the established safety and effectiveness of the predicate device (K130130) for its specified indications for use.
   • The "ground truth" for the materials used in SML-OSA2 Appliances (including new ones like POM and latex elastomers) is established by their prior use in cleared dental/intraoral devices or their inclusion in the FDA Biomaterials Compendium.

7. The sample size for the training set:

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

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

   • Not applicable, as there is no training set for this type of device.

In summary: The document from the FDA acknowledges a 510(k) premarket notification for the SML-OSA2 Appliances. It concludes that the device is substantially equivalent to a predicate device (ATG/SM-OSA Appliances, K130130), meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. This determination is made based on comparing the indications for use, technological characteristics (design, materials, scientific principle), and performance standards, primarily relying on existing data and prior clearances rather than new, extensive performance studies for the subject device. "No clinical testing is required for these devices."

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The ATG/SM-OSA appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The ATG/SM-OSA appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.

The ATG/SM-OSA APPLIANCES are primarily polymer trays that are used intraorally over the dentition to make the mandible protrude. Three designs are included: Adjustable Herbst, Adjustable Dorsal, and MIRS. The mandible protrusion is controlled by stainless steel tubes & rods or screws for the Herbst and Dorsal designs. The MIRS single-piece construction has a lingual rest to set the mandibular protrusion. Each device is fabricated to the prescription of a dentist.

The provided text describes a 510(k) premarket notification for the ATG/SM-OSA APPLIANCES. This submission is for a medical device that does not require a clinical study with acceptance criteria and performance data in the typical sense of an AI/ML device.

The basis for this 510(k) submission is substantial equivalence to a predicate device, meaning the new device (ATG/SM-OSA APPLIANCES) is essentially identical in intended use, design, function, and materials to an already legally marketed device (DynaFlex® Anti-snoring and Sleep Apnea Devices).

Therefore, many of the requested elements for an AI/ML device study (like sample size, ground truth, expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

Here's a breakdown of the relevant information provided and why other sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

No formal clinical study with acceptance criteria and a specific performance measurement was conducted or described in this document for the ATG/SM-OSA APPLIANCES. Instead, the "study" proving the device meets the acceptance criteria is a comparison and analysis of the new device against its predicate device to demonstrate substantial equivalence.

The manufacturer, Selane Products Inc., performed:

• An FMEA (Failure Mode and Effects Analysis) risk analysis.
• Evaluation of the materials of construction.
• Evaluation of the design.

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

• Not Applicable. No test set, clinical data, or performance data from human subjects was used for this 510(k) submission. The submission relies on demonstrating similarity to a previously cleared predicate device.

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

• Not Applicable. No ground truth for a test set was established as no clinical study or test set was mentioned.

4. Adjudication method for the test set

• Not Applicable. No test set 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. This is a physical medical device, not an AI/ML diagnostic or assistive tool.

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

• Not Applicable. This is a physical medical device.

7. The type of ground truth used

• Not Applicable. No ground truth was established for a performance study. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not Applicable. No training set was used. This is not an AI/ML device.

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

• Not Applicable. No training set was used.

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The Millenium Anti-Snoring Device is indicated for use in the treatment of snoring and mild to moderate obstructive sleep apnea in adult patients.

Not Found

The provided FDA 510(k) summary for the Millenium Anti-Snoring Device explicitly states that the device is being cleared as "substantially equivalent" to legally marketed predicate devices. This type of clearance generally means that the submission does not typically include a detailed clinical study demonstrating the device meets specific performance acceptance criteria as would be required for a novel or high-risk device. Instead, the focus is on showing similarity to existing products.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed training set information.

The core information provided is:

• Device Name: Millenium Anti-Snoring Device
• Intended Use: Treatment of snoring and mild to moderate obstructive sleep apnea in adult patients.
• Regulatory Status: Class II, regulated under 21 CFR 872.5570 for Intraoral Devices for Snoring and Intraoral Devices For Snoring And Obstructive Sleep Apnea.
• Clearance Type: 510(k) substantial equivalence rather than a PMA (Premarket Approval) which would require more extensive clinical evidence.

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The Snorkel is used to reduce tongue induced airway obstructions. The Snorkel is intended for use in patients, for the treatment of mild to moderate obstructive sleep apnea.

The Snorkel is an oral mandibular advancement device whose function is to artificially protrude the chin (mandible) forward so as to pull the tongue away from the back of the throat, thereby reducing tongue-induced airway obstruction.

The Snorkel device is custom-made and fitted based on dental impressions and used by the patient during sleep. The single mouth piece fits snugly onto the upper and lower crowns of the patient's teeth. As the patient falls asleep, thus relaxing their mandible, a silicon band provides tension such that the mandible is pulled forward along with the tongue.

The provided document describes "The Snorkel," a mandibular repositioning device for reducing snoring and treating mild to moderate obstructive sleep apnea. The submission for this device is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than providing extensive clinical trial data for new acceptance criteria.

Therefore, the following information is extracted from the document:

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

Since this is a 510(k) submission, there are no explicit "acceptance criteria" defined in the typical sense of a clinical trial with performance metrics. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device, K955503 (Adjustable PM Positioner), across various characteristics.

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

• Sample Size: Not applicable. No human clinical study was conducted for this 510(k) submission to evaluate the safety or effectiveness of The Snorkel device itself. The evaluation relied on non-clinical testing and comparison to the predicate device.
• Data Provenance: Not applicable for a "test set" in the context of clinical performance. The data provenance would be from internal non-clinical testing (physical properties, biocompatibility) and regulatory guidelines regarding risk assessment for such devices.

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

• Number of Experts: Not applicable. No "ground truth" was established based on expert review of a test set for this device in the context of a clinical performance study. The assessment was based on engineering design, material characteristics, and comparison to a predicate device.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. As no clinical test set was used, there was no need for an adjudication method by experts.

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:

• MRMC Study Done: No. This is a physical medical device (mandibular repositioning device), not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging device that would typically involve human readers.

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

• Standalone Performance: Not applicable. This is a physical medical device.

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

• Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence was the established safety, effectiveness, and technological characteristics of the predicate device (Adjustable PM Positioner, K955503), as well as the successful completion of non-clinical tests (physical properties, biocompatibility) and a risk assessment. There was no clinical ground truth established for The Snorkel itself through direct human clinical testing.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. There was no "training set" of data in the context of machine learning or clinical trials for this device.

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

• How Ground Truth for Training Set was Established: Not applicable. No training set was used.

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The Narval CC™ is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Narval CC is a removable intraoral device used for treating snoring and sleep apnea. It consist of two custom fabricated splints that fit separately over the upper and lower teeth and engage by means of adjustable rods. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving his/her ability to exchange air and reducing the tendency to snore. The device is custom made for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting.

The provided text is a 510(k) summary for the ResMed Narval CC device, which is an intraoral device for snoring and obstructive sleep apnea. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone study with acceptance criteria and device performance metrics in the way one might find for a novel diagnostic algorithm.

Here's a breakdown of why many of your requested items cannot be found in this specific document:

• This is a 510(k) Pre-Market Notification, not a clinical trial report or a performance study for a novel algorithm. The goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective. It generally doesn't require new clinical studies with detailed performance metrics and acceptance criteria for the new device if sufficient evidence of equivalence to a predicate exists.
• The device is a physical intraoral device, not an "AI algorithm." Many of your questions are geared towards the evaluation of AI/ML-based diagnostic systems. This product is a custom-fabricated physical medical device.

Therefore, many of your specific questions related to AI algorithm performance evaluation, such as "acceptance criteria," "reported device performance" in a metric table, "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," "type of ground truth," and "training set size/ground truth" are not applicable or not present in this type of regulatory submission for this type of device.

What can be extracted or inferred from the document:

The document primarily focuses on demonstrating substantial equivalence to predicate devices. This is the "study" in this context. The "acceptance criteria" here are met if the FDA agrees that the new device shares sufficient similarities with the predicate devices in terms of intended use, technological characteristics, and does not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (Implicit for 510(k) Substantial Equivalence): The device must be demonstrated to be "substantially equivalent" to predicate devices. This is achieved by showing that it has:
  • Essentially the same intended use and user population.
  • Equivalent technological characteristics.
  • Does not raise new questions of safety and effectiveness.
  • Is at least as safe and effective as the predicate devices.
• Reported Device Performance: Instead of specific quantitative performance metrics, the "performance" is demonstrated by asserting similarity to already cleared devices. The document explicitly states: "it is at least as safe and effective as the predicative devices."

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

• Not applicable / Not provided. This document does not describe a clinical performance study with a distinct "test set" in the context of an AI algorithm or a novel performance claim. The "study" here is a comparison to predicate devices based on design and intended use.

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. There is no "ground truth" establishment in the sense of expert annotation for a diagnostic algorithm. The ground truth for the predicate devices' effectiveness would have been established historically through their own clearance processes or clinical use, which are not detailed here.

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

• Not applicable. No adjudication method for a 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:

• Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

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

• Not applicable. This isn't an algorithm.

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

• Not applicable for this device's evaluation. The evaluation for this device is based on demonstrating similarity to legally marketed devices, whose "ground truth" (i.e., their efficacy and safety) was established through their own regulatory processes (e.g., clinical evidence, long-term use data, or previous equivalence findings).

8. The sample size for the training set:

• Not applicable. This isn't an AI/ML device requiring a training set.

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

• Not applicable.

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