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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 BFit Intraoral Appliances are likely to reduce snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age or older.

Optionally, the DentiTrac Micro-Recorder may be incorporated into the Bfit device. The DentiTrac is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac System.

The Bfit Intraoral Appliances are mandibular advancement devices which function by holding the jaw in a forward position during sleep (the principle of operation). The forward placement moves the tongue and pharyngeal tissue into a position to maintain an open airway, which allows the passage of more air per breath and helps in the treatment of snoring and mild to moderate Obstructive Sleep Apnea (OSA) - the intended effect. The Bfit Sleep and Bfit Engage use mild elastic pull during the different stages of sleep where muscle activity is lost. In addition, both models of the oral appliance may be provided to the patient with an embedded DentiTrac micro-recorder used to capture the patient's compliance to the prescribed oral appliance therapy. Each oral appliance is custom-fit to the patient. The Bfit is available in four possible configurations which differ only in connecting mechanism and whether a DentiTrac is installed: Bfit Sleep (elastics), Bfit Sleep with DentiTrac, Bfit Engage (tension springs), and Bfit Engage with DentiTrac.

The provided text does not contain information about the acceptance criteria and performance of the device in the context of clinical studies to prove its effectiveness in reducing snoring or OSA.

The document is a 510(k) summary for the Bfit Intraoral Appliances, which focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance testing and biocompatibility testing. It does not present clinical studies with human participants to establish clinical efficacy or define acceptance criteria for such efficacy.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (for clinical efficacy).
• Sample size used for the test set and data provenance (for clinical efficacy).
• Number of experts and qualifications for ground truth (for clinical efficacy).
• Adjudication method (for clinical efficacy).
• MRMC comparative effectiveness study results.
• Standalone algorithm performance (as this is a physical device, not an AI algorithm).
• Type of ground truth used (for clinical efficacy).
• Sample size for the training set (for clinical efficacy).
• How ground truth for the training set was established (for clinical efficacy).

What the document does provide regarding testing and criteria is related to the device materials and mechanical performance:

1. A table of acceptance criteria and the reported device performance (for non-clinical aspects):

In addition, the following non-clinical tests were performed by the material manufacturer, and "Bench testing to ensure durability of the appliance under normal wearing and cleaning conditions was also performed. The appliance passed all testing." No specific numerical acceptance criteria or performance metrics are detailed in the provided text for these tests:

• Tensile strength (ASTM D-638)
• Flexural Strength (ASTM D-790)
• Flexural Modulus of Elasticity (ASTM D-790)
• Compressive Strength (ASTM D-695)
• Density (ASTM D-792)
• Melt Flow Rate (ASTM D-1238)
• Melting Point (ASTM D-3418)
• Vicat Softening Point (ASTM D-1525)

2. Sample sized used for the test set and the data provenance: Not applicable to clinical efficacy in this document. For biocompatibility, the sample sizes are embedded within the "Study#" identifiers but not explicitly stated as number of units tested. Data provenance is implied by the testing standards (e.g., ISO, ASTM).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this document focuses on non-clinical and biocompatibility testing, not expert-adjudicated clinical outcomes.

4. Adjudication method for the test set: Not applicable for non-clinical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is a physical medical device, not an AI algorithm requiring MRMC study.

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: For biocompatibility, the ground truth is based on established biological and physical test standards (e.g., ISO 10993, absence of reactivity/irritation/sensitization). For the other non-clinical tests, it is based on the material properties and durability assessments.

8. The sample size for the training set: Not applicable, as this is not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor is intended to reduce snoring and mild to moderate obstructive sleep apnea (OSA) and monitor patient usage in an adult population.

The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor are simple hardware devices. They are oral appliances 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 OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor are intraoral devices used for treating and mild to moderate Obstructive Sleep Apnea (OSA). They consists of two custom fitted trays which fit over the upper and lower dentition of a patient and engage by means of adjustable metal screws or lugs. 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. Additionally nasal dilator buttons are attached to the upper appliance, that when engaged stretch the nasio-label tissue in order to increase space in the nasal airway passage thus reducing tissue obstructions that aid in reducing snoring and OSA.

The devices are retained on the teeth by labial and lingual positioned ball clasps, typically located in the undercuts of each splint and by the base material engaging the undercuts of the teeth.

The devices are custom made for each patient and have an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

Additionally, the devices include the Dentitrac ® patient monitoring system as characterized under the Braebon Dentitrac MAF 2557 to help monitor patient compliance to prescribed usage.

The provided text describes a 510(k) submission for the "OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor". This submission focuses on demonstrating substantial equivalence to a predicate device and does not involve a clinical study with specific acceptance criteria that would typically be found in direct performance evaluations of a new medical device's efficacy or diagnostic accuracy. Instead, the "acceptance criteria" are related to established safety and performance standards for similar devices and the successful integration of the monitoring system.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not describe a test set or data provenance in the context of a clinical study or performance evaluation with human subjects for the OASYS device itself. The evidence presented is primarily based on:

• Comparison to predicate devices: This involves structural and functional similarities, and the predicate device (K030440) served as the primary benchmark.
• Non-clinical testing: This refers to laboratory-based evaluations for biocompatibility, electrical safety, software, and general performance. The text does not specify sample sizes for these tests (e.g., how many units were tested for biocompatibility, though such tests are typically conducted on representative samples).
• Reference to Master File (MAF 2557): The DentiTrac® Patient Monitoring System's specific testing details (biocompatibility, electrical, performance, and characterization) are contained in a larger "Master File," which is a confidential document submitted to the FDA. The details of any test sets or sample sizes within that MAF are not disclosed in this summary.

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

This information is not applicable as the submission is a 510(k) for substantial equivalence, relying on non-clinical testing and comparison to existing devices rather than a de novo clinical study requiring expert-established ground truth on a test set.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is an oral appliance for treating snoring and sleep apnea, and a DentiTrac® monitoring system. It is not an AI-assisted diagnostic or assistive technology that would involve "human readers" or an MRMC study.

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

This information is not applicable. The DentiTrac® system monitors patient usage; it's a data collection system rather than an algorithm performing a diagnostic or assistive function that would have "standalone performance" in the context of AI.

7. The Type of Ground Truth Used

For the biocompatibility and performance testing, the ground truth is based on established international and national standards (e.g., ISO 10993-1, ISO 14971) and internal requirements/specifications. For the DentiTrac® system, the ground truth for its performance would be against its own specifications, validated as acceptable in MAF 2557, likely using calibrated instruments for accuracy of usage time measurement. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this 510(k) submission.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as the device is not an AI/machine learning system that requires training data.

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

This information is not applicable for the same reason as #8.

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The Prosomnus [CA] Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The DentiTrac® micro-recorder is completely embedded into the Prosomnus [CA] Sleep and Snore appliance. The micro-recorder is intended to measure patient compliance to the oral appliance therapy in combination with the DentiTrac® System.

The Prosomnus [CA] Sleep and Snore device consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate sleep apnea by holding the mandible forward during sleep. providing increased pharyngeal space. These separate upper and lower arch devices are designed with twin-mated posts and are CAD/CAM generated specifically for each prescription. Designed as a patient-specific device, the Prosomnus [CA] Sleep and Snore device series consists of one or multiple lower device(s) together with one or multiple mated-post upper device(s) that are manufactured to the dentist prescriber's requested advancement positions up to 11mm to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing the current upper or lower device and inserting the next upper or lower device in the mandibular advancing series. The Prosomnus [CA] Sleep and Snore device twin-mated post and lingualess design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear.

This submission adds the option for an embedded screw that allows for smaller discreet movements of the mandible in between the lower arch advancements. The inclusion of the embedded screw does not change the intended use, impact the operating principles nor impact the fundamental scientific principles of the device as established by the predicate device K133683, the MicrO2 OSA device. The same principles of operation to move the mandible forward are used to increase pharyngeal space and maximize the tongue space.

The Prosomnus [CA] Sleep and Snore device includes an optional Micro-recorder to monitor patient compliance.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in relation to an AI algorithm or its effectiveness in reducing snoring and sleep apnea.

The document is a 510(k) premarket notification for the Prosomnus [CA] Sleep and Snore Device and the Prosomnus [CA] Sleep and Snore Device with Micro-recorder. The purpose of this notification is to demonstrate substantial equivalence to previously cleared predicate devices, not to prove direct clinical efficacy or performance against defined acceptance criteria in a clinical study.

The "Substantial Equivalence" sections (pages 5 and 9) describe the basis for deeming the devices substantially equivalent to their predicates. This equivalence is primarily based on:

• Identical Indications for Use: Both the predicate and the subject devices are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
• Technological Characteristics: The operating principles, materials, manufacturing process (digital milling), and mechanism to move the mandible forward are considered similar.
• In Vitro Testing: The document mentions "Compression and Shear Torsion Testing" and "Package and Distribution Testing" as data relied upon to determine substantial equivalence. These are mechanical and packaging tests, not clinical performance studies related to snoring or OSA reduction.

Therefore, I cannot provide the requested information as it is not present in the given text. The document does not describe:

1. A table of acceptance criteria and reported device performance for clinical outcomes.
2. Sample size for a test set for clinical performance or its provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, effect size of human readers with/without AI assistance.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used for clinical efficacy (e.g., expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

The "studies" mentioned are in vitro technical tests for mechanical integrity and packaging, not clinical performance studies in humans.

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The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep appea (OSA) in adults 18 years of age or older.

When a DentiTrac® micro-recorder is embeded into the Acrylic Herbst Appliance, the micro-recorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System.

The Acrylic Herbst Appliance with Micro-Recorder is comprised of upper and lower customized acrylic splints which are connected bilaterally via a telescoping Herbst mechanism for the treatment of mild to moderate sleep apnea. The micro-recorder is embedded within the appliance. The device aims to improve the patient's air exchange thereby reduce snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible. The micro-recorder permits a patient's compliance to prescribed oral therapy to be monitored. The patient contacting portions of the appliance are comprised of medical grade polymethylmethacrylate (acrylic splints) and) which are connected bilaterally via a stainless steel (Herbst) mechanism.

The provided document is a 510(k) summary for a medical device (Acrylic Herbst Appliance with Micro-Recorder) seeking FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove they are met in the way a clinical trial for a novel AI device would.

Here's an analysis based on the information provided, noting what is explicitly stated and what is not applicable or not detailed in this type of submission:

1. Table of acceptance criteria and the reported device performance

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

• Not Applicable. This submission is for a physical medical device (intraoral appliance), not an AI/software device. The "test set" for performance was material testing, not patient data in the typical sense of AI evaluation.
• The material performance data appears to be from in-vitro laboratory testing, not specific patient data.

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

• Not Applicable. This information is irrelevant for a physical device where "ground truth" relates to material properties validated by standardized tests.

4. Adjudication method for the test set

• Not Applicable. No human adjudication of patient data for 'ground truth' was performed or described in this type of submission. Material testing results are objective measurements against standards.

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 not an AI device. No MRMC study was performed.

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

• Not Applicable. This is not an AI device.

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

• The "ground truth" for this device's performance relies on:
  • Material Standards (ISO): For mechanical and thermal properties.
  • Predicate Device Equivalence: The primary "ground truth" for the overall device's safety and effectiveness is its substantial equivalence to previously cleared predicate devices, meaning that if the predicate was safe and effective, and this device is sufficiently similar, then it is also considered safe and effective for its stated use.
  • Risk Analysis: Per the Class II Special Controls Guidance Document to identify and mitigate risks.

8. The sample size for the training set

• Not Applicable. This is not an AI device.

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

• Not Applicable. This is not an AI device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria, as described in this 510(k) summary, is not a clinical trial or an AI performance study, but rather a demonstration of substantial equivalence to legally marketed predicate devices.

The key "studies" presented are:

• Material Performance Testing: The device's materials were subjected to mechanical (Tensile strength, Elongation at tear, E-modulus, Flexion strength, Impaction strength, Rockwell hardness) and thermal (Vicat softening point, Thermoform resistance) performance tests against ISO standards. The results were found "satisfactory" because the identical material is used for both the subject and predicate devices, implying that the material properties are equivalent and thus acceptable.
• Biocompatibility Justification: No additional biocompatibility testing was supplied as the materials and fabrication processes are identical to the predicate device, which had already established biocompatibility.
• Comparative Analysis of Technological Characteristics: A detailed comparison table ([pages 5-6]) highlights the similarities in intended use, target population, prescription status, basic design, adjustability, and manufacturing methods between the proposed device and two predicate devices (SomnoDent® with Micro-Recorder K150369 and Acrylic Herbst Appliance K113126). The "differences" (e.g., adjustment mechanism, materials for the micro-recorder variant, adjustable range) were deemed not to raise new questions regarding safety or effectiveness.
• Risk Analysis: A risk analysis was performed per FDA guidance for intraoral devices for snoring and OSA, and identified risks were mitigated through the use of biocompatible materials (identical to predicate) and appropriate labeling.

In essence, the "study" is a regulatory comparison and material characterization, establishing that the new device is fundamentally the same as already cleared devices, and therefore does not require new clinical data to prove its safety and effectiveness. Clinical testing of the subject device was explicitly stated as not used in support of clearance.

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The MICRODENTAL, Inc. Micr02 device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Optionally, if the DentiTrac® micro-recorder is completely embedded in the MicrO2 device, the microrecorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System

The MicrO2 OSA device series consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower arch devices are designed with twin-mated posts and are CAD/CAM generated specifically for each prescription. Designed as a patient-specific device, the MicrO2 series consists of one or multiple lower device(s) together with one or multiple mated-post upper device(s) that are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing the current upper or lower device and inserting the next upper or lower device in the mandibular advancing series. The MicrO2 does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps or repositioning elastics. The MicrO2's twin-mated post and lingualess design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear.

The Micr02 OSA device with Micro-recorder is identical to the primary predicate device, Somnomed with Micro-Recorder except for the difference in the adjustment mechanism. The MicrO2 uses twin mated posts to adjust whereas the Somnomed uses embedded screws. Without the compliance chip the subject device is identical in materials and manufacturing to the reference predicate MicrO2 OSA device. Any differences introduced by these modifications when compared to the predicate device, do not introduce any new concerns.

This submission adds the option for any clinician to decide to incorporate a DentiTrac® Microrecorder compliance chip embedded into a MicrO2 OSA device to record a patient's compliance to the prescribed oral appliance therapy. The MicrO2 OSA device with Micro-recorder is to be used in combination with the DentTrac® System which includes a base station at the provider's office used to upload the data from the chip to a web application for cloud based reporting and tracking. During scheduled visits, the data within the DentiTrac® can be uploaded to a web application for cloud-based reporting and tracking using a DentiTrac® Base Station at the clinician's office. The DentiTrac® micro-recorder monitors the wear time through the oral temperature, as well as tracks movements and head position. This is the identical chip that is included in the predicate device – the Somnodent with Micro-Recorder. The inclusion of the embedded DentiTrac® micro-recorder, provides additional information when used in combination with the DentiTrac® System, but does not impact the operating principles of the Micr02 OSA device as established by the reference device, the MicrO2 OSA without the DentiTrac® Micro-recorder.

This FDA 510(k) summary describes the MicrO2 OSA Device with Micro-recorder. However, it explicitly states, "Clinical testing was not conducted on the subject device." Instead, the submission relies on demonstrating substantial equivalence to predicate devices through technical characteristics, material composition, and non-clinical performance testing. Therefore, the information requested in the prompt related to acceptance criteria for clinical performance, sample sizes for test sets, ground truth establishment, expert adjudication, or MRMC studies for an AI device is not applicable to this submission.

The document focuses on the mechanical performance and biocompatibility of the device and the embedded micro-recorder, not on the clinical efficacy of an AI-driven component.

Here's a breakdown of the available information, addressing the prompt as best as possible given the provided text:

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

The document does not provide a table of acceptance criteria in the traditional sense of numerical clinical performance targets for an AI device. Instead, it relies on demonstrating substantial equivalence to predicate devices through various comparisons and non-clinical testing. The "performance" reported is primarily in terms of meeting manufacturing specifications and maintaining structural integrity and biocompatibility.

2. Sample size 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 is described for the subject device. Non-clinical testing refers to lab-based assessments of materials and mechanical properties.

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 with expert-established ground truth is described.

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

Not applicable. No clinical test set with adjudication 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 algorithm 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 not an AI algorithm.

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

Not applicable. For the non-clinical tests described, the "ground truth" would be established engineering specifications, material standards, and validated testing methods.

8. The sample size for the training set

Not applicable. The device is not an AI algorithm and does not have a training set.

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

Not applicable. The device is not an AI algorithm and does not have a training set.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not present. No new study requiring expert ground truth establishment is detailed.

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

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

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

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

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

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

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

8. The sample size for the training set:

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

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

   • Not present. Follows from point 8.

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

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The SonmoDent® intraoral devices are intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

Optionally, if the DentiTrac® micro-recorder is completely embedded into the SomnoDent® device, the microrecorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System.

The SomnoDent family of intraoral devices consists of the following models: Classic, Flex, G2, Herbst Advance, and Fusion. The devices functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air 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 seep 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 submission adds the option for any clinician to decide to incorporate a DentiTrac® microrecorder embedded into a SomnoDent® to record a patient's compliance to the prescribed oral appliance therapy in combination with the DentiTrac® System. This option can be incorporated into the family member models listed above. During scheduled visits, the data within the DentiTrac® can be uploaded to a web application for cloud-based reporting and tracking using a DentiTrac® Base Station at the clinician's office. The DentiTrac® micro-recorder monitors the wear time through the oral temperature, as well as tracks movements and head position. The inclusion of the embedded DentiTrac® micro-recorder provides additional information when used in combination with the DentiTrac® System, but does not impact the operating principles or safety of the SomnoDent®

This document describes the SomnoDent® with Micro-Recorder, an oral appliance intended for the treatment of snoring and mild to moderate obstructive sleep apnea, with an optional embedded micro-recorder to measure patient compliance.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria or reported device performance metrics in a readily extractable table for the SomnoDent® with Micro-Recorder itself.

Instead, the submission for the SomnoDent® with Micro-Recorder relies on demonstrating substantial equivalence to a previously cleared predicate device (SomnoDent® Fusion Classic and SomnoDent® Fusion Flex, K140278). The key argument is that the addition of the DentiTrac® micro-recorder does not change the intended use or safety/effectiveness of the SomnoDent device for treating sleep apnea and snoring.

The table in Section 7.0 ("Comparison to the Predicate") lists several "Technological Characteristics" and indicates whether both the predicate and proposed device possess these characteristics. This table serves as a comparison to show that the fundamental design and intended use of the SomnoDent device itself remain unchanged. The only difference highlighted is the presence of the DentiTrac® Micro-recorder in the proposed device.

The section 8.0 Performance Testing states: "Since the characteristics of the SomnoDent® did not change, no new clinical performance data was necessary to substantiate this change." This indicates that no new clinical performance metrics or acceptance criteria for treatment effectiveness were established or evaluated for this 510(k) submission, as it is assumed to be equivalent to the predicate.

The performance testing mentioned focuses on the new component (DentiTrac® micro-recorder) and its integration:

• EMC and electrical safety
• Biocompatibility
• Software elements
• Process validation to ensure reliable embedding and retention of Quality Control functionality.

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

The document does not mention a traditional test set sample size in the context of clinical performance for the SomnoDent® with Micro-Recorder itself. The claim is substantial equivalence based on the predicate device's existing performance.

For the embedded DentiTrac® micro-recorder, the document refers to "Risk assessments and non-clinical testing." It mentions data being reported in "master file, MAF2557" which would presumably contain details on the testing of the micro-recorder's functionality, but the specifics of sample sizes or data provenance (country, retrospective/prospective) are not detailed in this 510(k) summary. Given the nature of these tests (EMC, electrical safety, biocompatibility, software, process validation), they typically involve testing of components or prototypes rather than large human subject cohorts.

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

This information is not provided as no new clinical study to establish ground truth for treatment effectiveness was necessary for this submission. For the non-clinical testing of the micro-recorder, expert involvement (e.g., in risk assessment or evaluation of test results) is implied for the master file, but not explicitly detailed regarding number or qualifications.

4. Adjudication Method for the Test Set

This information is not provided as no clinical adjudication for a human subject test set is mentioned.

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

No, a MRMC comparative effectiveness study was not done. The device is a physical intraoral appliance with an optional compliance recorder, not an imaging or diagnostic AI requiring human reader interaction.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

For the SomnoDent® device itself (for treatment of sleep apnea/snoring), it's a physical device that a clinician fits and adjusts. There is no algorithm-only performance in the typical sense.

For the DentiTrac® micro-recorder, its function is to objectively measure wear time, movements, and head position. This is an objective data collection function. While it uses internal algorithms to process raw sensor data into meaningful metrics (like wear time based on oral temperature), the document does not describe a standalone performance study of these algorithms in terms of accuracy against a ground truth for wear time. It refers to "software elements were assessed and tested" and "Process validation was generated from SomnoMed to ensure that the SomnoDent® devices can be repeatedly and reliably embedded and retain the Quality Control functionality of SomnoDent® and the DentiTrac®." This implies internal validation, but no external standalone study is detailed in this document.

7. Type of Ground Truth Used

For the SomnoDent® device's substantial equivalence, the "ground truth" for its effectiveness is implicitly the established effectiveness of the predicate device (K140278) which would have undergone its own clinical validation.

For the DentiTrac® micro-recorder, the "ground truth" for its compliance measurement function (wear time based on oral temperature, movement, head position) is not explicitly detailed in this document. It's likely that internal validation studies would have demonstrated the accuracy of its sensors and algorithms against known physical conditions or reference measurements, but these specifics are absent from the 510(k) summary.

8. Sample Size for the Training Set

This information is not applicable in the context of this 510(k) submission. The device is not an AI/ML algorithm that requires a separate training set. The DentiTrac® micro-recorder contains software, but it operates based on defined sensor input and algorithms, not machine learning models trained on large datasets in the way typical AI devices are.

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

This information is not applicable for the reasons stated in point 8.

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