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

The Hushd Pro Z-Link device series are removable intraoral patient-specific device intended for the treatment of snoring and mild to moderate obstructive sleep apnea. The device consists of custom-made maxillary and mandibular splints that fit over the upper and lower teeth, and are connected via a pair of detachable rigid connectors. When linked, the splints function as a mandibular repositioner by holding the lower jaw in a forward position during sleep, thereby preventing the tongue and soft tissues from collapsing into the airway.

Each device consists of one maxillary and one mandibular splint, designed and manufactured using 3D printing technology. The splints incorporate a pair of integrated studs that are located around the canine area for the maxillary splint and around the first molar area for the mandibular splint. These studs interface with slots on the detachable connectors to securely link the two splints together. This configuration permits the mandible to advance from the baseline position, offering improved patient comfort.

Titration is achieved by replacing the connectors with another pair of a different size. The connectors are available in 1.0 mm incremental lengths, allowing progressive mandibular advancement according to patient tolerance and clinical need. A standard set includes six pairs of connectors, ranging from -1 mm to +5 mm protrusion, while an extended set ranging from +6 mm to +10 mm is available upon request, providing a maximum mandibular protrusion of 10 mm.

The connectors are not elastic and do not contain adjustment mechanisms such as pistons, screws, straps, or repositioning elastics. The rigid connectors are manufactured with medical grade nylon PA12 using commercial injection molding process and are marked for easy identification.

The splints of this device are manufactured using selective laser sintering (SLS) 3D printing with EOS PA2200 polyamide (nylon) PA12 material. This material offers excellent mechanical properties, long-term stability, and has a history of safe use in oral medical devices. The manufacturing process includes mechanical or chemical polishing, cleaning, and rigorous quality control prior to packaging.

The Hushd Pro Z-Link is available for prescription only and designed based on optical or physical impressions taken by a licensed healthcare provider. The splints and connectors are designed exclusively by the device manufacturer and its authorized partners to ensure consistent quality and performance.

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The Mandibular Advancement Device is designed to advance the user's lower jaw and maintain this position during use, opening the airway to reduce snoring during sleep. It is intended for adults with at least 18 years old.

The L07 Mandibular Advancement Device is an intraoral device that is used to maintain the lower jaw in a forward position to increase pharyngeal space so as to improve the ability to exchange air and decrease air turbulence, a causative factor in snoring.

The L07 Mandibular Advancement Device include three types: Type A, Type B, Type C. Each type includes one upper tray and one lower tray. The upper tray of these three types are the same, while they are only different in lower tray. By combining upper tray with different lower tray, the device can be used for advancing lower jaw from 0mm to 6mm.

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to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults

The Double Tube Herbst appliance consists of upper and lower base appliances connected on each side by a telescopic apparatus that advances the mandible. Each telescopic apparatus is loosely but securely attached to wire loops formed at the ends of retentive anchors embedded in the acrylic on the outer (buccal) surfaces of the upper and lower base appliances. A telescopic apparatus consists of a double tube telescopic assembly that is attached to the back end of the upper wire loop; and a rod that is attached to the front end of the lower wire loop. The double tube telescopic assembly consists of a short internally threaded tube welded in parallel onto the back of a long straight tube in which the rod slides. The short internally threaded tube is adjustably attached to the back end of the upper wire loop by engaging the externally threaded lower end of a connector, the upper end of which ends in a helix that is twisted around the upper wire loop. The rod that slides in and out of the long tube is loosely but securely attached to the wire loop on the front end of the lower retentive anchor. The lengths of the telescopic assemblies can be adjusted in 1/2 mm increments along a range of 15 mm by disengaging the telescopic components, rotating the double tube assembly around the connecting arm, and sliding the rod back into the long tube to lock in the adjustment.
The Double Tube Herbst appliance is worn while sleeping to keep the mandible in a forward position prescribed by the treating dentist to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The customized appliance is inserted and removed by the patients every night, and it is adjusted by the prescribing dentist.

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The Nylon flexTAP is intended to reduce or alleviate nighttime snoring and mild to moderate obstructive sleep apnea, OSA for adults, 18 years of age and older.

The Nylon flexTAP is a custom-fit oral device intended to reduce or alleviate nighttime snoring and mild to moderate obstructive sleep apnea (OSA). The Nylon flexTAP device consists of 3 components:

1. Upper Tray that fits on the upper teeth
2. Lower Tray that fits on the lower teeth.
3. An Adjustment Mechanism attached to the lower tray that fits into an Adjustment Post on the upper tray.

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Oniris and Oniris Plus devices are indicated for use on adult patients 18 years of age or older as an aid for the reduction of snoring (OTC).

Oniris Plus device is indicated in the treatment of snoring and/or mild to moderate obstructive sleep apnea in adults. (Rx)

The Oniris and Oniris Plus devices are intraoral mandibular advancement appliances. Each device consists of two independent splints, over-molded with a thermoforming material, ensuring a customized fit for the user. One splint is designed for the maxillary arch (labeled "Up") and the other for the mandibular arch (labeled "Down"). The splints are custom-fitted by the end user at home using a simple "Boil-and-Bite" process, eliminating the need for professional dental impressions.

The two splints are connected via advancement hooks, which allow for mandibular protrusion adjustments. Oniris and Oniris Plus OTC devices offer 5 sizes of advancement hooks, while Oniris Plus Rx device provides 10 sizes, enabling precise customization of the mandibular advancement. These hooks maintain the mandible in a forward position, optimizing airflow and reducing air turbulence, a key factor in snoring and airway obstruction. Users can adjust the device for up to 6 mm (OTC) and 11 mm (Rx) of mandibular advancement by interchanging the hooks to achieve the most effective and comfortable setting.

As predicate devices, Oniris and Oniris Plus feature an independent bi-bloc design, allowing for vertical articulation. This enhances patient comfort and ensures a more natural fit.

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The Study that Proves the Device Meets the Acceptance Criteria

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

• Not applicable. This device is a physical intraoral appliance, not a software algorithm.

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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

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

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

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

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

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

What Can Be Inferred/Extracted from the Document:

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

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

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

Summary Based on Provided Document:

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

2. Sample Size and Data Provenance

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

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

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

4. Adjudication Method for the Test Set

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

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

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

6. Standalone Performance

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

7. Type of Ground Truth Used

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

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

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

8. Sample Size for the Training Set

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

9. How Ground Truth for the Training Set Was Established

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

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

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

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

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

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

Therefore, I cannot provide the requested information, including:

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

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

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