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Classic is a Mandibular Advancement Device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to alleviate or reduce snoring in adults.

Classic device is an intraoral device specially indicated for the treatment of snoring and obstructive sleep apnea syndrome. Its design makes it simple to use and comfortable to wear. It is intended for single-patient use by adults who are 18 years or older.

Classic device consists of two splints united to each other by a screw that allows controlled advancement of the mandible by the increase of the muscular tone at the airway level. Consequently, the flow of air through the upper airway is increased, and reducing snoring and apnea events.

The maximum protrusion of Classic arch form is 10 mm, measuring from patient's plate. This device needs an external controlling component such as screwdriver included in the kit. The device is according arches, maximizes tongue space and allow open, close and laterality movements during wear. These movements can be personalized by the doctor.

Each Classic device has the following components:

1. Upper splint
2. Lower splint
3. Activation key
4. Guide (Bar)
5. OrthoApnea screw

This document is an FDA 510(k) Premarket Notification for the "Classic" Mandibular Advancement Device (MAD). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a specific performance metric against a set of acceptance criteria derived from a novel clinical study.

Therefore, many of the requested elements regarding acceptance criteria, study design, expert involvement, and ground truth for demonstrating device performance are not applicable in the context of this 510(k) submission document. The submission relies heavily on non-clinical testing and comparison to predicates to assert safety and effectiveness.

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

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

This document does not present acceptance criteria in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy) derived from a specific clinical study aimed at proving the device meets those criteria. Instead, the "acceptance criteria" for a 510(k) submission are fundamentally about demonstrating substantial equivalence to a predicate device.

The closest one gets to "performance" here is demonstrating adherence to established standards and similar characteristics to the predicate.

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. This submission is for a physical medical device (intraoral device) and relies on non-clinical (bench) testing and comparison to predicates, not a clinical test set of patient data with a defined sample size as would be used for an AI/software device.
• Data Provenance: The bench testing likely occurred at the manufacturer's facility or a certified lab. The document does not specify the country of origin for the data or whether it was retrospective or prospective, as it's not clinical data.

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 human data requiring expert ground truth establishment was used in this 510(k) submission.

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

• Not Applicable. No clinical test set with human data requiring adjudication was used.

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

• Not Applicable. This is a physical device, not an AI or software-as-a-medical-device (SaMD) product. No MRMC study was performed or required for this type of submission.

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

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

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

• Not Applicable. For the non-clinical testing performed, the "ground truth" would be the established physical and chemical properties of the materials and the performance specifications of the device components as defined by the international standards (e.g., ISO, ASTM). Biocompatibility is assessed against the absence of toxic reactions as per ISO standards. There is no patient-level "ground truth" for disease state or outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device. It's not an AI/machine learning device.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.

The American Sleep Dentistry (ASD) Oral Appliances include five device models: the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo. All are removable, intraoral devices which reposition the mandible and each is patient specific to individual patient anatomy.

The devices are comprised of thermoformed polymer splints (copolyester or EVA), which are connected via a hook and base mechanism or elastic bands or straps.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

The document is a 510(k) Premarket Notification from the FDA regarding the "American Sleep Dentistry (ASD) Oral Appliances". It primarily focuses on demonstrating substantial equivalence to existing predicate devices for the purpose of market clearance.

It describes:

• The device's trade name, regulation number, and product code.
• The device's intended use: "reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older."
• A comparison of the technological characteristics (anatomic location, intended use, basic design, principles of operation, materials, manufacture) of the ASD Oral Appliances to several predicate devices.
• A detailed table comparing features like intended use, prescription/OTC use, principle of operation, design, materials, range and precision of adjustment, target population, where used, energy used/delivered, human factors, and sterility across the ASD devices and the predicate devices.

There is no mention of:

• Specific acceptance criteria (numerical thresholds for performance).
• Any performance studies, clinical trials, or validation test results demonstrating the device meets quantitative performance metrics.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Types of ground truth used or how it was established.

The conclusion simply states that the new device has the "same intended use" and "same technological characteristics" as the predicate devices, thus not raising "new questions of safety and effectiveness," and is therefore "substantially equivalent." This is a regulatory determination based on comparison to existing devices, not a performance validation study.

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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 OVENT is a removable medical device that is fitted in the patient is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea, OSA. The device is indicated for use during sleep to aid in the treatment of these conditions.

The OVENT is for prescription use only.

The OVENT device is for the treatment of snoring and/or obstructive sleep apnea and is comprised of:
• A titanium bimaxillary oral appliance which comprises, in one device, a lower tray fitted over the lower teeth and an upper tray fitted over the upper teeth.
• A dental polymer material in each tray which is in contact with and retaining in position, the user's top and bottom teeth.
• The lower jaw is retained in an advanced position to help open up the natural airway and alleviate the user's snoring condition.
• A breathing port at the front of the appliance with an enclosed airway on each side which passes between the teeth and the cheek. Each airway delivers the air at the rear of the mouth typically between the last teeth. The airways allow the user to breathe with the mouth closed.

The provided text, a 510(k) summary for the OVENT device, does not describe any clinical studies conducted to prove the device meets acceptance criteria. Instead, it explicitly states:

"Human clinical studies were not deemed necessary to evaluate the performance of the device to determine substantial equivalence as the OVENT does not:

• Use designs dissimilar from the predicate device and other previously-cleared devices under a 510(k);
• Use new technologies different from legally-marketed intramandibular repositioning devices for snoring and/or obstructive sleep apnea;
• Deviate from the indications for use identified in the predicate devices: the TAPIII and the LISA."

Therefore, I cannot provide the requested information regarding the acceptance criteria and the study that proves the device meets them, as no such study is detailed in this document.

The document does include non-clinical tests performed, such as biocompatibility and peel/bond strength testing. These tests had certain acceptance criteria, but they are not clinical performance measures.

Here's a summary of the non-clinical test information:

Non-Clinical Acceptance Criteria and Reported Performance

Regarding Clinical Studies:

• Sample size for the test set and data provenance: Not applicable, no clinical test set described.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, no clinical test set described.
• Adjudication method for the test set: Not applicable, no clinical test set described.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, no clinical study described.
• Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, device is a physical intraoral appliance, not an algorithm.
• The type of ground truth used: Not applicable, no clinical ground truth established.
• Sample size for the training set: Not applicable, no algorithm or clinical device training described.
• How the ground truth for the training set was established: Not applicable, no algorithm or clinical device training described.

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