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The ApnoDent® appliance is intended to reduce nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.

The ApnoDent® appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use. The ApnoDent® appliance reduces snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway. Designed as a patient-specific device, the ApnoDent® series 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 turning the advancing screws on both sides which are in contact with the inside of the lower teeth and guide the lower jaw forward. The ApnoDent® 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 for patient comfort. The ApnoDent® appliance consists of upper and lower interlocking, customized trays. The ApnoDent® appliance is customized on models of the patient's teeth, using standard orthodontic acrylics and standard orthodontic wires for clasps and retention. The ApnoDent® appliance allows for inter locking of the upper and lower trays to adjust the mandibular position of the user.

The provided text is a 510(k) Summary for the ApnoDent Appliance. It outlines the device description, indications for use, and a comparison to predicate devices, but it does not contain the specific information required to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/Machine Learning device study.

The document is a traditional medical device submission, focusing on material composition, mechanism of action, and comparison to existing non-AI devices. There is no mention of an algorithm, AI, machine learning, or any study involving a test set, ground truth experts, MRMC studies, or standalone performance of an algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving an AI device's performance from this document.

The document primarily focuses on establishing substantial equivalence to predicate devices based on:

• Intended Use: Reducing nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
• Technological Characteristics: Customized oral device with upper and lower trays, interlocking system, made from standard orthodontic acrylics and wires, and using screw adjustment for mandibular advancement.
• Performance: The document states that a "biocompatibility and physical properties assessment was completed based on the material composition of the primary predicate, which concluded that the subject device was substantially equivalent to the primary predicate device. A risk assessment has also been conducted with the subject device, which concluded there are no additional risks as compared to the predicate device(s)." This indicates the "acceptance criteria" likely pertained to material safety and function, not AI performance metrics.

To answer your specific questions, I would need a document detailing an AI/ML clinical validation study.

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The Panthera Anti-Snoring X3 Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Panthera Anti-Snoring X3 Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two customized splints that fit separately over the upper and lower teeth.

The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharvngeal space, improving their ability to exchange air during sleep.

The device is a prescription customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The maximum protrusion of the device is 5 mm in 1 mm increments.

This document is a 510(k) premarket notification for the Panthera Anti-Snoring X3 Device, seeking substantial equivalence to previously marketed devices. The document explicitly states that no human clinical study was deemed necessary to support substantial equivalence (page 12), and therefore, a study proving the device meets acceptance criteria based on human clinical data is not provided in this submission.

The acceptance criteria and device performance are instead established through non-clinical testing, primarily by demonstrating equivalence to a primary predicate device (The Panthera Anti-Snoring Device, K143244) and several reference predicate devices.

Here's a breakdown based on the provided text, addressing your points where possible, and indicating where information is not available due to the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical study was performed, the "reported device performance" against clinical acceptance criteria is not applicable. Instead, the non-clinical testing focused on establishing substantial equivalence based on material properties, design, and mechanical strength.

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

• Sample size: Not applicable for a clinical test set as no clinical study was performed. For non-clinical testing, specific sample sizes for material and fatigue tests are not provided in this summary but would have been part of the underlying test reports.
• Data provenance: Not applicable in terms of country of origin or retrospective/prospective for a clinical study. The non-clinical testing was conducted by Panthera Dental Inc.

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

Not applicable. As no human clinical study was performed, there was no ground truth established by experts for a test set in this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No human clinical study was performed with a test set requiring adjudication.

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

Not applicable. This device is a physical intraoral device, not an AI or imaging diagnostic tool, and 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 a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was established by industry standards (e.g., ASTM D638, NISTIR 8059) and regulatory biocompatibility standards (e.g., ISO 14971, ISO 10993). Equivalence to predicate devices with established safety and effectiveness also serves as a form of "ground truth" for substantial equivalence.

8. The sample size for the training set

Not applicable. No machine learning algorithm or training set was involved.

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

Not applicable. No machine learning algorithm or training set was involved.

Summary of the Study (Non-Clinical Evidence for Substantial Equivalence):

The Panthera Anti-Snoring X3 Device's substantial equivalence was established through non-clinical testing and comparison to legally marketed predicate devices rather than a human clinical study.

• Non-Clinical Testing:

  • Material Equivalence: The device uses the same raw material (polyamide type 12), supplied by EOS, and the same proprietary manufacturing process (Selective Laser Sintering) as its primary predicate, The Panthera Anti-Snoring Device (K143244). This allowed for leveraging performance testing (orthosis polishing, static and dynamic compression resistance) from the predicate's submission.
  • Mechanical Testing: A specific test was conducted to determine build locations for 3-D printing in accordance with FDA guidance and standards (ASTM D638, NISTIR 8059).
  • Fatigue Testing: Because the mechanism for mandibular protrusion differed from the primary predicate (stop-clip system assembly vs. interlocking rods), dedicated fatigue testing was performed on the stop-clip system assembly. The results demonstrated sufficient mechanical strength for its intended clinical application.
  • Biocompatibility: Assessed and confirmed to be biocompatible based on the use of identical materials, supplier, and manufacturing process as the primary predicate device, following ISO standards (14971, 10993-1, 10993-5, 10993-10).

• Rationale for No Clinical Study: The FDA submission states that a human clinical study was "not deemed necessary" because the Panthera AS X3:

  • Does not use a design dissimilar from the reference predicate devices.
  • Does not use new technologies different from the primary and reference predicate devices.
  • Does not deviate from the indications for use identified in the primary and reference predicate devices.

In essence, the "study" proving the device meets its "acceptance criteria" here is a comprehensive non-clinical assessment demonstrating that the device is materially, technologically, and functionally equivalent or superior in specific mechanical aspects to its established predicate devices, which already have demonstrated safety and effectiveness through their own market history or prior submissions.

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The TrueFunction® Adjustable Herbst Appliance is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The TrueFunction® Adjustable Herbst Appliance is a prescription only appliance that is customized by True Function Laboratory to dentist specific instructions.

TrueFunction® - Adjustable Herbst Appliances are primarily polymer trays that are used intraorally over the dentition to make the mandible protrude. Material composition of the proposed devices include acrylic PMMA, dual laminate polymers, stainless steel ball clasps, exing elements and adjustment key and colorant. Also provided with the device is a stainless steel key used to make necessary mandibular protrusion adjustments by turning the screws as needed.

They are available in three mandibular advancement models: The Dual Laminate, the Acrylic with Clasp, and the Acrylic without Clasp model.

The Dual Laminate - this model has a soft, rubbery surface on the inside of each piece and a hard acrylic surface on the outside without metal clasps for retention. The appliance is held in place by the soft, rubbery liner. Patients must have adequate natural undercuts for retention of the Dual Laminate model, because retention cannot be increased during treatment, and the appliance cannot be modified to accommodate new tooth restorations or the loss of posterior teeth.

The Acrylic with Clasp and Acrylic without Clasp - the acrylic with clasp model has several metal ball clasps, which can be adjusted to increase retention on teeth that have insufficient undercuts. The ball clasps can often be modified, should further dental work be performed and adjustments required. For the non-clasp model, the patient must have adequate natural undercuts because retention cannot be increased during treatment, and the appliance cannot be modified to accommodate new tooth restorations or the loss of posterior teeth.

TrueFunction® - Adjustable Herbst Appliances mandible protrusion is controlled by stainless steel tubes & rods or screws for all three mandibular advancement designs. Each device is fabricated to the prescription of a dentist.

TrueFunction® - Adjustable Herbst Appliances device components comes in contact with the patient's gum (please reference the diagram below), and are composed of Methyl Methacrylate, Thermoplastic Polyurethane and high grade Chromium-nickel steel.

Here's a breakdown of the requested information based on the provided text, focusing on the TrueFunction Adjustable Herbst Appliances:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance for the TrueFunction Adjustable Herbst Appliances is based on substantial equivalence to predicate devices, not on specific performance metrics with acceptance criteria like a diagnostic algorithm would have. Therefore, there's no table of numerical acceptance criteria or performance values provided for this type of device.

Instead, the acceptance criteria are met by demonstrating that the device has:

• Same intended use: "The reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA)" in adults, prescribed by a dentist, and customized by True Function Laboratory.
• Technological characteristics that do not raise new questions of safety and effectiveness: This is assessed by comparing design, function, and materials to previously cleared predicate devices.
• Compliance with relevant standards: ISO 7405 and ISO 10993 part 5 and part 10 for biocompatibility, as referenced in 21 CFR 872.5570.

Reported Device Performance:

The document states:

• "The TrueFunction® - Adjustable Herbst Appliances are essentially identical in indications for use to the predicate devices..."
• "Technological characteristics which do not raise new questions of safety and effectiveness."
• "The material composition... to comply with the Standard ISO 7405 and ISO 10993 part 5 and part 10..."
• "The material characteristic... meeting ASTM standards, have been found to be substantially equivalent to the predicate device material characteristics."
• "No new materials are used... all materials are already used in dental laboratories for previously cleared devices..."
• "No new concerns are introduced with the new TrueFunction® - Adjustable Herbst Appliances that are not present in the predicate devices."

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

Not applicable. This is a medical device clearance based on substantial equivalence, not a study involving a test set of data points as would be typical for an AI/algorithm-based device. No patient data (test set) was used for this clearance.

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

Not applicable. No ground truth for a test set was established as no clinical study was performed.

4. Adjudication Method for the Test Set

Not applicable. No test set was used.

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

No. This document does not mention any MRMC comparative effectiveness study or AI assistance. The device is a physical intraoral appliance, not an AI software.

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

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

7. The type of ground truth used

Not applicable. No clinical data or ground truth in the context of diagnostic performance was used for this 510(k) clearance. The "ground truth" for clearance is the established safety and effectiveness of the predicate devices and the demonstration that the new device is substantially equivalent to them.

8. The sample size for the training set

Not applicable. No training set was used.

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

Not applicable. No training set was used.

Summary of the K170578 Clearance for TrueFunction Adjustable Herbst Appliances:

This 510(k) clearance is for a physical medical device (intraoral appliance) and not for an AI diagnostic algorithm. Therefore, many of the questions related to clinical study design, test sets, training sets, ground truth, and expert adjudication are not applicable. The clearance is based on demonstrating substantial equivalence to already legally marketed predicate devices through a comparison of intended use, technological characteristics (design, function, materials), and compliance with relevant performance standards (biocompatibility). No new clinical data or human performance studies were required or submitted, leveraging the "least burdensome provisions" of the FDA Modernization Act of 1997.

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

The Dorsal Appliance is comprised of upper and lower customized acrylic splints for the treatment of mild to moderate sleep apnea. The upper splint comprises bilateral turnbuckle adjustment mechanisms. The device aims to improve the patient's air exchange thereby reducing snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible.

This document is a 510(k) premarket notification for the Dorsal Appliance, an intraoral device intended for the reduction of nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The submission argues for substantial equivalence to a predicate device, the Acrylic Herbst Appliance.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, there are no explicit "acceptance criteria" defined in terms of specific performance metrics or thresholds for the target device (Dorsal Appliance). Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Acrylic Herbst Appliance) through a comparison of technological characteristics, materials, and intended use. The performance "reported" is primarily a statement that the materials and fabrication processes are identical to the predicate device, implying similar performance.

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

• Sample size for the test set: Not applicable. The document explicitly states: "Clinical testing of the subject device was not used in support of clearance." This was a substantial equivalence submission based on non-clinical data (material properties, design comparison, risk analysis) relative to a predicate device.
• Data provenance: Not applicable, as there was no clinical test set. The data presented relates to material properties and comparative design analysis.

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

• Not applicable. There was no clinical test set requiring ground truth establishment by experts for performance evaluation.

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

• Not applicable. No clinical test set was used.

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

• Not applicable. This device is a mechanical intraoral appliance, not an AI-powered diagnostic or assistive technology.

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

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

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

• Not applicable for a clinical test set. The "ground truth" for the substantial equivalence argument relies on the established safety and effectiveness of the predicate device (Acrylic Herbst Appliance, K113126) and the materials used, as well as regulatory guidance for this device class.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning system that requires a "training set."

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

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

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

The Acrylic Herbst Appliance is comprised of custom-fabricated acrylic splints (methylmethacrylate) which are connected bilaterally via a telescoping Herbst mechanism (stainless steel).

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary and FDA clearance letter for the Acrylic Herbst Appliance, which establishes substantial equivalence to existing predicate devices.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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