Search Results

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.

Ask a specific question about this device

The O'Brien MPA is intended to reduce snoring and to treat mild to moderate obstructive sleep apnea. This individually fabricated, non-sterile prescription device is a single patient, multi-use product for use at home or in a sleep laboratory.

The O'Brien MPA is made of thermal plastic material (ADA approved materials). It is a very simple device that fits snugly over the upper and lower anterior teeth in such a way as to keep the mandible in a stationary, anterior protrusive position. The reason for this is to physically open the airway and thus potentially reduce the occurrence of snoring and sleep apnea. (This theory of airway management is common, standard operating procedures in the emergency medical field for airway management purposes.) The device also includes air channels to allow breathing through the mouth.

The provided 510(k) summary for the O'Brien MPA (Mandibular Positioning Appliance, K060744) does not contain information regarding acceptance criteria, a study proving the device meets acceptance criteria, or any details about a clinical study's methodology.

This 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices (SUAD - K023836, TAP - K962516, OASYS - Oral Airway System - K030440) based on similar design principles, materials, and intended use. The document describes the device, its intended use (reducing snoring and treating mild to moderate obstructive sleep apnea), and the regulatory classification.

Therefore, I cannot populate the table or answer the subsequent questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth. These types of details are typically found in a clinical study report, which is not part of this 510(k) summary.

Summary of what is NOT in the provided document:

• Acceptance Criteria for Device Performance: The document does not define specific metrics (e.g., percentage reduction in AHI, success rate for snoring reduction) that the O'Brien MPA must achieve.
• Study Proving Acceptance Criteria: No study is described that was designed to demonstrate the device meets any performance criteria.
• Device Performance Data: There are no reported numerical results or performance statistics for the O'Brien MPA regarding its effectiveness in reducing snoring or treating sleep apnea.
• Sample Size for Test Set: Not applicable as no clinical study is detailed.
• Data Provenance: Not applicable.
• Number of Experts for Ground Truth: Not applicable.
• Qualifications of Experts: Not applicable.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No such study is mentioned.
• Standalone Performance Study: No details of any performance study are provided.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• Ground Truth for Training Set: Not applicable.

The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials for every submission, particularly if the technology is well-understood and the risks are manageable. In this case, the FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This indicates that the approval was based on equivalence, not necessarily on a new clinical study demonstrating specific performance against predefined acceptance criteria for the O'Brien MPA itself.

Ask a specific question about this device

To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).

The TAP II Anti-Snoring device is comprised of:

• & Lower tray fitted over the lower teeth.
• Upper tray fitted over the upper teeth.
• Impression material
• Hook and Base mechanism to attach lower tray to upper tray.

The provided text does not contain detailed information about specific acceptance criteria for device performance, nor does it describe a study that explicitly proves the device meets such criteria using metrics like sensitivity, specificity, or accuracy. The document is a 510(k) premarket notification summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance thresholds in a clinical study.

Therefore, many of the requested details related to acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not present in the provided text.

However, based on the available information, here's what can be inferred or directly stated:

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

This information is not provided in the document. The document's purpose is to establish substantial equivalence to predicate devices, not to report on specific performance metrics against defined acceptance criteria.

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

This information is not provided in the document. The text does not describe a clinical study with a test set.

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

This information is not provided in the document.

4. Adjudication method for the test set:

This information is not provided in the document.

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

This information is not provided in the document. The device, TAP II, is an oral appliance (anti-snoring device), not an AI-assisted diagnostic tool for which an MRMC study would typically be conducted.

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

This information is not applicable/not provided in the context of an oral appliance. The TAP II is a physical medical device, not an algorithm.

7. The type of ground truth used:

This information is not provided in the document as no specific clinical study with ground truth establishment is detailed. The basis for substantial equivalence is comparison to legally marketed predicate devices.

8. The sample size for the training set:

This information is not provided in the document. The text does not detail the development of an algorithm that would typically involve a training set.

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

This information is not provided in the document.

Summary based on the provided text:

The provided documents, a Non-Confidential Summary of Safety and Effectiveness and an FDA clearance letter for the TAP II oral appliance, primarily focus on demonstrating substantial equivalence to predicate devices. This process does not typically involve the detailed performance studies, acceptance criteria, test sets, or expert ground truth adjudication that would be requested in the prompt. The clearance is based on the device having the same intended use, similar technological characteristics, and being as safe and effective as devices already on the market (listed as Nellcor Puritan Bennett - TAP-K962516, Thornton Oral Appliance - TOA-K972061, OASYS Oral Airway System - K030440).

Ask a specific question about this device