Search Results

Temporary treatment of obstructive sleep apnea and snoring to determine in which patients mandibular advancement and opening the bite will increase the patients air space

The EMA-T appliance is a modified functional orthodontic appliance. The modifications are: 1) clasps are not needed as the appliance is retained firmly to the teeth by dental impression material into undercut areas. Each tray holds the teeth in their present location not allowing tooth movement. 2) the bite is opened with bite planes as in the Elastic Mandibular Advancement appliance. 3) the mandible is advanced with an elastic strap similar to the Elastic Mandibular Advancement appliance.
The appliance is designed for universal application in adults with the use of one-sizefits all maxillary and mandibular hard plastic trays. On the night of the titration polysomnogram, the sleep technician makes impressions of the maxillary and mandibular teeth by placing a fast setting dental silicone putty material (such as E and D Dental Products Incorporated) in the tray and pushing the tray onto the patient's teeth. The trays and putty with the patient's impression are removed from the mouth. Just before the start of the sleep study, the impression and the patient's teeth are dried off. A liguid silicone "wash" is placed onto the patient's impression and placed on the maxillary and mandibular teeth and arches for the duration of the study. This "wash" holds the trays firmly on the patient's teeth and prevents their dislodgment during sleep. On the anterior of the maxillary tray is a rod that protrudes at the midline in front of the patient's central incisors. A Styrene Block Copolymer strap with a pull tab and holes 3 millimeters apart is connected to the mandibular tray. Mandibular advancement is achieved by pulling the tab forward and inserting the rod into one of the holes on the pull tab. The mandible is thereby held in an advanced position by the stationary maxilla, and is advanced in 3 millimeter increments. As the sleep lab technician advances the mandible, the polysomnogram will show a decrease, or even an elimination, of the patient's apneas on those responding. A prescription will then be given to the patient for a permanent custom made oral appliance.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Elastic Mandibular Advancement Titration (EMA-T) appliance:

K973884 - Elastic Mandibular Advancement Titration (EMA-T) Appliance

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 12 obstructive sleep apnea (OSA) patients.
• Data Provenance: Prospective. The study involved performing "overnight sleep studies with the EMA-T device" on these patients. The study was conducted at The University of Texas Medical Branch at Galveston, USA.

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., years of experience as a radiologist) used to establish the ground truth. It implies that the "sleep lab technician" observes the polysomnogram (PSG) during the titration, and that a "prescription will then be given to the patient for a permanent custom made oral appliance" if they respond. This suggests clinical judgment based on PSG readings. The final determination of "favorable response" for the 5 patients who received permanent appliances would have been made by a physician, presumably a specialist in sleep medicine.

4. Adjudication Method for the Test Set:

The document does not mention a specific adjudication method like 2+1 or 3+1. The assessment appears to be based on the real-time observation of "decrease, or even an elimination, of the patient's apneas" during the polysomnogram as the mandible is advanced. For the 5 patients who received permanent appliances, the "favorable response" likely refers to post-implantation clinical outcomes, which would have been assessed individually by the treating physicians, rather than a structured adjudication panel.

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

No, an MRMC comparative effectiveness study was not done. The study focuses on the performance of the device in identifying responders, not on comparing human reader performance with and without AI assistance.

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

No, a standalone evaluation of an algorithm was not performed. The EMA-T appliance is a physical medical device, not an AI or algorithm-based diagnostic tool. The device itself is used by human technicians to titrate and observe patient response.

7. The Type of Ground Truth Used:

The ground truth for determining a favorable response appears to be a combination of:

• Physiological Response Data: Reduction or elimination of apneas observed on a polysomnogram (PSG) during titration with the EMA-T.
• Clinical Outcomes Data: For the 5 patients who received a permanent custom oral appliance, their "favorable response" implies positive clinical outcomes after receiving the permanent treatment, leveraging the information gained from the EMA-T titration.

8. The Sample Size for the Training Set:

This device is a physical medical appliance, not an AI or machine learning model. Therefore, there is no training set in the context of AI. The "clinical testing" mentioned served as the validation study for the device's intended use.

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

As there is no training set for an AI/ML model, this question is not applicable. The device's efficacy was demonstrated through the clinical study on 12 patients, where the ground truth was established by real-time PSG observations and subsequent clinical outcomes for those who received permanent appliances.

Ask a specific question about this device

Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where repositioning of the mandible can increase the patients air space.

The Elastic Mandibular Advancement appliance is a modified functional orthodontic appliance. The modifications are: 1) clasps are not needed as the appliance is retained firmly to the teeth by pressure formed plastic into the undercut areas. Each tray holds the teeth in their present location not allowing tooth movement. 2) the bite is opened as in the SNOAR and NAPA appliances but not in one fixed position. Multiple bite openings are possible because of removable bite blocks or bite planes of varying thicknesses. 3) the mandible is advanced as in both the SNOAR and NAPA appliances except not in a fixed position , but in various amounts of forward advancement because of removable, replaceable elastic bands or straps to pull the mandible forward.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Elastic Mandibular Advancement (EMA) appliance:

It's important to note that this 510(k) summary is from 1997. Regulatory requirements and the detail expected in clinical studies for medical devices have evolved significantly since then. The information provided is considerably less detailed than what would typically be required for a similar submission today.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "the device must reduce AHI by X%"). Instead, it presents the observed clinical outcome from a single study as evidence of effectiveness.

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

• Sample Size (Test Set): 13 obstructive sleep apnea (OSA) patients.
• Data Provenance:
  • Country of Origin: United States (Clinical testing was done at The University of Texas Medical Branch at Galveston).
  • Retrospective or Prospective: The description "Overnight sleep studies with and without the EMA device were performed on 13 obstructive sleep apnea (OSA) patients" suggests a prospective study design, likely a pre-post comparison within the same patients. However, the study design details are very minimal.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth (diagnosis of OSA and AHI calculation). Given that it involved "Overnight sleep studies," it's highly probable that a sleep physician or a sleep technician interpreted the polysomnography (PSG) data. However, this is an inference, not explicitly stated.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. It simply states that sleep studies were performed and AHI was measured.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses solely on the device's impact on physiological parameters (AHI) in patients, without involving human readers assessing diagnostic performance or the effect of AI assistance.

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

This device is not an AI algorithm but a physical medical appliance. Therefore, the concept of a "standalone (algorithm only)" study is not applicable. The study performed assessed the direct physiological effect of the physical device on patients.

7. Type of Ground Truth Used

The ground truth used was physiological outcome data (Apnea-Hypopnea Index - AHI) derived from overnight sleep studies (polysomnography). This is an objective measurement of sleep-disordered breathing severity.

8. Sample Size for the Training Set

The document does not mention a training set. Since the device is a physical appliance and not an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable here. The clinical study described is a performance evaluation of the final device.

9. How Ground Truth for the Training Set Was Established

As there was no training set for an AI algorithm (see point 8), this question is not applicable.

Ask a specific question about this device