(137 days)
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.
| Acceptance Criteria (Implicit from study findings) | Reported Device Performance |
|---|---|
| Reduction in apnea-hypopnea index (AHI) for OSA patients | Mean AHI reduced from 60 events/hr (without appliance) to 21 events/hr (with EMA appliance) in patients with obstructive sleep apnea. This represents a 65% reduction in AHI. |
| Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring by increasing patient's air space | The study concludes: "Use of the EMA device significantly reduced episodes of obstructive sleep apnea." (No specific quantitative data for snoring or increased air space is provided, only AHI). |
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.
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Image /page/0/Picture/1 description: The image is a logo for "Design Frantz Incorporated". The logo is in a black and white color scheme. The word "FRANTZ" is in a bold, sans-serif font and is the most prominent element of the logo. The words "DESIGN" and "INCORPORATED" are above and below the word "FRANTZ", respectively, in a smaller font size.
SEP 2 9 1997
510(k) Summary
May 14, 1997 Date:
Donald Frantz, D.D.S. Frantz Design Incorporated 400 Medical Center. # 209 Webster. Texas 77598
Phone: (281) 338-6631 (281) 554-3033 Fax:
Device Name:
Trade/Proprietary Name: Elastic Mandibular Advancement (EMA) appliance Common Name: Sleep Apnea/Anti-snoring device Classification Name: Activator dental appliance
Substantial Equivalence Comparison:
The Elastic Mandibular Advancement (EMA) appliance is substantially equivalent to the NAPA [510(k) # K902790] and the SNOAR [510(k) # K880956] appliances.
Description:
The Elastic Mandibular Advancement appliance is a modified functional orthodontic The modifications are: 1) clasps are not needed as the appliance is appliance. 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.
Intended Use:
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.
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Technological characteristics:
The NAPA. SNOAR and EMA appliances advance the mandible to an anterior and inferior position with regard to the maxilla. This repositioning of the mandible pulls the tongue forward and increases the patient's airspace, thereby decreasing upper airway obstruction. Such obstruction can be a causative factor in snoring and obstructive sleep apnea. All three devices are prescribed for patients after diagnosis of obstructive sleep apnea by a physician. None of the appliances are indicated for the treatment of central sleep apnea.
The NAPA, SNOAR and EMA appliances are similar in that they all are individually customized mouthpieces that fit uniquely into patients mouths. None of the appliances allow for movement of the teeth. While the NAPA and SNOAR appliances maintain dental integrity with the use of wire the EMA appliance extends the appliance material into the undercut areas of the teeth, therefore maintaining integrity.
The NAPA, SNOAR and EMA appliances all allow for nasal and/or oral breathing. The NAPA and SNOAR appliances advance the mandible and hold it in place rigidly. The EMA appliance advances the mandible but allows for opening of the mouth therefore eliminating the need for a "breathing beak" as the NAPA appliance has.
Clinical Data:
Clinical testing was done at The University of Texas Medical Branch at Galveston. Overnight sleep studies with and without the EMA device were performed on 13 obstructive sleep apnea (OSA) patients with a mean apnea-hypopnea index of 60 events/hr. without the appliance. The EMA appliance advanced the mandible by an average 9 mm. EMA reduced the mean apnea-hypopnea index to 21 events/hr.
Clinical tests conclusions:
Use of the EMA device significantly reduced episodes of obstructive sleep apnea.
Sincerely,
Donald Frantz A.O.S.
Donald Frantz, D.D.S. 400 Medical Center, #209 Webster. Texas 77598 Phone (281) 338-6631 Fax (281) 554-3033
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP 2 9 1997
Donald Frantz, D.D.S. Frantz Design Incorporated 400 Medical Center, #209 Webster, Texas 77598
Re : K971794 Elastic Mandibular Advancement (EMA) Trade Name: Appliance Regulatory Class: Unclassified Product Code: LRK July 17, 1997 Dated: Received: July 21, 1997
Dear Dr. Frantz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Dr. Frantz
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timot A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Advancement (EMA) appliance Device Name: Elastic Mandibular
Indications For Use:
Indications for use: Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where advancement of the mandible and opening the bite can increase the patients air space.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, Division of Dental, Infection
and General Hospital Device 510(k) Number
Prescription Use r 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”