(28 days)
The American Dental Technologies Dental Operative Units are intended to supply power to and serve as a base for dental devices and accessories.
The American Dental Technologies Dental Operative Units are standard electrical or pneumatically operated dental operative units that will be available in two product lines, the Gulliver and the Classe A, and several models. Both the Gulliver and Classe A Dental Operative Units consist of the following major components:
- Patient Treatment Chair .
- The Dentist's Instrument Board .
- Assistants Board .
- Cuspidor/Water system .
- Overhead Dental Light .
This 510(k) submission (K012213) for the American Dental Technologies Dental Operative Units (Gulliver and Classe A) is a pre-market notification for a Class I medical device. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel performance data from clinical or human studies. Therefore, much of the requested information about acceptance criteria and study details for a new device's performance may not be directly applicable or available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a submission for a Class I dental operative unit, the "acceptance criteria" are primarily related to safety, electrical standards, and functional equivalence to the predicate device, rather than diagnostic accuracy or direct clinical outcomes. The document does not specify quantitative "acceptance criteria" for features like sensitivity, specificity, accuracy, or other performance metrics commonly associated with AI/ML devices.
Instead, the acceptance criteria are implicitly defined by compliance with recognized standards and substantial equivalence to the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety & Electrical Standards Compliance | Complies with the requirements of EN 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and EN 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility). |
| Intended Use Equivalence | Intended to supply power to and serve as a base for dental devices and accessories (same as predicate). |
| Design & Operational Equivalence | Uses similar components, and are similar in design, characteristics, and mode of operation to the predicate device. Both systems include a chair, dentist's instrument board, cuspidor, assistant's board, dental light, and footswitches. |
| Substantial Equivalence to Predicate Device (Sirona C8) | Declared substantially equivalent to the Sirona Dental Systems C8 (K983242). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. This submission does not describe a test set or a clinical study involving patients or data to evaluate performance metrics in the way AI/ML devices do. Performance is demonstrated through compliance with standards and design similarity.
- Data Provenance: Not applicable. No specific data is presented.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. As no test set for clinical performance evaluation is described, there's no mention of experts establishing ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. There is no test set described for performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, a MRMC study was not done. This device is a dental operative unit, not an AI/ML diagnostic or assistive tool, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:
- No, a standalone algorithm performance study was not done. This is a physical dental unit, not an algorithm.
7. The Type of Ground Truth Used:
- Not applicable in the context of typical AI/ML device evaluations. The "ground truth" for this device's safety and functionality assessment is compliance with established electrical and medical device standards (EN 60601-1, EN 60601-1-2) and the functional specifications of the predicate device.
8. The Sample Size for the Training Set:
- Not applicable. There is no AI/ML algorithm involved, and therefore no training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. There is no AI/ML algorithm involved, and therefore no training set or ground truth for it.
Summary based on the document:
The provided 510(k) summary (K012213) for the American Dental Technologies Dental Operative Units is a regulatory submission for a traditional Class I medical device. Its acceptance criteria and supporting "study" primarily revolve around demonstrating:
- Compliance with recognized electrical and safety standards: EN 60601-1 and EN 60601-1-2. This is the primary "performance testing" described.
- Substantial equivalence to a legally marketed predicate device (Sirona C8): This equivalence is established by comparing intended use, design, components, characteristics, and mode of operation.
The document does not contain information related to AI/ML performance metrics such as sensitivity, specificity, clinical study design, expert ground truth, or training/test sets, as these are not relevant for this type of device and submission.
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510(k) Summary for American Dental Technologies Dental Operative Units
1. SPONSOR
American Dental Technologies 5555 Bear Lane Corpus Christi, Texas 78405
Contact Person: John Vickers Telephone: 361-289-1145
Date Prepared: July 3, 2001
2. DEVICE NAME
Proprietary Name: Gulliver and Classe A Dental Operative Unit Common/Usual Name: Dental Operative Unit Classification Name: Dental Operative Unit with Accessories
3. PREDICATE DEVICES
Sirona Dental Systems Sirona C8 (K983242).
4. DEVICE DESCRIPTION
The American Dental Technologies Dental Operative Units are standard electrical or pneumatically operated dental operative units that will be available in two product lines, the Gulliver and the Classe A, and several models. Both the Gulliver and Classe A Dental Operative Units consist of the following major components:
- Patient Treatment Chair .
- The Dentist's Instrument Board .
- Assistants Board .
- Cuspidor/Water system .
- Overhead Dental Light .
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5. INTENDED USE
The Gulliver and Classe A Dental Operative Units are intended to supply power to and serve as a base for dental devices and accessories.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The American Dental Technologies Gulliver and Classe A Dental Operative Units and Accessories are substantially equivalent to the Sirona Dental Systems C8. The American Dental Technologies Gulliver and Classe A Dental Operative Units and the Sirona C8 have the same intended use.
The proposed and predicate devices use similar components, and are similar in design, characteristics, and mode of operation. Both systems include a chair, dentist's instrument board, cuspidor, assistant's board, dental light, and footswitches for control of the various functions.
PERFORMANCE TESTING 7.
The American Dental Technologies Dental Operative Units comply with the requirements of EN 60601-1 and 60601-1-2.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
AUG 1 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Donald J. Sherratt Medical Stream Director American Dental Technologies, Incorporated C/O Intertek Testing Services 70 Codman Hill Road 01779 Boxborough, Massachusetts
Re: K012213 Trade/Device Name: Gulliver and Classe A 872.6640 Requlation Number: Requlatory Class: I Product Code: EIA Dated: August 3, 2001 Received: August 7, 2001
Dear Mr. Sherratt:
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 legally marketed predicate abe beach in closes ate 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 of the Act. The general controls provisions 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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.
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Page 2 - Mr. Sherratt
concerning your device in the Eederal Register. Please note: concerning your device remarket notification submission does this response to your promobile have under sections 531 not arrect any obligation for devices under the Electronic through 542 of the Act for acvisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as mis receer will and of the premarket notification. The FDA described in your sistin promise of your device to a legally marketed predicate device results in a classification for your marketed predicate acvice results to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpoories and additionally 809.10 for in regulation (ar erk rires), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compliance at (501) 332 / 332 / 324 device, please contact che promocion and adversions (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). J Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers obtained from the Bivibion on binance at its toll-free number Incernational and combames - 6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Cim S f/on
Timothy A. Ulatowski 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): K 012213
Device Name: American Technologies Gulliver and Classe A Dental Operative Units
Indications For Use:
The American Dental Technologies Dental Operative Units are intended to supply power to and serve as a base for dental devices and accessories.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runno
(Division Sign-Off) Division of Ophthalmic De 510(k) Number
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR
Over-The-Counter Use __
(Optional Format 1-2-96)
American Dental Technologies 510(k) Gulliver and Classe A Dental Operative Units July 3, 2001
CONFIDENTIAL Page vi
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.