(87 days)
Low speed dental attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. Furthermore, the intended use extends to disking, cavity and crown preps, polishing, post and pin drilling and pin setting. The intended use is identical to that of the predicate low speed motor attachments.
Dental attachments and accessories to be used by the dental clinician during routine dental procedures. The attachments affix to a low speed dental motor.
This exemption is for a low-speed dental motor attachment, a mechanical device. The provided text doesn't describe a study with acceptance criteria and performance metrics in the way one would for an AI/ML medical device. The 510(k) submission primarily focuses on demonstrating "substantial equivalence" to existing predicate devices, particularly highlighting a design change from lubricated to non-lubricated bearings and bushings.
Therefore, many of the requested fields are not applicable to this type of device and submission.
Here's an attempt to address the prompt based on the available information, noting where information is not present:
Description of Acceptance Criteria and Study for K983574
The device under review, StarDental® LUBE FREE LOW SPEED MOTOR ATTACHMENTS, is a mechanical dental device. The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with quantitative acceptance criteria against a defined ground truth for medical diagnostic accuracy. The core "acceptance criteria" appear to be related to functional equivalence and safety, particularly concerning the change to "non-lubricated bearings and bushings."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from Submission) | Reported Device Performance (Inferred from Submission) |
|---|---|---|
| Functional Equivalence | Operation identical to predicate devices. | "Means of operation are identical, compressed air powers a variable speed rotary vane motor to provide power to the attachments through a geared drive train for various dental procedures." |
| Intended Use Equivalence | Intended use identical to predicate devices. | "The intended use is identical to that of the predicate low speed motor attachments," which includes "drilling and preparation of dental cavities for restoration, such as fillings... disking, cavity and crown preps, polishing, post and pin drilling and pin setting." |
| Material Equivalence | Materials similar to predicate devices. | "Materials used to manufacture the components are similar." |
| Safety (Non-Lubrication) | Redesign to non-lubricated doesn't compromise function or safety. | "The differentiation between the predicate devices and the submitted is the redesign of standard lubricated bearings to non-lubricated bearings and bushings." (Implied acceptance based on FDA clearance, but specific performance data on "lubefree" aspect is not provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the furnished 510(k) summary. Given the nature of the device (mechanical dental attachment), the "test set" would likely refer to engineering evaluations or bench testing, not a clinical data set in the way AI/ML devices are validated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided and is generally not applicable to the substantial equivalence pathway for a mechanical device like this. Ground truth for diagnostic performance, as applies to AI/ML devices, is not a concept used in this submission.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable to this type of medical device submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI/ML) where human reader performance is a key metric, which is not the case for a low-speed dental motor attachment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not applicable. The device is a mechanical instrument; there is no "algorithm" or standalone "AI" component to evaluate.
7. The Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as understood for diagnostic AI/ML devices is not applicable here. The "truth" for this device revolves around its functional performance, material compatibility, and intended use matching those of legally marketed predicate devices, which would have been assessed through engineering specifications and potentially bench testing rather than clinical ground truth labels.
8. The Sample Size for the Training Set
This information is not applicable as there is no "training set" for a mechanical device like this in the context of an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" or associated ground truth for a mechanical device.
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K98 3574
510(k) SUMMARY StarDental® LUBE FREE LOW SPEED MOTOR ATTACHMENTS
Company:
StarDental® . Division of DentalEZ® Owner/operator number 2520265
Contact Person:
William Guscott Product Development Engineer StarDental®, Division of DentalEZ® 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161 Fax: (717) 291-9742
Device Trade Name:
StarDental® TITAN® Series Motor Attachments
Common or Usual Name:
Low Speed Motor Attachments
Predicate Devices:
Star, Midwest, KAVO, W&H, NSK and Champion Dental low speed motor attachments.
Description/Intended Use:
Dental attachments and accessories to be used by the dental clinician during routine dental procedures. The attachments affix to a low speed dental motor.
Substantial Equivalence:
The Low Speed Attachments as submitted are substantially equivalent to other attachments currently being marketed by Star, Midwest, KAVO, W&H, NSK and Champion Dental. Materials used to manufacture the components are similar. Means of operation are identical, compressed air powers a variable speed rotary vane motor to provide power to the attachments through a geared drive train for various dental procedures. The differentiation between the predicate devices and the submitted is the redesign of standard lubricated bearings to non-lubricated bearings and bushings.
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Image /page/1/Picture/2 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 or other bird-like figure. The image is black and white.
JAN 8 1999
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William Guscott Product Development Engineer StarDental®, Division of DentalEZ® 1816 Colonial Village Lane Lancaster, Pennsylvania 17601
Re : K983574 StarDental® TITAN® 3 Lubefree Motor Trade Name: Attachments Regulatory Class: I Product Code: EGS Dated: September 29, 1998 Received: October 13, 1998
Dear Mr. Guscott:
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 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 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlation may result in requlatory 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 - Mr. Guscott
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) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamafin.html" .
Sincerely yours,
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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Statement of Intended Use
Low speed dental attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. Furthermore, the intended use extends to disking, cavity and crown preps, polishing, post and pin drilling and pin setting. The intended use is identical to that of the predicate low speed motor attachments.
Suan Reaser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 108 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.