(977 days)
AS ALL OTHER DENTAL HANDPIECES, WILL THIS DENTAL HANDPIECE, BE USED INTRA AND EXTRA ORALLY TO CENTAL DEVICES CRIND AND POLISH TEETH, OR ITEMS RELATED TO TEETH AND DENTAL DEVICES THAT MAY BE IN THE MOUTH OR TO BE PLACED IN THE MOUTH.
THE DENTAL HANDPIECE, PATENT NUMBER 5575647, WAS DESIGNED TO INTRA-ORALLY, ALIGNED WITH THE LONG AXIS OF EACH TOOTH. THIS EASE OF ALIGNMENT IN ALL AREAS OF THE MOUTH DECIDEDLY GIVES THE HANDPIECE A SAFETY MARGIN OVER ANY EXISTING HIGHSPEED HANDPIECE, UPON WHICH THE SUBSTANTIAL EQUIVALENCE IS BASED. ALL DENTAL HANDPIECES, SINCE THEIR INCEPTION IN THE LATE 1800'S, HAVE BEEN CONSRUCTED OF THE SAME MATERIALS: BRASS AND CHROME,OR STAINLESS, OR A COMBINATION OF BOTH. AALL DENTAL HANDPIECES HAVE BEEN BOTH DURABLE AND SAFE.
The provided text describes a 510(k) submission for a dental handpiece (K971732). However, it does not contain any information regarding acceptance criteria, study methodologies, performance metrics, sample sizes, expert qualifications, or ground truth establishment.
The document is a 510(k) summary/statement and the FDA's response letter indicating substantial equivalence to a predicate device. This type of regulatory submission typically focuses on demonstrating that a new device is as safe and effective as an already legally marketed device, often by highlighting similar design, materials, and intended use, rather than presenting detailed clinical study data with specific acceptance criteria and performance outcomes.
Therefore, I cannot populate the requested table or answer most of the questions based on the provided text.
Here's what I can extract, and why the other information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | The device is described as "durable and safe," similar to existing dental handpieces. The primary claim for substantial equivalence is based on "ease of alignment in all areas of the mouth," which is stated to give it a "safety margin over any existing highspeed handpiece." However, no specific performance metrics or quantitative acceptance criteria are provided. |
Missing Information: Quantitative acceptance criteria (e.g., specific thresholds for durability, ergonomic benefits, or any other performance aspect) are not mentioned. Corresponding quantitative performance results are also absent.
2. Sample size used for the test set and the data provenance
Missing Information: The document does not describe any specific test set, clinical study, or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: No information about expert involvement in establishing ground truth is provided, as no test set or study is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: No adjudication method is mentioned, as there is no description of a test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Missing Information: This device is a mechanical dental handpiece, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effectiveness are irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: This is not an algorithm or software device. No standalone performance data is relevant or provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing Information: No ground truth information is provided, as no specific study or clinical data is presented. The substantial equivalence relies on the comparison to predicate devices' known safety and efficacy, often inferred from long-standing market use (as implied by the statement "All dental handpieces, since their inception in the late 1800's, have been consructed of the same materials: brass and chrome, or stainless, or a combination of both. AALL dental handpieces have been both durable and safe.")
8. The sample size for the training set
Missing Information: No training set is mentioned or applicable to this device type and submission.
9. How the ground truth for the training set was established
Missing Information: No training set or ground truth for such a set is discussed.
Summary of Document Content:
The provided documents are a 510(k) "Substantial Equivalence" submission and the FDA's clearance letter for a dental handpiece (K971732). The basis for substantial equivalence is primarily:
- Similar materials: "Constructed of the same materials: brass and chrome, or stainless, or a combination of both" as other dental handpieces.
- Historical safety: "All dental handpieces... have been both durable and safe."
- Design feature leading to safety margin: The new handpiece's "ease of alignment in all areas of the mouth" is presented as a safety improvement over existing designs.
- Intended use: "To grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth," identical to other dental handpieces.
This type of submission often leverages known safety and performance of predicate devices without requiring new, specific clinical studies with detailed acceptance criteria or performance metrics for the new device.
{0}------------------------------------------------
JAN 1 1 2000
510(k) SUMMARY OR STATEMENT
THE DEVICE CONCERNED IS 510(k) NUMBER K971732, DENTAL HANDPIECE.
THE DENTAL HANDPIECE, PATENT NUMBER 5575647, WAS DESIGNED TO INTRA-ORALLY, ALIGNED WITH THE LONG AXIS OF EACH TOOTH. THIS EASE OF ALIGNMENT IN ALL AREAS OF THE MOUTH DECIDEDLY GIVES THE HANDPIECE A SAFETY MARGIN OVER ANY EXISTING HIGHSPEED HANDPIECE, UPON WHICH THE SUBSTANTIAL EQUIVALENCE IS BASED.
ALL DENTAL HANDPIECES, SINCE THEIR INCEPTION IN THE LATE 1800'S, HAVE BEEN CONSRUCTED OF THE SAME MATERIALS: BRASS AND CHROME,OR STAINLESS, OR A COMBINATION OF BOTH. AALL DENTAL HANDPIECES HAVE BEEN BOTH DURABLE AND SAFE.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JAN 1 1 2000
Dr. Kenneth Grubbs, D.D.S. 101 Davis Street Monroe, Georgia 30655
K971732 Re : Dental Handpiece Trade Name: Requlatory Class: I Product Code: EFB Dated: October 21, 1999 Received: October 25, 1999
Dear Dr. Grubbs:
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
{2}------------------------------------------------
Page 2 - Dr. Grubbs
obligation you might have under sections 531 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 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.fdaygov/cdrh/dsmamain.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
{3}------------------------------------------------
510(K) #971732
STATEMENT OF INDICATIONS FOR USE
THIS IS A STATEMENT OF INDICATIONS FOR USE, CONCERNING 510(K) NUMBER K971732, DENTAL HANDPIECE.
AS ALL OTHER DENTAL HANDPIECES, WILL THIS DENTAL HANDPIECE, BE USED INTRA AND EXTRA ORALLY TO CENTAL DEVICES CRIND AND POLISH
TEETH, OR ITEMS RELATED TO TEETH AND DENTAL DEVICES THAT MAY BE IN THE MOUTH OR TO BE PLACED IN THE MOUTH.
Susan Runyon
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital 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.