(25 days)
To be used by Dental Professionals for dental cleaning and periodontal (gum) therapy to remove calculus from the teeth.
The Hu-Friedy® brand Satin Swivel™ ultrasonic insert is similar to the predicate device with the addition of a swivel mechanism allowing for ease of rotational movement during dental cleaning procedures. This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth. The Satin Swivel™ ultrasonic insert has essentially the same internal design as the predicate device except for the addition of several stainless steel and resin components. The steel components enable the insert tip to swivel. The two different resin components allow for a positive grip for the dental professional and a smooth cone to tip transition for ease of use.
The provided 510(k) summary for the Hu-Friedy® brand Satin Swivel™ ultrasonic insert describes its equivalence to a predicate device and includes information about performance evaluation. However, it does not contain detailed statistical acceptance criteria or a comprehensive study report in the format typically required for medical device AI/ML performance evaluation. This document is for a mechanical device, not an AI/ML device, so many of the requested categories (like number of experts, adjudication, MRMC, training sets) are not applicable.
Based on the provided text, here's a summary of the acceptance criteria and study as described, with an acknowledgment of the limitations due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as inferred) | Reported Device Performance / Conclusion |
|---|---|---|
| Laboratory Tests | Safe and effective performance in: | The device performed similarly or better than the predicate device. |
| Cleaning | Sufficiently cleanable (implies meeting hygiene standards) | Met clinical requirements. |
| Sterilization | Capable of being sterilized (implies meeting sterilization efficacy standards) | Met clinical requirements. |
| Mechanical Life Testing | Durable and functional over its expected lifespan (implies meeting durability standards) | Met clinical requirements. |
| Field Evaluation | Clinician satisfaction and effective performance in: | The overall conclusion was that both the Satin Swivel™ and the predicate device met their clinical requirements. Clinicians had complete control of the Satin Swivel™ ultrasonic insert, and it did not turn on its own while in use. |
| Scaling Effectiveness | Effective removal of calculus from teeth | Met clinical requirements. |
| Vibration | Acceptable levels of vibration during use | Met clinical requirements. |
| Water Delivery | Adequate and consistent water delivery for cooling and lavage | Met clinical requirements. |
| Swivel Function | Smooth and controlled rotational movement for ease of use without unintended turning | Met clinical requirements. Clinicians had complete control, and it did not turn on its own. |
| Grip | Secure and comfortable grip for the dental professional | Met clinical requirements. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a numerical sample size. For the "field study," it mentions "clinicians were asked to evaluate the inserts." The number of clinicians or the number of cases/patients observed is not provided.
- Data Provenance: The study was a "field evaluation," implying prospective data collection during actual clinical use by dental professionals. The country of origin is not specified, but the applicant is based in Chicago, IL, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not explicitly stated. The study involved "clinicians" evaluating the device. It implies multiple clinicians, but the exact number is not given.
- Qualifications of Experts: They are referred to as "dental professionals" and "clinicians," indicating they are qualified to use and evaluate dental instruments. No specific years of experience or board certifications are mentioned.
4. Adjudication method for the test set
- Adjudication Method: Not described. The text states that "clinicians were asked to evaluate the inserts." It appears to be a direct assessment by the clinicians without a formal adjudication process described for conflicting opinions. The "overall conclusion of this evaluation" suggests a consensus or summary of their findings, but no specific method like 2+1 or 3+1 is mentioned.
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
- MRMC Study: No, an MRMC study was not conducted. This is not an AI/ML device, but a mechanical dental instrument. The comparison was between the new mechanical device and a predicate mechanical device, evaluated by clinicians.
- Effect Size of AI: This is not applicable as the device does not involve AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a mechanical device, not an algorithm. The "laboratory tests" can be considered a form of standalone testing for the mechanical properties of the device itself (cleaning, sterilization, mechanical life).
7. The type of ground truth used
- Ground Truth Type: For the field evaluation, the "ground truth" was established through expert opinion/assessment by dental professionals on the device's performance in real-world clinical use. For the laboratory tests, the ground truth would be based on established engineering and regulatory testing standards for cleaning, sterilization, and mechanical durability.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. As a mechanical device, it does not use machine learning, and therefore does not have a "training set" in the context of an AI/ML device.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable. No training set as it's not an AI/ML device.
{0}------------------------------------------------
JUL 27 2001
510(k) SUMMARY
Submitter
Keith Dunn Hu-Friedy Mfg. Co., Inc. 3232 N. Rockwell St. Chicago, IL 60618 Tel. 773-975-6100 Fax 773-868-3558
6/29/01 Date Prepared
Device Name
| Trade name | Satin Swivel™ Ultrasonic Insert |
|---|---|
| Common name | Ultrasonic Insert |
| Classification name | Ultrasonic Scaler |
Legally marketed Device to which equivalence is claimed
Hu-Friedy Ultrasonic Scaler Insert K953919
Description of the device
The Hu-Friedy® brand Satin Swivel™ ultrasonic insert is similar to the predicate device with the addition of a swivel mechanism allowing for ease of rotational movement during dental cleaning procedures.
This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth.
The Satin Swivel™ ultrasonic insert has essentially the same internal design as the predicate device except for the addition of several stainless steel and resin components. The steel components enable the insert tip to swivel. The two different resin components allow for a positive grip for the dental professional and a smooth cone to tip transition for ease of use.
{1}------------------------------------------------
To determine if the Satin Swivel™ ultrasonic insert performed similar to or better than the predicate device both laboratory and a field evaluation were undertaken. The laboratory tests included cleaning, sterilization, and mechanical life testing. For the field study clinicians were asked to evaluate the inserts as related to scaling effectiveness, vibration, water delivery, swivel function, and grip. The overall conclusion of this evaluation was that both the Satin Swivel™ and the predicate device met their clinical requirements. The clinicians had complete control of the Satin Swivel™ ultrasonic insert and it did not turn on its own while in use.
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 7 2001
Mr. Keith Dunn Manager of Regulatory Affairs Manager of Regulacor), Incorporation 3232 North Rockwell Street Chicago, Illinois 60618
K012060 Re : Hu-Friedy Brand Satin Swivel Trade/Device Name: Ultrasonic Insert Regulation Number: 872.4850 Regulatory Class: II Product Code: ELC Dated: June 29, 2001 July 2, 2001 Received:
Dear Mr. Dunn:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beceren above and we have determined the market the device fererenous above indications for device is subblancially ore) to legally marketed predicate use stated in the chorobase, commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to che enactment date or choclassified in accordance with the devices that have been al Food, Drug, and Cosmetic Act (Act).
provisions of the Federal Food, Drug, and Cosmetic the general provisions of the reactur rood, bray, asubject to the general The general controls controls provisions of the Act. controls provisions of include requirements for annual provisions of the not insteasines, 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 (Special Concrols) additional controls. Existing major be subject to bacting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal hegaturents. Ifree termination assumes compliance with subscancially equivalence aring Practice requirements, as set the Current Sood handsustem Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, beview. Scholar QS inspections, the Food and Drug chrough periodic go inbecurity such assumptions. Failure to Administration (121) Egulation may result in regulatory In addition, FDA may publish further announcements action.
{3}------------------------------------------------
Page 2 - Mr. Dunn
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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 regulation (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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
A. Ulatowski Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page__________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number (if known): K012060
Device Name: Hu-Friedy Brand Satin Swivel Ultrasonic Insert
Indications For Use:
To be used by Dental Professionals for dental cleaning and periodontal (gum) therapy to remove calculus from the teeth.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runser
Division Sign-Off) ison of Dental, Infection Control, Caneral Hospital Devices Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.