EXTENDED STRAIGHT ATTACHMENT by TEAM TECHNOLOGIES, INC.

Medical devices in Class I, by definition, present the lowest risk to the patient. They are subject to general controls, which primarily focus on ensuring good manufacturing practices, proper labeling, and reporting adverse events. For Class I devices, the FDA typically does not require extensive clinical studies or rigorous performance testing with specific acceptance criteria that demonstrate diagnostic accuracy or treatment efficacy. Instead, the clearance often hinges on demonstrating substantial equivalence to a predicate device already on the market.

Therefore, the detailed information requested regarding acceptance criteria and a study proving the device meets them (such as sample size, ground truth, expert opinions, MRMC studies, standalone performance) is generally not applicable or available for a Class I device 510(k) submission, especially one from 1999. The submission would have focused on engineering specifications, material safety, and comparison to a legally marketed predicate device rather than clinical performance metrics in the way a Class II or Class III device would.

Based on the provided document, here's what can be inferred:

Device Name: Extended Straight Attachment Disposable (Trade Name: Prophy Angle)
Intended Use: To be used during a prophylaxis treatment to polish the tooth surfaces of a patient.
Regulatory Class: I
Product Code: EGS

Addressing Your Specific Points (with the caveat that this information is not typically part of a Class I 510(k) from 1999):

A table of acceptance criteria and the reported device performance:
- Not applicable / Not provided. For a Class I device like a disposable prophy angle, "performance" is generally based on mechanical function, material compatibility, and intended use claims (e.g., "polishes tooth surfaces"). There wouldn't be quantitative diagnostic or treatment efficacy metrics like sensitivity, specificity, or AUC as seen in higher-risk devices. The "performance" demonstrated would be that it can attach to a dental handpiece and spin a prophy cup.
Sample size used for the test set and the data provenance:
- Not applicable / Not provided. There is no mention of a "test set" in the context of clinical or diagnostic performance studies. The "testing" would likely involve engineering verification (e.g., stress testing, material compatibility, dimensional accuracy), not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth, in the sense of expert consensus on a diagnostic outcome, is not relevant for a simple Class I mechanical device.
Adjudication method:
- Not applicable / Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done:
- Not applicable / Not provided. MRMC studies are used for diagnostic imaging devices or devices where human interpretation is critical, which is not the case for a prophy angle.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. This device is a mechanical tool, not an algorithm.
The type of ground truth used:
- Not applicable / Not provided.
The sample size for the training set:
- Not applicable / Not provided. This device does not involve machine learning or AI that would require a "training set."
How the ground truth for the training set was established:
- Not applicable / Not provided.

Summary Regarding Acceptance Criteria and Study:

For this specific 510(k) for a Class I disposable prophy angle, the "acceptance criteria" were primarily demonstrating substantial equivalence to a predicate device. This would typically involve:

Indications for Use: Matching or being substantially similar to a predicate device. (Confirmed by the "Statement of Indications for Use" in the document).
Technological Characteristics: Similar materials, design, and operating principles to a predicate device. (This information would be in the full 510(k) submission, not the clearance letter).
Performance Data: Often limited to bench testing (e.g., mechanical strength, material biocompatibility if applicable, verification of function) to ensure it performs as intended and is safe, without requiring clinical outcomes studies.

The "study" proving the device meets criteria would be the comparison to the predicate device and internal engineering testing results submitted to the FDA, rather than a clinical trial with predefined statistical endpoints. The clearance letter explicitly states: "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... to devices marketed in interstate commerce prior to May 28, 1976." This "substantial equivalence" is the primary "proof" required for Class I devices.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines representing movement or progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 2000 FEB

Mr. Bob Walton Team Technologies, Incorporated 5949 Commerce Boulevard Morristown, Tennessee 37814

Re: K994024 Extended Straight Attachment Disposable Trade Name: Prophy Anqle Requlatory Class: I Product Code: EGS Dated: November 23, 1999 Received: November 26, 1999

Dear Mr. Walton:

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 reqistration, 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. ਸਿ substantially equivalent determination assumes compliance with the Good Manufacturinq Practice for Medical Devices: General (GMP) regulation (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 requlatory 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

{1}------------------------------------------------

Page 2 - Mr. Walton

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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Statement of Indications for Use

The Extended Length Disposable Prophy Angle is to be used during a prophylaxis treatment to polish the tooth surfaces of a patient.

Susan Rann

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices વિદ્યારા કુલ તિ 510(x) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.