Polymerization of light-cured dental materials, Polymerization of restorative composite materials, and, Polymerization of bonding and sealing materials.

Device Description

The ACTA OEM Module is a sub-assembly of the ACTA Polymerization Light Curing Device which received 510(k) clearance for the polymerization of light-cured dental materials, the polymerization of restorative composite materials, and the polymerization of bonding and sealing materials (K961735) on July 31, 1996. The ACTA OEM Module maintains all the same functions and main components of the ACTA: it is a stand-alone sub-assembly manufactured by SATELEC with all the same components and materials used in the manufacture of the original ACTA product, which can be used in standard dental units. The intended use, technical performance, and clinical indications are identical to those of its predicate device, the ACTA (K961735).

The ACTA OEM Module is a multi-purpose high intensity curing light generator kit to be marketed as a modular sub-assembly ("Original Equipment Manufacturer" - OEM) The ACTA OEM Module, similar to its predicate to manufacturers of dental units. device ACTA (K961735) operates by producing a visible blue light in the 400 to 520 nm waveband of the spectrum which enables the polymerization of composite materials.

The ACTA OEM Module light will cure all dental restoratives activated by light in that wavelength range. The radiation from the halogen bulb (44 watt) is selectively reflected, focused, and filtered to reduce the ultraviolet, infrared radiation and unneeded visible light. Thus, only the radiation in the appropriate band is available to be absorbed by the light cured composite material. The radiation necessary for this process is in the wavelength range of 400 to 520 nanometers. A built-in filter system blocks the nonessential emitted radiation outside this blue radiation wavelength range.

An ergonomic handpiece is supplied with ACTA OEM Module Kit and is designed for ease of use, comfort and convenience. The handpiece casing is made of thermoplastic allov. The handpiece houses the low voltage halogen lamp, and a lamp cooling fan. The kit also includes a disconnectable silicone cord, and a box which consists of one (1) deflector of a 0.3 in, one (1) optic fiber of ø 0.3 in , four (4) protection caps. one (1) 44 W bulb, and one (1) instruction booklet. The Kit includes a connection diagram and PC board as well.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the ACTA OEM Module, a polymerization light-curing device. The document primarily focuses on establishing substantial equivalence to a predicate device (ACTA, K961735) rather than conducting a separate study to prove the device meets specific acceptance criteria based on direct performance measurements.

Therefore, for many of the requested categories, the information is not directly available in this 510(k) summary.

Here's an breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or a performance table. The core argument for acceptance is substantial equivalence to a predicate device.

Acceptance Criteria	Reported Device Performance
Primary Criterion: Substantial Equivalence to Predicate Device (ACTA K961735)
Same intended use	"The intended use...are identical to those of its predicate device, the ACTA (K961735)."
Same technical performance	"The technical characteristics of the ACTA are almost identical to those of the predicate, ACTA." "Differences that exist between these devices relating to technical specifications, materials, physical appearance, and control systems are minor and do not affect the relative safety or effectiveness of the ACTA OEM Module relative to its predicate."
Same clinical indications	"The intended use, technical performance, and clinical indications are identical to those of its predicate device, the ACTA (K961735)."
Production of visible blue light in 400-520 nm waveband for polymerization	"operates by producing a visible blue light in the 400 to 520 nm waveband of the spectrum which enables the polymerization of composite materials."
Curing of all dental restoratives activated by light in that wavelength range	"The ACTA OEM Module light will cure all dental restoratives activated by light in that wavelength range."
Built-in filter system to block non-essential emitted radiation outside 400-520 nm	"A built-in filter system blocks the nonessential emitted radiation outside this blue radiation wavelength range."

2. Sample sized used for the test set and the data provenance

Not applicable. There was no specific "test set" of patient data or clinical samples used to evaluate the ACTA OEM Module's performance against predefined acceptance criteria. The evaluation was based on a comparison to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No expert review of a "test set" to establish ground truth was conducted for this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No test set adjudication method was used.

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

Not applicable. This device is a light-curing device, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical instrument, not an algorithm. Its "standalone" performance is inherent in its operation as a light-curing device, which is considered equivalent to the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No direct "ground truth" was established for the ACTA OEM Module's performance in a study. The "truth" for its safety and effectiveness is inferred from its substantial equivalence to the previously cleared predicate device.

8. The sample size for the training set

Not applicable. As a medical device that cures dental materials, there is no "training set" in the context of an algorithm or AI model for this product.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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K972006

JUL 1 0 1997

SMDA Summary of Safety and Effectiveness - "510(k) Summary" 9.

A. Submittor Information

SATELEC Z.1. due Phare, BP 215 Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE

Telephone: 011-33-5-56-34-06-07

Contact Person:

Pascal Dupevron Regulatory Affairs

Date Prepared:

May 28, 1997

B. Device Identification
Common/Usual Name Proprietary Name:

Polymerization Light-Curing Device ACTA OEM Module

C. Identification of Predicate Device(s)

The ACTA OEM Module is substantially equivalent to its predicate, device, ACTA (K961735) previously cleared and currently marketed.

D. Device Description

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visible light. Thus, only the radiation in the appropriate band is available to be absorbed by the light cured composite material. The radiation necessary for this process is in the wavelength range of 400 to 520 nanometers. A built-in filter system blocks the nonessential emitted radiation outside this blue radiation wavelength range.

E. Substantial Equivalence

The technical characteristics of the ACTA are almost identical to those of the predicate, ACTA. Differences that exist between these devices relating to technical specifications, materials, physical appearance, and control systems are minor and do not affect the relative safety or effectiveness of the ACTA OEM Module relative to its predicate.

The ACTA OEM Module is intended for the polymerization of light-cured dental materials, polymerization of restorative composite materials, and polymerization of bonding and sealing materials.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three stripes representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jacqueline E. Masse ·Sr. Consultant Interactive Consulting, Incorporated 70 Walnut Street Wellesley, Massachusetts 02181

JUL 1 0 1997

K972006 Re : Trade Name: ACTA OEM Module . Regulatory Class: II Product Code: EBZ May 28, 1997 Dated: Received: May 30, 1997

Dear Ms. Masse:

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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Druq 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 obligation you might have under sections 531

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Page 2 - Ms. Masse

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 leqally 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) 594-4618. 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 one regaration" (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.fida.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Tim v 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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Page 1 of 1

510(k) Number (if known): K972006

Device Name: ACTA OEM Module

Indications For Use:

· Polymerization of light-cured dental materials,
Polymerization of restorative composite materials, and, .
Polymerization of bonding and sealing materials. .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

(Division Sign-Off) Division of Dental, Infoction Contr and General Hospital I 510(k) Number

Prescription Use レ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.