MINI L.E.D. OEM MODULE by SATELEC

The Satelec Mini L.E.D. OEM Module is classified as an Ultraviolet Activator for Polymerization (21 C.F.R.§ 872.6070) because it is a device intended for the photopolymerization of light cured dental materials, restorative composite materials, and orthodontic bonding and sealing materials. The Mini L.E.D. OEM Module is a universal photo-polymerization light curing source and producing visible blue light in the 430 to 480 nm waveband of the spectrum with a power density comprised between 1,000 400 mm Waveband of the Spottain Mar 2,000 W/cm2 (BoosterTip 5,5 mm lightguide).

AI/ML Overview

This document describes a 510(k) premarket notification for the "Mini L.E.D. OEM Module," a polymerization light-curing device. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new performance studies against specific acceptance criteria in the way a PMA (Premarket Approval) might.

Therefore, the information you're requesting regarding explicit acceptance criteria and a study proving those criteria are met, particularly with details like sample sizes, expert qualifications, and ground truth methodologies, is generally not found within a 510(k) summary for a device like this.

The "study" in this context is the comparison demonstrating substantial equivalence. The device's performance is reported relative to the predicate device's established performance.

Here's the breakdown based on the provided text, highlighting what is (and isn't) present:

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

Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Mini L.E.D. OEM Module)
Intended Use: Photopolymerization of light-cured dental materials, restorative composite materials, and orthodontic bonding and sealing materials.	Same intended uses as the predicate device.
Wavelength: Visible blue light in the 430 to 480 nm waveband.	Produces visible blue light in the 430 to 480 nm waveband.
Power Density: Sufficient for intended uses (implied by predicate's efficacy).	Power density comprised between 1,000 and 2,000 W/cm2 (with BoosterTip 5.5mm lightguide), stated as "sufficient for the Mini L.E.D. product intended uses."
Safety and Efficacy: Safe and efficacious for its intended use (implied by predicate's clearance).	Stated as having "nearly identical characteristics and intended uses" to the predicate, which "has been determined to be safe and efficacious."
Classification: Ultraviolet Activator for Polymerization (21 C.F.R.§ 872.6070).	Classified as an Ultraviolet Activator for Polymerization (21 C.F.R.§ 872.6070).

Explanation: In a 510(k), the "acceptance criteria" for the new device are essentially that it performs as safely and effectively as the predicate device for the same intended use. The performance of the predicate device (Satelec Mini L.E.D., K032465) sets the benchmark. The submitter asserts that the Mini L.E.D. OEM Module meets these, primarily by having "nearly identical characteristics and intended uses."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable in the context of this 510(k) summary. There is no mention of a clinical "test set" or patient data for evaluation of this device. The demonstration of equivalence is based on technical specifications and comparison to the predicate.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This type of expert review for ground truth is typically associated with clinical performance studies or diagnostic device evaluations, which are not detailed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned as there is no "test set" requiring such.

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 polymerization light-curing device, not an AI-assisted diagnostic or imaging system. Thus, MRMC studies and AI assistance metrics are irrelevant.

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

Not applicable. This device is a standalone medical device (light curing unit), not an algorithm.

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

Not applicable in the typical sense. The "ground truth" for the predicate device's safety and efficacy would have been established through its own clearance process, likely based on performance testing and potentially clinical data (though not detailed here). For the OEM module, the "ground truth" is its demonstrated equivalence to the predicate's established performance.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device does not involve machine learning or AI models that require training data.

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

Not applicable. See above.

Summary of 510(k) Approach:

The core of this 510(k) submission is the argument of substantial equivalence to a previously cleared device (Satelec Mini L.E.D., K032465). This is a regulatory pathway that relies on demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, and does not raise different questions of safety and effectiveness. Clinical studies with explicit acceptance criteria, detailed sample sizes, and ground truth establishment methods as you've requested are typically more prominent in PMA submissions or for novel devices, not for demonstrating substantial equivalence based on similar design and function.

Summary

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APR 2 8 2004

K04 0408

SMDA Summary of Safety and Effectiveness "510(k) Summary" 9.
A. Submittor Information

SATELEC Z.I. due Phare, BP 215 17 Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE Telephone: 011-33-56-34-06-07

Contact Person: Pascal Dupeyron Regulatory Affairs

March 26, 2004 Date Prepared:

B. Device Identification

Common/Usual Name:	Polymerization Light-Curing Device
Classification Name:	Ultraviolet Activator for Polymerization
Proprietary Name:	Mini L.E.D. OEM Module

C. Identification of Predicate Device(s)

The Mini L.E.D. OEM Module is substantially equivalent to the following previously cleared and currently marketing device:

Satelec Mini L.E.D. (K032465)

D. Device Description and Intended Use
The Satelec Mini L.E.D. OEM Module is classified as an Ultraviolet Activator for Polymerization (21 C.F.R.§ 872.6070) because it is a device intended for the photopolymerization of light cured dental materials, restorative composite materials, and orthodontic bonding and sealing materials. The Mini L.E.D. OEM Module is a universal photo-polymerization light curing source and producing visible blue light in the 430 to 480 nm waveband of the spectrum with a power density comprised between 1,000 400 mm Waveband of the Spottain Mar 2,000 W/cm2 (BoosterTip 5,5 mm lightguide). These power densities are sufficient for the Mini L.E.D. product intended uses, namely:
photo-polymerization in the 430-480 nm waveband of visible light cured (VLC) dental A materials,
photo-polymerization in the 430-480 nm waveband of visible light cured (VLC) 公 restorative composite materials, and
photo-polymerization in the 430-480 nm waveband of visible light cured (VLC) ア orthodontic brackets, and orthodontic bonding and sealing materials.
E. Substantial Equivalence

The Satelec Mini L.E.D. OEM Module has nearly identical characteristics and intended uses as the 510(k) cleared light curing unit, the Satelec Mini L.E.D. (K032465), for the photo-polymerization of dental materials, restorative composite materials, and polymerization of bonding and sealing materials. This device is well established and has been determined to be safe and efficacious.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2004

SATELEC C/O Ms. Jaqueline E. Masse Senior Consultant Interactive Consulting 70 Walnut Street Wellesley, Massachusetts 02481

Re: K040808

Trade/Device Name: Mini LED OEM Module Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: March 26, 2004 Received: March 29, 2004

Dear Ms. Masse:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Fxisting major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Jaqueline E. Masse

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97) you may obtain. Other general information on vour responsibilities under the Act mav be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Charles

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

Device Name:

Mini L.E.D. OEM Module

1040809

Indications For Use:

Polymerization of light-cured dental materials Polymerization of restorative composite materials 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)

Fichets Betz DDS d/b/a Susan Kummer

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K040808

Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Use_______

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.