SPECTRUM 800 CURING UNIT by DENTSPLY INTL.

The provided text is a 510(k) summary for a dental curing light, the SPECTRUM™ 800 CURING UNIT. It describes the device and claims substantial equivalence to a predicate device, the Spectrum™ Curing Light (K951425). However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a modern AI/software as a medical device (SaMD) submission would.

The document is a premarket notification for a physical medical device, not a software algorithm. Therefore, many of the requested categories (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable or not provided in the context of this type of submission for this device.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Explicit acceptance criteria are not stated in the document for the SPECTRUM™ 800 CURING UNIT in the format of specific quantitative metrics.	The device is described as having "an increased wattage light bulb" and an "intensity adjustment feature" that "will ensure the operator quality repeat output performance every time the light is used."
	The "same filter used for the Spectrum™ Curing Light is used for the SPECTRUM™ 800 CURING UNIT and controls the wavelength of light that is emitted by the unit."
	The device features a "digital type" radiometer in the base, replacing a "red light/green light type" in the predicate device.
Overall Implicit Acceptance: Demonstrating substantial equivalence to the predicate device in terms of safety and effectiveness for its intended use.	Overall Implicit Performance: Achieved substantial equivalence to the Spectrum™ Curing Light (K951425) through similar technological characteristics and performance (e.g., controlling wavelength, providing light for curing VLC resin). No formal study results are provided in this summary.

Missing/Not Applicable Information for AI/SaMD Context:

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

Not Applicable/Not Provided: This is a physical device, and the submission primarily relies on comparison to a predicate device and description of its technological characteristics. There is no mention of a "test set" in the context of data for an algorithm.

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/Not Provided: There is no "ground truth" establishment in the context of evaluating an algorithm. The "truth" for this device would relate to its physical properties and functionality.

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

Not Applicable/Not Provided: No test set or adjudication method described.

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/Not Provided: This is not an AI/SaMD device, so an MRMC study is irrelevant.

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

Not Applicable/Not Provided: Not an algorithm.

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

Not Applicable/Not Provided: Not an algorithm. Ground truth for a curing light would involve physical measurements (e.g., light intensity, wavelength) or performance characteristics (e.g., ability to cure resins), but no specific data is presented.

8. The sample size for the training set

Not Applicable/Not Provided: There is no training set mentioned, as this is not an AI/SaMD.

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

Not Applicable/Not Provided: No training set, no ground truth establishment for a training set.

Summary of the Device's "Proof of Meeting Criteria" from the Document:

The "proof" in this 510(k) summary is based on demonstrating substantial equivalence to a previously cleared predicate device rather than presenting a performance study against explicit quantitative acceptance criteria. The key arguments for substantial equivalence are:

Identical Intended Use: "The SPECTRUM™ 800 CURING UNIT provides visible light irradiation for the curing of dental VLC resin products." This is implicitly the same as the predicate.
Similar Technological Characteristics:
- It uses the "same filter" as the predicate to control emitted light wavelength.
- The core function (visible light photopolymerization) is the same.
Minor Changes: The differences are characterized as "cosmetic changes to the appearance and operating features," an "increased wattage light bulb," and a change from a "red light/green light type" radiometer to a "digital type." The "intensity adjustment feature" is presented as an improvement that ensures "quality repeat output performance."

The document states: "We believe that the similarity of the SPECTRUM™ 800 CURING UNIT to the predicate device and the performance and safety data provided support the safety and effectiveness of the SPECTRUM™ 800 CURING UNIT for the indicated use." This "performance and safety data" is not detailed in the provided summary but would have been part of the full 510(k) submission to the FDA. The FDA's letter (SEP 1 5 1998) confirms that they reviewed the submission and determined "the device is substantially equivalent...for the indications for use stated in the enclosure."

In essence, for this type of medical device submission from 1998, the "acceptance criteria" were met by successfully demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit numerical thresholds detailed in this public summary.

Summary

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SEP 1 5 1998

DENTSPLY

510(k) SUMMARY

NAME & ADDRESS:

DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 777 8542343

P. J. Lehn Telefax (717) 849-4343

CONTACT: P. Jeffery Lehn

June 29, 1998 DATE PREPARED:

TRADE OR PROPRIETARY NAME: SPECTRUM™ 800 CURING UNIT

CLASSIFICATION NAME: Unclassified

Visible light activator for polymerization COMMON OR USUAL NAME:

Spectrum™ Curing Light K951425 PREDICATE DEVICES:

DEVICE DESCRIPTION: The SPECTRUM™ 800 CURING UNIT is a visible light emitting photopolymerization unit that produces light used to photoactivate dental resin products.

INTENDED USE: The SPECTRUM™ 800 CURING UNIT provides visible light irradiation for the curing of dental VLC resin products.

TECHNOLOGICAL CHARACTERISTICS: The SPECTRUM™ 800 CURING UNIT is identical to the Spectrum™ Curing Light (K951425) except for cosmetic changes to the appearance and operating features and an increased wattage light bulb. The same filter used for the Spectrum™ Curing Light is used for the SPECTRUM™ 800 CURING UNIT and controls the wavelength of light that is emitted by the unit. Both curing units feature a radiometer built into the base. However, the SPECTRUM™ 800 CURING UNIT radiometer is a digital type, whereas the Spectrum™ Curing Light radiometer is a red light/green light type.

An additional difference in the SPECTRUM™ 800 CURING UNIT from the Spectrum™ Curing Light is the intensity adjustment feature of the light. The operator can dial the intensity of the light. This feature will ensure the operator quality repeat output performance every time the light is used. This feature also allows the operator the ability to match the restoration type with the intensity required.

We believe that the similarity of the SPECTRUM™ 800 CURING UNIT to the predicate device and the performance and safety data provided support the safety and effectiveness of the SPECTRUM™ 800 CURING UNIT for the indicated use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 1998

Mr. P. Jeffrey Lehn Director, Corporate Compliance and Requlatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

Re : K982318 Spectrum 800 Curing Unit Trade Name: Requlatory Class: II Product Code: EBF June 29, 1998 Dated: Received: July 2, 1998

Dear Mr. Lehn:

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, Druq, 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 misbrandinq 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. ದ substantially equivalent determination assumes compliance with the Good Manufacturing 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 regulation 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 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.

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Page 2 - Mr. Lehn

This letter will allow you to beqin 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 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

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

510(K) Number:

Device Name:

SPECTRUM™ 800 CURING UNIT

ﺪ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﻨﺘﺠﺎﺕ ﺍﻟ

The SPECTRUM™ 800 CURING UNIT provides visible light irradiation for the curing of dental VLC resin products.

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻠﺴ Prescription Use

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Susan Curry

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .

00007

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.