Laser periodontal indications including:
· Sulcular debridement (curettage, removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival bleeding index, probe depth, attachment loss, and tooth mobility).
· Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket.

Device Description

The Ultrafast series (Ultrafast, Ultrafast Plus, and Ultrafast Lite) are cordless diode laser systems designed for a wide variety of dental soft tissue procedures. The products have three separate models under the model names: Ultrafast, Ultrafast Plus and Ultrafast Lite. They use solid-state laser diodes as sources of infrared radiation. The energy from the infrared radiation is delivered to the treatment site via a single-use fiber optic tip.

The product kit consists of a laser handpiece, laser goggles, charging stand, power adapter, laser shield, barrier sleeves, product warning labels and instructions for use. The laser handpiece is constructed from anodized aluminum and contains a single-use, disposable fiber optic tip and main body containing laser diode, main control and a rechargeable battery assembly. The main control houses the control circuitry with microprocessor and user interface to control and deliver the laser and a green aiming beam to guide the laser procedures. The charging stand allows for the placement of the handpiece in a holder with electrical connection to the power adapter as the source for charging the rechargeable battery.

Based on the wavelength and power of the laser diodes used, the kit can be preconfigured into three separate models:

Trade Name	Wavelength (nm)	Max CW Power (Watt)
Ultrafast	808	3
Ultrafast Plus	980	3
Ultrafast Lite	808	1.5

AI/ML Overview

The provided text, a 510(k) summary for the DentLight Inc. Ultrafast series dental lasers, describes the device's technical specifications and asserts its substantial equivalence to previously cleared predicate devices. It does not present a study with acceptance criteria and device performance data in the typical format of an AI/ML device performance study.

Instead, the document focuses on demonstrating that the Ultrafast series shares similar indications for use, technology, design, and performance characteristics with its predicates. The "performance testing" mentioned is related to non-clinical safety and design specifications, not clinical efficacy or diagnostic accuracy as would be relevant for an AI/ML-driven device.

Therefore, I cannot extract the information required for your request in the format you provided because the document describes a traditional medical device (dental laser) and its regulatory clearance process through substantial equivalence, not an AI/ML-driven device that would involve concepts like sensitivity, specificity, human reader performance, ground truth establishment by experts, or training/test sets for machine learning models.

The "acceptance criteria" for this device are implicitly tied to meeting the safety and performance standards demonstrated by the predicate devices and relevant IEC/ISO standards. The "study proving the device meets acceptance criteria" refers to non-clinical bench testing and compliance with those aforementioned standards.

Here's what can be inferred from the document regarding "acceptance criteria" and "performance" for a dental laser, but please note this is NOT an AI/ML performance study as you've outlined:

Based on the provided document, the "acceptance criteria" and "study proving the device meets acceptance criteria" are aligned with demonstrating substantial equivalence for a dental laser, not an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance (as inferred for a laser device):

Acceptance Criteria (Implied by Predicate Equivalence & Standards)	Reported Device Performance (from document)
Safety Standards Compliance	• Complies with IEC 60601-1 (medical electrical equipment general requirements)
	• Complies with IEC 60601-1-2 (electromagnetic compatibility)
	• Complies with IEC 60825-1 (safety of laser products)
	• Complies with IEC 60601-2-22 (particular requirements for surgical and therapeutic laser equipment)
Biocompatibility	• Complies with ISO 10993-1 (Biological Evaluation of Medical Devices)
Power Accuracy	• Power Accuracy: ±20% (Ultrafast/Ultrafast Plus/Ultrafast Lite) – Matches predicate device
Wavelength	• Ultrafast/Ultrafast Lite: 808 ± 10 nm
	• Ultrafast Plus: 980 ± 10 nm
Maximum CW Power	• Ultrafast/Ultrafast Plus: 3 Watt (vs. predicate 1.5W, reference 3.5W)
	• Ultrafast Lite: 1.5 Watt (vs. predicate 1.5W, reference 3.5W)
Maximum Pulse Power	• Ultrafast/Ultrafast Plus: 5 Watt (vs. predicate 2W, reference 6W)
	• Ultrafast Lite: 2 Watt (vs. predicate 2W, reference 6W)
Fiber Core Diameter	• 400 µm (Matches predicates)
Aiming Beam Specifications	• 525 (±10nm, 0.6mW) (vs. predicate 650nm/0.5mW, reference 635nm/5mW – noted as a difference but not a concern for substantial equivalence)
Operational Modes	• Continuous / Pulse (Matches predicates)
Design Specifications & Key Features	• Meets all design specifications; similar design, construction materials, weight, size, and key features to predicate devices. (e.g., LCD vs OLED, green vs red aiming beam noted as differences not affecting equivalence)
Indications for Use (Substantial Equivalence)	• Has the same indications for use as the predicate/reference devices.

2. Sample size used for the test set and the data provenance:

Not applicable in the context of an AI/ML test set. The document describes non-clinical performance testing for optical, thermal, electrical, and mechanical safety, and biocompatibility. This typically involves testing of physical units of the device, not a "data set" in the AI/ML sense. Data provenance would be from internal lab testing.

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

Not applicable. This relates to clinical data ground truth, which is not part of this 510(k) summary for a non-AI/ML device.

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

Not applicable. This relates to clinical data adjudication, not applicable here.

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:

No. This is a dental laser device, not an AI/ML product. MRMC studies are not relevant for this type of device clearance.

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

Not applicable. This is a physical laser device, not an algorithm.

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

Not applicable. For this device, "ground truth" equates to established engineering and safety standards (e.g., IEC, ISO) and the performance of the predicate devices. Performance is measured against these technical specifications and safety limits.

8. The sample size for the training set:

Not applicable. This refers to machine learning training data, which is irrelevant for this traditional medical device.

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

Not applicable.

In summary, the provided text is a regulatory filing for a dental laser device, demonstrating substantial equivalence through non-clinical testing against established safety standards and comparison to predicate devices' specifications, not an AI/ML device requiring clinical performance studies with human readers, ground truth from experts, or training/test datasets.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 26, 2021

DentLight Inc. Richard Liu President 1825 Summit Ave. Ste 210 Plano, Texas 75074

Re: K201387

Trade/Device Name: Ultrafast, Ultrafast Plus, Ultrafast Lite Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: NVK, GEX Dated: February 9, 2021 Received: February 12, 2021

Dear Richard Liu:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Michael Adjodha Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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III. Indications for Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K201387

Device Name

Ultrafast/Ultrafast Plus/Ultrafast Lite

Indications for Use (Describe)

Dental soft tissue indications: incision, vaporization, ablation, and coagulation of oral soft tissues including the following:

· Gingival troughing for crown impression
· Gingivectomy
· Gingivoplasty
· Gingival incision and excision
· Hemostasis and coagulation
· Excisional and incisional biopsies
· Exposure of unerupted teeth
· Fibroma removal
· Frenectomy and frenotomy
· Implant recovery
· Incision and drainage of abscess
· Leukoplakia
· Operculectomy
· Oral papillectomies
· Pulpotomy
· Pulpotomy as an adjunct to root canal therapy
· Reduction of gingival hypertrophy
· Soft tissue crown lengthening
· Treatment of canker sores, herpetic and ulcers
· Vestibuloplasty
· Tissue retraction for impression

Laser periodontal indications including:

· Sulcular debridernent (curettage, removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival bleeding index, probe depth, attachment loss, and tooth mobility).

· Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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IV. 510(k) Summary

K201387

This summary of 510(k) substantial equivalence is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. APPLICANT

DentLight Inc. 1825 Summit Ave., Suite 210 Plano, TX 75074

Phone: 972-889-8857 Fax: 972-346-6550 Contact Person: Richard Liu Date Prepared: Feb. 8, 2021

2. DEVICE NAME

Proprietary Name: Ultrafast/Ultrafast Plus/Ultrafast Lite

Common/Usual Name: Dental Diode Laser

Classification Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology (878.4810)

Product Code: GEX

3. PRIMARY PREDICATE DEVICE

Styla Microlaser (K081214), manufactured by Zap Lasers, LLC.

REFERENCE DEVICE

K2 Mobile (K200693), manufactured by Hu Laser.

4. INTENDED USE / INDICATIONS FOR USE

Dental soft tissue indications: incision, excision, vaporization, and coagulation of oral soft tissues including the following:

Gingival troughing for crown impression
· Gingivectomy
Gingivoplasty
· Gingival incision and excision
Hemostasis and coagulation
· Excisional and incisional biopsies
Exposure of unerupted teeth
Fibroma removal
Frenectomy and frenotomy
Implant recovery
· Incision and drainage of abscess
· Leukoplakia

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Operculectomy
· Oral papillectomies
· Pulpotomy
Pulpotomy as an adjunct to root canal therapy
· Reduction of gingival hypertrophy
· Soft tissue crown lengthening
· Treatment of canker sores, herpetic and ulcers
· Vestibuloplasty
· Tissue retraction for impression

Laser periodontal indications including:

· Sulcular debridement (curettage, removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility).

· Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket.

5. DEVICE DESCRIPTION

Based on the wavelength and power of the laser diodes used, the kit can be preconfigured into three separate models:

Trade Name	Wavelength (nm)	Max CW Power (Watt)
Ultrafast	808	3
Ultrafast Plus	980	3
Ultrafast Lite	808	1.5

6. DEVICE CHARACTERISTICS AND SUBSTANDTIAL EQUIVALENCE

Ultrafast/Ultrafast Plus/Ultrafast Lite are substantially equivalent to the primary predicate device Styla Microlaser (K081214), manufactured by Zap Lasers, LLC (now Denmat) and the reference device K2 Mobile (K200693), manufactured by Hu Laser. A comparison table on performance and technology with the predicate and reference devices lists key features and characteristics of the subject and predicate devices. It shows the subject products have technology characteristics as the predicate devices.

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Subject Device Performance and Technological Comparison

Parameter\ Name		Ultrafast / Ultrafast Plus /Ultrafast Lite	Styla Microlaser (Primary Predicate Device)	K2 MOBILE (Reference Device)
	Manufacturer	DentLight	Zap Laser/Denmat	Hu Laser
510(k) Number		K201387	K081214	K200693
	Light Source	Diode Laser	Diode Laser	Diode Laser
	Regulation Number	878.4810	878.4810	878.4810
	Device Class	II	II	II
	Product Code	GEX	GEX	GEX
Peak Wavelength		808±10 nm (Ultrafast/Ultrafast Lite)980±10 nm (Ultrafast Plus)	808±5 nm	980±10 nm
Maximum CW Power(Watt)		3 (Ultrafast/Ultrafast Plus)1.5 (Ultrafast Lite)	1.5	3.5

Maximum Pulse Power(Watt)		5 (Ultrafast/Ultrafast Plus)2 (Ultrafast Lite)	2	6

	Power Accuracy (W)	±20%	±20%	±20%
	Fiber Core Diameter(μm)	400	400	400
	Aiming Beam	525 (±10nm, 0.6mW)	650 (±10nm, 0.5mW)	635 (5 mW)
	OPERATIONMODE	Continuous / Pulse	Continuous / Pulse	Continuous / Pulse
	Display	LCD	OLED	OLED
	Audible Notification	Yes	Yes	Yes
	Visual Notification	Yes	Yes	Yes
	Length(without fiber tip)	163	175	205
Weight	Handpiece	100	55	135
(grams)	ChargingStand	88	340	150
	Battery	Lithium ion	Lithium ion	Lithium ion
	Power Supply Input	100-240V, 50/60Hz	Input: 100-240V, 50-60Hz	Input: 100-240V, 50-60Hz
	Structure	Ergonomic aluminum wand	Ergonomic aluminum wand	Ergonomic aluminum/plastic wand
Compliance Standards		IEC 60601-1; IEC 60601-1-2; IEC60825-1; IEC 60601-2-22	IEC 60601-1; IEC 60825-1;IEC 60601-2-22	IEC 60601-1; IEC 60825-1; IEC60601-2-22

Subject Device Indications for Use Comparisons

Parameter Name	Ultrafast / Ultrafast Plus/Ultrafast Lite	Styla Microlaser(Primary Predicate Device)	K2 MOBILE(Reference Device)
Manufacturer	DentLight	Zap Laser/Denmat	Hu Laser
510(k) Number	K201387	K081214	K200693
Indications for Use	Dental soft tissue indications:incision, excision, vaporization,ablation, and coagulation of oralsoft tissues including thefollowing:• Gingival troughing for crownimpression• Gingivectomy• Gingivoplasty• Gingival incision and excision• Hemostasis and coagulation• Excisional and incisional	Intended for ablating,incising, excising,vaporizing, and coagulationof oral soft tissues using acontact fiber optic deliverysystem. The following are theoralpharngeal indications foruse for which the device willbe marketed:• Excisional and incisionalbiopsies• Hemostasis assistance	Intended for use by dentistsfor excision, incision,vaporization, ablation andcoagulation of oral soft tissueprocedures, including ToothWhitening and the temporaryrelief of pain. The Specificindications are as follows:• Biopsies• Crown lengthening• Exposure of unerupted teeth• Fibroma removal

DentLight Inc. 510(k) - K201387 Feb. 8, 2021

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biopsies	• Treatment of aphthousulcers	• Frenectomy
• Exposure of unerupted teeth	• Frenectomy and frenotomy	• Gingival troughing
• Fibroma removal	• Gingival Incision andExcision	• Gingivectomy
• Frenectomy and frenotomy	• Gingivectomy	• Gingivoplasty
• Implant recovery	• Gingivoplasty	• Pulpotomy
• Incision and drainage of abscess	• Incision and drainage ofabscess	• Root canal therapy
• Leukoplakia	• Operculectomy	• Hemostasis and coagulation
• Operculectomy	• Oral papillectomy	• Leukoplakia
• Oral papillectomies	• Removal of fibromas	• Implant recovery
• Pulpotomy	• Soft tissue crownlengthening	• Incision and drainage ofabscess
• Pulpotomy as an adjunct to rootcanal therapy	• Sulcular debridement(removal of diseased orinflamed soft tissue in theperiodontal pocket)	• Operculectomy
• Reduction of gingivalhypertrophy	• Vestibuloplasty	• Papillectomies
• Soft tissue crown lengthening		• Reduction of gingivalhypertrophy
• Treatment of canker sores,herpetic and aphthous ulcers		• Treatment of Aphthous-ulcer canker sores andherpetic
• Vestibuloplasty		•Vestibuloplasty
• Tissue retraction for impression
Laser periodontal indicationsincluding:		Periodontal procedures:
• Sulcular debridement (curettage,removal of diseased, infected,inflamed and necrosed soft tissuein the periodontal pocket toimprove clinical indices includinggingival index, gingival bleedingindex, probe depth, attachmentloss, and tooth mobility).		• Sulcular debridement
• Laser removal of diseased,infected, inflamed and necrosedsoft tissue within the periodontalpocket.		• Topical heating for thepurpose of elevating tissuetemperature for temporaryrelief of minor muscleand joint pain and stiffnessminor arthritis pain, ormuscle spasm, minor sprainsand minor muscular backpain; the temporary increasein local blood circulation; thetemporary relation of muscle
		• Laser Assisted whitening

Similarities between Ultrafast Plus/Ultrafast Lite and Predicate/Reference Devices:

· Ultrafast/Ultrafast Plus/Ultrafast Lite have the same indications for use as the predicate/reference devices.
· Ultrafast/Ultrafast Plus/Ultrafast Lite have substantially equivalent operating modes as the predicate/reference devices.
· Ultrafast/Ultrafast Plus/Ultrafast Lite have substantially equivalent design, construction materials, weight, size, performance characteristics and key features as the predicate/reference devices.
· Ultrafast/Ultrafast Plus/Ultrafast Lite are substantially equivalent to the predicate/reference devices in standards compliance.

Differences between the Ultrafast Plus/Ultrafast Lite and Predicate/Reference Devices:

Ultrafast/Ultrafast Plus/Ultrafast Lite have an LCD display instead of an OLED display by the predicate and reference devices. They use green aiming beams instead of red aiming beams by the predicate and reference devices. The difference in display and aiming beam improves the operator's ease of use and does not raise any substantial equivalence concerns as it has similar performance of the predicate and reference devices. The device modifications do not potentially alter the fundamental scientific technology of the device.

7. NON-CLINICAL PERFORMANCE TESTING

The subject devices have been tested for optical, thermal, electrical and mechanical safety and comply with the electrical and optical safety requirements as the predicate devices: IEC 6060-1, IEC 60601-1-2, IEC 60825-1 and IEC 60601-2-22.

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The subject devices have been tested for biocompatibility and comply with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process. The subject devices have tested and verified to meet all design specifications that are substantially equivalent to the predicate devices.

8. CONCLUSION

Based on similarities in indications for use and technology together with results from performance testing, we believe that Ultrafast Plus/Ultrafast Lite Diode Lasers are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.