The Ascent 3D is a polymerization light source device for delivering light energy to polymerizable dental materials applied to human teeth in conjunction with a variety of procedures and treatments. This energy is generated by solid-state light-emitting diodes (LEDs), which provide a consistent and reliable generation of light energy at 390-520nm with an average optical output of 1600 milliwatts. The LEDs are positioned at the terminal end of the device, allowing for direct illumination of the treatment site without the use of light pipes or other optically conductive appendages. The device features three LEDs that are spatially positioned to illuminate three surfaces or planes of the tooth simultaneously. The device controls allow the operator to select which combination of LEDs are active and the emission time. Emission is initiated by pressing a button, and can be interrupted by pressing the same button or by allowing the selected emission time to expire. The device is constructed of a biocompatible plastic such as ABS, and coated aluminum. The device is powered from an internal rechargeable battery that is charged from an external power supply when not in use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device, the Ascent 3D. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the specifics of a study proving the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (Palmlight 10) through a comparison of technical characteristics and compliance with general safety and performance standards. It mentions "bench testing on an evaluation sample" and lists various internal test reports and compliance with IEC standards, but these are general statements of testing performed, not a detailed study fulfilling the criteria you've outlined (like specific metrics, sample sizes, expert involvement, and ground truth establishment).

Based on the provided text, here's what can be extracted and what information is missing:

Information Present:

Device Name: Ascent 3D
Intended Use: For light activated polymerization of dental materials such as composites, luting cements, adhesives, and sealants using visible and near-UV light.
Predicate Device: Palmlight 10 (K061341)
General Performance Characteristics (Comparison to Predicate): Wavelength, Optical Output Intensity, Optical Output Fluence, Cooling System, Emission Patterns, Light Source, Cycle Times, Battery Specifications, Input Power Requirements, Power Supply Specifications, Enclosure Materials of Construction, Dimensions, Weight.
Conformity to Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-57, IEC 62304.
Mentioned Bench Tests: "Ascent 3D Depth of Cure Analysis" (according to ISO 4049:2009), "QAC-I03481 Final process inspection of Ascent 3D Probe," "QAC-103482 Final process inspection of Ascent 3D Handpiece," "Ascent 3D Sensor Verification Test," "Ascent 3D Main and Safety Specification Verification Test."

Information NOT Present (and therefore cannot be provided from this text):

A specific table of acceptance criteria and reported device performance beyond the general technical specifications. The document implies compliance with standards and equivalence to the predicate, but not explicit acceptance thresholds for a study as you describe.
Sample sizes used for the test set (other than "an evaluation sample").
Data provenance (country of origin, retrospective/prospective).
Number of experts used to establish ground truth for any test set.
Qualifications of experts.
Adjudication method for any test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers. This is a device for curing dental materials, not an AI diagnostic tool, so such a study would be highly unlikely and irrelevant to this submission.
If a standalone (algorithm only) performance study was done. This is not an AI algorithm.
The type of ground truth used (e.g., pathology, outcomes data). The "Depth of Cure Analysis" would imply a physical measurement of cured material, which could be considered a form of ground truth for that specific performance aspect.
The sample size for the training set. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established. (Not applicable as it's not an AI/ML device).

Given the nature of the device (an ultraviolet activator for polymerization, a dental curing light) and the context of a 510(k) submission, the "study" proving it meets acceptance criteria would primarily involve bench testing to demonstrate performance specifications (e.g., light intensity, wavelength, energy delivery, depth of cure) and compliance with established electrical and safety standards (IEC). These submissions typically do not involve clinical trials with human subjects in the way an AI diagnostic device would, nor do they involve experts establishing ground truth for diagnostic accuracy, as the device's function is purely physical/chemical.

The "acceptance criteria" for a device like this are generally:

Meeting its stated performance specifications (e.g., optical output intensity, wavelength range).
Being safe for its intended use (electrical safety, EMC, biocompatibility of materials).
Demonstrating substantial equivalence to a legally marketed predicate device in terms of indications for use, technological characteristics, and safety/effectiveness.

The document states, "Bench testing on an evaluation sample of the submitted was performed consistent with internal requirements," and lists specific internal test procedures as well as the ISO 4049:2009 standard for Depth of Cure Analysis. This implies that the 'study' performed was a series of in-house verification and validation tests against established performance metrics and safety standards, rather than a clinical trial or AI model validation study.

Summary Table of Available Information (from the document):

Acceptance Criterion (Inferred from device type and 510k)	Reported Device Performance (as stated or implied)
Wavelength Range	390-520nm (Matches predicate's range of 377-490nm sufficiently for substantial equivalence)
Optical Output Intensity (Nominal)	1-LED: 550mW, 2-LEDs: 1000mW, 3-LEDs: 1550mW (Compared to predicate's Standard: 1100mW, Boost: 1425mW)
Optical Output Fluence (Nominal)	> 750 mW/cm² per LED (Compared to predicate's Standard: 2200 mW/cm², Boost: 2850 mW/cm²)
Depth of Cure	Tested according to ISO 4049:2009. Comparative testing to Palmlight 10 (K061341) was also conducted. (Specific numerical results for depth of cure or acceptance criteria for this specific test are not provided in this document.)
Electrical Safety & Performance	Conformity to IEC 60601-1:2005 3rd Ed., IEC 60601-1-2:2014 4th Ed., IEC 60601-1-6:2013 Ed. 3.1, IEC 60601-2-57:2011 1st Ed.
Software Life Cycle Processes	Conformity to IEC 62304:2006 1st Ed.
Functional Verification	Covered by internal tests: QAC-I03481 Final process inspection of Ascent 3D Probe, QAC-103482 Final process inspection of Ascent 3D Handpiece, Ascent 3D Sensor Verification Test, Ascent 3D Main and Safety Specification Verification Test.

In summary, the provided document does not contain the detailed study information as typically requested for AI/ML or diagnostic devices. Instead, it demonstrates performance through compliance with engineering standards and direct comparison of technical specifications to a predicate device, which is typical for electromechanical medical devices like a dental curing light.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 31, 2015

CAO Group, Inc. Mr. Robert K. Larsen Regulatory Affairs Manager 4628 West Skyhawk Drive West Jordan, Utah 84084

Re: K150585

Trade/Device Name: Ascent 3D Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet activator for polymerization Regulatory Class: II Product Code: EBZ Dated: November 19, 2015 Received: November 23, 2015

Dear Mr. Larsen:

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. 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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina Kiang
-s

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150585

Device Name Ascent 3D

Indications for Use (Describe)

For light activated polymerization of dental materials such as composites, luting cements, adhesives, and sealants using visible and near-UV light.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for CAO GROUP, INC. The logo consists of a red square with a white Chinese character inside, followed by the text "CAO GROUP, INC." in black. Below the company name, there is a tagline that reads "Easier · Faster · Better™".

510(k) Summarv

Prepared By: Robert K. Larsen Preparation Date: December 21, 2015

Device Name:

Trade Name:	Ascent 3D
Common Name:	Dental Curing Light
Product Code:	EBZ
Regulation:	872.6070
Product Classification:	Ultraviolet Activator for PolymerizationClass II

Legally Marketed Predicate Devices for Substantial Equivalence:

Palmlight 10, manufactured by CAO Group, Inc. (K061341)

Rationale for Substantial Equivalence:

The submitted device and identified predicate device share exactly identical indications for use: For light activated polymerization of dental materials such as composites, luting cements, adhesives, and sealants using visible and near-UV light. The submitted device and predicate device share similar design features including emission sources, operating controls, key constructional components, and materials of construction. The devices share similar methods of control systems, safety features, and performance monitoring. The devices share similar performance specifications including power output, emission wavelngth, and energy type.

Description of Submitted Device:

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Image /page/4/Picture/0 description: The image shows the logo for CAO Group, Inc. The logo consists of a red square with a white Chinese character inside, followed by the text "CAO GROUP, INC." in black. Below the text is the tagline "Easier · Faster · Better™".

4628 W. Skyhawk Drive	801.256.9282 [phone]
West Jordan, UT 84084	877.877.9778 [toll free]
www.caogroup.com	801.256.9287 [fax]

Indications for Use of the Submitted Device:

The submitted device is indicated for use -

For light activated polymerization of dental materials such as composites, luting cements, adhesives, and sealants using visible and near-UV light.

Technological Characteristics and Substantial Equivalence:
	CAO Group, Inc. Ascent 3D	CAO Group, Inc. PalmLight 10
Wavelength	390-520nm	377-490nm
Optical Output Intensity	1-LED: 550mW2-LEDs: 1000mW3-LEDs: 1550mW	Standard: 1100mWBoost: 1425mW
Optical Output Fluence	> 750 mW/cm² per LED	Standard: 2200 mW/cm²Boost: 2850 mW/cm²
Cooling System	Passive heatsink	Passive heatsink
Emission Patterns	Left, Center, Right, Left-Center, Center-Right,Left-Right, Left-Center-Right	Continuous, Pulse (0.25s pulse width, 4Hz),Ramp (0 to standard intensity within first 5seconds), Boost (approximately 120% ofstandard)
Light Source	LED	LED
Cycle Times	3, 5, or 10 seconds	5, 10, 15, or 20 seconds
BatterySpecifications	7.4VDC, 1400mAh	7.4VDC, 1400mAh
Input PowerRequirements	12VDC, 1.7A	12VDC, 1.7A
Power SupplySpecifications	100-240 VAC @ 50-60Hz, 0.6A	100-240 VAC @ 50-60Hz, 0.6A
EnclosureMaterials ofConstruction
- Handpiece	Cast aluminum	Cast aluminum
- Probe	ABS (acrylonitrile-butadiene-styrene)	ABS (acrylonitrile-butadiene-styrene)
- Lens Cover	PC (polycarbonate)	PC (polycarbonate)
Dimensions
- Handpiece	16.5cm L x 2.6cm W x 3.5cm D(6.5 x 1.0 x 1.3 inches)	16.5cm L x 2.6cm W x 3.5cm D(6.5 x 1.0 x 1.3 inches)
- Probe	10.5cm L x 2.9cm W x 3.4cm D(4.1 x 1.1 x 1.3 inches)	10.2cm L x 1.9cm W x 1.9cm D(6.5 x 1.0 x 1.3 inches)
Weight	7 ounces (200 grams)	7.8 ounces (220 grams)
510(k) Number	K150585	K061341
Indications for Use	For light activated polymerization of dentalmaterials such as composites, lutingcements, adhesives, and sealants usingvisible and near-UV light.	For light activated polymerization of dentalmaterials such as composites, lutingcements, adhesives, and sealants usingvisible and near-UV light.

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Image /page/5/Picture/0 description: The image shows the logo for CAO Group, Inc. The logo consists of a red square with a white Chinese character inside, followed by the text "CAO GROUP, INC." in black. Below the company name is the tagline "Easier · Faster · Better™" in a smaller font size.

4628 W. Skyhawk Drive
West Jordan, UT 84084
www.caogroup.com
801.256.9282 [phone]
877.877.9778 [toll free]
801.256.9287 [fax]

Conformity to Standards:

The Ascent 3D is designed to comply with the performance requirements of IEC 60601-1: 3° Edition, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-57.

Performance Data:

Bench testing on an evaluation sample of the submitted was performed consistent with internal requirements:

. Ascent 3D Depth of Cure Analysis
- This test was conducted according to the following standard: ISO 4049:2009 - Dentistry - Polymerbased restorative materials Comparative testing to Palmlight 10 (K061341) was also conducted
QAC-I03481 Final process inspection of Ascent 3D Probe ●
QAC-103482 Final process inspection of Ascent 3D Handpiece ●
Ascent 3D Sensor Verification Test
Ascent 3D Main and Safety Specification Verification Test

These tests were conducted according to the following standards:

IEC 60601-1:2005 3rd Edition - Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014 4th Edition - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard Electromagnetic

compatibility — Requirements and tests

IEC 60601-1-6:2013 Edition 3.1 - Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

IEC 60601-2-57:2011 1st Edition - Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source

equipment intended for therapeutic, diagnostic, monitoring and

cosmetic/aesthetic use

IEC 62304:2006 1st Edition - Medical device software - Software life cycle processes

Conclusion:

The Ascent 3D is substantially equivalent to the listed predicate. This device shares identical intended uses, identical operating principles, similar design features, and similar functional and performance characteristics.

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.