The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, gingivectomy, troughing, and removal of inflamed edematous tissue;
Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

Device Description

The Sterling Supreme Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.

The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is incorporated into the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.

AI/ML Overview

The provided text does not describe a study involving an AI/ML medical device, clinical performance metrics, or a comparative effectiveness study. It pertains to a 510(k) premarket notification for a medical device called the "Sterling Supreme Diode Laser."

This submission describes changes to the device's labeling and the method of delivering single-use tips (now non-sterile, requiring end-user sterilization) compared to a previously cleared predicate device. It addresses electrical safety, electromagnetic compatibility, performance bench testing, biocompatibility, and end-user sterilization verification and validation.

Therefore, I cannot extract the information required to answer your request about acceptance criteria and a study proving the device meets them, specifically regarding AI/ML performance, ground truth, expert consensus, or multi-reader multi-case studies.

The document states:

"No new risks or concerns regarding device performance are raised in modifying the device to provide the single-use tips to the market in a non-sterile state. No performance characteristics or specifications of the device are modified."
"The modifications consist only of changes to the device labeling and instructions for use for the end-user to be aware of the present condition of the tips and to properly prepare the tips for use. All other aspects of the device, including indications for use, are not affected by this change."
The performance data sections focus on ensuring that the non-sterile delivery of tips and subsequent end-user sterilization do not negatively impact the device's safety or efficacy.

To answer your specific questions in the context of this document, here's what can be inferred or explicitly stated regarding the closest equivalent "acceptance criteria" and "study":

Acceptance Criteria (Implied for the Change):
The primary acceptance criterion for this 510(k) submission regarding the change from sterile to non-sterile tips is that the modification does not introduce new risks or adversely affect the safety and effectiveness of the device, and that end-user sterilization is effective.

Reported Device Performance (for the change):
The testing confirmed that:

The device still complies with relevant electrical safety (21 CFR 1040.10, 1040.11, IEC 60601-2-22, IEC 60825-1, IEC 60601-1: 3rd Edition, IEC 60601-1-2, IEC 60601-1-6).
No performance characteristics or specifications of the device were modified.
No new risks or concerns regarding device performance were raised.
Biocompatibility was not affected as no materials were modified.
End-user sterilization of tips with an approved liquid chemical sterilant is capable of achieving a log 6 reduction in bioburden without adversely impacting performance or specifications.
Rinsing after sterilization adequately removes residual sterilant.

Given this context, I will provide a table and address your points based on the closest applicable information in the document, acknowledging that it's not an AI/ML clinical performance study.

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

Acceptance Criteria (Implied for the Change)	Reported Device Performance
Maintains Electrical Safety & Electromagnetic Compatibility	The Sterling Supreme Diode Laser complies with 21 CFR 1040.10 & 1040.11, IEC 60601-2-22 Edition 3, IEC 60825-1 Edition 2, IEC 60601-1: 3rd Edition, IEC 60601-1-2, and IEC 60601-1-6.
No adverse impact on device performance/specifications	Performance bench testing confirmed "No new risks or concerns regarding device performance" and "No performance characteristics or specifications of the device are modified" due to the non-sterile tip delivery.
No new biocompatibility risks due to material changes	"There are no modifications to the materials used in the device." Risk assessment showed no increased risks as long as instructions for use are followed.
End-user sterilization achieves required bioburden reduction & safety	"Verification and validation testing indicate that treatment of the tips with an approved liquid chemical sterilant is capable of achieving a log 6 reduction in bioburden, without adversely impacting the performance or specifications of the tip." Also, "rinsing the tips after treatment with the sterilant adequately removes residual sterilant from the tip."
No change in device's fundamental safety and effectiveness or Indications for Use	The modifications "do not present any new concerns over safety and effectiveness of the device." "All other aspects of the device, including indications for use, are not affected by this change." The device is considered "substantially equivalent" to its predicate device, signifying it meets the safety and effectiveness profile for its intended use.

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

The document does not detail specific sample sizes for electrical safety, EMC, performance bench testing, or biocompatibility, as these are typically standard engineering and material tests, not clinical studies with patient populations. The tests pertain to the device itself and the sterilization process for the tips. The data provenance is internal testing performed by the manufacturer, CAO Group, Inc. (U.S.A.). The tests are likely retrospective, as they apply to a modified product seeking clearance.

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

This information is not applicable to the type of tests described (electrical safety, EMC, performance bench testing, biocompatibility, sterilization validation). These tests rely on established engineering standards and laboratory protocols, not human expert interpretation for "ground truth" in the way it's used for AI/ML image analysis.

4. Adjudication method for the test set

Not applicable. There is no mention of human-in-the-loop assessment or expert adjudication for the technical tests performed.

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 diode laser, not an AI/ML diagnostic system. No MRMC study was performed or is relevant to this submission.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

For electrical safety and EMC, the "ground truth" is adherence to recognized international and federal standards (e.g., IEC 60601 series, 21 CFR 1040).
For performance bench testing and biocompatibility, the "ground truth" is the device's original validated performance and material safety profile, which the modifications must not adversely affect.
For end-user sterilization, the "ground truth" for efficacy is a "log 6 reduction in bioburden," which is a standard microbiological criterion for sterilization, and proof of adequate residual sterilant removal.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.

September 10, 2019

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

Re: K181614

Trade/Device Name: Sterling Supreme Diode Laser 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: GEX Dated: June 8, 2018 Received: June 19, 2018

Dear Robert 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. 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.

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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 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 (QS) 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 medical devices and radiation-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.

Purva Pandya Acting Assistant Director Light Based Energy Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181614

Device Name Sterling Supreme Diode Laser

Indications for Use (Describe)

The Sterling Supreme Diode Laser is indicated for dentistry and oral soft tissue procedures of:

The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, gingivectomy, troughing, and removal of inflamed edematous tissue;
Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

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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510(k) Summary K181614

Applicant Information:

Company Name:	CAO Group, Inc.
Company Address:	4628 West Skyhawk DriveWest Jordan, Utah 84084 U.S.A.
Company Phone:	1-801-256-9282
Company Fax:	1-801-256-9287
Contact Person:	Robert K. Larsen
Preparation Date:	September 9, 2019

Device Name:

Trade Name:	Sterling Supreme Diode Laser
Common Name 1:	Soft Tissue Diode Laser
Product Code 1:	GEX
Regulation 1:	878.4810
Product Classification 1:	Class II

Legally Marketed Predicate Devices for Substantial Equivalence:

Sterling Supreme Diode Laser, manufactured by CAO Group, Inc. (K171986)

Description of Submitted Device:

Indications for Use of the Submitted Device:

The Sterling Supreme Diode Laser is indicated for dentistry and oral soft tissue procedures of:

1. The removal of lesions, excision, vaporization, ablation, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular

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debridement, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue;

1. Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
1. Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

Rationale for Substantial Equivalence:

The submitted device is the exact same device as the predicate, excepting for labeling changes that are presented in this application. There is no change in the indications for use. There is no change in the materials of construction. There is no change in operating principle. A modification is presented in the submitted device wherein the single-use disposable applicator tips provided for the device shall not be delivered to the end-user in a sterile condition. The device instructions for use indicate suitable materials and method for the end-user to sterilize the tip prior to use. This change represents only a labeling change to the device, and the intended use of the modified device, as described in its labeling, has not changed as a result of the modification.

Performance Data:

ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY

The Sterling Supreme Diode Laser is designed to comply with the performance requirements of 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50, dated June 24, 2007. The device also complies with the recognized standards of IEC 60601-2-22 Edition 3 and IEC 60825-1 Edition 2. The device is designed in compliance to the entirety of IEC 60601-1: 3° Edition, IEC 60601-1-2, and IEC 60601-1-6.

PERFORMANCE BENCH TESTING

No new risks or concerns regarding device performance are raised in modifying the device to provide the single-use tips to the market in a non-sterile state. No performance characteristics or specifications of the device are modified.

BIOCOMPATIBILITY

There are no modifications to the materials used in the device. Risk assessment activities demonstrate that presenting the single-use tips to the end-user in a non-sterile state does not introduce any increased risks or concerns so long as provided instructions for use are followed relative to processing the tips by the end-user prior to use.

END-USER STERILIZATION

Verification and validation testing indicate that treatment of the tips with an approved liquid chemical sterilant is capable of achieving a log 6 reduction in bioburden, without adversely impacting the performance or specifications of the tip. Verification tests show that rinsing the tips after treatment with the sterilant adequately removes residual sterilant from the tip.

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Conclusion:

The modifications to the Sterling Supreme Diode Laser wherein the single-use tips are delivered to the end-user in a non-sterile condition do not present any new concerns over safety and effectiveness of the device. The modifications consist only of changes to the device labeling and instructions for use for the end-user to be aware of the present condition of the tips and to properly prepare the tips for use. All other aspects of the device, including indications for use, are not affected by this change.

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.