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

Device Description

The Precise SHP 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 document is a 510(k) summary for the Precise SHP Diode Laser. It outlines the device's characteristics, intended uses, and claims of substantial equivalence to predicate devices. However, it does not contain the specific acceptance criteria or details of a study that proves the device meets those criteria in the format of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or other quantitative measures of effectiveness).

Instead, the document focuses on demonstrating substantial equivalence based on:

Similar intended uses: Both the proposed device and predicates are for dentistry and oral soft tissue procedures, temporary pain relief, and teeth whitening.
Similar technological characteristics: Wavelength, operating controls, laser delivery method, control systems, safety features, and performance monitoring.
Conformity to standards: Compliance with regulatory standards like 21 CFR 1040.10, 1040.11, IEC 60601-2-22, IEC 60825-1, IEC 60601-1 (3rd Edition), IEC 60601-1-2, IEC 60601-1-4, and IEC 60601-1-6.
Bench testing: A general statement about bench testing indicating the device met design criteria, satisfied performance requirements of 21 CFR 1010 and 21 CFR 1040, and that outputs were within requirements and safety features functioned correctly.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the requested format (e.g., sensitivity, specificity, accuracy) because this information is not present in the provided text. The document describes a bench testing study, but not a clinical study with detailed performance metrics.

Here's an analysis of what is provided, based on your requested categories:

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

Acceptance Criteria (Inferred from regulatory and design compliance)	Reported Device Performance (from Bench Testing)
Compliance with 21 CFR 1040.10 and 1040.11 (Laser Product Performance Standards)	Device met performance requirements of 21 CFR 1010 (related to general radiological health) and 21 CFR 1040 (performance standards for light-emitting products).
Compliance with IEC 60601-2-22 Edition 3 (Medical Electrical Equipment - Specific Requirements for Basic Safety and Essential Performance of Surgical, Therapeutic and Diagnostic Laser Equipment)	Device is designed to comply with this standard.
Compliance with IEC 60825-1 Edition 2 (Safety of laser products - Part 1: Equipment classification and requirements)	Device is designed to comply with this standard.
Compliance with IEC 60601-1: 3rd Edition (General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment)	Device is designed in compliance to this standard.
Compliance with IEC 60601-1-2 (Electromagnetic disturbances)	Device is designed in compliance to this standard.
Compliance with IEC 60601-1-4 (Programmable electrical medical systems)	Device is designed in compliance to this standard.
Compliance with IEC 60601-1-6 (Usability)	Device is designed in compliance to this standard.
Essential performance design criteria	Device met the design criteria for essential performance.
Device output within performance requirements	Device outputs were within performance requirements.
Safety features and functions operating correctly	All safety features and functions were operating correctly.

Note: This table is an interpretation based on the provided text, which states the device "met the design criteria for essential performance, and satisfied the performance requirements indicated in 21 CFR 1010 and 21 CFR 1040. Device outputs were within performance requirements and all safety features and functions were operating correctly." Specific numerical or qualitative performance metrics beyond these general statements are not given.

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

Sample Size: "an evaluation sample of the current device." The exact number of devices in this sample is not specified.
Data Provenance: Not specified, but generally, bench testing for a 510(k) submission would be conducted by the manufacturer (CAO Group, Inc.) in a controlled lab environment. It is not patient or human data, so "country of origin" and "retrospective/prospective" are not applicable in a clinical sense.

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

Not applicable. The study was bench testing, not a clinical study involving human assessment or ground truth established by experts. The "ground truth" would be the engineering specifications and regulatory requirements.

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

Not applicable. This refers to clinical studies where different experts might disagree on an assessment. Bench testing typically involves objective measurements against predefined specifications.

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 was a bench test of a laser device, not an AI-based diagnostic tool. Therefore, MRMC studies and AI assistance are not 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 algorithm, but a physical medical device (laser). The bench testing described essentially represents the "standalone" performance of the device against its specifications.

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

The "ground truth" for the bench testing would be the engineering specifications and performance requirements defined by the manufacturer and relevant regulatory standards (e.g., maximum power output, wavelength accuracy, safety feature functionality).

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no training set in the machine learning sense. The "training" for the device would be its design and manufacturing process.

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

Not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is evenly spaced around the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

August 23, 2013

Robert K. Larsen Cao Group, Inc. 4628 West Skyhawk Drive West Jordan, Utah 84084

Re: K123443

Trade/Device Name: Precise SHP 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: August 13, 2013 Received: August 20, 2013

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 10 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. Isting 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Robert K. Larsen

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 go to http://www.fda.gov/AboutlFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Mark N.Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number : K123443

Device Name:

Indications For Use:

The Precise SHP Diode Laser is indicated for dentistry and oral soft tissue procedures of:

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

x Over-The-Counter Use_ Prescription Use AND/OR (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden: ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number_K123443

Page _________________________________________________________________________________________________________________________________________________________________________

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510(k) Summary of Safety and Effectiveness

CAO Group, Inc. 4628 West Skyhawk Drive West Jordan. UT 84084 Tel: 801-256-9282 Fax: 801-256-9287

Prepared By: Robert K. Larsen, Preparation Date: November 5, 2012

Device Name:

Trade Name:	Precise SHP Diode Laser
Common Name:	Soft Tissue Diode Laser
Product Classification:	Powered Laser Surgical Instrument

Legally Marketed Predicate Devices for Substantial Equivalence:

Precise SHP Diode Laser, manufactured by CAO Group, Inc. (K113472)

Pilot Diode Laser, manufactured by CAO Group, Inc. (K100143)

ezlase, manufactured by Biolase, Inc. (K082938)

Rationale for Substantial Equivalence:

The aforementioned devices share similar indications for use with the present device for excision, incision, ablation, photocoagulation, and infrared heating of tissue for temporary pain relief on soft tissue for a variety of procedures in dentistry. These devices also share an indication for a light source to activate tooth whitening materials and assist in tooth whitening procedures. The predicate devices and submitted device share similar design features including wavelength, operating controls, and laser delivery method. The devices share similar methods of control systems, safety features, and performance monitoring. The devices share similar performance specifications including power output and energy type.

Description of Submitted Device:

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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.

Intended Uses of the Submitted Device:

The Precise SHP Diode Laser is indicated for dentistry and oral soft tissue procedures of:

l) The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular 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 blood 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.

Technological Characteristics and Substantial Equivalence:

The Precise SHP 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 ± 20mm 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 Pilot Diode Laser uses solid state diodes to generate laser energy in the 810mm range. This system uses a fiber delivery system to transmit laser energy to the treatment site. The system also features a 630nm aiming beam and features controls that allow for adjusting the

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output of the working beam, and switching between a continuous or pulsed-mode laser emissions. The maximum output of the working beam is 9 watts.

The ezlase uses solid state diodes to generate laser energy in the 940nm range. This system uses a fiber delivery system to transmit laser energy to the treatment site. The system also features a 630nm aiming beam and features controls that allow for adjusting the output of the working beam, and switching between a continuous or pulsed-mode laser emissions. The maximum output of the working beam is 7 watts.

Conformity to Standards:

The Precise SHP 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: 3rd Edition, IEC 60601-1-2, IEC 60601-1-4, and IEC 60601-1-6.

Performance Data

Bench testing on an evaluation sample of the current device revealed that the device met the design criteria for essential performance, and satisfied the performance requirements indicated in 21 CFR 1010 and 21 CFR 1040. Device outputs were within performance requirements and all safety features and functions were operating correctly.

Conclusion

The Precise SHP Diode Laser is substantially equivalent to the listed predicate devices without raising any new issues of safety or effectiveness. This device shares similar intended uses, operating principles, design features, and similar functional and performance characteristics. The device is designed to comply with relevant federal and international safety and performance standards.

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.