The Opelaser Family is CO2 Medical Laser Systems (and the delivery system that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.

Device Description

These are CO2 Laser devices designed for surgical applications. The maximum power output for the PRO model is 7 watts, and for the LITE model, 5 watts. Type of laser is a CO2 gas laser (class 4); Oscillation system: RF discharge excitation oscillation; Light guiding system: SiO2 hollow fiber or 6 point articulated arm depending on model; Oscillation wavelength: 10.6um.

AI/ML Overview

The provided text is a 510(k) summary for the OPELASER PRO II and OPELASER Lite II surgical laser devices. It outlines the device's identification, description, indications for use, and a comparison to predicate devices. Crucially, it primarily discusses the regulatory process of demonstrating "substantial equivalence" to already legally marketed devices, rather than a clinical study establishing specific performance metrics against pre-defined acceptance criteria for a novel AI/software component.

Therefore, many of the requested details about acceptance criteria, clinical study specifics, ground truth, and expert involvement are not present in the provided document, as this type of information is typically associated with studies demonstrating the performance of a diagnostic or algorithmic device, especially in the context of AI. This document focuses on the safety and effectiveness of a physical surgical laser, not an AI or software-based diagnostic tool.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantifiable metrics. The overarching criterion is "Substantial Equivalence" to predicate devices for safety and effectiveness.	"This device has the same indications for use as the predicate device and employs nearly identical technology to accomplish the same task. Delivered energy levels and wavelengths are essentially the same." "The OPELASER systems have undergone extensive safety and bench testing as well as software validation and risk analysis." "The ability to sterilize the laser tips has been validated." "Tested and certified by the NRTL (Nationally Recognized Test Lab) Intertek. Certification to IEC/UL 60601-1 and IEC 60601-1-22 has been accomplished."

Acceptance Criteria

Reported Device Performance

Not explicitly stated as quantifiable metrics. The overarching criterion is "Substantial Equivalence" to predicate devices for safety and effectiveness.

"This device has the same indications for use as the predicate device and employs nearly identical technology to accomplish the same task. Delivered energy levels and wavelengths are essentially the same." "The OPELASER systems have undergone extensive safety and bench testing as well as software validation and risk analysis." "The ability to sterilize the laser tips has been validated." "Tested and certified by the NRTL (Nationally Recognized Test Lab) Intertek. Certification to IEC/UL 60601-1 and IEC 60601-1-22 has been accomplished."

Note: The document focuses on regulatory compliance and substantial equivalence rather than specific performance metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI or diagnostic device studies.

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

Sample Size for Test Set: Not applicable/Not provided. The submission describes non-clinical safety, bench, and software validation tests directly on the device, not a test set of data.
Data Provenance: Not applicable/Not provided.

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. This type of expert involvement would be relevant for a diagnostic AI study, but the provided text concerns a physical surgical laser.

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

Not applicable/Not provided.

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 document does not mention an MRMC study or any AI component designed to assist human readers.

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

Not applicable. The device is a surgical laser, not a standalone algorithm.

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

Not applicable/Not provided. The "truth" in this context is the device's ability to meet safety standards and perform its intended surgical functions as demonstrated through engineering tests and comparison to predicates.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a training set as this is not an AI/machine learning submission.

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

Not applicable/Not provided.

Summary

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510(K) Summary, 510(k) K120932 Submitter: DEC 7 2012 THE YOSHIDA DENTAL MFG. CO., LTD 1-3-6 Kotobashi, Sumida-ku Tokyo, Japan ZIP 130-8516 TEL: +81-3-3631-2165 (International Business Div.) FAX: +81-3-3631-2685 (International Business Div.) Contact: Hidenori Watanabe, Regulatory Affairs, hi-watanabe@yoshida-net.co.jp Date Prepared: March 15, 2012

1. Identification of the Device:

Proprietary-Trade Name: OPELASER PRO II and OPELASER Lite II Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Product Code GEX Common/Usual Name: Powered laser surgical instrument

Equivalent legally marketed devices: K031440, DEKA, Model Smart US 20D; K030147 2. Lumenis Model: UltraPulse SurgiTouch
Description of the Device: These are CO2 Laser devices designed for surgical applications. The 3. maximum power output for the PRO model is 7 watts, and for the LITE model, 5 watts. Type of laser is a CO2 gas laser (class 4); Oscillation system: RF discharge excitation oscillation; Light guiding system: SiO2 hollow fiber or 6 point articulated arm depending on model; Oscillation wavelength: 10.6um.
Indications for Use. The Opelaser Family is CO2 Medical Laser Systems (and the delivery system 4. that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.
Safety and Effectiveness, comparison to predicate device. This device has the same indications 5. for use as the predicate device and employs nearly identical technology to accomplish the same task. Delivered energy levels and wavelengths are essesntially the same.
Description of Testing, nonclinical tests submitted: The OPELASER systems have undergone 6. extensive safety and bench testing as well as software validation and risk analysis. The ability to sterilize the laser tips has been validated. The OPELASER systems have been tested and certified by the NRTL (Nationally Recognized Test Lab) Intertek. Certification to IEC/UL 60601-1 and IEC 60601-1-22 has been accomplished.
Substantial Equivalence: A detailed comparison of specifications and technologies, as well as 7. comparisons of indications for use shows that the OPELASER device are substantially equivalent to the predicate devices. Safety standards applied are the same, as well.
The conclusions drawn from the nonclinical and clinical tests demonstrate that the 8. Conclusion: device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 2, above.

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Exhibit 6. Truthful and Accuracy Statement as required per 21CFR807.87(k).

I certify that, in my capacity as Executive Chief Operating Officer of the Laser division of The Yoshida Dental Mfg. Co., Ltd., I believe, to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate, and that no material fact has been omitted.

高橋三浄
(Signature)

Mioki Hirohashi Date: March 13, 2012

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure embracing a sphere, symbolizing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem. The logo is presented in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service .

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002

December 7, 2012

The Yoshida Dental Mfg. Co., Ltd. % Kamm and Associates Mr. Daniel Kamm 8870 Racello Court Naples, Florida 34114

Re: K120932

Trade/Device Name: Opelaser Pro II and Opelaser Lite II 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: November 29, 2012 Received: December 03, 2012

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have and have 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.

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

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Page 2 – Mr. Daniel Kamm

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -Si 2012.12.07 17:09:12 -05'00'

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 (if known): K120932

Device Name: QPELASER PRO II and OPELASER Lite II

Indications For Use:

Prescription Use _X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

AND/OR

Neil R Ogden
2012.12.07 16:46:19 -05'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number

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.