The Shadowless Operation Light ZF 720 is intended to be used to provide visible illumination of the surgical area or the patient with high intensity and shadow free light during surgical procedures.

Device Description

The Surgical Light ZF 720 is applicable for Open surgery, Endoscope surgery or other surgical procedures. With ceiling, wall and floor versions, the Surgical Light ZF 720 Systems are well-suited for various operating rooms. The device can be adjusted the color temperature, light intensity and light focus in accordance with the different visual habit by the users. And it is workable to connect to the monitor, video or other expansion devices with the requirements of the surgical environment. The Surgical Light ZF 720 consists of base assembly, pendent system and light head assembly integrated into one system. The Surgical Light ZF 720 provides optimum shadow resolution and ease of maneuverability. And the extension arm on the central block possesses the movement mechanism which enables the light heads swivel in all directions. With ceiling, wall and floor versions, the Surgical Light ZF 720 is well-suited for various operating rooms. It is also available in single, dual and triple configurations in compliance with users' requirements. The software is equipped in the device. Dispense with training before using the device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a surgical light, the Umbel Corporation ZF 720. However, the details regarding clinical study design, specific acceptance criteria for performance metrics (e.g., lux levels, color temperature, shadow resolution), sample sizes for test and training sets, expert composition, adjudication methods, MRMC studies, or the method of ground truth establishment are not present in the provided document.

Instead, the performance data section states:

"The Hazard Analysis of the device is in accordance with ISO 14971 Medical Application of Risk Management to Medical Devices."
"The performance of product has been tested and verified by users."
"Performance testing was conducted to verify the Surgical Light ZF 720 meets the requirements for Medical Electrical Equipment as defined in IEC 60601-1 and IEC 60601-2-41."

This indicates that the device's performance was evaluated against engineering and safety standards (IEC 60601-1 and IEC 60601-2-41), and general user verification, rather than detailed clinical performance metrics derived from a study involving image analysis, AI assistance, or human reader performance. The device is a surgical lamp, not an AI/imaging diagnostic device, so the typical criteria associated with AI algorithms (e.g., sensitivity, specificity, AUC, human reader improvement with AI) are not applicable or expected for this type of submission.

Therefore, I will present what acceptance criteria and performance are stated or implied in the provided text, along with the limitations of the information for the questions asked.

Acceptance Criteria and Device Performance for Umbel Corporation ZF 720 Surgical Light

The provided documentation details the regulatory submission for a surgical light (ZF 720), which is a medical device for illumination during surgery. The performance evaluation for such a device typically focuses on meeting established electrical, safety, and functional standards, rather than diagnostic accuracy or human interpretation metrics common for AI-driven imaging devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (as implied/stated)	Reported Device Performance/Verification Method
Risk Management	Compliance with medical device risk management standards	The device's Hazard Analysis is in accordance with ISO 14971 Medical Application of Risk Management to Medical Devices.
Electrical Safety & Performance	Compliance with general and specific medical electrical equipment standards	Performance testing was conducted to verify the Surgical Light ZF 720 meets the requirements for Medical Electrical Equipment as defined in IEC 60601-1 and IEC 60601-2-41.
User Verification/Functionality	User satisfaction with performance (e.g., light intensity, shadow-free illumination, adjustability)	The performance of the product has been "tested and verified by users."
Substantial Equivalence	Demonstration of equivalence to predicate devices (Stryker Visum Surgical Lighting System K031068, MAQUET POWERLED Surgical Light System K070442) in intended use, technological characteristics, and performance.	Concluded to be "substantially equivalent to the predicate devices and effective when used as intended." (FDA conclusion)

2. Sample Sizes Used for the Test Set and Data Provenance

Information Not Provided: The document does not specify test set sample sizes for any performance evaluations (e.g., number of units tested, number of users involved in verification).
Data Provenance: Not explicitly stated, but the submission is from a US-based company (Umbel Corporation, Diamond Bar, CA), suggesting testing was likely conducted in a relevant controlled environment or lab setting conforming to international standards. The nature of the device (surgical lamp) means "retrospective or prospective" data is not applicable in the typical clinical study sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Information Not Provided: This question is more relevant to diagnostic devices where expert consensus forms ground truth. For a surgical light, "ground truth" is measured against engineering specifications (e.g., lux meters, colorimeters) and user feedback on functional aspects rather than "expert interpretation of images." The "users" who verified performance are not detailed in terms of number or specific qualifications.

4. Adjudication Method for the Test Set

Information Not Provided/Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies with multiple readers interpreting data where discrepancies need resolution to establish ground truth. This concept does not apply to the performance testing of a surgical light against technical standards or general user verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, not applicable: An MRMC study is designed to assess the performance of diagnostic imaging (or AI-assisted diagnostic) systems by comparing the accuracy of multiple human readers across multiple cases, often with and without AI assistance. The ZF 720 is a surgical illumination device, not a diagnostic imaging or AI system. Therefore, an MRMC study was not conducted nor would it be relevant for its intended use and regulatory pathway. The concept of "human readers improving with AI vs. without AI assistance" does not apply here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, not applicable: Similar to the MRMC study, this concept relates to the performance of artificial intelligence algorithms in a standalone diagnostic capacity. The ZF 720 is a physical surgical light, not an algorithm. Its performance is inherent to its physical design and measured through engineering standards and user feedback.

7. The Type of Ground Truth Used

Engineering Standards and User Verification: The "ground truth" for the ZF 720's performance is established by:
- Compliance with IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
- Compliance with IEC 60601-2-41 (Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis)
- User verification of functional aspects like "high intensity and shadow free light."

8. The Sample Size for the Training Set

Not Applicable: "Training set" refers to data used to train machine learning models. As the ZF 720 is a physical device and not an AI algorithm, there is no "training set" in this context. The design and development process for a physical device involves engineering design, prototyping, and testing, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: Since there is no training set for this type of device, the concept of establishing ground truth for it does not apply.

Summary

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JUN 3 0 2014

Summary

Submitter's Information

Company: Umbel Corporation 2339 Canyon Park Dr, Diamond Bar, CA91765 Contact: Hayden Wood (714) 784 - 5204 Phone: Email: umhayden@aol.com

Device Identification

Common Name:	Surgical Light, Surgical Lamp
Propriety Name:	Surgical Light
Model Name:	ZF 720
Device Class:	Class II
Product Code:	FSY .

Predicate Device Information

Predicate Device1:	Stryker Visum Surgical Lighting System
510(k) number:	K031068
Predicate Device2:	MAQUET POWERLED Surgical Light System
510(k) number:	K070442

Device Description

The device can be adjusted the color temperature, light intensity and light focus in accordance with the different visual habit by the users. And it is workable to connect to the monitor, video or other expansion devices with the requirements of the surgical environment.

Indication for Use

The Shadowless Operation Light ZF 720 is intended to be used to provide visible illumination of the surgical area or the patient with high intensity and shadow free light during surgical procedures.

Technological Characteristics

005 - Summary

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The Surgical Light ZF 720 consists of base assembly, pendent system and light head assembly integrated into one system. The Surgical Light ZF 720 provides optimum shadow resolution and ease of maneuverability. And the extension arm on the central block possesses the movement mechanism which enables the light heads swivel in all directions.

With ceiling, wall and floor versions, the Surgical Light ZF 720 is well-suited for various operating rooms. It is also available in single, dual and triple configurations in compliance with users' requirements. The software is equipped in the device. Dispense with training before using the device.

Performance Data

The Hazard Analysis of the device is in accordance with ISO 14971 Medical Application of Risk Management to Medical Devices. The performance of product has been tested and verified by users.

Performance testing was conducted to verify the Surgical Light ZF 720 meets the requirements for Medical Electrical Equipment as defined in IEC 60601-1 and IEC 60601-2-41.

Conclusion

Based upon the information provided herein this 510(k) Premarket Notification, we conclude that Surgical Light ZF 720 is substantially equivalent to the predicate devices and effective when used as intended.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 30, 2014

Umbel Corporation Mr. Hayden Wood Project Director 2339 Canyon Park Drive Diamond Bar, California

Re: K132551

Trade/Device Name: ZF 720 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: May 27, 2014 Received: May 28, 2014

Dear Mr. Wood:

We have reviewed vour 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, 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 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

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Page 2 - Mr. Hayden Wood

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/ResourcesforYou/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/ReportalProblem/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 yours,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510{k} Number (if known) K132551

Device Name ZF 720

Indications for Use (Describe)

The Shadowless Operation Light ZF 720 is intended to be used to provide visible illumination of the surgical area or the patient with high intensity and shadow free light during surgical procedures.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.