HERMES OPERATING ROOM CONTROL CENTER WITH THE WOM 20L INSUFFLATOR by COMPUTER MOTION, INC.

The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver and WOM 20L Insufflator. It can be used in where nasopharyngoscopy, ear endoscopy, and sinuscopy a laparoscopy, general laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic repair, laparoscopic cholecystectomy, laparoscopic hernia laparoscopic surgeries are ymph node dissection, laparoscopically assisted laparoscopic pelvic appendectomy, hysterectomy, laparoscopic & thorascopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the HERMES ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Device Description

The HERMES Operating Room Control Center is a robotic computer-driven system whose basic function is offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control.

The intent of the HERMES OR Control Center is to allow for simplified and more direct control of medical device settings by the physician, thereby eliminating the necessity of using the various interfaces existing on the Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver and WOM 20L Insufflator in the Operating setting, or relying upon verbal communications between the surgeon and other personnel in the operation room in order to adjust surgical equipment.

AI/ML Overview

The provided document is a 510(k) summary for the HERMES OR Control Center System. This document focuses on the regulatory aspects and the intended use of the device, rather than detailed performance study results with specific acceptance criteria.

Based on the information available, a table of acceptance criteria and reported device performance cannot be fully constructed in the manner requested, as the document does not contain clear, measurable acceptance criteria or detailed study results beyond a statement of functional test requirements.

However, I can extract and infer some information related to the device's testing and regulatory approval based on the text:

Missing Information:
Many of the requested data points (sample size for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth used) are not available in this 510(k) summary document. This document is a regulatory submission summary and typically does not include the detailed raw data or study methodologies to that extent.

Available/Inferred Information from the Document:

Acceptance Criteria and Reported Device Performance:

The document mentions "HERMES System Functional Test Requirements" as a standard the device was designed and tested to. However, the specific criteria within those requirements and the numerical performance results are not detailed in this summary. The only "performance" discussed is the intended function of the device: to offer voice control for medical device settings, simplifying control and eliminating the need for verbal communication with other personnel or direct interaction with individual device interfaces.

Acceptance Criteria (Inferred from functionality description)	Reported Device Performance (Inferred/Stated Intent)
Functional Control: Ability to offer additional option for surgeon selection of attachment device parameter settings utilizing voice control.	The device's basic function is to offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control. (Implies successful implementation of this core functionality, though no quantitative metrics are given).
Simplification of Control: Elimination of the necessity of using various interfaces on connected devices (Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator).	The intent is to allow for simplified and more direct control, thereby eliminating the necessity of using the various interfaces existing on the [listed] devices. (This is a statement of intent and assumed outcome, not a quantified performance metric from a study).
Reduction of Verbal Communication: Elimination of reliance upon verbal communications between surgeon and other personnel for adjusting surgical equipment.	The intent is to eliminate relying upon verbal communications between the surgeon and other personnel in the operating room in order to adjust surgical equipment. (Again, an intended outcome, not a measured performance metric from a study detailed here).
Compliance with Standards: Adherence to relevant electrical, medical electrical equipment, and EMC standards (IEC 601-1, IEC 601-1 Amendment 1, IEC 601-2-18, UL 2601-1, EMC Directive 89/336/EEC, CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92). This implies passing tests related to safety, electrical compatibility, and performance per those standards.	The device is designed and tested to the following Computer Motion and voluntary standards. (This implies successful compliance, but no specific test results or failure rates are provided. This is a regulatory requirement for safety and basic functionality, not directly a performance metric related to the primary clinical benefit of voice control accuracy or efficiency). "HERMES System Functional Test Requirements" were also cited, but specifics are not given.

The Study that Proves the Device Meets Acceptance Criteria:

The document broadly states that the device "is designed and tested to the following Computer Motion and voluntary standards," and lists several standards (IEC 601-1, UL 2601-1, EMC Directive, etc.) in addition to "HERMES System Functional Test Requirements."

The term "study" in the context of clinical performance demonstrating quantitative improvements (e.g., accuracy, efficiency) is not explicitly detailed with methodologies or results in this summary.
The primary evidence of "safety and effectiveness" for this 510(k) submission appears to be based on substantial equivalence to an existing predicate device (HERMES Operating Room Control Center and Accessories K973700). This means the FDA determined the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. This often relies on meeting recognized consensus standards for safety and performance, and demonstrating that the new device functions similarly to the predicate.

Given this context, the document doesn't describe a specific, detailed study with quantitative performance results against explicit acceptance criteria in the way one might expect for a novel diagnostic algorithm. Instead, it attests to design and testing according to established engineering and regulatory standards, and relies on the concept of substantial equivalence.

Specific Requested Information (and why it's mostly unavailable from this document):

Sample size used for the test set and the data provenance: Not mentioned. This would typically be found in detailed verification and validation reports, not a 510(k) summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. Such details are usually part of a clinical validation study.
Adjudication method: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. This type of study is more common for diagnostic imaging AI. For a control system, "effectiveness" might be measured in terms of time savings, error reduction, or surgeon satisfaction, but such a study is not described.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not directly applicable or mentioned. This device is a human-in-the-loop system (voice control by a surgeon). Any standalone performance would be about the voice recognition accuracy and system response, which isn't detailed.
The type of ground truth used: Not explicitly stated for performance testing. For a control system, ground truth might relate to whether commands were accurately interpreted and executed, or whether the system successfully integrated with and controlled the indicated medical devices. This would be part of functional testing.
The sample size for the training set: Not mentioned. AI/ML models usually require training sets; while this device uses voice control, it's not described as a deep learning AI in the modern sense. It's more of a robotic control system with voice interface.
How the ground truth for the training set was established: Not mentioned.

In summary, this 510(k) notification focuses on the regulatory requirements for showing substantial equivalence and compliance with engineering standards for a medical device. It does not provide the kind of detailed clinical or algorithm performance study description (with specific acceptance criteria, sample sizes, expert qualifications, etc.) that would typically be associated with modern AI/ML device submissions, especially those involving image analysis or diagnostic applications. The "study" here is primarily composed of general design and testing to established standards to ensure safety and functional requirements, leading to a determination of substantial equivalence.

Summary

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JUL 13 1998

K980787

16. Premarket Notification 510(k) Safety and Effectiveness Summary

HERMES OR Control Center System 510(k) Summary

In accordance with 21 CFR section 807.92 Computer Motion is submitting the following safety and effectiveness summary.

Submitter Information

Computer Motion. Inc. 130-B Cremona Drive Goleta, CA 93117

Contact: David Thomas Prepared: February 26, 1998

1. Name of Device:
  Proprietary Name: HERMES Operating Room Control Center and Accessories Common Name is HERMES Classification Name: Laproscope for Use in General and Plastic Surgery, Regulation Number 876.1500, Class II.
1. Substantially equivalent to HERMES Operating Room Control Center and Accessories K973700.
1. The HERMES Operating Room Control Center is a robotic computer-driven system whose basic function is offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control.

The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver and WOM 20L Insufflator. It can be used in laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a general laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic symph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting, where endoscopic visualization in indicated and examination of the evacuated cardiac chamber during

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performance of valve replacement. The users of the HERMES ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists

1. The HERMES OR Control Center is designed and tested to the following Computer Motion and voluntary standards.
  IEC 601-1 Second Edition 1988 International Standard for Medical Electrical Equipment IEC 601-1 Amendment 1 1991 International Standard for Medical Electrical Equipment IEC 601-2-18 First Edition 1990 International Standard for Medical Electrical Equipment UL 2601-1

EMC Directive European Union 89/336/EEC CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92

HERMES System Functional Test Requirements

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 1998

Mr. Douglas P. Bueschel Director. Regulatory Affairs/Quality Assurance Computer Motion, Inc. 130 Cremona Drive, Suite B Goleta, California 93117

K980787 Re: Trade Name: Hermes Operating Room Control Center Regulatory Class: II Product Code: GCJ Dated: June 2, 1998 Received: June 3, 1998

Dear Mr. Bueschel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Mr. Douglas P. Bueschel

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K980787
Device Name:	Hermes OR Control Center

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Device
510(k) Number	K980787

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.