The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, 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 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Device Description

The 1688 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible and infrared spectrum. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible scopes, which are attached to the camera head. The 1688 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU (integrated or standard); and (3) a coupler for attaching an endoscope to the camera head.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Stryker 1688 4K Camera System) and does not contain the kind of information typically found in a study proving a device meets acceptance criteria for an AI/ML-based diagnostic or assistive system.

Specifically, this document describes a traditional medical device (an endoscopic camera system) and its substantial equivalence to a predicate device. The performance data presented are for standard engineering and safety tests (e.g., torque, electrical safety, EMC, software verification, cleaning/disinfection, sterilization), not for diagnostic accuracy or human-AI interaction.

Therefore, I cannot extract the information required by your prompt, as the prompt's questions are geared towards the evaluation of an AI-powered medical device, which this document does not describe.

To answer your prompt, there would need to be a section explicitly detailing:

Acceptance Criteria for an AI-powered Diagnostic/Assistive System: This would specify metrics like sensitivity, specificity, AUC, or agreement rates for an AI in identifying conditions or assisting human performance.
A "Study" with a Test Set: This would involve a clinical or simulated clinical study using a dataset of medical images/data, with rigorously established ground truth, to evaluate the AI's performance.
Sample Size and Data Provenance for AI Evaluation: Details on the number of cases, patient demographics, and how the data was collected (retrospective/prospective, country).
Ground Truth Establishment for AI: Information on how experts reviewed the cases, their qualifications, and adjudication methods.
MRMC Study Design and Results: If human readers were part of the evaluation, showing how AI assistance impacted their performance.
Standalone AI Performance: Metrics for the algorithm operating independently.
Training Set Details: Information on the data used to train the AI, including its size and how ground truth was obtained for it.

The provided document explicitly states:

NOTE: The 1688 4K Camera System does not require clinical studies to support the determination of substantial equivalence.

This confirms that the evaluation performed for this device is not a clinical study involving human or AI evaluation of diagnostic performance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Stryker April Malmborg Director, Regulatory Affairs 5900 Optical Ct San Jose, California 95138

Re: K200310

Trade/Device Name: 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 4, 2020 Received: February 6, 2020

Dear April Malmborg:

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.

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

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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 mediation-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,

Jessica Mavadia-Shukla Acting Assistant Director 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)

K200310

Device Name

1688 4K Camera System with Advance Imaging Modality

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R Part 807.92(c).

Submitter:

Applicant:	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person:	April Malmborg, RACDirector, Regulatory AffairsPhone: (408) 754-2473Facsimile: (408) 754-2598Email: april.malmborg@stryker.com
Date Prepared:	February 4, 2020

Subject Device:

Name of Device:	1688 4K Camera System with Advance Imaging Modality
Common orUsual Name	3-chip Video Camera
ClassificationName:	Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500)
Regulatory Class:	II
Product Code:	GCJ
510(k) ReviewPanel:	General & Plastic Surgery

Predicate Device(s):

1688 4K Camera System with Advance Imaging Modality	K182160
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NOTE: The predicate devices have not been subject to a design-related recall.

Device Description:

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Indications for Use:

The 1688 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ arthroscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy. Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, 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 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Item	Subject Device	Predicate Device
	1688 4K Camera System	1688 4K Camera System
Manufacturer	Stryker	Same as subject device
Submission Reference	Current Submission	K182160
Intended Use	Endoscopic visible and near-infrared light illumination andimaging during surgical endoscopicprocedures	Same as subject device
Indications for Use	NOTE 1	Same as subject device
Imaging Modes	White LightNear-infrared – fluorescenceNear-infrared - transillumination	Same as subject device
Safety Standards	IEC 60601-1IEC 60601-2-18IEC 60601-1-2	Same as subject device
Principles of Operation	Via an optical scope and coupler,light is projected onto one or morecomplementary metal oxidesemiconductor image sensors whichacquire a continuous stream ofimage data. The image data isprocessed to provide a video streamthat is then sent to a display forviewing.	Same as subject device
Image Sensor	CMOS image sensor	Same as subject device
Image Processing/ VideoOutput	Digital	Same as subject device
Resolution	4K (up to3840 x 2160)	Same as subject device
Frame Rate	60 frames per second	Same as subject device
System Components	Camera Control UnitCamera Head(s): Standard,Integrated, and PendulumCoupler	Camera Control UnitCamera Head(s): Standard & IntegratedCoupler

Comparison of Technological Characteristics with the Predicate Device:

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NOTE 1: The 1688 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for 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 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Performance Data:

The following performance data were provided in support of the substantial equivalence determination.:

Test	Method/ Rationale	Results
Performance Testing	Locking Knob Actuation TorqueRotating Endobody TorquePendulum Focus Ring TorqueOptical ComplianceCoupler Transmission	Pass
Electrical	ANSI AAMI ES60601-1:2005 + A1:2012IEC 60601-1-6:2010 + A1:2013IEC 60601-2-18:2009	Pass
EMC	IEC60601-1-2:2014	Pass
Software Verification	IEC 62304:2015	Pass
Cleaning & Disinfection	AAMI TIR 12:2010AAMI TIR 30:2011ASTM E2314:2014ISO 17664:2017	Pass
Sterilization	AAMI TIR 12:2010AAMI TIR 17:2008AAMI ST58:2013AAMI ST77:2013ISO 17664:2017ISO 14937:2009	Pass

NOTE: The 1688 4K Camera System does not require clinical studies to support the determination of substantial equivalence.

Conclusions:

The 1688 4K Camera System with Advance Imaging Modality is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. There are no new issues of safety and/or effectiveness introduced by the 1688 4K Camera System with Advance Imaging Modality when used as instructed.

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.