The Precision S 4K Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including thinology, and endoscopic plastic and reconstructive surgery.

Device Description

Stryker's Precision S 4K Sinuscopes are tubular optical instruments used to provide a view of internal patient anatomy for examination, diagnosis, and therapy during otorhinolaryngology procedures. The devices are available in a variety of outer diameters and working lengths.

The sinuscopes are reusable devices initially supplied as non-sterile to the user and requiring the user to process (i.e. clean and sterilize) the device for initial use, as well as to reprocess the device after each use. The sinuscope connects to the camera system through a separate coupler. The coupler is provided by the camera system and is not subject of this premarket notification.

The sinuscopes achieve their intended use by guiding light to illuminate and image a patient's internal anatomy, then relaying the image out of the surgical site for processing and display by a separate camera system. The sinuscope's optical system consists of a series of lenses, which includes an objective lens to image the intended object, a relay rod lens system to transmit the image along the working length, and an ocular lens to form the final image size.

AI/ML Overview

Based on the provided text, the device in question is the Stryker Precision S 4K Sinuscope. The document describes its intended use, technological characteristics, and various performance tests conducted for its 510(k) submission to the FDA.

However, the document does not describe acceptance criteria and associated study details in the manner requested for an AI/device performance study. This document is a 510(k) summary for a medical device that is a sinuscope (a rigid optical instrument), not an AI/software device. The performance testing listed (Biocompatibility, Cleaning, Sterilization, Electrical Safety, Optical Performance, etc.) are standard tests for a physical medical device, demonstrating its safety and effectiveness for its intended use, and not evaluation of an algorithm's diagnostic performance against a ground truth.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria in the context of AI/algorithm performance. The document describes the device as a physical instrument that helps human practitioners visualize internal anatomy, rather than an AI system providing diagnostic outputs.

Here's why the provided text doesn't contain the information you're looking for, followed by what can be extracted:

No AI/Algorithm: The "Precision S 4K Sinuscope" is described as a "tubular optical instrument" with "rigid rod lenses" that "relays the image out of the surgical site for processing and display by a separate camera system." This clearly indicates it's a hardware device for viewing, not an AI or software that analyzes images/data or makes diagnostic recommendations.
No Diagnostic Performance Claims: The document focuses on the physical and functional aspects of the sinuscope itself (e.g., optical properties, reusability, sterilization, biocompatibility). There are no claims about its ability to detect or diagnose any conditions, which would necessitate performance metrics like sensitivity, specificity, or AUC, and thus, ground truth, expert readers, etc.

What information can be extracted relevant to the physical device's "performance" criteria (though not for an AI study):

The document lists various performance tests carried out and their results, which for a physical device serve as a form of "acceptance criteria" demonstrating its safety and functionality.

1. Table of "Acceptance Criteria" (as Performance Tests) and Reported Device Performance

Acceptance Criteria Category (Test Category)	Reported Device Performance (Result)
Biocompatibility	Pass
Cleaning	Pass
Disinfection	Pass
Sterilization	Pass
Electrical Safety & Temperature Testing	Pass
Packaging Qualification	Pass
Optical Performance	Pass
Design Validation (Human Factors)	Pass
Performance - Bench (Device Specifications)	Pass

2. Sample Size for Test Set and Data Provenance:
This concept is not applicable here as it's a physical device, not an AI algorithm evaluated on a data set. The "tests" performed are on the device itself (e.g., how well it can be cleaned, how durable it is, its optical clarity). The document does not specify a "sample size" for these physical tests in terms of number of manufactured units, nor does it refer to "data provenance" as one would for a medical image dataset.

3. Number of Experts and Qualifications for Ground Truth:
Not applicable. Ground truth for an AI algorithm is established by experts labeling data. For a physical medical device like a sinuscope, "ground truth" relates to measurable physical properties or successful execution of reprocessing protocols, not diagnostic accuracy.

4. Adjudication Method for Test Set:
Not applicable. This is relevant for resolving discrepancies in labels in AI datasets.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study measures human reader performance with/without AI assistance. The device is a viewing instrument, not an AI.

6. Standalone (Algorithm Only) Performance:
Not applicable. This applies to AI algorithms.

7. Type of Ground Truth Used:
Not applicable in the context of AI. For this physical device, "ground truth" implicitly refers to established scientific and engineering standards (e.g., ISO for biocompatibility and sterilization, IEC for electrical safety), against which the device must demonstrate compliance.

8. Sample Size for Training Set & 9. How Ground Truth for Training Set was Established:
Not applicable. This is for AI/machine learning models. The manufacturing process of a physical device does not involve a "training set" in this sense.

In summary, the provided document describes the regulatory clearance of a physical medical device (a sinuscope), not an AI-powered diagnostic or assistive tool. Therefore, the requirements for describing an AI study's acceptance criteria and proven performance cannot be fulfilled from this text.

Summary

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September 6, 2019

Stryker Jessie Duong Sr. Staff, Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138

Re: K191102

Trade/Device Name: Precision S 4K Sinuscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: April 23, 2019 Received: April 25, 2019

Dear Jessie Duong:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,

for Srinivas Nandkumar, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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)

Device Name Precision S 4K Sinuscope

Indications for Use (Describe)

The Precision S 4K Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including thinology, and endoscopic plastic and reconstructive surgery.

Type of Use (Select one or both, as applicable)
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|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Submitter:

Applicant	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person	Jessie DuongSenior Staff Regulatory Affairs SpecialistPhone: (408) 754-2077Facsimile: (408) 754-2598Email: jessie.duong@stryker.com
Date Prepared	April 23, 2019

Subject Device:

Name of Device	Stryker Precision S 4K Sinuscope
Common or Usual Name	Sinuscope
Classification Name	Nasopharyngoscope, 21 CFR 874.4760
Regulatory Class	Class II
Product Code	EOB

Predicate Device:

Note: The predicate device has not been subject to a design-related recall.

Device Description:

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Indications for Use:

The Precision S 4K Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.

Feature	Subject Device	Predicate Device
	Precision S 4K Sinuscope	Schoelly Sinuscope
Manufacturer	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138USA	Schoelly Fiberoptic GmbHRobert-Bosch-Str. 1-379211 DenzlingenGermany
Submission Reference	Current Submission	K142249
Indications for UseStatement	The Precision S 4K Sinuscope isintended for use in otolaryngologyand Head and Neck procedures,including rhinology, and endoscopicplastic and reconstructive surgery	The Schoelly Sinuscope is intendedfor use in otolaryngology and Headand Neck procedures, includingrhinology, and endoscopic plasticand reconstructive surgery
Image Transmission	Rigid rod lenses	Rigid rod lenses
Outer diameter	4.0mm, 3.1mm	4.0mm, 2.7mm
Working Length	125mm - 180mm	110mm - 175mm
DOV	0°-70°	0°-70°
FOV	80°-105°	80°-100°
Key Patient-ContactingMaterials	Stainless Steel, Optical Glass,Glass Fibers	Stainless Steel, Optical Glass,Glass Fibers, Co-Cr-Ni Alloy
Single Use or Reusable	Reusable	Reusable
Cleaning	Manual and Automated	Manual and Automated
Disinfection	Manual and Automated	Not available
SterilizationMethods	Autoclave, Steris VPRO,APS Sterrad	Autoclave, APS Sterrad
Sterility Assurance Level	10-6	10-6

Comparison of Technological Characteristics with the Predicate Device:

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Performance Testing:

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

Test Category	Applicable Standards / Guidance	Result
Biocompatibility	ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-11FDA Guidance: Use of InternationalStandard ISO 10993-1	Pass
Cleaning	AAMI TIR30AAMI ST15883-5	Pass
Disinfection	AAMI TIR 12ISO 15883-2	Pass
Sterilization	ISO 14937ANSI/AAMI ST79ANSI/AAMI ST58ISO 17665-1	Pass
Electrical Safety &Temperature Testing	IEC 60601-1IEC 60601-2-18	Pass
Packaging Qualification	ASTM D4149	Pass
Optical Performance	ISO 8600-1	Pass
Design Validation	AAMI/ANSI HE75AAMI/IEC 62366FDA Guidance: Applying HumanFactors and Usability Engineering toMedical Devices	Pass
Performance - Bench	In accordance with deviceperformance specifications	Pass

Conclusions:

The Precision S 4K Sinuscope 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 Precision S 4K Sinuscope when used as instructed.

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.