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The Outlook Surgical Versa One System is a video nasopharyngoscopy system that provides illumination and live video stream of a patient's internal anatomy during otolaryngology and head and neck examinations and procedures. The device is composed of an endoscope, a connection cable available in 6ft or 12ft lengths, a wireless enabled display unit, and a wireless HDMI receiver. Users attach accessory instruments to the semi-flexible shaft of the endoscope enabling the user to visualize with the instrument attached.
The device will be used by clinical practitioners in a sterile field in an operating room, healthcare clinic, or medical office. The Outlook Surgical Versa One System is a reusable device 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 Versa One Endoscope has a semi-flexible shaft that enables the user to attach instruments. The semi-flexible shaft is rigid near the adapter end and semi-flexible at the distal end to conform the shape of the attached instrument. When an instrument is attached to the scope, the flexible portion becomes rigid and the scope functions as a rigid endoscope. The Versa One endoscope is compatible with Versa One straight and curved sheaths.
The Outlook Surgical Versa One System live stream video can be viewed on the display unit and an off-the-shelf monitor connected to the display unit via an HDMI cable or wirelessly. The off-the shelf monitor is not provided with the device. The device operates off rechargeable battery power.
The Versa One Endoscope uses an integrated LED light source to illuminate glass fiber bundles in the shaft and a CMOS sensor at the distal tip to send the signal to a custom PCB in the endoscope handle that converts the signal to live video.

AI/ML Overview

Based on the provided FDA 510(k) Clearance Letter, the "Outlook Surgical Versa One System" is a medical device for examination and visualization in otolaryngology and head and neck procedures, and not an AI/ML powered device. Therefore, the information typically required for an AI/ML device's acceptance criteria, such as a table of performance metrics (sensitivity, specificity, AUROC), sample size for test/training sets, expert qualifications, and comparison to human readers, is not present in this document.

The document discusses the substantial equivalence of the "Outlook Surgical Versa One System" to a predicate device (Stryker Precision S 4K Sinuscope) based on physical and functional characteristics, and a range of non-AI/ML specific performance tests.

Here's an analysis of what information is provided regarding the device's performance and acceptance, and why the requested AI/ML specific details are absent:

Acceptance Criteria and Device Performance (as per the document):

The acceptance criteria for this device are demonstrated through various performance tests, with the reported device performance consistently being "Passed. All acceptance criteria were met."

Test	Test Method Summary	Results (Device Performance / Acceptance)
Performance Testing: Simulated Use/Cycling	Versa One endoscope tested through multiple simulated use procedures and repeated instrument attachment/detachment cycles.	Passed. All acceptance criteria were met. Demonstrated intended performance as a rigid scope and safe use throughout its minimum expected life.
User Validation	Multiple users followed IFU to set up and use the system with an anatomical model and confirmed results in a cadaver model, following FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" and IEC 62366-1.	Passed. All users were able to choose appropriate attachment, attach instrument, and perform simulated procedure as intended.
Performance Testing: Optical Performance	Tested according to ISO 8600-X, ISO 12233, and ISO 15739 for optical performance. Evaluated signal to noise ratio, dynamic range, image quality (geometric distortion, MTF, FOV), image intensity uniformity, color accuracy, and endoscope image latency.	Passed. All devices met performance criteria.
Performance Testing: Simulated Use (Specifics)	Tested automatic exposure control, wireless link distance, Display power up, battery charge, battery status indicator, image rotation, HDMI port activity. Evaluated shaft durability and bend radius using an automated process.	Passed. All systems met performance criteria. Demonstrated reliable performance and wireless link reliability.
Performance Testing: Electrical Requirements (non 60601-1)	Inspected Versa One Display and Wireless HD Receiver for electrical requirements not included in IEC 60601-1 or IEC 60601-2-18 testing. Inspected Device charger, Display MOPP, isolation barriers, and HDMI connectors.	Passed. All devices met criteria. Demonstrated safe and reliable electrical performance.
Performance Testing: Dimension, Material, Environmental	Tested patient-contacting surface temperature, water splash, ambient temperature, dimensional and material requirements, cable force measurement, and leak testing of the distal end.	Passed.
Electrical Safety, electromagnetic compatibility (EMC), and RF Safety	Tested in compliance with IEC 60601-1, IEC 60601-2-18 (electrical safety), IEC 60601-1-2 (EMC), IEC 63195-1, and ANSI/IEEE C95.1-1 (RF Safety).	Passed.
Photobiological Safety	Tested in accordance with IEC 62471.	Passed.
Cleaning Validation	Tested per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," AAMI TIR12 and AAMI ST98.	Passed.
Biocompatibility Testing	Tested per FDA Guidance, "Use of International Standard ISO 10993-1," ISO 10993-5, ISO 10993-10, ISO 10993-23.	Passed. Non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, and non-pyrogenic.
Sterilization Validation	For scope: ISO 22441:2022 (low temp vaporized hydrogen peroxide). For sheaths: ISO 11135:2014 (ethylene oxide). Overkill test method used for scope.	Passed.

Regarding the specific AI/ML and clinical study requirements you listed, the document does not provide the following information:

Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device with a test set of data. The "test sets" here refer to physical devices undergoing various engineering and biological tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an imaging device like this is primarily about validating its physical performance against standards and its ability to capture high-quality images, not expert interpretation of AI outputs. "User Validation" involved multiple users, but their qualifications are not specified beyond being "clinical practitioners" in the "use environment."
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this device, "ground truth" is established through engineering specifications, international standards (ISO, IEC, ANSI/IEEE), and regulatory guidance documents (FDA). For instance, optical performance is validated against ISO standards, and biocompatibility against ISO 10993. The "User Validation" involved using anatomical models and cadaver models, which serve as a form of ground truth for assessing usability and visualization capability.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) clearance letter details the substantial equivalence of a medical imaging device (a nasopharyngoscope) by demonstrating its physical, electrical, and performance characteristics meet established safety and effectiveness standards, and are comparable to a predicate device. It is not an AI/ML device, and therefore the specific criteria, studies, and data provenance related to AI/ML device performance are not present in this document.

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