The Auris Robotic Endoscopy System (ARES) is intended to be used by qualified physicians to provide visualization to the Bronchial Tree during Bronchoscopic procedures. The ARES consists of four major components, (1) the Patient Side System (PSS), (2) Controller Cart, (3) Surgeon Console (also known as the Master Device Workstation) and (4) the Bronchoscope and Accessories.

The Patient Side System (PSS) includes the robot cart, two robot arms, both Endoscope and Sheath IDMs, IDS. servo drives box, Endoscope camera control box, power control box. illumination controller, and necessary cabling between the IDM/IDS and the robot cart.

The Controller Cart houses the electronic systems required to power and operate the robotic systems. The Controller Cart is broken into two smaller carts, the system controller cart, and the arm controller cart.

The Master Device Workstation is the workstation from which the surgeon drives the ARES. The console consists of a pendant that allows the surgeon to control various aspects of the system during a procedure.

The system is based on a master - slave model, where the user (i.e. physician) is controlling the robots (slaves) using a pendant (master). The flexible bronchoscope is attached at the end effector of a robotic arm with multiple degrees of freedom. The flexible bronchoscope has a working channel and a camera at the tip. The Bronchoscope has an articulated tip that can bend in four directions. The working channel of the Bronchoscope is used for irrigation and aspiration.

Each Slave includes a robotic arm with 6 degrees of freedom and an IDM (Instrument Drive Mechanism) with 4 actuated axes. The robotic arms are used to steer the Bronchoscope.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Auris Robotic Endoscopy System (ARES). It details the device's indications for use, comparison to predicate devices, and testing completed. However, it does not contain specific acceptance criteria, reported device performance data, information about sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance data, or details about the training set.

The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant medical device standards.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets them with the level of detail requested, as that information is not present in the provided text.

Here is what can be extracted or inferred from the text related to your request, with significant limitations:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly stated in the document. The document mentions "Preclinical testing included standard bench or in vitro testing confirming functionality and durability (e.g., tensile and other durability and functional evaluation)." and "Verification and validation testing was completed in compliance with the following standards: ... All clinical input requirements were validated." These statements imply that acceptance criteria were met, but the specific criteria and corresponding performance results are not provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not specified for bench or in vitro testing.
Data Provenance: The document states that a "Porcine animal model was used to validate system performance in vivo." This indicates some in vivo testing was performed in an animal model, but no details on the number of animals or the country of origin are provided. The broader preclinical testing would be considered prospective for the device's development.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided. Given the nature of the preclinical and animal model testing described, "ground truth" would likely be established by veterinary pathologists or engineers, but no specifics are given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided.

5. 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:

This device is not an AI/CAD-based diagnostic system. It is a robotic endoscopy system for visualization. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be applicable to this type of device and is not mentioned or implied.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This device is a robotic system that is explicitly described as a "master - slave model, where the user (i.e. physician) is controlling the robots (slaves) using a pendant (master)." Therefore, it is inherently a "human-in-the-loop" device, and a standalone algorithm-only performance study would not be applicable. Its performance is tied directly to the physician's control.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the "in vivo" validation mentioned, the ground truth would likely be based on direct observation, procedural success (e.g., successful navigation, visualization), and potentially post-procedure pathology or findings in the porcine model. However, the document does not specify the exact nature of the ground truth. For the in vitro testing, ground truth would be based on engineering measurements and specifications.

8. The sample size for the training set:

The document mentions "Preclinical testing" and "Verification and validation testing." These types of studies are typically performed after development (which includes training/optimization) is complete. The document does not provide any information about a "training set" or how the device's control algorithms or visual processing might have been "trained." This is not an AI/machine learning device in the context of typical training sets.

9. How the ground truth for the training set was established:

As no training set is described, this information is not provided.

In summary, the provided document details the regulatory submission (510(k)) for a robotic endoscopy system, focusing on its substantial equivalence to predicate devices and compliance with safety and performance standards. It broadly states that "clinical input requirements were validated" and "Preclinical testing included standard bench or in vitro testing confirming functionality and durability" and an "animal model was used to validate system performance in vivo." However, it does not provide the specific quantitative acceptance criteria or detailed study results for these tests that would address most of the points in your request.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.

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

May 26, 2016

Auris Surgical Robotics, Inc. % Mr. Michael Daniel President, Daniel & Daniel Consulting, Llc Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, Nevada 89460

Re: K152319

Trade/Device Name: Auris Robotic Endoscopy System (ARES) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ Dated: April 28, 2016 Received: April 29, 2016

Dear Mr. Daniel:

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. 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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" (21 CFR 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/ReportaProblem/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,

Jennifer R. Stevenson -A

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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6. Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(K) Number (if known)

K152319

Device Name

Auris Robotic Endoscopy System (ARES)

· Indications for Use (Describe)

The Auris Robotic Endoscopy System (ARES) is intended to provide bronchoscopic visualization of patient airways.

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)

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

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 El

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7. Premarket Notification 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K152319

Applicant Information:

Date Prepared: May 26, 2016

Name:	Auris Surgical Robotics
Address:	125 Shoreway Road, Suite DSan Carlos, CA 94070
Contact Person:	Michael A Daniel, Consultantmadaniel@clinregconsult.com
Mobile Number:	(415) 407-0223
Office Number:	(775) 392-2970
Facsimile Number:	(610) 545-0799
Company Contact:	Joy Sacmar, VP RA/QA, Auris Surgical Roboticsjoy.sacmar@aurisrobotics.com

Device Information:

Device Trade Name:	Auris Robotic Endoscopy System (ARES)
Common Name:	Bronchoscope (Flexible) and Accessories
Classification Name(s):	Bronchoscope (Flexible) and Accessories
Product Code/ Regulation:	EOQ 21 CFR 874.4680
Classification:	Class II

Predicate Device:

Karl Storz Video Bronchoscope System - K071530
In compliance with FDA Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" we are including the following as reference devices:

Reference Devices:

Olympus Bronchoscope K121959 ●
Hansen Medical catheter articulation system - K052480

Device Description:

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K152319-S002 - Auris Response to FDA RFAI and Q-Sub 160066 May 26, 2016

Surgeon Console (also known as the Master Device Workstation) and (4) the Bronchoscope and Accessories.

Each Slave includes a robotic arm with 6 degrees of freedom and an IDM (Instrument Drive Mechanism) with 4 actuated axes. The robotic arms are used to steer the Bronchoscope.

Indications for Use:

The Auris Robotic Endoscopy System (ARES) is intended to provide bronchoscopic visualization of patient airways.

Comparison to Predicate and Reference Devices

The tables on the following pages provide a summary of substantial equivalence between the subject device and the cited predicate as well as the similarity between the subject device and the chosen reference device. The subject device has the same intended use and substantially equivalent technological characteristics that do not raise different questions of safety or effectiveness.

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Key Attributes	Subject Device	Predicate Device	ReferenceDevice 1	ReferenceDevice 2
ARES System(electromechanicalcontrol system plusintegratedBronchoscope)	Karl StorzBronchoscope	OlympusBronchoscope	Hansen MedicalCatheter and ControlSystem
K Number	K152319	K071530	K121959	K052480
Indication for Use	The Auris RoboticEndoscopy System(ARES) is intendedto providebronchoscopicvisualization ofpatient airways.	The Karl Storz VideoBronchoscopeSystem is intendedfor use by physiciansfor diagnostic andtherapeuticprocedures in nasal,sinus andnasopharyngealendoscopy,bronchoscopy,tracheoscopy andesophagoscopy andlaryngoscopy. TheKarl Storz; VideoBronchoscope isintended to providevisualization via avideo monitor.	These instrumentshave been designedto be used with anOlympus videosystem center, lightsource,documentationequipment, videomonitor, endo-therapy accessories(such as biopsyforceps) and otherancillary equipmentfor endoscopy andendoscopic surgerywithin the airwaysand tracheobronchialtree.	The Hansen MedicalCatheter ControlSystem, SteerableGuide Catheter,Sheath, andaccessories areintended to facilitatemanipulation,positioning andcontrol, for collectingelectrophysiologicaldata within the heartatria with electro-anatomic mappingand recordingsystems, using thefollowingpercutaneousmapping catheters...
Method of Distal tipmovement	Pull Wires	Pull Wires	Pull Wires	Pull Wires
Method of pullingpull wires	Electromechanical(servo/stepper motors+ software)	Mechanical linkageto handle (noelectromechanics)	Mechanical linkageto handle (noelectromechanics)	Electromechanical(servo/stepper motors+ software)
Control / Physicianinterface	Joysticks and buttonson pendant controller	Thumb and fingerwheels on handle	Thumb and fingerwheels on handle	Joysticks and buttonson pendantcontroller?
BronchoscopeDimensions andoptical attributes	Reference Bronchoscope Comparison Chart below			N/A
Scope	Channel I.D.	Scope O.D.	Working Length
Olympus BF-Q190	2.0 mm	4.8 mm	60 cm
Olympus EVIS Exera (BF-3C160)	1.2 mm	3.8 mm	60 cm
Olympus Exera (BF-MP160F)	2.0 mm	4.0 mm	600 mm
Olympus Diagnostic (BF-XP190)	1.2 mm	3.1 mm	600 mm
Storz Broncho-fiberscope (11003)	1.2 mm	2.8 mm	N.S.

Comparison to Predicate and Reference Devices:

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K152319-S002 - Auris Response to FDA RFAI and Q-Sub 160066 May 26, 2016

Testing Completed:

Preclinical testing included standard bench or in vitro testing confirming functionality and durability (e.g., tensile and other durability and functional evaluation). The Porcine animal model was used to validate system performance in vivo.

Verification and validation testing was completed in compliance with the following standards:

IEC 60601-1:2005 + CORP. 1 (2006) + CORP. 2 (2007) + AM1 (2012) or IEC 60601-. 1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
IEC/EN 60601-1-2:2007/AC:2010, Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3). FDA recognition number: 19-2
IEC 60601-2-18 Edition 3.0 2009-08, Medical electrical equipment Part 2-18: . Particular requirements for the basic safety and essential performance of endoscopic equipment. FDA recognition number: 9-61
ISO 10993-1:2009(R) 2013, Biological evaluation of medical devices Part 1: . Evaluation and testing within a risk management process (Biocompatibility). FDA recognition number: 2-156
. ISO 10993-5: 2009/(R) 2014, Biological evaluation of medical devices - part 5: tests for in vitro cytotoxicity. (Biocompatibility). FDA recognition number: 2-153
. ISO 10993-6: 2007/(R) 2010, Biological evaluation of medical devices - part 6: tests for local effects after implantation (Biocompatibility). FDA recognition number: 2-120
ISO 10993-10: 2010, Biological evaluation of medical devices-part 10: tests for . irritation and skin sensitization. (Biocompatibility). FDA recognition number: 2-173
. ISO 10993-11: 2006/(R)2010, Biological evaluation of medical devices-part 11: tests for systemic toxicity. (Biocompatibility). FDA recognition number: 2-118

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ISO 14971:2012, Medical devices application of risk management to medical . devices. FDA recognition number: 5-40
ISO 14937:2009, Sterilization of health care products General requirements for . characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices. FDA recognition number: 14-291
. ISO 11137-2:2013, Sterilization of health care products - radiation- Part 2: Establishing the sterilization dose. FDA recognition number: 14-409
. ANSI/AAMI ST81:2004 (R)2010, Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices. FDA recognition number: 14-295
ANSI/AAMI ST79:2010, Comprehensive guide to steam sterilization and sterility assurance in . health care facilities. FDA recognition number: 14-439
ISO 8600-3 First Edition 1997. Optics and Optical instruments Medical endoscopes and ● endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics [Including: Amendment 1 (2003)]. FDA recognition number: 9-84

Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. All clinical input requirements were validated.

Summary:

Based upon the Intended Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the Auris Robotic Endoscopy System (ARES), has been shown to be substantially equivalent to the cited predicates and very similar to the cited reference device.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.