OTOPLAN is intended to be used by otologists and neurotologists as a software interface allowing the display, segmentation, and transfer of medical image data from medical CT, MR, and XA imaging systems to investigate anatomy relevant for the preoperative planning and postoperative assessment of otological procedures (e.g., cochlear implantation).

Device Description

OTOPLAN consolidates a DICOM viewer, ruler function, and calculator function into one software platform. The user can

import DICOM-conform medical images and view these images.
navigate through the images and segment ENT-relevant structures (semi-automatic), which can be highlighted in the 2D images and 3D view.
use a virtual ruler to geometrically measure distances and a calculator to apply established formulae to estimate cochlear length and frequency.
create a virtual trajectory, which can be displayed in the 2D images and 3D view.
identify electrode array contacts of a cochlear implant to assess electrode insertion and position.
input audiogram-related data that were generated during audiological testing with a standard audiometer and visualize them in OTOPLAN.
OTOPLAN allows the visualization of third-party information, that is, a cochlear implant electrode array portfolio.
The information provided by OTOPLAN is solely assistive and for the user. All tasks performed with OTOPLAN require user interaction; OTOPLAN does not alter data sets but constitutes a software platform to perform tasks that are otherwise performed manually. Therefore, the user is required to have clinical experience and judgment.
OTOPLAN is designed to run on a PC and requires the 64 bit Microsoft Windows 10 operating system. A PDF Reader such as Adobe Acrobat is recommended to access the instructions for use.
For computation and usability purposes, the software is designed to be executed on a computer with touch screen capabilities. The minimum hardware requirements are:
12.3in wide screen
8GB of RAM
2 core CPU (such as a 5th generation i5 or i7)
dedicated GPU with OpenGL 4.0 capabilities
250GB hard drive

AI/ML Overview

The provided text is a 510(k) summary for the OTOPLAN device. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific acceptance criteria and performance metrics for an AI/algorithm component.

Based on the provided text, OTOPLAN is described as a software interface for displaying, segmenting, and transferring medical image data for pre-operative planning and post-operative assessment. It does include functions like semi-automatic segmentation and calculations based on manual 2D measurements, but it largely appears to be a tool that assists human users and does not replace their judgment or perform fully autonomous diagnostics. Therefore, it's unlikely to have the kind of acceptance criteria typically seen for AI/ML diagnostic algorithms (e.g., sensitivity, specificity, AUC).

The document states that "Clinical testing was not required to demonstrate the safety and effectiveness of OTOPLAN. This conclusion is based upon a comparison of intended use, technological characteristics, and nonclinical performance data (Software Verification and Validation Testing, Human Factors and Usability Validation, and Internal Test Standards)." This explicitly means there was no clinical study of the type that would prove the device meets acceptance criteria related to diagnostic performance.

However, I can extract information related to the closest aspects of "acceptance criteria" and "study that proves the device meets the acceptance criteria" from the provided text, focusing on the software's functional performance and usability. Since this is not a diagnostic AI/ML device in the sense of making independent clinical decisions, the "acceptance criteria" will be related to its intended functions and safety.

Here's a breakdown based on the information available:

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

The document does not provide a formal table of specific, quantifiable performance acceptance criteria (e.g., segmentation accuracy, measurement precision) with numerical results as one would expect for an AI diagnostic algorithm. Instead, the "performance" is demonstrated through various validation activities.

Category	Acceptance Criteria (Implied from testing focus)	Reported Device Performance
Software Functionality	Software functions as intended; outputs are accurate and reliable (e.g., correct calculation of cochlear length, correct display of information, accurate 2D measurements). Software is "moderate" level of concern.	"All tests have been passed and demonstrate that no question on safety and effectiveness is raised by this technological difference." "The internal tests demonstrate that the subject device can fulfill the expected performance characteristics and no questions of safety or performance were raised." (Referencing comparison with known dimensions).
Human Factors & Usability	Device is safe and effective for intended users, uses, and use environments; users can successfully perform tasks and there are no critical usability errors. Conformance to FDA guidance and AAMI/ANSI/IEC 62366-1:2015.	"OTOPLAN has been found to be safe and effective for the intended users, uses and use environments."
Safety and Effectiveness	No questions of safety or effectiveness are raised by technological differences or overall device operation.	"The subject device is equivalent to the predicate device with regard to intended use, safety and efficacy." "The subject device is substantially equivalent to the predicate device with regard to device performance."

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

Software Verification and Validation Testing & Internal Test Standards:
- The document mentions "tests with known dimensions which were loaded into OTOPLAN." No specific "sample size" of medical images or data is mentioned for these internal software tests, nor is the provenance of this "known dimension" data explicitly stated (e.g., synthetic, real anonymized clinical data). Given it's internal testing of software functionality rather than clinical performance, it's likely proprietary test cases.
Human Factors and Usability Validation:
- Sample Size: "15 users from each user group." (User groups are not specified, but typically refer to the intended users like otologists and neurotologists).
- Data Provenance: "to be carried out in the US". This implies prospective usability testing with human users.

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)

Software Verification and Validation & Internal Test Standards: The concept of "ground truth" as established by experts for medical image interpretation is not directly applicable here for these functional tests. The ground truth refers to "known dimensions" or expected calculation results, which are determined by the software developers and internal quality processes rather than expert radiologists.
Human Factors and Usability Validation: No "ground truth" in the diagnostic sense is established by experts for this type of testing. The "ground truth" for usability testing relates to whether users can successfully complete tasks and if the device performs as expected according to the user.

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

Not applicable. "Adjudication" methods (like 2+1 or 3+1 consensus) are used to establish ground truth in clinical image interpretation studies, typically when there's ambiguity or disagreement among expert readers. Since no clinical study involving image interpretation by multiple readers in this manner was performed (as explicitly stated that clinical testing was not required), no such adjudication method was used.

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

No. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of OTOPLAN." Therefore, no MRMC comparative effectiveness study was conducted.

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

Standalone Performance: The documentation focuses on the software's functional correctness. It states that OTOPLAN "does not alter data sets but constitutes a software platform to perform tasks that are otherwise performed manually." It emphasizes that "All tasks performed with OTOPLAN require user interaction" and "the user is required to have clinical experience and judgment."
- The internal tests seem to evaluate the standalone computational aspects (e.g., "correct calculation according to the published formula and display of the information," "tests with known dimensions which were loaded into OTOPLAN and results compared to the know dimension"). This validates the algorithm's performance for specific computational tasks but not its overall clinical diagnostic performance in a "standalone" fashion that replaces human judgment.

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

Software Verification and Validation & Internal Test Standards: "Known dimensions" and
"Published formulas" for calculations. This indicates a ground truth based on pre-defined, mathematically verifiable inputs and outputs.
No ground truth from expert consensus, pathology, or outcomes data was used for a clinical study, as no clinical study was performed.

8. The sample size for the training set

The document describes OTOPLAN as a software interface with functions like segmentation and measurement, often based on user interaction or published formulas. It does not describe a machine learning or deep learning model that requires a "training set" in the conventional sense. The "semi-automatic" segmentation is mentioned, but if it uses algorithms that learn from data, no information is provided about such a training set size. This device appears to be a software tool with algorithmic functions rather than a continuously learning AI model.

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

Not applicable, as no "training set" for a machine learning model is described in the document.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.

August 20, 2021

CAScination AG Jean-Francois Clemence Head of Quality and Regulatory Affairs Steigerhubelstrasse 3 Bern. CH-3008 Switzerland

Re: K203486

Trade/Device Name: Otoplan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QQE Dated: July 19, 2021 Received: July 23, 2021

Dear Jean-Francois Clemence:

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/cfpmr/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 medical devices and radiation-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,

Shuchen Peng -S

Shu-Chen Peng, Ph.D. Assistant Director DHT1C: Division of Dental and ENT 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) K203486

Device Name OTOPLAN

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "CAScination" in green font with a red and white Swiss flag at the end. The letters are all lowercase except for the first two letters, "CA", which are uppercase and larger than the rest of the letters. The Swiss flag is a white cross on a red background. The logo is likely for a company or organization based in Switzerland.

510(k) Summary

510(k) Number: K203486

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

I. SUBMITTER

Manufacturer:	CAScination AGSteigerhubelstrasse 3CH-3008 BernSwitzerlandTel: +41 31 632 0440Fax: +41 31 552 04 41
Contact Person:	Dr. Jean-François ClémenceHead of Regulatory and Clinical Affairs
Date Prepared:	August 20, 2021 (version 5)

II. SUBJECT DEVICE

Device Name:	OTOPLAN
Classification Name:	Medical Image Management and Processing System
Regulation:	892.2050
Regulatory Class:	Class II
Product Code:	QQE

III. PREDICATE DEVICE

Primary Predicate Device

Company:	Surgical Theater, Inc.
Device name:	Surgical Planner (SRP) BrainStorm
510(k) number:	K201465

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Reference Device

Company:	Brainlab AG
Device name:	iPlan (iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan CMF, iPlan View, iPlan Spine)
510(k) number:	K113732

IV. DEVICE DESCRIPTION

OTOPLAN consolidates a DICOM viewer, ruler function, and calculator function into one software platform. The user can

import DICOM-conform medical images and view these images.
. navigate through the images and segment ENT-relevant structures (semi-automatic), which can be highlighted in the 2D images and 3D view.
. use a virtual ruler to geometrically measure distances and a calculator to apply established formulae to estimate cochlear length and frequency.
create a virtual trajectory, which can be displayed in the 2D images and 3D view.
identify electrode array contacts of a cochlear implant to assess electrode insertion and position.
input audiogram-related data that were generated during audiological testing with a standard . audiometer and visualize them in OTOPLAN.

OTOPLAN allows the visualization of third-party information, that is, a cochlear implant electrode array portfolio.

The information provided by OTOPLAN is solely assistive and for the user. All tasks performed with OTOPLAN require user interaction; OTOPLAN does not alter data sets but constitutes a software platform to perform tasks that are otherwise performed manually. Therefore, the user is required to have clinical experience and judgment.

OTOPLAN is designed to run on a PC and requires the 64 bit Microsoft Windows 10 operating system. A PDF Reader such as Adobe Acrobat is recommended to access the instructions for use.

For computation and usability purposes, the software is designed to be executed on a computer with touch screen capabilities. The minimum hardware requirements are:

. 12.3in wide screen
8GB of RAM ●
2 core CPU (such as a 5th generation i5 or i7)
dedicated GPU with OpenGL 4.0 capabilities ●
. 250GB hard drive

V. INDICATIONS FOR USE

OTOPLAN is intended to be used by otologists and neurotologists as a software interface allowing the display, segmentation, and transfer of medical image data from medical CT, MR, and XA

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Image /page/5/Picture/0 description: The image shows the word "CAScination" in green font. To the right of the word is a red square with a white plus sign in the center. The font is sans-serif and the letters are all capitalized. The image is likely a logo or branding for a company or organization.

imaging systems to investigate anatomy relevant for the preoperative planning and postoperative assessment of otological and neurotological procedures (e.g., cochlear implantation).

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVICE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

Intended use Both the subject and predicate devices have the same intended use to . plan surgical procedures in the head and neck area by medical professionals.
Design Features The predicate and subject device design features & modules are ● summarized in the Table 1.
. Energy Source - Not applicable because both are software devices.
. Materials - Not applicable, because both are software devices and do not have patient contact.
. Performance Testing - Human Factors & Usability Validation, Software Design V&V and documentation, formal Internal Testing were done with both the predicate and subject devices

Item	Subject Device(OTOPLAN)	Predicate DeviceSuRgical Planner (SRP)BrainStorm K201465	Reference Device (iPlan)K113732	Conclusion
RegulationNumber	Regulation Number: 21CFR 892.2050Product Code: ...	Regulation Number: 21CFR 892.2050Product Code: LLZ	Regulation Number: 21CFR 892.1750Product Code: JAK, LLZ	⇒ SameBoth thesubject andpredicatedevices havethe sameregulationnumber
Intended Use
Intended Use	Plan surgical procedures inthe head and neck area bymedical professionals	Plan surgical proceduresin the head and neck areaby medical professionals	Plan surgical procedures inthe head and neck area, andother anatomy by medicalprofessionals	⇒ SameBoth thesubject andpredicatedevice have the
				same intended use
Indicationsfor usestatement	OTOPLAN is intended tobe used by otologists andneurotologists as asoftware interface allowingthe display, segmentation,and transfer of medicalimage data from medicalCT, MR, and XA imagingsystems to investigateanatomy relevant for thepreoperative planning andpostoperative assessmentof otological andneurotological procedures(e.g., cochlearimplantation).	The SuRgical Planner(SRP) BrainStorm isintended for use as asoftware interface andimage segmentationsystem for the transfer ofimage information from aCT, MR, or X-ray 3DAngiography (XA) medicalscanner to an output file.It can also be used forpre-operative planning andsurgical training in avirtual environment.	iPlan's indications for use are theviewing, presentation anddocumentation of medicalimaging, including differentmodules for image processing,image fusion, atlas assistedvisualization and segmentation,intraoperative functional planningwhere the output can be usede.g. with stereotactic imageguided surgery or other devicesfor further processing andvisualization. Example proceduresinclude but are not limited to:- Planning and simulation ofcranial surgical procedures suchas tumor resection, shuntplacement, minimal-invasivestereotactic interventions, biopsy,planning and simulation oftrajectories for stimulation andelectrode recording- ENT procedures such as sinussurgery, tumor surgery- Spine procedures such astumor surgery, pedicle screwplanning, vertebroplastyplanning- Plan View is an applicationwhich is intended to be used forreviewing existingtreatment plans-Planning and simulation ofcranlo-maxillofacial proceduresTypical users of iPlan aremedical professionals, includingbut not limited to surgeons andradiologists.	⇒ SameBoth thesubject andpredicatedevices havethe sameintended use toplan surgicalprocedures inthe head andneck area bymedicalprofessionals
User	Medical professionals	Medical professionals	Medical professionals	⇒ Same
Technical Characteristics
Type	Standalone Software.Does notcontrol the functions orparameters of anymedical device	Standalone Software.Does notcontrol the functions orparameters of anymedical device	Standalone Software.Does notcontrol the functions orparameters of any medicaldevice	⇒ Same
OperatingSystem	Windows 10	Windows	Windows 7, 8, 10	⇒ Same
Functions	• Data Management• Viewing• 3D reconstruction• Trajectory Planning	• Data Management• Viewing• 3D reconstruction• Trajectory Planning	• Data Management• Viewing• 3D reconstruction• Trajectory Planning	⇒ Same
	• Patient/ImageInformation (incl.otological information)	• Patient/ImageInformation (incl.brainwave information)	• Patient/ImageInformation	⇒ Differenttechnologicalcharacteristic:⇒ No question ofsafety andeffectiveness israised
Material	NA	NA	NA	⇒ Same
EnergySource	NA	NA	NA	⇒ Same
PerformanceTesting	Human Factors andUsability ValidationSoftware designverification andvalidation anddocumentation (thesoftware for this devicewas considered a"moderate" level ofconcern.)Formal Internal TestingStandards	Human Factors andUsability ValidationSoftware designverification andvalidation anddocumentation (thesoftware for this devicewas considered a"moderate" level ofconcern.)Formal Internal TestingStandards	Human Factors andUsability ValidationSoftware designverification and validationand documentationFormal Internal TestingStandards	⇒ Same

Table 1 - Summary Substantial Equivalence Comparison to predicate devices:

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Image /page/6/Picture/0 description: The image shows the word "CAScination" in green font with a Swiss flag at the end. The letters are all lowercase except for the first two letters, which are uppercase. The Swiss flag is a red square with a white cross in the center. The word is written in a sans-serif font and is easy to read.

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Image /page/7/Picture/0 description: The image shows the word "CAScination" in green letters with a red square containing a white cross to the right of the word. The letters are all capitalized and in a sans-serif font. The red square with the white cross is a symbol of Switzerland.

Steigerhubelstrasse 3 CH-3008 Bern Switzerland

Technological Differences:

The subject, predicate and reference device all provide general patient/image information and specific patient information. The difference in the subject device is that it provides specific otological information such as the estimation of the cochlea length, a frequency map, display audiogram related data and catalogue information.

The estimation of the cochlear length and frequency map is based on a manual 2D measurement by the user and the application of published formulas. The same estimation is possible with the

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Image /page/8/Picture/0 description: The image shows the logo for CAScination. The logo is green and features the word "CAScination" in a sans-serif font. To the right of the word is a red square with a white plus sign in the center. The logo is simple and modern.

predicate and reference device by caring out the 2D measurement in the software and then using an external tool to apply the published formula. CASCINATION carried out a test of the 2D measurement according to internal standards with both the subject and reference device. Additionally, CASCINATION carried out specific software tests to confirm the correct calculation according to the published formula and display of the information.

The display of audiogram related data (manually input by the user) and catalogue information has been verified by specific software verification tests to confirm the correct display of the information.

All tests have been passed and demonstrate that no question on safety and effectiveness is raised by this technological difference.

Same as with the predicate and subject device human factors and usability validation, software design verification and validation and formal internal testing has been carried out with the subject device to demonstrate the safety and effectiveness of the overall device.

Conclusion - Comparison of the technological characteristics:

The subject device is equivalent to the predicate device with regard to intended use, safety and efficacy. This conclusion is based upon a comparison of intended use, technological characteristics and non-clinical performance testing.

VII. PERFORMANCE DATA

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

Biocompatibility Testing

Not Applicable to the subject device, because the device is stand-alone software.

Electrical safety and electromagnetic compatibility (EMC)

Not Applicable to the subject device, because the device is stand-alone software.

Mechanical and Acoustic Testing

Not Applicable to the subject device, because the device is stand-alone software.

Software Verification and Validation Testing

Software verification and validation testing were provided to demonstrate safety and efficacy of the subject device. Software validation and documentation was prepared according to the

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Image /page/9/Picture/0 description: The image shows the word "CAScination" in green font, with a red square containing a white cross to the right of the word. The font is sans-serif and the letters are all capitalized. The word is likely a company or organization name. The red square with the white cross is a symbol often associated with Switzerland.

"Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).

This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern similar to the predicate device.

Human Factors and Usability Validation

Human Factors and Usability validation was carried out according to the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff (2016-02)" and international standard "AAMI / ANSI / IEC 62366-1:2015, Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices". The Human Factors and Usability Validation includes a summative evaluation to be carried out in the US with15 users from each user group. OTOPLAN has been found to be safe and effective for the intended users, uses and use environments.

Internal Test Standards

Internal Test Protocols were executed and documented in test Reports to demonstrate performance characteristics of OTOPLAN. This included tests with known dimensions which were loaded into OTOPLAN and results compared to the know dimension. The results were in the expected range. The internal tests demonstrate that the subject device can fulfill the expected performance characteristics and no questions of safety or performance were raised.

Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

Clinical Studies

Clinical testing was not required to demonstrate the safety and effectiveness of OTOPLAN. This conclusion is based upon a comparison of intended use, technological characteristics, and nonclinical performance data (Software Verification and Validation Testing, Human Factors and Usability Validation, and Internal Test Standards).

VIII. CONCLUSIONS

The subject device is substantially equivalent to the predicate device with regard to device performance. This conclusion is based upon a comparison of the intended use, technological characteristics, and benchtop testing.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).