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, and 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 arrav portfolio. The information provided by OTOPLAN is solely assistive and for the benefit of 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.

AI/ML Overview

The provided text discusses the OTOPLAN device (v2.0) and its substantial equivalence to a predicate device (OTOPLAN v1.3). The information regarding acceptance criteria and a detailed study proving the device meets these criteria is not fully presented in a standalone format as requested for all fields. However, based on the available text, I can extract and infer the following:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and performance metrics for the OTOPLAN v2.0 device itself. Instead, it focuses on demonstrating substantial equivalence to the predicate device, OTOPLAN v1.3, and verifying the new features.

However, for the new feature of "Electrode Contact Identification," performance testing was conducted. While specific numerical acceptance criteria (e.g., accuracy percentages) are not explicitly stated in a table, the conclusion states that the "testing demonstrated that the algorithm can accurately identify the electrode contacts."

Since the document stresses "substantial equivalence" and the safety/effectiveness of the updated device, the implicit acceptance criteria are that the OTOPLAN v2.0 performs at least as well as and does not adversely affect the safety and effectiveness compared to the predicate device, and for new features, they perform "accurately."

Feature/Metric	Acceptance Criteria (Implicit)	Reported Device Performance
All Existing Functions	Substantially equivalent to OTOPLAN v1.3; does not adversely affect safety and effectiveness. Software design verification and validation, hazard analysis, and established moderate level of concern.	OTOPLAN v2.0 maintains the same intended use and functions as OTOPLAN v1.3 for cochlear parametrization, audiogram, virtual trajectory planning, postoperative quality checks, and export report. Existing 3D reconstruction functions (temporal bone, incus, malleus, stapes, facial nerve, chorda tympani, external ear canal) are also the same. Performance is demonstrated through internal testing and software validation.
New 3D Reconstruction Functions(Cochlea, Sigmoid sinus, Cochlear bony overhang, Cochlear round window)	Same technological characteristics as functions in the predicate device (e.g., uses similar reconstruction methods). Safety and performance demonstrated through software validation activities and documentation.	These functions use the same reconstruction methods and processes as existing functions in the predicate device. For example, Cochlea uses the same method as temporal bone reconstruction. This was verified through software validation.
New 3D Reconstruction Function(Electrode contacts - automatic detection)	Accurate identification of electrode contacts. Does not adversely affect the safety and effectiveness of the subject device.	"The testing demonstrated that the algorithm can accurately identify the electrode contacts." Performance was demonstrated through specific non-clinical performance testing and software validation using human temporal bone cadaver specimens.
Overall Safety and Effectiveness	Substantially equivalent to the predicate device with regard to intended use, safety, and effectiveness.	The subject device is concluded to be substantially equivalent to the predicate device based on comparison of intended use, technological characteristics, and non-clinical performance testing (Software Verification and Validation, Human Factors and Usability Validation, Internal Test Standards).

2. Sample Size Used for the Test Set and Data Provenance

For the specific new feature of "Electrode Contact Identification":

Sample Size for Test Set: "human temporal bone cadaver specimens" (the exact number is not specified).
Data Provenance: The specimens were "scanned with a Micro CT" (for ground truth) and "clinical CTs" (for test datasets). This implies a laboratory or research setting. The country of origin is not explicitly stated. The study is likely retrospective as it uses pre-existing or specially prepared cadaver specimens rather than living patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the "Electrode Contact Identification" test set. It only states that electrode contacts were "marked for the ground truth dataset."

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). It only mentions that electrode contacts were "marked for the ground truth dataset" for the micro CT scans.

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, an MRMC comparative effectiveness study was not done. The document primarily focuses on demonstrating substantial equivalence to a predicate device and verifying new features, not on the comparative effectiveness of human readers with vs. without AI assistance. The device is described as "assistive" and requiring "user interaction," but no study on human performance improvement is detailed. Human Factors and Usability Validation was performed on the predicate device, not a comparative effectiveness study with AI assistance.

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

Yes, a standalone performance test was done for the "Electrode Contact Identification" algorithm. The text states: "The electrode contact identification algorithm has been applied on the test dataset. The testing demonstrated that the algorithm can accurately identify the electrode contacts." This confirms standalone algorithm testing. The user then "reviews the result and can manually adjust the contacts points," indicating the human-in-the-loop aspect during clinical use, but the initial detection was algorithm-only.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the "Electrode Contact Identification" feature: The ground truth was established by "electrode contacts marked" on "human temporal bone cadaver specimens" scanned with a Micro CT. This suggests expert marking/annotation on high-resolution imaging (Micro CT is considered a gold standard for anatomical detail beyond clinical CT).

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set for any of the algorithms or features. It focuses on the validation of the new features.

9. How the Ground Truth for the Training Set Was Established

Since the sample size for the training set is not provided, the method for establishing its ground truth is also not described in this document.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

June 24, 2022

Cascination AG Jean-Francois Clemence Head of Quality and Regulatory Affairs Steigerhubelstrasse 3 Bern, 3008 Switzerland

Re: K220300

Trade/Device Name: Otoplan Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QQE Dated: May 19, 2022 Received: May 23, 2022

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/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 (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/cdrl-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,

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220300

Device Name OTOPLAN

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CER 801 Subpart D)
□ Over-The-Counter Use (21 CER 801 Subpart C)

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Document ID:	CASC18-610911768-2798
Document Version:	5.0
Page:	1 of 8

Document Title:	Part ID and Name:
510(k) Summary	5200 OTOPLAN

510(K) SUMMARY

510(k) Number: K220300

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 5520441
Contact Person:	Dr. Jean-François ClémenceHead of Quality and Regulatory Affairs
Date Prepared:	June 22, 2022

II. SUBJECT DEVICE

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

The Subject Device (OTOPLAN version 2.0) is an updated version of the Predicate Device (OTOPLAN version 1.3).

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III. PREDICATE DEVICE

Primary Predicate Device

Company: CASCINATION AG, Steigerhubelstrasse 3, CH-3008 Bern, Switzerland Device name: OTOPLAN 510(k) number: K203486

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 arrav portfolio.

The information provided by OTOPLAN is solely assistive and for the benefit of 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) with a clock speed of 2.4 GHz .
. dedicated GPU with OpenGL 4.3 capabilities
. 250GB hard drive

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V. INDICATIONS FOR USE

VI. SUBSTANTIAL EQUIVALENCE

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 and 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 – Same for the subject and predicate device (new human factors testing was not required for the software update in the subject device).

Table 1

Summary of the Substantial Equivalence Comparison to Predicate Device

Item	Subject Device(OTOPLAN version 2.0)	Predicate Device(OTOPLAN version 1.3)	Conclusion
Intended Use
Intended Use	Plan surgical procedures inthe head and neck area bymedical professionals	Plan surgical procedures inthe head and neck area bymedical professionals	⇒ SameBoth the subject andpredicate deviceshave the sameintended use
Item	Subject Device(OTOPLAN version 2.0)	Predicate Device(OTOPLAN version 1.3)	Conclusion
Indications ForUse Statement	OTOPLAN is intended to beused by otologists andneurotologists as a softwareinterface allowing the display,segmentation, and transfer ofmedical image data frommedical CT, MR, and XAimaging systems to investigateanatomy relevant for thepreoperative planning andpostoperative assessment ofotological and neurotologicalprocedures (e.g., cochlearimplantation).	OTOPLAN is intended to beused by otologists andneurotologists as a softwareinterface allowing the display,segmentation, and transfer ofmedical image data frommedical CT, MR, and XAimaging systems to investigateanatomy relevant for thepreoperative planning andpostoperative assessment ofotological and neurotologicalprocedures (e.g., cochlearimplantation).	⇒ SameBoth the subject andpredicate deviceshave the sameindications for usestatement
User	Medical professionals suchas otologists,neurotologists, andaudiologists	Medical professionals suchas otologists,neurotologists, andaudiologists	⇒ SameBoth the subject andpredicate deviceshave the same user
Technical Characteristics
Type	Standalone Software. Doesnot control the functions orparameters of any medicaldevice	Standalone Software. Doesnot control the functions orparameters of any medicaldevice	⇒ Same
OperatingSystem	Windows 10	Windows 10	⇒ Same
Functions	• Cochlear Parametrization(based on establishedformula)• Audiogram• Electrode Visualization• Virtual Trajectory Planning• Postoperative QualityChecks• Export Report	• Cochlear Parametrization(based on establishedformula)• Audiogram• Electrode Visualization• Virtual Trajectory Planning• Postoperative QualityChecks• Export Report	⇒ Same
3DReconstructionFunctions(same)	• 3D reconstruction• Temporal bone• Incus, Malleus• Stapes• Facial nerve• Chorda tympaniExternal ear canal	• 3D reconstruction• Temporal bone• Incus, Malleus• Stapes• Facial nerve• Chorda tympaniExternal ear canal	⇒ Same
Item	Subject Device(OTOPLAN version 2.0)	Predicate Device(OTOPLAN version 1.3)	Conclusion
3DReconstructionFunctions(NEW withSAMEtechnical.Characteristic.)	• 3D reconstruction• Cochlea• Sigmoid sinus• Cochlear bony overhang• Cochlear round window		⇒ Sametechnical characteristicas functionsincluded in thepredicate device(see discussionbelow)
3DReconstructionFunctions(NEW withDIFFERENTtechnical.Characteristic.)	• 3D reconstruction• Electrode contacts		⇒ Differenttechnical characteristicwhich does notaffect the safety andeffectiveness. (seediscussion below)
PerformanceTesting	Software design verificationand validation anddocumentation (thesoftware for this devicewas considered a"moderate" level ofconcern.)Formal Internal TestingStandards	Software design verificationand validation anddocumentation (thesoftware for this devicewas considered a"moderate" level ofconcern.)Formal Internal TestingStandardsHuman Factors Testing	⇒ Same(new Human Factorsand UsabilityTesting was notrequired for thesoftware update inthe subject device)

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Substantial Equivalence Discussion

The Subject Device OTOPLAN (version 2.0) is an updated version of the Predicate Device OTOPLAN (version 1.3). Both the Subject Device OTOPLAN (version 2.0) and the Predicate Device OTOPLAN (version 1.3) have the same Intended Use.

The subject device introduces five new functions in the 3D reconstruction module.

From those five functions, four functions have the same technological characteristics as functions already included in the predicate device. They use the same process and numerical computation as functions in the predicate device. Those functions are same as the functions already included in the predicate device, for illustration purposes only.

Cochlea and Cochlear bony overhang functions: Use the same reconstruction method as the temporal bone function in the predicate device. The user selects the boundary box and intensity threshold for the segmentation and reviews the result. This results in an illustration of the Cochlea and Cochlear bony overhang.

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Sigmoid sinus function: Uses the same reconstruction method as the facial nerve function in the predicate device. In both the user must set landmark points along the structure (facial nerve or sigmoid sinus). In a second step, the user must adjust the border points manually in a panoramic view along the structure. This results in an illustration of the Sigmoid sinus.

Cochlear round window function: Same as in the Stapes function of the predicate device, there is no numerical algorithm involved. The user manually defines four landmark points surrounding the round window. Based on these anatomical landmarks, an ellipse is fitted for illustrating the round window.

This safety and performance have been demonstrated through Software validation activities and documentation.

Discussion of Technological Differences:

The subject device and predicate device have one different technological characteristic in the 3D reconstruction module. The subject device allows the automatic detection of electrode contacts. Specific Non-Clinical Performance Testing and Software Validation has been carried out for this function. Human temporal bone cadaver specimens with cochlear implant electrodes arrays implanted were scanned with a Micro CT and electrode contacts marked for the ground truth dataset. The same specimens were scanned with clinical CTs for the test datasets. The electrode contact identification algorithm has been applied on the test dataset. The testing demonstrated that the algorithm can accurately identify the electrode contacts. The user reviews the result and can manually adjust the contacts points (same as in the predicate device). Through performance testing (see Section VII), it has been demonstrated that this technological difference does not adversely affect the safety and effectiveness of the subject device and is substantially equivalent to the predicate device.

Conclusion - Substantial Equivalence Discussion:

The subject device is substantially equivalent to the predicate device with regard to intended use, safety, and effectiveness. 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 determination.

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.

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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 effectiveness of the subject device. Software validation and documentation was prepared according to the "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 with the predicate device 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 included a summative evaluation carried out in the US with 15 users from each user group. OTOPLAN has been found to be safe and effective for the intended users, uses, and use environments. New human factors testing was not required for the software update from the predicate device (version 1.3) to the subject device (version 2.0).

Internal Test Standards

Internal Test Protocols were executed and documented in test Reports to demonstrate performance characteristics of OTOPLAN. This included tests with data sets with known dimensions which were loaded into OTOPLAN and results compared to the know dimension. For the electrode contact identification function, the data sets consisted of human temporal bone cadaver specimens which were scanned with a Micro CT for ground truth and clinical CT for the test datasets. All test 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 non-clinical

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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).