Sira Medical Augmented Reality Application is intended as a medical imaging system that allows the processing, review, analysis, and communication of augmented reality images acquired from the same data used to generate conventional CT scans and MRIs. Sira Medical software is designed for preoperative surgical planning and intended to be used by trained and qualified clinicians who are responsible for making patient management decisions.

Device Description

The Sira Medical Augmented Reality Application is used for viewing and manipulating 3D models created by the Sira 3D Image Preparation Service from customer-supplied anonymized (de-identified) imaging in Augmented Reality (AR) on a Head Mounted Display (HMD). The application allows the user to manipulate one or more 3D models in real time in an Augmented Reality (AR) environment. The user can view the model, adjust the orientation, scale, rotate and position the models within the AR visual space. Models can be sliced to create separate objects or merged together to create a single object. These models are used for preoperative surgical planning but are not used intraoperatively (during surgical procedures).

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria, a study proving the device meets those criteria, or quantitative performance metrics for the Sira Medical Augmented Reality Application.

The document discusses the device's intended use, its substantial equivalence to a predicate device (Albolit Technologies, LLC, Aibolit 3D+), and general non-clinical performance testing. However, it does not provide the specific data needed to complete the requested table or answer the specific questions about sample sizes, ground truth establishment, or multi-reader multi-case studies.

Here's a breakdown of what is and is not available in the provided text:

Information Available:

Acceptance Criteria/Performance (General): The document states that "The results demonstrated that the Sira Medical, Inc. Augmented Reality Application performs according to its specifications and functions as intended." This is a general statement of performance but lacks specific, quantifiable acceptance criteria or reported device performance metrics.
Study Types: Non-clinical performance testing included:
- Software verification and validation testing (IEC 62304).
- Human factors testing (IEC 62366-1).
Ground Truth Type (Implied for training or preparation): The process involves a radiologist annotating (segmenting) images and identifying organs, which forms a kind of expert-derived ground truth for the 3D model generation. This isn't for testing the AI, but rather for the workflow of creating the augmented reality models.

Information NOT Available (and thus cannot be answered from the text):

A table of specific acceptance criteria and reported device performance.
Sample sizes used for test sets.
Data provenance (country of origin, retrospective/prospective).
Number of experts used for ground truth or their qualifications for a test set.
Adjudication method for a test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study information (effect size, human reader improvement with/without AI).
Standalone (algorithm-only) performance data.
Specific ground truth type used for testing the device's performance against quantifiable criteria.
Sample size for the training set.
How the ground truth for the training set was specifically established beyond "Radiologist annotates sample (segments) images." (e.g., how consistency was ensured, specific software used for ground truth labeling if applicable to an AI component if one existed for segmentation).

Based on the available text, here is what can be inferred or directly stated, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified quantitatively in the provided text.	"The results demonstrated that the Sira Medical, Inc. Augmented Reality Application performs according to its specifications and functions as intended." (No quantitative metrics provided.)

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not specified in the provided text.
Data Provenance: Not specified in the provided text. The device processes "customer-supplied anonymized (de-identified) imaging."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified for a test set.
Qualifications: For the workflow description (how the 3D models are created), it states "Radiologist annotates sample (segments) images" and "Radiologist reviews images generated by imaging technician." This implies medical doctors, specifically radiologists, are involved in defining anatomical structures.

4. Adjudication method for the test set

Not specified in the provided text, as specific test set details are absent.

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

Not mentioned or detailed in the provided text. The device is for "preoperative surgical planning" and helps clinicians, but there's no mention of a comparative effectiveness study with AI assistance on human reader performance.
- Note: The subject device's workflow states "Radiologist annotates sample (segments) images," while the predicate's workflow mentions "AI software facilitates annotation of available images under guidance and control by the Radiologist." This difference might imply the predicate has an AI component for annotation, but the subject device does not explicitly mention AI for this specific function in its workflow description.

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

Not mentioned or detailed in the provided text. The device is described as "designed for preoperative surgical planning and intended to be used by trained and qualified clinicians who are responsible for making patient management decisions," implying a human-in-the-loop context.

7. The type of ground truth used

For the generation of 3D models (part of the device's function): Expert consensus/annotation by Radiologists (MDs) is used for image segmentation and organ identification. This forms the basis for the 3D models viewed in AR. This isn't a "ground truth" for testing the device's accuracy against a gold standard, but rather how the input data for the AR visualization is prepared.
For performance testing of the device itself: Not explicitly stated. The "Software verification and validation testing" and "Human factors testing" are mentioned, but the nature of the ground truth or criteria for these tests isn't detailed.

8. The sample size for the training set

Not specified in the provided text.

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

Not explicitly stated for a "training set." However, for the process of creating the 3D models viewed by the device, the text states: "By Radiologist (MD) - Manual annotation is done for all image data" for image segmentation, and organ identification is "By Radiologist." This suggests expert manual annotation by radiologists is the method for establishing the anatomical definitions used by the system. If there were an AI component for segmentation, this manual annotation would likely be its ground truth for training. The subject device description indicates manual annotation ("Radiologist annotates sample (segments) images") for the generation of the images used by the AR application.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Sira Medical, Inc. % Richelle Helman Senior Director MEDIcept. INC, 200 Homer Avenue ASHLAND, MASSACHUSETTS 01721

February 1, 2024

Re: K232339

Trade/Device Name: Augmented Reality Application Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: August 4, 2023 Received: January 11, 2024

Dear Richelle Helman:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jessica Lamb

Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232339

Device Name Augmented Reality Application

Indications for Use (Describe)

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)

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Image /page/3/Picture/0 description: The image shows the logo for SIRA MEDICAL. The logo consists of a blue cube on the left, followed by the text "SIRA MEDICAL" in blue and black. The "SIRA" part of the text is in blue, while the "MEDICAL" part is in black.

Date:	31-January-2024
Company:	Sira Medical, Inc.14 Stanford Heights AvenueSan Francisco, CA 94127Phone: (917) 864-5083
Official Contact:	Richelle HelmanSenior Director, Regulatoryrhelman@medicept.com
Proprietary or Trade Name:	Augmented Reality Application
Regulation Name:	Medical Image Management and Processing System
Classification Name:	System, Image Processing, Radiological
Regulation Number:	21 CFR 892.2050, Class IIClassification Product Code: LLZ

Device Description:

Indications for Use:

Substantial Equivalence:

The Sira Medical, Inc. Augmented Reality Application is substantially equivalent to the predicate device, the Albolit Technologies, LLC, Aibolit 3D+ (510(k) K211443). The table below presents the similarities and differences between the products for substantial equivalence purposes. The differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness. Performance data are available to support substantial equivalence.

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Image /page/4/Picture/0 description: The image shows the logo for SIRA MEDICAL. The logo consists of a blue cube on the left and the text "SIRA MEDICAL" on the right. The letters "SI" and "RA" are in blue, while the rest of the letters are in black.

Characteristic	Subject Device:	Predicate Device:
	Augmented Reality Application	Aibolit 3D+
Indications for Use	Sira Medical Augmented RealityApplication is intended as amedical imaging system thatallows the processing, review,analysis, and communication ofaugmented reality imagesacquired from thesame data used to generateconventional CT scans and MRIs.Sira Medical software is designedfor preoperative surgical planningand intended to be used by trainedand qualified clinicians who areresponsible for making patientmanagement decisions.	[510(k) K211443]Aibolit 3D+ is intended as a medicalimaging system that allows theprocessing, review, analysis,communication and mediainterchange of multidimensionaldigital images acquired from CTimaging devices. It is also intendedas software for preoperative surgicalplanning, training, patientinformation and as software for theintraoperative display of themultidimensional digital images.Aibolit 3D+ is designed for use byhealth care professionals and isintended to assist the clinician whois responsible for making all finalpatient management decisions.
Intended Use	Provides one or more capabilitiesrelating to the review and digitalprocessing of medical images forthe purposes of interpretation by atrained practitioner of diseasedetection, diagnosis or patientmanagement. The softwarecomponents may provideadvanced or complex imagingprocessing functions for imagemanipulation, enhancement, orquantification that are intended foruse in the interpretation andanalysis of medical images.Advanced image manipulationfunctions may include 3Dvisualization.	Provides one or more capabilitiesrelating to the review and digitalprocessing of medical images forthe purposes of interpretation by atrained practitioner of diseasedetection, diagnosis or patientmanagement. The softwarecomponents may provide advancedor complex imaging processingfunctions for image manipulation,enhancement, or quantification thatare intended for use in theinterpretation and analysis ofmedical images. Advanced imagemanipulation functions may include3D visualization.
Mechanism of Action	Capture and enhancement of(DICOM) digital images viasoftware-based conversion to 2-Dand 3-D anatomical structureimages that can be manipulatedfor viewing	Capture and enhancement of(DICOM) digital images viasoftware-based conversion to 2-Dand 3-D anatomical structureimages that can be manipulated forviewing
Intended Users	Health care professionals	Health care professionals
Intended Use Environment	Healthcare facilities such ashospitals and clinics	Healthcare facilities such ashospitals and clinics
Format of Captured Images	DICOM	DICOM
Security	Data coded and HIPAA compliant	Data coded and HIPAA compliant
Characteristic	Subject Device:	Predicate Device:
	Augmented Reality Application	Aibolit 3D+
		[510(k) K211443]
Form of Device	Sira Medical is a software only device that permits electronic image uploads, provides image conversion and allows viewing on a head mounted device.	Aibolit 3D+ is a software only device that permits electronic image uploads, provides image conversion and allows viewing on a mobile device or standard computer monitor.
Image processing	High-definition digital images	High-definition digital images
Functions	Generation of 2D and 3D images from DICOM data Organ segmentation and structure identification Dimensional and volume references Multi-axis image rotation Organ transparency	Generation of 2D and 3D images from DICOM data Organ segmentation and structure identification Dimensional and volume references Multi-axis image rotation Organ transparency Organ retraction animation
Body contact	None	None
User Interface and System Work-Flow	Physician uploads DICOM images and specifies desired anatomical segments of interestRadiologist annotates sample (segments) imagesSoftware facilitates annotation of available images under guidance and control by the RadiologistImaging technician generates multi-axis rotatable image and retraction modelRadiologist reviews images generated by imaging technician and returns output file to requesting physician	Physician uploads DICOM images and specifies desired anatomical segments of interestRadiologist annotates sample (segments) imagesAI software facilitates annotation of available images under guidance and control by the RadiologistImaging technician generates multi-axis rotatable image and retraction modelRadiologist reviews images generated by imaging technician and returns output file to requesting physician
External / Internet Connections	Web-based software	Web-based software
Image Uploading	By requesting physician	By requesting physician
Other User Inputs	List of organ structures to be annotated and displayed, patient ID and demographics	List of organ structures to be annotated and displayed, patient ID and demographics
Characteristic	Subject Device:	Predicate Device:
Image Segmentation	By Radiologist (MD) - Manual annotation is done for all image data	Aibolit 3D+[510(k) K211443]By Radiologist (MD) - Manual annotation is done for all CT slices with optional use of AI/ML algorithms as determined by Radiologist and with Radiologist's approval
Organ Identification	By Radiologist	By Radiologist
3D Image generation	3D image file generated by 3rd party software (Osirix MD) following Radiologist review and approval of annotation	3D image file generated by 3rd party software (3D Slicer) following Radiologist review and approval of annotation
Organ structure identification	Proprietary software assigns color coding to each structure identified by Radiologist and displays color-coded image	Proprietary software assigns color coding to each structure identified by Radiologist and displays color-coded image with labeled key to color/structure identity
Image editing permission	Only the radiologist can alter or edit images following review - User physicians cannot edit images - Physicians have option to show or hide organs on display	Only the radiologist can alter or edit images following review - User physicians cannot edit images - Physicians have option to show or hide organs on display
Device Output Devices	3D image can be displayed on augmented reality 3D headset	3D image can be displayed on standard monitor
Supplemental outputs	Organ structure dimensions, volume, organ labels, patient ID, CT date and demographics	Organ structure dimensions, volume, organ labels, patient ID, CT date and demographics
Output image manipulation by user	Physician user can show or hide individual organ structures, zoom capability, rotational capability and transparency capability	Physician user can show or hide individual organ structures, zoom capability, rotational capability and transparency capability

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Image /page/5/Picture/0 description: The image shows the logo for SIRA MEDICAL. The logo consists of a blue cube-like shape on the left, followed by the text "SIRA MEDICAL" in blue and black. The "SIRA" part of the text is in blue, while the "MEDICAL" part is in black.

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Image /page/6/Picture/0 description: The image shows the logo for SIRA MEDICAL. The logo consists of a blue cube on the left, followed by the text "SIRA MEDICAL" in blue and black. The "SIRA" part of the text is in blue, while the "MEDICAL" part is in black.

From the comparison form above, the subject device and predicate device have the same intended use and the same operating principle as a medical imaging system for the display of multidimensional digital images. The minor differences in the devices do not raise different questions of safety or effectiveness.

Non-clinical performance testing:

Bench / Performance Testing -

Software verification and validation testing were conducted as required by IEC 62304 . and documentation was provided as recommended by FDA Guidance "Content of Premarket Submissions for Software Contained in Medical Devices".
. Human factors testing was conducted in compliance with the requirements of IEC 62366-1 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices". Test participants representing the intended users of the device were included in the human factors validation testing. Observational data as well as interview

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Image /page/7/Picture/0 description: The image shows the logo for SIRA MEDICAL. The logo consists of a blue cube-like shape on the left, followed by the text "SIRA MEDICAL" in blue and black. The "SIRA" part of the text is in blue, while the "MEDICAL" part is in black.

data were recorded. The observation of participant performance and the assessment of their understanding of essential information through the interview confirmed that the design of the device is safe and effective for the intended users, uses and use environments.

The results demonstrated that the Sira Medical, Inc. Augmented Reality Application performs according to its specifications and functions as intended.

Substantial Equivalence Conclusion

The Sira Medical, Inc. Augmented Reality Application has the same intended use and the same operating principle as the predicate device. The performance testing demonstrated that the subject device can perform the same intended use as safely and effectively as the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.

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).