The VAULT® System is intended for use as a software interface and image manipulation system for the transfer of imaging information from a medical scanner such as Computerized Axial Tomography (CT) or Magnetic Resonance Imaging (MRI). It is also intended as pre-operative software for simulating/evaluating implant placement and surgical treatment options. The physician chooses the out-put data file for printing and/or subsequent use in CAD modeling or CNC/Rapid-prototyping.

Device Description

The VAULT® System software described here was developed in conformance with reference to the FDA Guidance Document for Industry "Guidance for the Submission of Premarket Notifications for Medical Image Management Devices, July 27, 2000". Based on the information contained in Section G of that document, a final determination of submission content was developed. A secondary reference entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. May 11, 2005 was also used and resulted in a determination of a "MODERATE" level of concern for the software.

The UAULT® System software is made available to the user via a web-accessed software interface. The program is a surgeon directed surgical planning package primarily but not exclusively directed at trauma and orthopedic indications. After secure log-in the user requests, creates, reviews and finally authorizes their desired surgical plan. When authorizing, the surgeon/user may choose additional options such as implant sizing and/or various file output options.

AI/ML Overview

The VAULT® System Surgery Planning Software received 510(k) clearance (K124051) from the FDA. The submission focused on demonstrating substantial equivalence to predicate devices (Mimics Software - K073468 and TraumaCAD Software- K073714) rather than a direct study against predefined acceptance criteria for a novel device. The performance data was evaluated through non-clinical testing.

Here's an breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission demonstrating substantial equivalence, explicit "acceptance criteria" in the sense of predefined thresholds for diagnostic performance metrics (like sensitivity, specificity, AUC) are not presented in the same way as for a novel diagnostic AI device. Instead, the "acceptance criteria" are implied by the functional and safety requirements defined for the VAULT® System and its performance being "equivalent" to the predicates.

Feature/Requirement	Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence
Image Transfer	Transfer imaging information from CT/MRI scanners.	The VAULT® System is intended for use as a software interface and image manipulation system for the transfer of imaging information from a medical scanner such as Computerized Axial Tomography (CT) or Magnetic Resonance Imaging (MRI).
Preoperative Planning	Simulate/evaluate implant placement and surgical treatment options.	It is also intended as pre-operative software for simulating/evaluating implant placement and surgical treatment options.
Output File Generation	Physician chooses output data file for printing/CAD modeling/CNC/Rapid-prototyping.	The physician chooses the out-put data file for printing and/or subsequent use in CAD modeling or CNC/Rapid-prototyping. Additional options include implant sizing and/or various file output options.
DICOM Image Use	Use DICOM images.	Yes, uses DICOM images (from feature comparison table). Digital file image upload controlled by DICOM process met specifications. The VAULT® System performs initial conversion of image files to graphical formats (JPEG, BMP, PNG, TIFF) before planning, an improvement over predicates which convert post-plan.
Overlays & Templates	Support overlays and templates.	Yes, supports overlays and templates (from feature comparison table).
Accuracy & Integrity
Anatomical Model Testing	Required level of accuracy and functionality for anatomical and phantom models.	Anatomical and phantom model digital file testing demonstrated the required level of accuracy and functionality.
Image File Integrity	Image file integrity, accuracy, and suitability after conversion, save, and transfer operations.	Image file integrity, accuracy and suitability following required conversion, save and transfer operations met all specifications.
Image Calculations & Measurement	Calculations & measurement of anatomic features and landmarks meet specifications.	Image calculations & measurement of anatomic features and landmarks meets specifications.
Safety	Absence of control over life-saving devices; adherence to safety risk/hazard analysis.	Does not control life-saving devices (from feature comparison table). Safety requirements were developed using a safety risk/hazard analysis based on ISO 14971:2007 approach.
Software Validation	Traceability, boundary values, and stress testing as per FDA guidance.	Functional requirements as defined by the VAULT® System Software Requirements Specification (SRS) were tested and traceability was performed and documented using FDA's General Principles of Software Validation guidance document. Validation included boundary values and stress testing as defined by the FDA's Guidance for the Content of Premarket Submission for Software Contained in Medical Devices guidance document.

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

The document does not specify a distinct "test set" with a particular sample size of patient data. The non-clinical performance data relied on:

"Anatomical and phantom model digital file testing": The exact number of models used is not specified.
The testing of various software functionalities (DICOM process, image file integrity, calculations, measurements).

The data provenance is not explicitly stated as country of origin or retrospective/prospective data for a clinical study. The testing appears to be primarily software functional and performance testing using internal data (anatomical and phantom models) rather than a large clinical dataset.

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

The document does not describe the use of human experts to establish ground truth for a diagnostic test set in the conventional sense. The "ground truth" for the software's performance seems to be based on:

Specifications: Whether the software performed according to its defined functional and safety specifications ("met specifications").
Accuracy against known physical/digital models: For anatomical and phantom model testing, the "ground truth" would be the known parameters of these models.

There are no details provided about experts involved in establishing this "ground truth" or their qualifications.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe an adjudication method as would be used for a clinical study involving human readers or interpretation of results. The testing was focused on meeting software specifications.

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 involving human readers with and without AI assistance was not described or conducted. This submission focused on the functional equivalence of the software to existing predicate devices.

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

Yes, the performance testing described is essentially "standalone" in the sense that it evaluates the software's inherent functions (image processing, calculations, file handling) without explicitly measuring its impact on human reader performance or a human-in-the-loop scenario. The assessment is of the software itself fulfilling its defined requirements.

7. The Type of Ground Truth Used

The ground truth used for testing appears to be primarily:

Software Specifications: The software's ability to "meet specifications" for various functions (DICOM process, image integrity, calculations, measurements).
Reference Data/Models: For "anatomical and phantom model digital file testing," the ground truth would be the known, accurate parameters of these models against which the software's output was compared.

It does not mention ground truth derived from expert consensus, pathology, or outcomes data in a clinical trial setting.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI algorithm development. The VAULT® System appears to be a rule-based or traditional image processing software rather than an AI/ML-driven device that requires training data. No training set size is mentioned.

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

Not applicable, as a training set for machine learning is not mentioned or implied by the device's description or the validation approach.

Summary

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K124051

Section 510(k) Releasable Summary

VAULT® System Surgery Planning Software

MAY 1 7 2013

Proprietary Name:

Surgery Planning Software

Classification Name

& CFR Reference:

Common Name:

Sec. 892.2050 System, image processing, radiological

(a) Identification. A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its' hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

(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). [63 FR 23387. Apr. 29. 1998]

Regulatory Class: Class II

Device Product Code: LLZ

Company Contact:

Mr. David W. Schlerf Somersault Orthopedics, Inc. 142 N. Milpitas Blvd., Suite 262 Milpitas, CA 95035-4401 925.768.0247 - Direct

April 12. 2013 Date Prepared:

Predicate Device(s): 1) Mimics Software - K073468 · 2) TraumaCAD Software- K073714

Summary Device Description: The WAULT® System software described here was developed in conformance with reference to the FDA Guidance Document for Industry "Guidance for the Submission of Premarket Notifications for Medical Image Management Devices, July 27, 2000". Based on the information contained in Section G of that document, a final determination of submission content was developed. A secondary reference entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. May 11, 2005 was also used and resulted in a determination of a "MODERATE" level of concern for the software.

187

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Discussion of Similarities and Differences: The primary and most immediately noticeable difference is that the VAULT® Sustem software is Web-based while the predicate devices are local (PC/Laptop/Notebook) or local server based (hospital/clinic/office). Locally installed software presents minor to major complicating factors related to version, hardware, speed, operating system conflicts, etc. Those complicating factors are eliminated or reduced by direct company control of single edition server based web-portal program access. All users access the same optimized revision level software.

A second apparent difference in the basic operation of the Vault System and the predicate(s) software is the initial mass conversion and use of graphical images such as JPEG, BMP, PNG, of TIFF by the Vault System for planning. Both Mimics and TraumaCAD perform their planning on the DICOM images and then save/export files to JPEG file format(s) for presentation and export/import purposes.

The difference between the systems is the fact that the predicate software packages perform DICOM to JPEG conversion as a post-plan individual step. The WAULT® Sustem software performs this activity initially, converting all image files at once before planning and saving or exporting, Functionally there is no significant difference between the program capabilities other than improved performance on the part of the VAULT® System software.

188

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Feature	VAULT® System	MimicsK073468	TraumaCADK073714
Indication for	The VAULT® System is intended for	Mimics software is intended	The TraumaCAD program is
Use:	use as a software interface and	for use as a software interface	indicated for assisting healthcare
	image manipulation system for the	and image manipulation	professionals in preoperative
	transfer of imaging information	system for the transfer of	planning of orthopedic surgery.
	from a medical scanner such as	imaging information from a	The device allows for overlaying
	Computerized Axial Tomography	medical scanner such as a CT	of prosthesis templates on
	(CT) or Magnetic Resonance	scanner or Magnetic	radiological images, and
	Imaging (MRI). It is also intended	Resonance Imaging scanner	includes tools for performing
	as pre-operative software for	to an output file. It is also	measurements on the image and
	simulating/evaluating implant	intended as preoperative	for positioning the template.
	placement and surgical treatment	software for simulating /	Clinical judgments and
	options. The physician chooses the	evaluating surgical treatmentoptions. Mimics is not	experience are required toproperly use the software.
	out-put data file for printing and/orsubsequent use in CAD modeling	intended for mammography
	or CNC/Rapid-prototyping	imaging.
Classification:	Class II	Class II	Class II
ProCode:	LLZ	1.1.7.	1.1.7.
Computer:	PC Compatible	PC & Workstation	PC Compatible
		Compatible
# of on-Screen	J	()ne	Onc
. Images
Runs on	Yes	ا es	Yes
Server
Elective
Procedures	Yes	Yes	Yes
Overlav &
Templates	Yes	Yes	Yes
Preoperative
Planning	Yes	Yes	Yes
Controls Life
Saving Devices	No	No	No
Uses DICOM
images	Yes	Yes	Yes
Expandability	Yes	Yes	Yes

Summary Non-Clinical Performance Data: Performance data were evaluated by conducting and repeating a defined series of objective and subjective test conditions. Results of this testing demonstrates that the UAULT® System provides an equivalent level of performance and clinical utility to the cited equivalent comparison software systems. Functional requirements as defined by the VAULT® System Software Requirements Specification (SRS) were tested and traceability was performed and documented using FDA's General Principles of Software Validation guidance document.

Safety requirements were developed using a safety risk/hazard analysis based on ISO 14971:2007 approach. Validation included boundary values and stress testing as defined by the FDA's Guidance for the Content of Premarket Submission for Software Contained in Medical Devices guidance document. Software testing addressed the following areas of functionally.

. Anatomical and phantom model digital file testing demonstrated the required level of accuracy and functionality.
. Digital file image upload controlled by DICOM process met specifications.

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Image file integrity, accuracy and suitability following required conversion, save and . transfer operations met all specifications.
. Image calculations & measurement of anatomic features and landmarks meets specifications.

Indication for Use: The VAULT® System is intended for use as a software interface and image manipulation system for the transfer of imaging information from a medical scanner such as Computerized Axial Tomography (CT) or Magnetic Resonance Imaging (MRI). It is also intended as pre-operative software for simulating/evaluating implant placement and surgical treatment options. The physician chooses the out-put data file for printing and/or subsequent use in CAD modeling or CNC/Rapid-prototyping.

Conclusion: Substantial equivalence is represented by comparison with the published capabilities of the predicate software devices. The referenced devices have equivalent uses, restrictions, clinical utility, safety and effectiveness to the VAULT® System. It is concluded that the VAULT® System may be reasonably expected to perform in a manner equivalent to the predicate devices. No new issues of either safety or effectiveness are raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird-like figure with three wing-like shapes.

Public Health Service

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

May 17, 2013

Somersault Orthopedics, Inc. % Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

Re: K124051

Trade/Device Name: Vault® System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Il Product Code: LLZ Dated: April 15, 2013 Received: April 19, 2013

Dear Mr. Job:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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Page 2 - Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K124051

Device Name:

VAULT® System

Indications for Use:

The VAULT® System is intended for use as a software interface and image manipulation system for the transfer of imaging information from a medical scanner such as Computerized Axial Tomography (CT) or Magnetic Resonance Imaging (MRI). It is also intended as preoperative software for simulating implant placement and surgical treatment options. The physician chooses the out-put data file for printing and/or subsequent use in CAD modeling or CNC/Rapid-prototyping.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Smh7).

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k): K124051

Page 1 of 1

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).