The OFIX MIS App software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The app allows service providers to plan surgical procedures by making measurements for the placement of surgical implants. Clinical judgement and experience are required to properly use the software.

Device Description

The OFIX MIS App will provide a novel mobile phone solution to supplement the use of calipers when selecting rods used in immobilization of pedicle screw type spinal systems. The App will rely on capturing 2D images used in spinal implant procedures through use of mobile phone camera. The App measures the difference between known Orthofix pedicle screw diameters and provides feedback useful in determining appropriate rod length with corresponding Orthofix product number.

AI/ML Overview

The OFIX MIS App is a software designed to assist healthcare professionals in viewing, storing, measuring images, and planning orthopedic surgeries, specifically by measuring anatomical components for the placement of surgical implants. The device helps determine appropriate rod length with corresponding Orthofix product numbers by capturing 2D images used in spinal implant procedures via a mobile phone camera.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly detail specific quantitative acceptance criteria (e.g., minimum accuracy percentages, maximum error margins) and their corresponding reported device performance values. Instead, it broadly states that "The testing demonstrated that the App meets the required specifications." and "The OFIX MIS App demonstrated accuracy and usability with bench top and simulated use testing."

However, based on the device's function, the implied acceptance criteria would revolve around the accuracy of measurements and the usability of the app for surgical planning. The provided information indicates compliance with these general requirements.

Acceptance Criteria (Implied)	Reported Device Performance (Summary from text)
Accuracy of measurements	"demonstrated accuracy"
Usability for surgical planning	"demonstrated usability"
Meeting required specifications	"meets the required specifications"
Safety and effectiveness	"testing data support the safety and effectiveness"
Performance as intended	"demonstrate performance as intended in the specified use conditions"

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

The document does not specify the sample size used for the test set. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the images used for testing). The testing is described as "bench top and simulated use testing," which implies either synthetic data, controlled clinical images, or a mix, but no details are given.

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

The document does not provide information regarding the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the test set (e.g., 2+1, 3+1, none).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not indicate that an MRMC comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance and usability of the OFIX MIS App.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was implicitly done. The "Software Verification and Validation Testing" and "Usability Testing" sections describe the evaluation of the App itself to ensure it meets specifications and demonstrates accuracy and usability. The statement "The OFIX MIS App demonstrated accuracy and usability with bench top and simulated use testing" suggests testing of the algorithm's performance and the app's functionality independent of clinical human performance metrics.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the nature of the device (measurement and planning), it is highly probable that a "gold standard" of measurement, likely derived from manual measurements by qualified experts or using high-precision instruments on the test images, would have been used as the ground truth.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions the algorithm is "not machine-learning based," which implies that there might not have been a traditional "training set" in the machine learning sense. Instead, the algorithm relies on "information specific to Orthofix implant systems."

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

Since the algorithm is explicitly stated as "not machine-learning based" and uses "information specific to Orthofix implant systems," there wouldn't be a typical training set with corresponding ground truth established in the way machine learning models are trained. Instead, the "ground truth" or foundational data for the algorithm would be the known, precise specifications and dimensions of Orthofix's pedicle screws and rods, likely derived from their engineering and manufacturing data. The algorithm would then use these pre-defined parameters to process the captured images and recommend appropriate rod lengths.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

Orthofix US LLC % Shant Aghyarian Regulatory Affairs Program Manager 3451 Plano Parkway LEWISVILLE TX 75056

September 26, 2023

Re: K230252

Trade/Device Name: OFIX MIS App Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: January 31, 2023 Received: August 30, 2023

Dear Shant Aghyarian:

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 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

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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/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, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K230252

Device Name

OFIX MIS App

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 features the logos of two companies, Orthofix and SeaSpine, side by side. The Orthofix logo is in blue and black, with a stylized blue symbol to the left of the company name. The SeaSpine logo is in orange and blue, with a stylized blue symbol to the left of the company name.

510(k) SUMMARY

K230252

OFIX MIS App

510(k) Owner InformationName:Address:	Orthofix US LLC3451 Plano ParkwayLewisville, TX, USA
Telephone Number:Fax Number:Email:	214-937-2176214-937-3322shantaghyarian@orthofix.com
Registration Number:	2183449
Contact Person:	Shant Aghyarian
Date Prepared:	September 21, 2023
Name of DeviceTrade Name / ProprietaryName:	OFIX MIS App
Common Name:	OFIX MIS App
Product Code(s):	LLZ
Classification Name:	System, Image Processing, Radiological
Regulatory Class:	Class II per 21 CFR 892.2050
Predicate Devices:	Nemaris Surgimap 2.0, K141669

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Image /page/4/Picture/0 description: The image shows the logos of two companies, Orthofix and SeaSpine. The Orthofix logo is on the left and consists of a blue abstract shape followed by the word "ORTHOFIX" in bold, black letters. To the right of the Orthofix logo is the SeaSpine logo, which features a stylized wave design in blue and gray, followed by the word "SeaSpine" in orange.

Device Description OFIX MIS App

The OFIX MIS App will provide a novel mobile phone solution to supplement the use of calipers when selecting rods used in immobilization of pedicle screw type spinal systems. The App will rely on capturing 2D images used in spinal implant procedures through use of mobile phone camera. The App measures the difference between known Orthofix pedicle screw diameters and provides feedback useful in determining appropriate rod length with corresponding Orthofix product number.

Indications for Use

The OFIX MIS App software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The App allows service providers to plan surgical procedures by including tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

Technological Comparison

The technological comparison is provided as the Substantial Equivalence table below.

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Image /page/5/Picture/0 description: The image shows the logos of two companies, Orthofix and SeaSpine, side by side. The Orthofix logo is on the left and consists of a blue abstract shape followed by the company name in black, bold letters. A vertical line separates the two logos, and the SeaSpine logo is on the right, featuring a stylized wave design in gray and the company name in orange.

Substantial Equivalence Table

Specification/Property	Predicate DeviceNemaris Surgimap 2.0 (K141669)	Subject DeviceOFIX MIS App	Discussion
Intended Use / Indications forUse	The Surgimap software assists healthcare professionalsin viewing, storing, and measuring images as well asplanning orthopedic surgeries. The device allows serviceproviders to perform generic as well as specialtymeasurements of the images, and to plan surgicalprocedures. The device also includes tools for measuringanatomical components for placement of surgicalimplants and offer online synchronization of the databasewith the possibility to share data among Surgimap users.Clinical judgment and experience are required toproperly use the software.	The OFIX MIS App software assistshealthcare professionals in viewing,storing, and measuring images as wellas planning orthopedic surgeries. Theapp allows service providers to plansurgical procedures by makingmeasurements for the placement ofsurgical implants. Clinical judgementand experience are required toproperly use the software.	The OFIX App doesn't measure anatomicalcomponents but helps measure distances onanatomical components between placed marker(pedicle screws).The predicate is more involved in overall pre-operative planning. This could be determinant ofthe surgical procedure or approach taken by thesurgeon. The OFIX MIS App, is a lower risk toolused to streamline the process of measuring andchoosing the correct rod to be used in the surgicalprocedure. The surgical procedure and approachwould already be decided at this point. As asafeguard, the surgeon has access to traditionalmeans of measurement such as calipers. This is acheck in case the surgeon wants to confirm theOFIX MIS App's measurement.
Device Classification Name	Medical image management and processing system	Medical image management andprocessing system	Same
Software Functionalities/Modalities	Generic, Spine, and Lower Limbs Measurements, Pre-opPlanning, Templating (vendor specific implants andcustom implants), Database, Case Sharing	Templating (vendor specificimplants), Database	The OFIX MIS App is a simplified software thatfor templating Orthofix specific implants. It iscomparable to the predicate in that manner withoutthe additional functionalities that the predicateoffers. The predicate has previously been used bymedical professionals to template Orthofiximplants. After measuring, the OFIX MIS Apprecommends a rod length pulled from its databaseThis doesn't not affect the safety and effectivenessof the device and the OFIX MIS App is of lowerrisk than the predicate.
Algorithms	Osteotomy Module	Orthofix Implants Module (Notmachine-learning based)	The OFIX MIS App is a simplified software thatis for templating Orthofix specific implants. Thealgorithm used is not machine learning based anduses information specific to Orthofix implantsystems to analyze the captured image (input) andrecommend the correct implant (output).
User Interface	PC	Mobile Device	This difference is expanded on more in the 510(k)Summary in which the OFIX MIS App iscompared with the Surgimap 2.0 predicate and theNuvaline reference devices. All the devices areused outside the sterile field and are accessiblewithout impedance (no gloves). Compared the PCinterface of Monitor/Keyboard/Mouse, TheMobile Device touch screen provides the samesufficient image handling (moving/zooming in)needed to perform the steps to measure andtemplate the implantCompared to the predicate, as discussed above,the overall risk is lower for the OFIX MIS Appcompared to the predicate in terms of its singlefunctionality. The mobile interface makes it moreaccessible in the intraoperative environment. Thesafety and effectiveness of the App isdemonstrated through user validation and testing,and this difference does not render the OFIX MISApp not substantially equivalent.
Obtaining an image	DICOM	Transferred from other devices	Yes	Mobile Device Camera	N/A	This difference is expanded on more in the 510(k)Summary in which the OFIX MIS App iscompared with the Surgimap 2.0 predicate and theNuvaline reference devices. The Nuvaline(K162647) uses a Mobile Device Camera toobtain the image and predicated against theSurgimap 2.0. The use of a Mobile DeviceCamera to obtain the image has been validated todemonstrate sufficient input to the OFIX MISApp to measure and output an accurate implantlength. User validation was performed to ensuresafety and effectiveness. This difference does notrender the App not substantially equivalent.	The OFIX MIS App, is a lower risk tool used to streamline the process of choosing the correct rod to be used in the surgical procedure. It processes pictures of a fluoroscopy monitor acquired by a cell phone camera.

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Image /page/6/Picture/0 description: The image shows the logos of two companies, Orthofix and SeaSpine. The Orthofix logo is on the left and consists of a blue abstract shape followed by the company name in black, sans-serif font. The SeaSpine logo is on the right and features a stylized wave graphic in blue and gray, followed by the company name in orange, sans-serif font.

Non-Clinical Test Conducted for Determination of Substantial Equivalence

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The testing demonstrated that the App meets the required specifications.

Usability Testing

The OFIX MIS App demonstrated accuracy and usability with bench top and simulated use testing.

Conclusion

The OFIX MIS App is substantially equivalent to the predicate despite the minor technological differences described. The testing data support the safety and effectiveness of the OFIX MIS App and demonstrate performance as intended in the specified use conditions. This performance is comparable to the predicate's respective software functionality.

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).