MODEL-BASED RSA SOFTWARE by HALIFAX BIOMEDICAL, INC.

Orthopaedic specialists and/or Halifax Biomedical Inc image processing labs use the Model-based RSA Software as standalone analytical software package for the evaluation of orthopaedic implant fixation , bone segment motion. Model-based RSA software measures the in-vivo 3D position and/or relative motion of metal implants, marker beads, and/or bone segments. When interpreted by trained physicians these measurements may be useful to derive conclusions for patient treatment. NOT FOR MAMMOGRAPHY.

Device Description

This is a Windows based software only product. It represents an advancement and extension of the same software cleared in K042383. Model-based RSA (Roentgen Stereophotogrammetric Analysis) is a stand-alone analytical software package for RSA digital image post-processing that runs on standard workstations running a Microsoft Windows operating system. This software is used to analyze roentgen images. It accepts digital images in the specific formats from all the major roentgen manufacturers (DICOM - CR and DX modality) as well as scanned roentgen films in bitmap (BMP) format. Generally, a pair of stereo roentgen images is taken of a patient's joint pre-operatively or postoperatively at one or more time points. Model-based RSA software is then used to measure the three dimensional (3D) relative position and/or relative motion of 3D models in the RSA images. Models may generally represent orthopaedic implants, a group of implanted markers (small tantalum beads), or bones. The 3D relative position and/or relative motion measures may provide information regarding of implants, wear of implants, and excessive or reduced motion between bones such as in spine instability and spine fusion

AI/ML Overview

The Halifax Biomedical Inc. Model-based RSA Software, K133966, did not include specific acceptance criteria or quantitative performance metrics in the provided documentation. The submission focuses on demonstrating substantial equivalence to a predicate device (K042383, the RSA-CMS) through qualitative comparisons of features and a general claim of safety and effectiveness based on software validation, clinical evaluation, and risk analysis.

Here's a breakdown of the requested information based on the provided text, with details that could not be found explicitly noted:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic / Metric	Acceptance Criteria (Not explicitly stated)	Reported Device Performance
Accuracy of Migration Calculations	Not explicitly stated in quantitative terms	"migration calculations by the Model-based RSA software are not biased and have high accuracy and precision."
Precision of Migration Calculations	Not explicitly stated in quantitative terms	"migration calculations by the Model-based RSA software are not biased and have high accuracy and precision."
Bias of Migration Calculations	Not explicitly stated in quantitative terms	"migration calculations by the Model-based RSA software are not biased"

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

Sample Size for Test Set: The document mentions "Five studies in all showed that migration calculations by the Model-based RSA software are not biased and have high accuracy and precision." However, the specific sample sizes (number of phantom experiments or clinical cases) for these five studies are not provided.
Data Provenance: The document mentions "phantom experiments" for validation and "clinical experiments" for assessing accuracy and precision. The country of origin for the data is not specified. It's stated that Halifax Biomedical Inc. is located in Nova Scotia, Canada, which might imply Canadian data, but this is not confirmed. The clinical data type is retrospective as it is an analytical software package processing existing scans.

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

Number of Experts: The document does not specify the number of experts used to establish ground truth for the test set.
Qualifications of Experts: The document mentions that the measurements "When interpreted by trained physicians these measurements may be useful to derive conclusions for patient treatment." This implies trained physicians would interpret the output, but it does not clarify their role in establishing ground truth for the validation studies, nor their specific qualifications (e.g., years of experience, subspecialty).

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth in the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the software's standalone measurement capabilities.
Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The device is described as "standalone analytical software package" and the validation includes "comparing the calculated migrations with accurately applied translations and rotations using a micromanipulator in phantom experiments" and "clinical experiments studied the accuracy and precision of migration calculations using Model-based RSA." This indicates standalone algorithm performance was assessed.

7. Type of Ground Truth Used

For the non-clinical (bench) testing, the ground truth was established by "accurately applied translations and rotations using a micromanipulator in phantom experiments." This can be considered a phantom-based, precisely controlled measurement.
For the clinical testing, the document states "clinical experiments studied the accuracy and precision of migration calculations." The exact nature of the ground truth for these clinical experiments is not explicitly detailed but would typically involve highly accurate reference measurements (e.g., from high-resolution imaging, physical markers, or another established gold standard method) against which the RSA software's calculations are compared. It does not mention pathology or outcomes data as direct ground truth.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This suggests that the software's underlying algorithms may be deterministic or based on established physical models rather than a machine learning model that requires explicit training data in the typical sense.

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

Since no training set is described, information on how its ground truth was established is not applicable/not provided.

Summary

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510(k) Summary K133966 Halifax Biomedical Inc. 11493 Route 19, Mabou Nova Scotia, Canada, BOE 1X0 +1 902 945 2762 Phone Fax +1 902 945 2324 Contact: Chad Munro, CEO President Date Prepared: February 20, 2014

MAR - 6 2014

1. Identification of the Device: Proprietary-Trade Name: Product Code Device: Regulation Description: Regulation Medical Specialty Regulation Number Device Class
  Model-based RSA Software LLZ System, Image Processing, Radiological Picture archiving and communications system. Radiology 892.2050 2
Equivalent legally marketed devices:. The Model-based RSA Software employs the software 2. cleared in K042383, the RSA-CMS.
1. Indications for Use (intended use): Orthopaedic specialists and/or Halifax Biomedical Inc image processing labs use the Model - based RSA Software as standalone analytical software package for the evaluation of orthopaedic implant fixation, bone segment motion. Model - based RSA software measures the in - vivo 3D position and/or relative motion of metal implants, marker beads, and/or bone segments. When interpreted by trained physicians these measurements may be useful to derive conclusions for patient treatment. NOT FOR MAMMOGRAPHY.
1. Description of the Device: This is a Windows based software only product. It represents an advancement and extension of the same software cleared in K042383. Model-based RSA (Roentgen Stereophotogrammetric Analysis) is a stand-alone analytical software package for RSA digital image post-processing that runs on standard workstations running a Microsoft Windows operating system. This software is used to analyze roentgen images. It accepts digital images in the specific formats from all the major roentgen manufacturers (DICOM - CR and DX modality) as well as scanned roentgen films in bitmap (BMP) format. Generally, a pair of stereo roentgen images is taken of a patient's joint pre-operatively or postoperatively at one or more time points. Model-based RSA software is then used to measure the three dimensional (3D) relative position and/or relative motion of 3D models in the RSA images. Models may generally represent orthopaedic implants, a group of implanted markers (small tantalum beads), or bones. The 3D relative position and/or relative motion measures may provide information regarding of implants, wear of implants, and excessive or reduced motion between bones such as in spine instability and spine fusion
1. Safety and Effectiveness, comparison to predicate device. The results of software validation, clinical evaluation, and risk analysis indicates that the new device is as safe and effective as the predicate device.
1. Substantial Equivalence Chart, Model-based RSA Software: Please see the chart below.

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K133966
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Characteristic	K042383, the RSA-CMS.	Model-based RSA Software
Intended Use:	RSA-CMS has been developed for theobjective and reproducible analysis ondigital roentgen images (DICOM CRor DX) or digitised images in a PACSenvironment. Orthopedic specialistand core labs use the RSA-CMSstandalone analytical softwarepackage In image post-processing forthe evaluation of new implantdesigns, coatings and newcementation techniques in clinicaltrials. When interpreted by trainedphysicians these parameters may beuseful to derive conclusions fromthese clinical trials.	Orthopaedic specialists and/or HalifaxBiomedical Inc. image processing labs usethe Model-based RSA Software asstandalone analytical software package forthe evaluation of orthopaedic implantfixation , bone segment motion. Model-based RSA software measures the in-vivo3D position and/or relative motion of metalimplants, marker beads, and/or bonesegments. When interpreted by trainedphysicians these measurements may beuseful to derive conclusions for patienttreatment. NOT FOR MAMMOGRAPHY.
Target Users	Trained physicians	SAME
Specialty	Orthopaedic	SAME
Image Types	DICOM, BMP, TIFF	Same
PC Workstation	Yes	Yes
Receive digital imagesfrom various sources	Yes	Yes
Transmit data to remoteviewing PACS stationsover a medical imagingnetwork	Yes	No
Digital image postprocessing	Yes	Yes
Scaling of image facility	Yes	Yes
Measurementcapabilities	Yes	Yes
Preoperative Planning	No	Yes
Assessment of 2Dmigration of prostheses	Yes	Yes
Assessment of 3Dmigration of prostheses	Yes	Yes

Description of non-clinical (bench) testing: Software documentation was executed according to the 7. recommendations of the FDA Guidance Document: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. This included validation and risk analysis. Validation of Model-based RSA software is done by comparing the calculated migrations with accurately applied translations and rotations using a micromanipulator in phantom experiments.
Description of clinical testing: Clinical experiments studied the accuracy and precision of migration 8. calculations using Model-based RSA. Five studies in all showed that migration calculations by the Modelbased RSA software are not biased and have high accuracy and precision.
1. Conclusion: After analyzing software validation, bench tests, clinical data, and risk analysis, it is the conclusion of Halifax Biomedical that the Model-Based RSA Software is as safe and effective as the predicate devices, has no significant technological differences, and has no new indications for use, (In fact USING the predicate devices) thus rendering it substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle. The text is written in all capital letters.

Public Health Service

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

March 6, 2014

Halifax Biomedical, Inc. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K133966

Trade/Device Name: Model-Based RSA Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 20, 2013 Received: December 24, 2013

Dear Mr. Kamm:

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. Kamm

. . .

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Smh.7)

ਿੱ

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): K133966

Device Name: Model-Based RSA Software

Indications For Use:

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)

Smh.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K133966 510(k)

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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).