SR SUITE 1.0 by HALIFAX BIOMEDICAL, INC.

The Halifax SR Suite is compromised of two regulatory approved X-Ray imaging systems; the two systems are integrated through a synchronization switch. The switch allows the two X-Ray imaging systems to fire simultaneously, providing a pair of X-Ray images from different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA). RSA is a stereo x-ray technique that enables measurements more precise than single plane radiography based on phantom precision studies. The resulting level of precision provides measurements of joint replacement stability. The components are: 1: Stand. 2: Tube housings, 3: Collimators, 4: Reference Box Cover, 5: SR reference box, 6: Detector Plates, 7: SR Support Arm. The SR Suite employs the software cleared in K042383, the RSA-CMS.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study conducted for the Halifax Biomedical Inc. SR Suite 1.0, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document focuses on demonstrating substantial equivalence to predicate devices and detailing the technical specifications and testing for the SR Suite 1.0, particularly its RSA capabilities. It doesn't explicitly state quantitative acceptance criteria in the typical sense (e.g., "sensitivity must be > X%, specificity > Y%") for a diagnostic AI device. Instead, the acceptance is based on the performance of the RSA component (precision) and overall safety and effectiveness compared to predicate devices for general radiography.

Therefore, the "acceptance criteria" listed below are derived from the performance claims and testing detailed in the submission, treated as the target performance the device met for demonstrating safety and effectiveness.

Characteristic / Acceptance Criteria	Reported Device Performance
RSA Precision (Bench Testing using Phantoms)
Translational Precision (X-axis)	x = 0.0018mm
Translational Precision (Y-axis)	y = 0.0017mm
Translational Precision (Z-axis)	z = 0.0039 mm
Combined Precision (using rotating carbon fiber plate)	0.005mm
General Radiography Performance
Safety and Effectiveness (compared to predicate devices)	The results of bench, clinical, and standards testing indicate that the new device is as safe and effective as the predicate devices. Risk analysis has been performed.
Compliance with Safety and EMC Standards	External laboratory safety and EMC testing was performed to standards IEC 60601 + Am1& 2 and IEC 60601-1-2. (Implies compliance was met)
Effective Doses for RSA Examinations	Internal laboratory testing was performed to determine Effective Doses for RSA Examinations. (Implies determination was successful and likely within acceptable limits, though specific values are not provided as acceptance criteria)
Software Validation & Risk Analysis	Performed. (Implies successful completion and acceptable risk profile)
Total System Performance (Clinical Image Validation)	Clinical images were obtained to validate total system performance. (Implies satisfactory performance during clinical validation)

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

Test Set Sample Size: For the RSA precision bench testing, the translational precision was evaluated by taking 10 repeated measures of a carbon fiber phantom box. The combined precision was evaluated using a rotating carbon fiber plate (no specific number of repeated measures stated, but implied to be sufficient for precision calculation). For "clinical images... to validate total system performance," no specific number or sample size of clinical images is provided.
Data Provenance:
- Bench Testing (Phantoms): This data is laboratory-generated using physical phantoms (carbon fiber phantom box, rotating carbon fiber plate). This is not patient data; it's an engineered test environment.
- Clinical Images: The document states that "Clinical images were obtained to validate total system performance." No information is provided regarding the country of origin of this data or if it was retrospective or prospective. Given the context of a 510(k) submission for a medical device that includes general radiography and RSA procedures, these clinical images would typically be from human subjects, but specifics are lacking.

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

For the RSA precision testing, the "ground truth" is established by the known physical properties and measurements within the phantoms themselves (e.g., expected inter-bead distances). Therefore, no human experts were used to establish ground truth for this aspect of the test set.

For the "clinical images... to validate total system performance," the document does not specify if or how experts were involved in establishing ground truth, nor their number or qualifications. This validation likely focused on image quality and the system's ability to produce images suitable for RSA and general radiography, rather than a diagnostic performance evaluation against an expert-established ground truth.

4. Adjudication Method for the Test Set

As the primary "test set" described is a phantom study, there was no adjudication method involving human reviewers or experts. The ground truth was inherent in the phantom design and physical measurements. For the "clinical images" validation, no information about adjudication is provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not described in the provided document. The submission focuses on the technical precision of the RSA system and demonstrating substantial equivalence for general radiography, not on quantifying the improvement of human readers with AI assistance. The SR Suite 1.0 is primarily a diagnostic imaging system with specialized RSA capabilities, not an AI-assisted diagnostic interpretation tool in the typical sense of a CAD system.

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

Yes, the RSA precision testing using phantoms represents a standalone performance evaluation of the system's ability to measure movement with high accuracy. The reported translational and combined precisions (e.g., 0.0018mm, 0.005mm) are purely algorithmic/system outputs based on image acquisition and software processing without human-in-the-loop diagnostic interpretation. The RSA-CMS software, which performs the RSA analysis, operates in a standalone capacity to generate these measurements.

7. The Type of Ground Truth Used

Bench Testing (RSA Precision): The ground truth was physical measurements/properties inherent to the phantoms. For example, the ground truth for "inter-bead distance" is a known, precise physical separation within the phantom.
Clinical Images Validation: The document does not explicitly state the type of ground truth used for validating total system performance with clinical images. It likely involved qualitative assessment of image quality and suitability for intended procedures, rather than a definitive diagnostic outcome or pathology.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI models. The RSA-CMS software mentioned is described as having been "cleared in K042383" and "designed specifically to perform Roentgen Stereophotogrammetric Analysis," implying a deterministic algorithm based on biophysical principles of RSA, rather than a machine learning model that requires a training set.

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

Since no training set is described for a machine learning model, this question is not applicable. The underlying principles of Roentgen Stereophotogrammetric Analysis (RSA) are based on established physics and geometry, which would have informed the deterministic design of the RSA-CMS software.

Summary

{0}------------------------------------------------

510(k) Summary K121345 Halifax Biomedical Inc. 11493 Route 19, Mabou Nova Scotia, Canada, BOE 1XO +1 902 945 2762 Phone Fax +1 902 945 2324 Contact: Chad Munro, CEO President Date Prepared: June 1, 2012

1. Identification of the Device: Proprietary-Trade Name: SR Suite 1.0 Classification Name: Stationary X-ray system, Product Codes Product Codes KPR, MQB, and LLZ Common/Usual Name: Diagnostic X-ray Units with Digital X-ray receptor panel.
1. Equivalent legally marketed devices: The SR Suite 1.0 employs the same digital panel as described in K092439, the Canon CXDI-50RF and many of the same components described in K090279, the Sedecal Millennium Plus. The SR Suite employs the software cleared in K042383, the RSA-CMS.
1. Indications for Use (intended use): This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography.
1. Description of the Device: The Halifax SR Suite is compromised of two regulatory approved X-Ray imaging systems; the two systems are integrated through a synchronization switch. The switch allows the two X-Ray imaging systems to fire simultaneously, providing a pair of X-Ray images from different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA). RSA is a stereo x-ray technique that enables measurements more precise than single plane radiography based on phantom precision studies. The resulting level of precision provides measurements of joint replacement stability. The components are: 1: Stand. 2: Tube housings, 3: Collimators, 4: Reference Box Cover, 5: SR reference box, 6: Detector Plates, 7: SR Support Arm. The SR Suite employs the software cleared in K042383, the RSA-CMS.
The key difference between the Halifax SR Suite 1.0 and the predicate Sedecal Millennium is the use of 5. two generators, tube heads, collimators, and detector panels in order to be able to take simultaneous images from two angles as shown in the illustration above. This allows for the RSA-CMS software cleared in K042383. The SR Suite employs the RSA-CMS software cleared in K042383.

{1}------------------------------------------------

This software was designed specifically to perform Roentgen Stereophotogrammetric Analysis.

1. Testing summary: External laboratory safety and EMC testing was performed to standards IEC 60601 + Am1& 2 and IEC 60601-1-2. Internal laboratory testing was performed to determine Effective Doses for RSA Examinations and RSA precision, including bench testing that was performed using phantoms to evaluate variables in the image acquisition (e.g., scatter, setup, marker size) that could impact the system performance. The precision was evaluated using a stationary carbon fiber phantom box and a rotating carbon fiber plate. Translational precision was evaluated by taking 10 repeated measures of the carbon fiber phantom box containing two grids of 26 tantalum beads, and by calculating the standard deviation of the repeated measurements of the inter-bead distance. Translational precision was found to be x = 0.0018mm, y = 0.0017mm, and z =0.0039 mm. In the same manner, a combined precision was calculated using a rotating carbon fiber plate containing 47 tantalum beads. The combined precision was found to be 0.005mm. Software validation and risk analysis was performed. Clinical images were obtained to validate total system performance.
1. Safety and Effectiveness, comparison to predicate device. The results of bench, clinical, and standards testing indicates that the new device is as safe and effective as the predicate devices. Risk analysis has been performed.

Characteristic	Sedecal Millennium Digital K090279	Halifax SR Suite 1.0
Intended Use:	These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.	This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures.) Not for mammography.
Generator	Sedecal SHF635RF	Sedecal SHF635RF (Two used)
Maximum output	50 kW to 80 kW.	64 kW (Two used)
Stand	Supplied by Sedecal	Sedecal and Acceleray
Image Acquisition	Digital or Film	Digital, dual panels.
Digital Panel Size	17 x 17	17 x 17
Digital PanelSupplier	Canon panels, multiple models: 50C, 50G, 40C & 40G	Canon CXDI-50RF (Two used, cleared in K092429)
Digital Resolution	Pixel size 160 × 160 $ μ $ mImage matrix size 2208 × 2688 pixelsNumber of pixels Approx. 5.9 million pixels	Pixel size 160 × 160 $ μ $ mImage matrix size 2208 × 2688 pixelsNumber of pixels Approx. 5.9 million pixels .
Software	DICOM, via O&R software cleared in K091364	The SR Suite employs the software cleared in K042383, the RSA-CMS. The software was designed specifically to perform Roentgen Stereophotogrammetric Analysis.
AcquisitionSoftware	The Sedecal Millenium employs the acquisition softare cleared in the Canon digital panels: K023750, K031337, and K060433,	SR Suite 1.0 employs the acquisition software cleared in K092429 for the digital panel.
Collimator	Ralco or Heustis	Ralco R225
Safety	UL. listed	UL, listed

1. Substantial Equivalence Chart, Halifax SR Suite 1.0
  Conclusion: After analyzing bench, clinical, risk analysis, and standards testing data; it is the 9. conclusion of Halifax Biomedical that the SR Suite 1.0 X-Ray System 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.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image contains a logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three distinct strokes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol, indicating the organization it represents.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

JUN - 1 2012

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

Re: K121345

Trade/Device Name: SR SUITE 1.0 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, LLZ, and MQB Dated: May 2, 2012 Received: May 4, 2012

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

{3}------------------------------------------------

Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you don't the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):K12J345

Device Name: SR SUITE 1.0

Indications For Use:

This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures.) Not for mammography.

Prescription Use X (Part 21 CFR 801 Subpart D)

510K

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safoty
K121345

Page 1 of 1

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.