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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.

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

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

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.

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

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.

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.

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.

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