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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 consists of two 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 Halifax Imaging Kit is part of the SR Suite product line and provides an alternative path to creating an SR Suite. The Halifax Imaging Kit consists of FDA cleared and/or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing Digital Radiography (DR) system are synchronized by replacing the trigger switches of the two systems with either the Universal Synchronization Switch or the Imaging Kit Control Module (IKCM).

The Universal Synchronization Switch or IKCM ensures the two X-Ray imaging systems fire simultaneously, therefore providing a pair of X-Ray images from two different perspectives taken at the exact same time. There are two versions of the Halifax Imaging Kits:

a) UNIVERSAL SYNCHRONIZATION (NON-GE BASED CONFIGURATION) The Universal Synchronization Switch synchronizes two independent X-ray systems as accurately as possible by using the manual pushbutton interface of each X-ray system. This replaces the synchronization switch that was described in our predicate K121345.

b) IMAGING KIT CONTROL MODULE (GE BASED CONFIGURATION) The general purpose of the IKCM is to coordinate and control the activities of the detector and workstation with the activities of the generator, as well as coordinate the exposures between the client's clinical system and the Halifax Imaging Kit for RSA exposures. The current version of the IKCM is designed specifically for interfacing with the following components:

•GEHC WDR1 Upgrade Kit which consists of a 'Flashpad' detector, a workstation named 'MagicPC', and a 'Cabinet' for power distribution and communication control. Integrating with a pre-existing system (GEHC Discovery XR656 Plus).

· EMD Technologies Epsilon Series generator. (Or generators already on site)

The provided text describes a 510(k) premarket notification for the "Halifax Imaging Kit," a stationary digital x-ray system. The submission focuses on demonstrating substantial equivalence to a predicate device (Halifax SR Suite 1.0, K121345).

Based on the information provided in the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

No specific acceptance criteria table or quantitative performance metrics are explicitly stated in this 510(k) summary. The submission focuses on demonstrating "substantial equivalence" rather than proving specific performance metrics of the device itself. The primary "study" to meet acceptance criteria relies on demonstrating that the new device configuration (Halifax Imaging Kit) is as safe and effective as its predicate device and that its components (like digital panels) already have their own 510(k) clearances.

Therefore, the "acceptance criteria" here is primarily about fulfilling the FDA's requirements for substantial equivalence, rather than meeting specific quantifiable performance targets for a diagnostic or AI-driven system.

However, I can extract information related to the closest aspects of your request:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there is no explicit table of acceptance criteria with quantitative performance metrics for this device as it's not a diagnostic AI system. The acceptance criteria for a 510(k) submission of this nature are generally qualitative and relate to safety, effectiveness, and substantial equivalence to a predicate device.

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

• Test Set Description: The "test set" primarily refers to components, bench tests, and a phantom study.
• Sample Size: Not applicable in the traditional sense of a clinical or image-based test set for an AI/diagnostic algorithm.
  • For the bench testing, no "sample size" of patients or images is mentioned. It refers to testing of the Universal Synchronization Switch (board level functionality, firmware, enclosure wiring) and the Imaging Kit Control Module.
  • For the phantom study (for precision validation per installation), the sample size would be the "small carbon fibre box" used for in vitro precision and accuracy calculation. No specific number of phantom images or measurements is given, but it implies a single phantom setup used for validation.
• Data Provenance: Not explicitly stated for specific data points other than the general context of the company being Halifax Biomedical Inc. (Canada) and the submission to FDA (USA). The phantom study refers to validation at a "[Hospital]" in "[City]" ([Room details]), "[State/Province]", "[Country]" – implying it could be anywhere, but the company is Canadian. The data is prospective in the sense that the bench testing and phantom validation are performed as part of the device development and installation process.

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

• Not applicable. This submission does not involve human expert adjudication of medical images to establish ground truth for a diagnostic algorithm. The "ground truth" for the device's functionality relates to its mechanical/electrical performance, precise synchronization, and ability to perform RSA measurements.
• The "experts" would be the engineers and QA personnel performing the bench tests and the precision validation (phantom study). Their qualifications are typically implied by their roles in medical device development and testing.

4. Adjudication Method for the Test Set

• Not applicable. No human image-reading adjudication method is mentioned as this is not a diagnostic imaging AI system. The "adjudication" of performance is done through objective bench test results and phantom study measurements against expected performance, rather than through consensus of human readers interpreting clinical images.

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 study was not done. This device is an X-ray system, not an AI or CAD system intended to assist human readers. The document explicitly states "Clinical testing was not required to establish equivalence because all of the new digital receptor panels already have their own 510(k) clearances."

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

• Not applicable. This is an X-ray imaging system, not a standalone algorithm. While it produces images for Roentgen Stereophotogrammetric Analysis (RSA), the "algorithm" for RSA (RSA-CMS software) is stated to be "Unchanged" from the predicate device and was cleared under K042383. The submission is about the kit that acquires the images, not a new RSA analysis algorithm.

7. The Type of Ground Truth Used

• Engineering specifications and physical measurements (for bench testing and phantom studies).
  • For the Universal Synchronization Switch and Imaging Kit Control Module: Proper Board level functionality, firmware performance, proper enclosure internal wiring assemblies and connections.
  • For the RSA System precision: In vitro precision and accuracy calculated using a phantom study (small carbon fibre box) consistent with common RSA validation techniques. This relies on the known physical properties and movements of the phantom as the "ground truth."
  • For the digital receptor panels: Their own prior 510(k) clearances serve as evidence of their established performance and safety, essentially acting as their "ground truth" for those components.

8. The Sample Size for the Training Set

• Not applicable. This device is an X-ray imaging system, not an AI or machine learning algorithm that requires a training set. The software for RSA analysis (RSA-CMS) is unchanged from the predicate and would have had its own development and validation process earlier, but details are not in this document.

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

• Not applicable. See point 8.

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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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Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.

The Tantalum Bead Set consists of 1mm spherical x-ray markers made of commercially pure, unalloyed tantalum. The tantalum beads are used as radio opaque markers that are implanted in bone or soft tissue. The tantalum beads are used to measure changes in position of prostheses and anatomical structures with the aid of x-ray images. The tantalum beads are implanted with a manual instrument. The tantalum beads are provided in a cartridge (set of 16 beads, "The tantalum Bead Set") that is inserted into the manual instrument. The instrument inserts one Tantalum bead via manual activation by the surgeon. The Tantalum Bead Set is provided in the sterile condition; sterility is achieved by means of gamma radiation with a sterility assurance of 10 to the power of -6 SAL.

This document describes a 510(k) submission for the "The Tantalum Bead Set," a set of 1mm spherical tantalum markers used as radio-opaque markers. The key change from the predicate device is the sterilization method: the subject device is supplied sterile via gamma irradiation, whereas the predicate was non-sterile and required steam sterilization prior to use.

Since this submission is a Special 510(k) for a change in manufacturing process (sterilization method), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the new sterilization process and updated cartridge material do not negatively impact the device's safety and effectiveness and that the newly sterilized device performs as well as the predicate device. Therefore, the information provided relates to testing done to establish substantial equivalence rather than traditional AI performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify exact sample sizes for each test. For "Functional testing of the Tantalum Bead Set," it implies that the testing was performed on the device itself. For "Sterility validation" and "Package integrity and shelf-life testing," these are standard medical device validation tests that involve a sufficient number of samples according to the referenced ISO and ASTM standards, but specific numbers are not given here.

• Data Provenance: The manufacturing company, Halifax Biomedical, Inc., is located in Mabou, Nova Scotia, CANADA. Therefore, the testing and data would originate from or be overseen by this Canadian manufacturer. The nature of these tests (functional, sterility, packaging) indicates laboratory-based studies rather than clinical data from human patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the submission is for a physical medical device and changes to its manufacturing/sterilization, not an AI or imaging diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is established via validated laboratory testing methods and engineering principles.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication method is used for clinical studies involving multiple readers for diagnostic accuracy, which is not the nature of this submission. The tests performed are laboratory validations against established standards.

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

Not applicable. This device is a physical marker, not an AI or imaging system. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. This device is a physical marker, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed is based on:

• Functional performance: Observational assessment during device operation to detect debris or abrasion.
• Sterility: Quantitative measurement against ISO 11137-1 and -2:2006 to achieve a 10⁻⁶ SAL.
• Packaging and Shelf-life: Measurement and testing against ISTA 2A:2008 and ASTM standards (F1980, F2096, F1140) to confirm package integrity over time.

These are objective, standard-based laboratory validations, not ground truth derived from expert medical interpretation or clinical outcomes.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" or corresponding ground truth to establish for this type of device.

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Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an xray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.

The Tantalum Bead Set consists of 1mm spherical x-ray markers made of commercially pure, unalloyed tantalum. They are used as radio-opague markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray. The beads are applied with a manual surgical instrument. The beads are provided non-sterile in a cartridge which includes 16 beads. The cartridge, manufactured from PEEK is designed to be used with the Halifax RSA Bead Inserter (Class 1 device) to allow surgeons to deploy the beads into the bone and tissue surrounding an orthopaedic implant. The inserter and cartridge containing the beads must be sterilized by the hospital prior to use.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Halifax Biomedical Inc. Tantalum Bead Set. This document is a premarket notification to the FDA for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with acceptance criteria and performance data in the way you've requested for an AI/device performance study.

Therefore, the information you're asking for regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data is NOT present in this document.

This document describes a physical medical device (tantalum beads) that serves as a radiographic marker. Its approval is based on demonstrating that its materials, intended use, and design are substantially equivalent to a previously approved device (Biomet's Tantalum Beads - K010348), not on a clinical performance study with specific metrics like sensitivity, specificity, or reader improvement.

To directly answer your request based only on the provided text, I must state that this document does not contain the information requested.

If you are looking for an example of a device and its study that would contain such information, you would typically need a document pertaining to an AI/ML-based medical device where diagnostic accuracy or a similar performance metric is the primary subject of the 510(k) or a clinical study report.

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