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The Orthoscan TAU Mini C-arm X-ray system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.

The proposed modifications to Orthoscan TAU Mini C-Arm system models 1000-0015, 1000-0016, 1000-0017 retain identical function as the predicate Orthoscan TAU Mini C-arm (K213113) and the Orthoscan VERSA Mini C-arm (K243452) as a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders and knees and hips. The system consists of C-arm support attached to the image workstation.

The changes to the Orthoscan TAU Mini C-Arm X-ray system models 1000-0015, 1000-0016, 1000-0017 represent a modification of our presently legally marketed devices Orthoscan TAU Mini C-Arm (K213113) and Orthoscan VERSA Mini C-arm (K243452). The proposed modifications to the predicate encompass the implementation of a LINUX based operating system upgrade from Ubuntu version 16.04 to Ubuntu version 20.04, revisions to generator printed circuit board to improve power management efficiency, implementation of an alternate generator radiation shielding material to reduce environmental impact of lead, update to wireless footswitch communication protocol, an alternate detector for Orthoscan TAU Mini C-arm model 1000-0017 and the introduction of an optional 32in. display monitor.

The proposed device replicates the features and functions of the predicate devices without impacting image clarity or dose levels.

For both the predicate TAU (K213113) and proposed device, the following are unchanged; C-arm support of flat panel detector, generator and x-ray controls, mechanical connections, balancing, locking, rotations, work-station platform, main user interface controls, touch screen interface, selectable imaging, X-ray technique control, entry of patient information, wired footswitch operation, interface connection panel and DICOM fixed wire and wireless network interfaces.

The provided FDA 510(k) clearance letter and summary for the Orthoscan TAU Mini C-Arm details a modification to an existing device rather than a new device with novel performance claims. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily focused on demonstrating substantial equivalence to existing predicate devices, particularly in terms of image quality and safety, rather than establishing absolute performance metrics for a completely new clinical claim.

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

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate devices (Orthoscan TAU Mini C-Arm K213113 and Orthoscan VERSA Mini C-arm K243452) in terms of image quality, safety, and functionality, despite the implemented modifications.

Since this is a modification to an existing fluoroscopic X-ray system, the "performance" is assessed relative to the predicate, with the aim of ensuring no degradation, and ideally, slight improvement in certain aspects. The document doesn't provide a table of precise quantitative acceptance criteria for image quality metrics (e.g., spatial resolution in lp/mm, contrast-to-noise ratio) because the primary goal was comparative equivalence, not meeting predefined numerical thresholds for a new claim.

However, the reported device performance, relative to the predicate, is implicitly stated:

Study Details:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a numerical "sample size" in terms of number of unique phantoms or individual images. It states "Numerous image comparison sets were taken" and "Images collected included phantom motion that was representative of typical clinical use". For the alternate detector evaluation, "Images collected included phantom motion... These images were reviewed by a Certified Radiologist who confirmed that the image quality acquired using the proposed alternate detector was of equal or slightly improved image quality...".
   • Data Provenance: The data was generated through "Non-clinical image and dose lab testing" and "bench testing". This implies controlled laboratory conditions, not patient data. Country of origin for data generation is not explicitly stated but can be inferred as likely being in the US, given the US-based company and FDA submission. The study was inherently prospective in that new images were generated for the purpose of the comparison.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: "a Radiologist" (singular) performed an assessment of individual images.
   • Qualifications of Experts: "Certified Radiologist". No further details on years of experience are provided, but "Certified" implies meeting professional board certification standards.

3. Adjudication method for the test set:

   • The document states "a Radiologist performed an assessment of individual images arranged in groups of image sets." There is no mention of an adjudication method involving multiple readers, as only a single radiologist was used for the image quality assessment.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. The document explicitly states: "Orthoscan TAU Mini C-arm system did not require live human clinical studies to support substantial equivalence...". The image quality assessment was performed by a single certified radiologist using phantom images. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported, as AI assistance is not the subject of this 510(k) (it's a hardware/OS/component modification, not an AI diagnostic tool).

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

   • This question is not applicable in the context of this 510(k). The device is an imaging system (C-arm), not an AI algorithm that performs standalone diagnoses. Its performance is assessed in terms of image generation quality, which is then interpreted by a human user (physician).

6. The type of ground truth used:

   • The "ground truth" for the image quality comparison was established by expert assessment (a Certified Radiologist's qualitative judgment) of images generated from anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms. This is considered a "phantom-based" ground truth, which is a common approach for demonstrating equivalence in imaging system modifications where clinical studies are not deemed necessary.

7. The sample size for the training set:

   • Not applicable. The document describes modifications to an existing fluoroscopic X-ray system, including an OS upgrade and hardware changes. There is no indication of a machine learning or AI component that would require a "training set" in the conventional sense of data used to train an algorithm. The development involved risk analysis, design reviews, component testing, integration testing, performance testing, safety testing, and product use testing of the system itself.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for an AI algorithm in this context.

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The Orthoscan VERSA Mini C-arm X-ray system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgency, traumatology, orthopedic, critical care, or physician office environments.

The proposed modifications to Ziehm-Orthoscan, Inc. VERSA Mini C-Arm series (which we will refer to internally and in this submittal as Orthoscan VERSA, for distinction from predicate Orthoscan TAU and Orthoscan Mobile DI) retain identical function as the predicate TAU Mini C-arm (K2131130) and predicate Mobile DI (K113708) as a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders and knees. The system consists of C-arm support attached to the image workstation.

The changes to the Orthoscan VERSA Mini C-arm X-ray system represent a modification of our presently legally marketed device Orthoscan TAU Mini C-Arm K213113 and Orthoscan Mobile DI Mini C-arm (K113708). The proposed modifications to the predicate encompass the implementation of a LINUX based operating system upgrade from Ubuntu version 16.04 to Ubuntu version 20.04 and related software revisions, modification to the mechanical design to further facilitate desk top use, revisions to generator printed circuit board to improve power management efficiency, implementation of an alternate generator radiation shielding material to reduce environmental impact of lead and an update to wireless footswitch communication protocol.

The provided text describes the Orthoscan VERSA Mini C-Arm, a fluoroscopic X-ray system. The 510(k) summary outlines the device's characteristics, modifications, and the studies conducted to demonstrate substantial equivalence to predicate devices (Orthoscan TAU Mini C-Arm K213113 and Orthoscan Mobile DI Mini C-Arm K113708).

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with numerical performance targets and reported device performance based on objective metrics. Instead, the "acceptance criteria" are implied through the statement that the device was tested to be "certified compliant with 60601-1 ED 3.2 series, including IEC 60601-2-54" and "met all applicable sections of 21 CFR Subchapter J performance standards." These regulatory and consensus standards serve as the de facto acceptance criteria.

The "reported device performance" is qualitative and comparative, focusing on maintaining or improving image quality and safety compared to the predicate devices.

Implied Acceptance Criteria and Reported Performance (from the text):

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: "Numerous image comparison sets were taken" using anthropomorphic (PMMA) phantoms and anatomical simulation phantoms. The exact number of images or comparison sets is not specified.
   • Data Provenance: The data was generated through "Non-clinical image and dose lab testing" using phantoms. This implies the data was generated specifically for this study, likely in the US, and is prospective in nature as it involved creating new images with the proposed and predicate devices.

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

   • Number of Experts: "A Radiologist" (singular) performed the assessment.
   • Qualifications: The qualification mentioned is "Radiologist." No further details on experience or specialization are given.

3. Adjudication Method for the Test Set:

   • Method: "A Radiologist performed an assessment of individual images arranged in groups of image sets." It appears to be a single-reader assessment without an explicit multi-reader adjudication process (e.g., 2+1 or 3+1) mentioned.

4. 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 was not an MRMC study and did not involve AI assistance. The study was a direct image comparison between the modified device and predicate devices performed by a single radiologist.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Not Applicable: This device is an X-ray imaging system, not an AI algorithm. Its performance is assessed through its ability to produce images and meet regulatory standards, with human assessment of image quality.

6. The Type of Ground Truth Used:

   • Ground Truth: The ground truth for image quality comparison was established by the qualitative "assessment" of the single radiologist, who concluded that the image quality was "equivalent or slight improvement" over the predicate device. This is effectively an expert consensus (single expert) on image quality, derived from images of phantoms. It is not pathology or outcomes data.

7. The Sample Size for the Training Set:

   • Not Applicable: This is a hardware modification submission for a medical imaging device, not an AI/machine learning device. Therefore, there is no "training set" in the context of data science.

8. How the Ground Truth for the Training Set Was Established:

   • Not Applicable: As there is no training set mentioned, this question is not relevant to this submission.

In summary, the substantial equivalence demonstration for the Orthoscan VERSA Mini C-Arm primarily relied on non-clinical bench testing, compliance with international and federal standards, and a qualitative image quality comparison by a single radiologist using phantom images, rather than human clinical studies or complex AI validation methods. The acceptance criteria were broadly defined by compliance with specified regulatory and consensus standards, and the reported performance was a qualitative assessment of non-inferiority or slight improvement in image quality.

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