Search Results

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.

Ask a specific question about this device

The Orthoscan TAU Mini C-arm 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 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, Inc. TAU Mini C-Arm series (which we will refer to internally and in this submittal as Orthoscan TAU 2.0, for distinction from predicate Orthoscan TAU) retain identical function as the predicate TAU Mini C-arm (K183220) 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, knees, and Hips. The system consists of C-arm support attached to the image workstation.

The changes to the Orthoscan TAU series of Mini C-arm X-ray systems represent a modification of our presently legally marketed device Orthoscan TAU mini C-Arm K183220. The proposed modifications to the predicate encompass the implementation of an optional IGZO 15 cm x 15 cm Flat Panel Detector (FPD) in the 15x12cm and 15x15cm device detector sizes, a new LINUX based operating system and related software, image processing board revisions and a revised Power Manager Board for AC to DC conversion that will distribute 24Vdc via a medical grade DC power supply. The proposed device incorporates software architecture and other improvements that replicate the features and functions of the predicate device and improve image clarity without increasing dose levels.

This FDA 510(k) summary describes the modified Orthoscan TAU Mini C-arm (Orthoscan TAU 2.0) and its substantial equivalence to its predicate device (Orthoscan TAU Mini C-arm, K183220). The device is an image-intensified fluoroscopic x-ray system.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative manner for specific benchmarks. Instead, it focuses on demonstrating substantial equivalence to the predicate device by comparing technological characteristics and asserting overall safety and effectiveness.

The document highlights differences in the modified device (Orthoscan TAU 2.0) compared to the predicate (Orthoscan TAU):

• Optional IGZO Flat Panel Detector (FPD): The predicate used CMOS detectors. The modified device offers CMOS or optional IGZO for 15x12cm and 15x15cm sizes.
  • Reported Performance: "Substantially Equivalent. The introduction of the optional IGZO technology was found to be equal in safety and effectiveness including image quality (Essential Performance). IGZO sensor technology demonstrates equal/better image quality to that of the predicate... and provides slightly improved image quality at equal dose values as the predicate."
• Linux-based Operating System: The predicate used Windows 8.1 Embedded.
  • Reported Performance: "Substantially Equivalent operating system was shown to support nearly identical workflows to achieve the same basic functionality with new proposed device software application. During verification and validation activities this change did not raise any safety and/or effectiveness concerns. The difference does not affect the safety or efficacy of the device."
• Revised Power Manager Board: For AC to DC conversion.
  • Reported Performance: "Substantially Equivalent. The AC to DC conversion will provide intrinsic value through risk reduction such as leakage, while standardizing distribution of 24Vdc."
• Software Architecture (OrthoTouch Application vs. OrthoMini Application):
  • Reported Performance: "Software architecture design is Substantially Equivalent to that of the predicate device... The OrthoTouch Application provides the main user interface to Orthoscan fluoroscopic X-Ray products, identical to OrthoMini, application. OrthoTouch on LINUX operating system performs equal to OrthoMini."
• Graphical User Interface (GUI):
  • Reported Performance: "Substantially Equivalent GUI application are nearly Identical in workflows to achieve the same basic functionality with new proposed device software application. During verification and validation activities this change did not raise any safety and/or effectiveness concerns. The difference does not affect the safety or efficacy of the device."
• Minor Differences in Detector Specifications (Pixel Spacing, Dynamic Range, DQE) for IGZO:
  • Reported Performance: These differences "do not affect the safety or efficacy of the device."

The overall "acceptance criteria" seem to be the demonstration of substantial equivalence to the predicate device, ensuring at least the same level of safety and effectiveness, including image quality.

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

• Test Set: The "test set" for the image quality comparison consisted of:
  • "Numerous Image comparison sets"
  • Images from "Anthropomorphic (PMMA material) phantoms"
  • Images from "anatomical simulation phantoms"
• Sample Size: The exact number of images or phantoms in the "numerous image comparison sets" is not specified.
• Data Provenance: The study was a retrospective lab test image comparison study conducted by Orthoscan, Inc. (the manufacturer). There is no mention of country of origin for the data; it was an internal company lab study.

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

• Number of Experts: One expert.
• Qualifications: A "board-certified Radiologist." No details on years of experience or specialization are provided beyond this.
• Ground Truth Establishment: The radiologist performed an "assessment of individual images arranged in groups of image sets." Their conclusion served as the basis for the ground truth regarding image quality comparison between the modified and predicate devices.

4. Adjudication Method for the Test Set

• Adjudication Method: None mentioned or implied. Only one radiologist was involved in the assessment, so there was no multi-reader consensus or adjudication process.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The study involved a single radiologist's assessment of image sets from phantoms.
• Effect Size: Not applicable, as no MRMC study was performed.

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

• Standalone Study: The device is a fluoroscopic X-ray system, not an AI algorithm in the context of standalone performance studies typically seen for AI/ML devices. The "algorithm" here refers to image processing within the device. The performance assessment was based on visual evaluation of the output images by a human expert. Therefore, a standalone algorithm-only performance study in the way it's usually defined for AI software was not conducted or described. The performance tested was for the integrated device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for image quality was established by expert consensus (albeit by a single expert) and comparison of visual characteristics ("image quality") based on images of "anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms." The expert's conclusion stated "the image quality at same or similar patient dose rates will result in a slight improvement in patient care (images) for the proposed modified TAU device over the Predicate device."

8. The Sample Size for the Training Set

• Training Set Sample Size: This submission is for a medical device (Mini C-arm X-ray system), not an AI/ML software. It describes modifications to an existing device, including a new operating system and detector options. There is no mention of a training set in the context of machine learning. The device itself is not presented as an AI-powered diagnostic tool requiring a separate training process for its core functionality.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for machine learning.

Ask a specific question about this device

The OrthoScan TAU Mini C-arm 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 pediatic populations when imaging limbs/extremittes, shoulders; at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.

The OrthoScan TAU Mini C-Arm is a mobile fluoroscopic mini Carm 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, knees, and Hips. The system consists of C-arm support attached to the image workstation. The proposed device provides the option of three CMOS flat panel detector sizes and identical X-ray source HVPS monoblock generator assembly with continuous or pulsed operation for image acquisition. The C-arm supports the CMOS FPD, X-Ray controls, collimator, high voltage generator with a fixed SID imaging. The C-arm and support arm which is connected to the mobile workstation platform are mechanically balanced allowing the operator precise positioning and locking of the vertical, horizontal, orbital and rotational movements at various angles and distances when imaging the patient's anatomical structures. The main workstation platform that supports the C-arm assembly contains the power control system, image processing system, system software, monitor display control and main user interface controls. The combination of C-Arm and workstation provides the clinician with a stable platform to obtain precise angles for localizing the patient's anatomical structures and visualization of pathology during live fluoroscopic imaging. The touch screen interface and keyboard provide user concise selectable imaging, X-ray technique control, entry of patient demographics and related procedural information. The workstation supports both an optional wired or wireless fluoroscopic footswitch allowing optimal positioning for the clinician. The optional connector interface panel of the OrthoScan TAU Mini C-Arm provides convenient connection of peripheral devices such as thermal video printers, image storage devices (USB) and DICOM fixed wire and wireless network interfaces.

The provided text is a 510(k) Summary for the OrthoScan TAU Mini C-Arm, which is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on non-clinical testing to support the claim of substantial equivalence, rather than a full clinical study with specific acceptance criteria and performance metrics typically seen for novel devices or AI/software as a medical device (SaMD) where performance improvement is a key claim.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment, which are standard for AI/SaMD studies, are not explicitly provided in this document as it pertains to a traditional medical imaging device (C-arm) that primarily demonstrates substantial equivalence to existing technology.

However, I can extract the information that is present regarding device performance and the "study" conducted to support substantial equivalence.

Here's a breakdown of what can be inferred or directly stated from the document, and what is missing due to the nature of this 510(k) submission for an imaging device, not an AI algorithm:

Acceptance Criteria and Reported Device Performance

The document doesn't present a table of "acceptance criteria" in the traditional sense of specific numerical thresholds for diagnostic performance (e.g., sensitivity, specificity, AUC) that an AI algorithm would be tested against. Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The performance is assessed through "image comparison" and "dose assessment" to show that the new device performs "as intended" and provides "similar image quality with new IDR filter" at "lower entrance dose level" compared to the predicate.

The table below summarizes the comparative technological characteristics which are used to argue substantial equivalence, and indirectly imply performance. The primary "performance" studied here is image quality and dose reduction, not diagnostic accuracy of an AI.

Table of Performance Comparison (Excerpted and Reinterpreted from the Provided Document)

Study Details (as inferable from the 510(k) Summary)

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

   • Test Set Images: 330 individual images arranged in 20 groups of image sets.
   • Data Provenance: The study involved images taken from "anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms." This means the data is synthetic/phantom-based, not from human patients. The country of origin is not specified, but given the FDA submission, it's presumed to be a controlled laboratory setting. The study is inherently non-clinical (not retrospective or prospective on human subjects).

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

   • Number of Experts: 1 Radiologist.
   • Qualifications: "a board-certified Radiologist." No specific years of experience or sub-specialty are explicitly mentioned beyond board certification.

3. Adjudication Method for the Test Set:

   • There is no mention of an adjudication method (like 2+1 or 3+1). The evaluation was "conducted by a board-certified Radiologist." This implies a single reader assessment for comparison.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. The document explicitly states: "OrthoScan TAU mobile fluoroscopic mini C-arm system did not require live human clinical studies to support substantial equivalence... Therefore, OrthoScan conducted a lab test image comparison study employing the use of anthropomorphic phantoms..." The study was a "lab test image comparison study" and involved a "Radiologist performed an assessment of 330 individual images." This is not an MRMC study.
   • Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable, as this is a device clearance, not an AI algorithm. The device aims to provide better image quality at lower dose, which indirectly can improve human interpretation, but this was not quantified in an MRMC study.

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

   • Not applicable as this is a medical imaging device (C-arm), not an AI algorithm. The "performance" being evaluated is the direct image output of the device itself and its dose characteristics, not a diagnostic output from an automated algorithm.

6. The Type of Ground Truth Used:

   • Phantom-based comparison with expert assessment. The "ground truth" for image quality and dose reduction in this context is established by the comparative assessment of images generated using standardized phantoms and evaluated by a qualified radiologist in conjunction with laboratory performance data (e.g., on dose). There's no "pathology" or "outcomes data" ground truth as this is a technical assessment of an imaging device.

7. The Sample Size for the Training Set:

   • Not applicable. This is a medical device, not an AI/machine learning algorithm, so there is no "training set" in the computational sense. The device's design and software are developed through engineering and quality processes, not through autonomous learning from a dataset.

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

   • Not applicable due to the reasons stated above.

Ask a specific question about this device