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The BodyTom 64 system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture. The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.

BodyTom 64 system can be used for low dose lung cancer screening. The screening must be performed in compliance with the approved and established protocols as defined by professional medical societies.

BodyTom 64 computed tomography (CT) system provides the same functionality as the previous version of the device BodyTom 64 (K213649). Both CT systems are identical in terms of the high resolution, multi row, 85 cm bore, and 60 cm field of view. The lightweight translating gantry consists of a rotating disk with a solid-state x-ray generator, Gd202S detector array, collimator, control computer, communications link, power slipring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch. x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has retractable rotating caster wheels and electrical drive system so the system can be moved easily to different locations. The interventional radiology package should not be used in an operating room during surgery.

The provided document, a 510(k) Premarket Notification from the FDA, states that the "BodyTom 64" device is "substantially equivalent" to a predicate device (BodyTom 64, K213649) and does not provide an extensive acceptance criteria table or detailed study results for a new clinical performance study.

Typically, when a device is found to be "substantially equivalent" based on technological characteristics and performance testing to an already cleared predicate, the FDA does not require new, large-scale clinical studies with human subjects, especially if the changes are limited to software updates and new features that do not raise new questions of safety or effectiveness. The document instead focuses on demonstrating adherence to recognized standards, quality system regulations, and bench testing to show that the modified device performs comparably and safely.

Therefore, many of the requested details about acceptance criteria, detailed performance metrics, sample sizes, expert ground truth establishment, MRMC studies, or multi-reader studies are not explicitly stated or applicable in this type of 510(k) submission where substantial equivalence is being demonstrated based on non-clinical performance and technological characteristics.

However, based on the information provided, here's what can be extracted and inferred:

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

The document primarily states that the device meets existing standards and performs comparably to its predicate. Specific quantitative acceptance criteria for clinical performance are not listed with corresponding results because the submission focuses on substantial equivalence through technical verification.

• Noise
• Slice thickness
• Low contrast resolution
• High contrast resolution
• Radiation metrics
• Modulation transfer function (MTF) | "Imaging metrics successfully demonstrated that the proposed device has comparable image quality with its previous version, predicate device (K213649) and meets all the image quality criteria that are used for testing." |
  | Electrical Safety / Electromagnetic Compatibility (EMC/EMI) | "proved to be in compliance with IEC 60601-1-2. and IEC 60601-1-2. and IEC 60601-2-44." |
  | Software Functionality and Safety | "Software is critical to the operation of the BodyTom 64 CT system and a malfunction or design flaw in the software could result in delay in delivery of appropriate medical care. As such, the risk management analysis identified potential hazards which were controlled and mitigated during development of BodyTom 64. The verification/validation testing ensured substantial equivalence of BodyTom 64."
  "The proposed BodyTom 64 device demonstrated that the new features did not exhibit any negative effects on the requirements in place, as well as they did not exhibit any concerns."
  "The proposed BodyTom 64 device was shown to meet all requirements and to not have any impact on imaging." |
  | Mechanical Safety | "To minimize electrical, mechanical and radiation hazards, NeuroLogica adheres to recognized and established industry practices." |
  | Compliance with Federal Diagnostic Equipment Performance Standard and applicable regulations (21 CFR §1020.30 and §1020.33) | "All components...are certified to meet those requirements." |
  | Compliance with Quality System Regulations and ISO 13485:2016 | "BodyTom 64 CT system is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements." |

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

• Sample Size: Not applicable/not specified for a clinical test set since this submission relies on bench testing (phantom image quality tests), software verification/validation, and regulatory compliance, rather than a clinical study with human patients.
• Data Provenance: Not applicable, as no patient data was used for this substantial equivalence demonstration. The data pertains to engineering and phantom testing.

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)

• Not applicable. Ground truth, in the context of phantom testing for image quality, is established by known physical properties of the phantoms and measurements of the system's output against defined engineering specifications, not by expert human interpretation.

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

• Not applicable, as no human reader studies requiring adjudication were conducted.

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. This submission does not describe an MRMC study. The device is a CT system with software functionality updates, not an AI-assisted diagnostic tool that aids human readers in interpretation.

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

• Not applicable in the context of an algorithm's diagnostic performance. The "performance" being evaluated is the technical and physical output of the CT system and its software, not a diagnostic algorithm.

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

• The "ground truth" for the performance described generally refers to:
  • Engineering Specifications: For image quality metrics (noise, resolution, etc.), the performance is measured against established quantitative specifications derived from physical principles and industry standards using phantoms.
  • Regulatory Requirements & Harmonized Standards: For safety (electrical, mechanical, radiation) and quality, the ground truth is compliance with the detailed requirements outlined in standards like IEC 60601 series, ISO 14971, IEC 62304, and FDA regulations (21 CFR §1020.30, §1020.33).
  • Predicate Device Performance: Implicitly, the performance of the predicate device (K213649) serves as a benchmark for "comparable image quality."

8. The sample size for the training set

• Not applicable. This device is a CT scanner, not a machine learning algorithm that requires a "training set" for its core function of image acquisition and reconstruction. The software updates mentioned likely relate to system control, user interface, or image processing, which undergo traditional software verification and validation, not machine learning model training.

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

• Not applicable, as there was no training set in the context of machine learning model development.

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The OmniTom Elite computed tomography (CT) system is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 40cm aperture, primarily the head and neck.

The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age The CT images can be obtained either with or without contrast.

OmniTom Elite with photon counting detectors (PCD) configuration has multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI). OmniTom Elite with PCD is supported for adult imaging of the head and neck.

The subject OmniTom Elite Computed Tomography (CT) system provides the same functionality as the previous version of the device, OmniTom Elite (K223447). Both computed tomography systems are identical in terms of the high resolution, 16 row, 40 cm bore, and 30 cm field of view. The lightweight translating gantry consists of a rotating disk with a solid-state x-ray generator, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has omni-directional wheels that allow for robust diagonal, lateral, and rotational 360-degree movement and electrical drive system so the system can be moved easily to different locations.

The ability to upgrade the OmniTom Elite system with photon counting detector (PCD) remains the same. PCD provides the ability to capture CT data in multiple energy bands that can provide information on material composition of different tissues and contrast media. The multiple sets of CT data are acquired at the same time with configurable energy thresholds without any cross talk between images.

The provided text describes the OmniTom Elite Computed Tomography (CT) system and its updates, focusing on the Photon Counting Detector (PCD) configuration. However, it does not contain specific numerical acceptance criteria for performance metrics or detailed results from a study that quantifies these criteria. The document states that the device successfully meets "all the image quality criteria that are used for testing" and that images were "confirmed diagnostic quality," but it doesn't provide the actual criteria or the numerical outcomes.

Therefore, many parts of the request cannot be fully answered with the given information.

Here's an attempt to answer based on the provided text, highlighting where information is missing:

Acceptance Criteria and Study Details for OmniTom Elite with PCD

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

The document does not explicitly state numerical acceptance criteria for image quality metrics. It broadly claims that the device "meets all the image quality criteria that are used for testing" and that images were of "diagnostic quality."

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: "Volunteers underwent CT scanning for a full head scan, the top of the skull, the midbrain, and through the sinuses." The number of volunteers is not specified.
• Data Provenance: The study involved prospective scanning of volunteers. The country of origin is not specified.

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

• Number of Experts: "independent board-certified practicing radiologists." The number of radiologists is not specified.
• Qualifications of Experts: "board-certified practicing radiologists."

4. Adjudication method for the test set

The document does not specify an adjudication method (e.g., 2+1, 3+1). It only states that images were "reviewed by independent board-certified practicing radiologists."

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

• MRMC Study Done: No. The study described is a clinical evaluation of the device's image quality, not an MRMC study comparing human reader performance with and without AI assistance. The device itself is a CT system, and while it introduces new image processing features (like MD Plus for bone removal, VNC, ultra-high resolution), it doesn't appear to be an AI-assisted diagnostic tool for humans, but rather an imaging system that produces images that radiologists interpret.
• Effect Size: Not applicable as an MRMC comparative effectiveness study with AI assistance was not performed or described.

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

Yes, elements of standalone performance were evaluated.

• Bench Testing: Software development and testing in accordance with IEC 62304 and FDA guidance for software functions, including risk management analysis and verification/validation testing, indicate standalone algorithm assessment for software functions.
• Image Quality Evaluation: "Image quality metrics such as noise, slice thickness, low and high contrast resolution, radiation metrics, and modulation transfer function were measured utilizing phantom image quality tests." This constitutes standalone testing of the imaging system's output characteristics without human interpretation.

7. The type of ground truth used

• For Image Quality Evaluation: Physical phantom measurements were used to assess image quality metrics.
• For Clinical Evaluation: The "ground truth" for diagnostic quality was established by the consensus or interpretation of "independent board-certified practicing radiologists." This is expert consensus on the diagnostic acceptability of the images. No mention of pathology or outcomes data as ground truth is made.

8. The sample size for the training set

The document does not provide information regarding a training set size or methodology, as the study described is an evaluation of the CT system's performance, not an AI algorithm that requires a distinct training phase. The MD Plus algorithm is mentioned, but its training details are not.

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

Not applicable/no information provided, as details about a training set for an AI algorithm are not given.

Ask a specific question about this device

The OmniTom Elite CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck. The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.

OmniTom Elite with photon counting detectors (PCD) configuration has multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI). OmniTom Elite with PCD is only supported for adult axial imaging for head and neck.

The subject OmniTom Elite Computed Tomography (CT) system provides the same functionality as the previous version of the device, OmniTom Elite (K211711). Both computed tomography systems are identical in terms of the high resolution, 16 row, 40 cm bore, and 30 cm field of view. The lightweight translating gantry consists of a rotating disk with a solid-state x-ray generator, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has omni-directional wheels that allow for robust diagonal, lateral, and rotational 360-degree movement and electrical drive system so the system can be moved easily to different locations.

The ability to upgrade the OmniTom Elite system with photon counting detector (PCD) remains the same. PCD provides the ability to capture CT data in multiple energy bands that can provide information on material composition of different tissues and contrast media. The multiple sets of CT data are acquired at the same time with configurable energy thresholds without any cross talk between images.

Here's a breakdown of the acceptance criteria and study details based on the provided text, formatted to answer your specific questions:

Acceptance Criteria and Device Performance Study

The NeuroLogica OmniTom Elite CT system, particularly with its Photon Counting Detector (PCD) configuration, underwent various tests to demonstrate its safety, effectiveness, and substantial equivalence to its predicate device. The primary focus of the new features described is the multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific, quantified table of "acceptance criteria" for the new multi-energy CT functionality in terms of specific performance metrics tied to a pass/fail threshold. Instead, it describes various tests and their successful outcomes, demonstrating that the device performs as intended and is comparable to the predicate. The overall acceptance criterion is inferred to be that the new features do not raise new questions of safety or effectiveness and provide diagnostically acceptable images, similar to the predicate device.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a numerical sample size (e.g., number of patients/scans) for the clinical evaluation (test set). It states, "Volunteers underwent CT scanning for a full head scan, from the upper jaw to the top of the skull to aid in generation of comparative images." The provenance is described as "Comparative study was conducted under an IRB" using "Volunteers." It implies a prospective study, but the geographic origin (country) is not specified.

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

The clinical images "were reviewed by three independent board-certified practicing radiologists." No specific number of years of experience is provided, but 'board-certified' is a standard qualification.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated beyond "reviewed by three independent board-certified practicing radiologists." It's unclear if consensus was required, if a majority rule was applied for disagreement, or if all three had to independently confirm diagnostic quality without formal adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader study was conducted to compare OmniTom Elite with PCD and OmniTom Elite with EID (existing detector technology). However, this was not a comparative effectiveness study designed to quantify how much human readers improve with AI vs. without AI assistance. The study's purpose was to confirm the diagnostic quality and equivalence of the images from the new PCD system compared to the existing EID system, verifying that the new technology does not compromise diagnostic utility. Therefore, an effect size of human improvement with AI assistance is not provided, as that was not the study's objective.

6. Standalone (Algorithm Only) Performance

The document does not describe a standalone (algorithm only without human-in-the-loop performance) study for the diagnostic interpretation of images. The performance data is primarily focused on the system's ability to generate diagnostically acceptable images, perform material decomposition, and adhere to image quality metrics. The "clinical evaluation" always refers to images being reviewed by radiologists. The material decomposition phantom study could be considered a form of standalone performance for that specific function.

7. Type of Ground Truth Used for the Test Set

The ground truth for the clinical evaluation test set was established by expert consensus/review of the images. "Three independent board-certified practicing radiologists" confirmed the "diagnostic quality of the images." For the material decomposition functionality, the ground truth was based on a manufactured "multi-energy CT phantom, where three basic materials, water, iodine and calcium were decomposed." This phantom represents a known, measurable composition.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set (if any machine learning components were involved in the new features). Given that the submission focuses on hardware and software feature upgrades rather than a new AI diagnostic algorithm, a distinct "training set" may not be applicable in the traditional sense of machine learning model development. This is more of a system validation rather than an AI model clearance.

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

As no training set is described in the document, there is no information on how its ground truth was established.

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The NL4100 BodyTom 64 CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture.

The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.

Body Tom 64 CT system can be used for low dose lung cancer screening. The screening must be performed in compliance with the approved and established protocols as defined by professional medical societies.

The BodyTom 64 is an improved version of the BodyTom Elite (K170238) computed tomography system, providing enhanced functionality. It still has the same high resolution, multi row, 85 cm bore, and 60 cm field of view x-ray computed tomography system. The lightweight translating gantry consists of a rotating disk with a solid-state x-ray generator, Gd2O2S detector array, collimator, control computer, communications link, power slipring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has retractable rotating caster wheels and electrical drive system so the system can be moved easily to different locations.

The BodyTom 64 x-ray detector has been updated to allow for 64 cross-sectional CT images (slices) of your body to be generated, instead of the 32 images produced by the predicate BodyTom Elite device (K170238).

Based on the provided document (K213649 510(k) Summary for the BodyTom 64 CT system), here's an analysis of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is a 510(k) summary for a Computed Tomography X-Ray System (BodyTom 64), not an AI/ML medical device. Therefore, many of the typical acceptance criteria and study designs applicable to AI devices (e.g., MRMC studies, expert consensus for ground truth on disease detection, effect size of human improvement with AI) are not relevant for this type of device.

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate CT device by proving its technological characteristics, safety, and effectiveness. The "acceptance criteria" here are primarily related to meeting performance standards, image quality metrics, and regulatory compliance, rather than clinical performance for a specific disease detection task with AI assistance.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for the BodyTom 64, as described in this 510(k) summary, are primarily focused on demonstrating that the updated device performs equivalently to its predicate and meets established safety and performance standards. These are not acceptance criteria for a diagnostic AI algorithm in the typical sense.

Here's a table based on the provided text, outlining the performance aspects assessed:

Summary of Device Performance: The BodyTom 64 successfully demonstrated that its enhancements had no negative impact on clinical performance, it met all image quality criteria used for testing, and it complies with all relevant safety and performance standards and regulations.

Study Details (as applicable for a CT system, not an AI device)

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

   • Test Set: The primary testing for image quality was conducted using an ACR Phantom. This is a standard phantom designed for objective assessment of CT image quality.
   • Data Provenance: Not applicable in the context of phantom testing. This is laboratory/bench testing. No patient data (retrospective or prospective) from specific countries is mentioned for the performance testing, as it's a hardware/software update to a CT system, not a diagnostic algorithm based on patient images.

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

   • Not applicable. For a CT system, "ground truth" for technical performance is established by known phantom properties and physical measurements, not by human expert interpretation of clinical images. The study is about the device's technical specifications and how well it generates images, not about its ability to diagnose conditions.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1) are used for resolving disagreements among human readers or annotators in clinical AI studies. This study is based on objective phantom measurements and engineering verification/validation.

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:

   • No. An MRMC study is relevant for evaluating the clinical impact of an AI-assisted diagnostic tool on human performance. The BodyTom 64 is a CT scanner, not an AI tool in that sense. The study focused on demonstrating technical equivalence and compliance with performance standards.

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

   • A "standalone" performance evaluation in the context of an AI algorithm would typically mean assessing its diagnostic accuracy (e.g., sensitivity, specificity). For the BodyTom 64, the "standalone" performance is its ability to produce images that meet specified technical image quality metrics (e.g., noise, resolution) when scanning a phantom. This was indeed done (Bench/Image Testing).

6. The Type of Ground Truth Used:

   • Phantom Properties / Physical Measurements: For image quality, the ground truth is derived from the known physical properties and design of the ACR Phantom, combined with objective measurements (e.g., CT number, noise standard deviation, spatial resolution targets).
   • Compliance with Industry Standards and Regulations: For safety and operational aspects, the ground truth is defined by the requirements of the referenced IEC and NEMA standards, as well as FDA regulations (e.g., 21 CFR §1020.30, §1020.33).

7. The Sample Size for the Training Set:

   • Not applicable. This is not an AI/ML device in the sense of requiring a large training dataset of medical images for a learning algorithm. The software updates were to a control system and data acquisition, not a trainable diagnostic model.

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

   • Not applicable for the same reason as above. The "training" for such a device is its design and engineering to meet specifications, not an iterative learning process from data.

Ask a specific question about this device

The OmniTom Elite computed tomography (CT) system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40cm aperture, primarily head and neck.

The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.

OmniTom Elite with photon counting detectors (PCD) can generate spectral CT images at multiple energy levels. OmniTom Elite with PCD is only supported for adult imaging for anatomy that can be imaged in the 40cm aperture, primarily head and neck.

The subject OmniTom Elite Computed Tomography (CT) system provides the same functionality as the previous version of the device, OmniTom Elite (K202526). We have included some other design changes to make the system more robust and reliable. Both computed tomography systems are identical in terms of the high resolution, 16 row, 40 cm bore, and 30 cm field of view. The lightweight translating gantry consists of a rotating disk with a solid-state x-ray generator, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has omni-directional wheels that allow for robust diagonal, lateral, and rotational 360-degree movement and electrical drive system so the system can be moved easily to different locations.

We have added the ability to upgrade the OmniTom Elite system with photon counting detector (PCD). OmniTom Elite with PCD is the same system as the predicate device OmniTom Elite energy integrating detector (EID) with the only difference being the detector array system, instead of the current gadolinium oxysulfide EID, it has a cadmium telluride based PCD.

PCD provides the ability to capture CT data in multiple energy bands that can provide information on material composition of different tissues and contrast media. The multiple sets of CT data are acquired at the same time with configurable energy thresholds without any cross talk between images. OmniTom Elite with PCD has the capacity to more than double the EID detector spatial resolution.

The provided text describes the OmniTom Elite CT system, which offers an optional Photon Counting Detector (PCD) upgrade. The submission aims to demonstrate substantial equivalence to its predicate device, OmniTom Elite with Energy Integrating Detector (EID) (K202526).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around demonstrating the safety, effectiveness, and comparable image quality of the OmniTom Elite with PCD to its EID counterpart, without raising new questions of safety or effectiveness. Specific quantitative acceptance criteria are not explicitly listed in easily consumable metrics such as sensitivity/specificity/accuracy, but rather implied through compliance with standards, successful performance tests, and expert review.

• "NeuroLogica adheres to recognized and established industry practices."
• "OmniTom Elite CT system is designed and manufactured to comply with the FDA Quality System Regulations (21 CFR part 820) and ISO 13485:2016 requirements."
• Conformance with numerous harmonized standards including ISO 14971 (Risk Management), IEC 60601-1 (Basic Safety), IEC 60601-1-2 (EMC), IEC 60601-1-3 (Radiation Protection), IEC 60601-2-44 (CT Equipment Specific), NEMA XR 25, 26, 28, 29, 21 CFR §1020.30, §1020.33.
• "The OmniTom Elite with PCD underwent Electrical Safety and Electromagnetic Compatibility testing and proved to be in compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-44."
• "The risk management analysis identified potential hazards which were controlled and mitigated during development." |
  | Effectiveness/Functionality | Device performs as intended for CT imaging, including new PCD capabilities (multi-energy, spectral CT), without negative impact from design changes. | - "The proposed OmniTom Elite device demonstrated that the new features did not exhibit any negative effects on the requirements in place, as well as they did not exhibit any concerns that may impact safety and effectiveness."
• "Software verification and software validation testing was executed to confirm all software requirements were met. The proposed OmniTom Elite device was shown to meet all requirements and to not have any impact on imaging."
• PCD capabilities were tested to demonstrate properties of PCD in count and multi-energy mode. Imaging metrics demonstrated stability of the detector, analysis of the count rate and limited pileup loss at low dose scanning.
• "Comparative study was conducted... The comparative study involved scanning the same subject using both the EID and the PCD CT systems at the same anatomical sections... These images were reviewed by two independent board-certified radiologists and confirmed diagnostic quality of the images demonstrating the effectiveness of the subject device for clinical scanning." |
  | Image Quality | Image quality metrics (noise, slice thickness, resolution) are comparable to the predicate device and meet established criteria. | - "Imaging metrics such as noise, slice thickness, low and high contrast resolution, radiation metrics, and modulation transfer function were measured utilizing phantom image quality tests in accordance with the equipment performance standards for diagnostic x-ray systems administered by the FDA."
• "Imaging metrics successfully demonstrated that the proposed device with PCD has comparable image quality with its previous version, predicate device (K202526) that had EID and meets all the image quality criteria that are used for testing." |
  | PCD Specific Functionality | Ability to generate spectral CT images at multiple energy levels with configurable thresholds, minimal crosstalk, and enhanced spatial resolution for adults in head/neck. Stable detector and acceptable count rate. | - "PCD provides the ability to capture CT data in multiple energy bands that can provide information on material composition... The multiple sets of CT data are acquired at the same time with configurable energy thresholds without any cross talk between images."
• "OmniTom Elite with PCD has the capacity to more than double the EID detector spatial resolution."
• "No crosstalk noticed between images."
• "Imaging metrics demonstrated stability of the detector, analysis of the count rate and limited pileup loss at low dose scanning." |
  | Usability/Movement Control | Enhanced movement controls for simpler/easier navigation, improved durability, and ease of operator transport. | - "The addition of a drive camera (SmartDrive) and new transport wheels (OmniWheels) for simpler navigation; the drive bar mechanism was enhanced for durability, easier manufacturability and ease of operator overall transportation of device."
• "The improvements in movement performance were implemented to solely allow the operator to transport the device with ease." |
  | Software Integrity | Software developed and tested in accordance with relevant standards and guidance; no negative impact on imaging. | - "The software contained in the proposed device has been developed & tested in accordance with IEC 62304, and the FDA guidance for Content of Premarket Submissions for Software Contained in Medical Devices."
• "Software verification and software validation testing was executed to confirm all software requirements were met."
• "The proposed OmniTom Elite device was shown to meet all requirements and to not have any impact on imaging." |

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

• Test Set Sample Size: The text states, "Volunteers underwent scanning to aid in generation of comparative images." It does not specify the exact number of volunteers. It implies a small number, as it talks about "the same subject" being scanned.
• Data Provenance: Not explicitly stated, but the mention of "an IRB" (Institutional Review Board) implies a prospective study involving human subjects. The country of origin is not specified but is likely the US given the FDA submission. It was a prospective study involving volunteers.

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

• Number of Experts: "two independent board-certified radiologists."
• Qualifications: "board-certified radiologists." No further details on years of experience are provided, but board certification implies a high level of expertise in medical imaging interpretation.

4. Adjudication Method for the Test Set

The text states: "These images were reviewed by two independent board-certified radiologists and confirmed diagnostic quality of the images demonstrating the effectiveness of the subject device for clinical scanning."

This indicates a consensus or agreement-based approach for diagnostic quality, where both radiologists had to confirm it. There is no mention of a formal adjudication process (e.g., 2+1 or 3+1 where a third or fourth reader resolves discrepancies), beyond the agreement on diagnostic quality. It seems the goal was to confirm diagnostic quality, not necessarily to create a "ground truth" for specific disease detection where adjudication for disagreements would be critical.

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

No, a formal MRMC comparative effectiveness study to assess improvement in human readers with AI vs. without AI assistance was not conducted or described. The study described was a comparative imaging study to show that images from the new PCD system were of diagnostic quality and comparable to the EID system. The focus was on the device's image quality and diagnostic utility as a standalone imaging system, not its impact on human reader performance.

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

Yes, a standalone assessment was a primary component of the submission. The "Image quality evaluation" section describes rigorous phantom testing and measurements of "noise, slice thickness, low and high contrast resolution, radiation metrics, and modulation transfer function." This demonstrates the algorithm's (and hardware's) performance in generating images. The clinical evaluation with radiologists also served to confirm the diagnostic quality of the images generated by the device itself, implicitly assessing its standalone performance.

7. The Type of Ground Truth Used

The ground truth for the device's image quality and diagnostic utility was established through:

• Phantom Tests: For objective image quality metrics (noise, resolution, MTF, etc.).
• Expert Consensus/Opinion: For confirming the "diagnostic quality" of the clinical images by two independent board-certified radiologists. This isn't a "pathology" or "outcomes data" ground truth, but rather a subjective assessment by experts of the image's clinical utility.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is because the device is a CT scanner, not an AI/ML diagnostic algorithm that requires a separate training set of patient data for model development. The "training" here refers to the engineering and validation processes (design verification, software testing, bench testing, etc.) that ensure the system functions correctly and produces high-quality images.

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

As explained above, there isn't a "training set" in the sense of patient data used to train an AI model. The system's "ground truth" (i.e., its correct operational parameters and expected image output) was established through:

• Engineering Specifications and Design Requirements: What the system was designed to achieve.
• Reference Standards: Adherence to IEC 60601-x standards, NEMA, and FDA performance standards.
• Phantom Studies: Objective measurements against known targets.
• Bench Testing: Verification and validation of hardware and software components against their specified functions.

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The OmniTom Elite CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40cm field of view, primarily head and neck.

The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.

The OmniTom Elite is an improved version of OmniTom computed tomography system, providing enhanced functionality. It still has the same high resolution, multi row, 40 cm bore, and 30 cm field of view x-ray computed tomography system. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, Gd2O2S detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has omnidirectional wheels that allow for robust diagonal, lateral, and rotational 360-degree movement and electrical drive system so the system can be moved easily to different locations.

The provided text is a 510(k) summary for the OmniTom Elite CT system, which is a medical device. This type of regulatory document focuses on establishing substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a complete study report for a novel AI/software component, particularly for diagnostic performance metrics like those specified in the prompt.

The document primarily discusses comparative technical characteristics and conformance to established standards for computed tomography X-ray systems, rather than an AI or software algorithm's diagnostic performance. Therefore, many of the requested points, especially those related to diagnostic performance study design (test set size, ground truth, experts, MRMC, standalone performance), are not applicable or not present in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for an AI algorithm. Instead, it compares the technical specifications of the subject device (OmniTom Elite) to its predicate device (OmniTom). The "performance" assessment focuses on image quality metrics measured using phantoms and overall system safety and effectiveness.

Study Proving Acceptance Criteria:

The document states that "internal verification and validation activities and external testing of product safety and EMC / EMI was completed successfully." The "study" mentioned for image quality and diagnostic relevance primarily relies on phantom testing and expert review of those phantom-generated images.

• "Image quality metrics such as noise, slice thickness, low and high contrast resolution, radiation metrics, and modulation transfer function were measured utilizing phantom image quality tests in accordance with the equipment performance standards for diagnostic x-ray systems administered by the FDA. The OmniTom Elite system successfully demonstrated that it has comparable image quality as the predicate device OmniTom (K171183) and meets all the image quality criteria that are used for testing the OmniTom."
• "Clinical performance of the CT system was evaluated using an ACR Phantom was used to measure image metrics, such as CT number linearity, image slice thickness, image noise, low contrast resolution and high contrast resolution. The data provided clinical demonstration of the operation of the device and the images reviewed by a board-certified radiologist were of diagnostic quality."

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified in terms of patient cases. The evaluation involved "phantom image quality tests" and an "ACR Phantom."
• Data Provenance: The data appears to be from internal lab testing using phantoms, not human patient data. Therefore, country of origin and retrospective/prospective designations are not applicable.

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

• Number of Experts: "a board-certified radiologist" (singular, implied one) reviewed the images from the ACR Phantom.
• Qualifications of Experts: "board-certified radiologist." No further details on years of experience or subspecialty are provided.

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

• Adjudication Method: Not applicable/not specified. The review was by a single "board-certified radiologist" for diagnostic quality of phantom images. There's no indication of multiple readers or an adjudication process for a "ground truth" derived from patient cases.

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

• MRMC Study: No. This document describes a CT scanner (hardware and basic software functions), not an AI diagnostic algorithm. The "Metal Artifact Reduction (MAR)" is a post-processing algorithm, but its evaluation does not appear to be a comparative effectiveness study involving human readers with and without AI assistance. The focus for MAR was simply demonstrating artifact mitigation without new safety/effectiveness concerns.

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

• Standalone Performance: Not applicable in the context of diagnostic AI. The document primarily concerns the performance of the CT scanner hardware and integrated software features. While MAR is an algorithm, its "standalone" performance is described in terms of its effect on artifacts in phantom images, not as a diagnostic accuracy measure on patient data.

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

• Ground Truth: For image quality, the ground truth is against expected values and characteristics of reference phantom images. For the diagnostic quality assessment, the "ground truth" for ensuring images were "of diagnostic quality" was the subjective assessment by the board-certified radiologist of the phantom images. This is not a ground truth for a disease state based on patient data.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This document does not describe the development or validation of a machine learning model that would require a training set. The software updates mentioned are general enhancements and workflow improvements, not an AI algorithm for diagnostic inference.

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

• Training Set Ground Truth: Not applicable, as there is no described training set for an AI algorithm.

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The NL3000 [CereTom Elite] CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 25cm field of view, primarily head and neck.

The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.

The CereTom Elite is an improved version of CereTom computed tomography system providing enhanced functionality. It still has the same high resolution, 8 row, 32 cm bore and 25cm field of view. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, Gd2O2S detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system and brushless DC servo drive system (disk rotation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, xray indicators, interlocks, patient alignment laser and 110% x-ray timer. CereTom Elite also has a scanner drive system (SDS), so that the system can be moved easily to different locations.

The provided text describes the CereTom Elite Computed Tomography system and compares it to a predicate device (CereTom K051765) and a reference device (Philips Brilliance CT 16-slice Configuration K012009). The document focuses on demonstrating substantial equivalence rather than presenting a standalone study with specific acceptance criteria and performance metrics for a novel AI/algorithm.

Based on the information provided, here's an analysis of the requested points, with the understanding that this is a CT system, not an AI algorithm in the typical sense for which these questions are usually posed:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with reported numerical performance values in the context of an AI-driven diagnostic accuracy study. Instead, it discusses the device's conformance to safety, performance, and image quality standards, and its equivalence to a predicate device.

The "acceptance criteria" here are implied by the compliance with recognized consensus standards and the demonstration of comparable image quality to the predicate device.

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

The document describes phantom image quality tests for the CereTom Elite system. It does not mention a test set based on patient data, nor does it specify a sample size for these phantom tests (e.g., how many phantom scans were performed).

• Sample Size: Not specified for image quality tests, but they were conducted using an "anatomical phantom."
• Data Provenance: The tests are internal verification and validation activities, and external testing, implying controlled laboratory or manufacturing settings using phantoms. No patient data provenance (country, retrospective/prospective) is provided as it's not a clinical study on patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable in the context of the provided document. The CereTom Elite is a CT imaging device, and its performance evaluation primarily involves physical measurements using phantoms and comparing those measurements to established engineering and medical device standards. There is no mention of human experts establishing "ground truth" for diagnostic accuracy in a clinical dataset.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a human expert diagnostic reading study or any adjudication process for a test set of clinical images. The evaluation is based on technical performance metrics from phantom scans.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. This typically involves human readers interpreting cases with and without an AI's assistance to measure the AI's impact on diagnostic performance. The document describes the technical performance and equivalence of a CT scanner.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study in the context of an "algorithm only without human-in-the-loop performance" is not explicitly performed or detailed in the way typically expected for an AI algorithm. The document assesses the standalone technical performance of the CT scanner hardware and its integrated software features (like AEC, MAR, reconstruction algorithms) through phantom testing. The performance metrics cited (spatial resolution, noise, etc.) are inherent to the device's image generation capabilities.

7. Type of Ground Truth Used

The "ground truth" for the technical and image quality tests primarily relies on:

• Phantom measurements: Physical properties and known configurations of the phantoms.
• Engineering specifications and regulatory standards: Conformance to established benchmarks for CT system performance (e.g., spatial resolution targets, dose limits, safety standards).
• Comparison to predicate device: The performance of the predicate device (CereTom K051765) serves as a benchmark for equivalence.

8. Sample Size for the Training Set

This information is not applicable. The CereTom Elite is a CT imaging system. While it has embedded software with algorithms for image reconstruction, artifact reduction, and dose control, it is not described as a deep learning or machine learning system that requires a distinct "training set" of patient data in the typical AI sense. The algorithms are likely based on traditional signal processing and image reconstruction techniques, which are validated against known inputs and expected outputs, not "trained" on large datasets.

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

This information is not applicable for the same reasons as point 8. No explicit training set or ground truth establishment method for it is mentioned. Development and validation would involve engineering principles and testing against known physical properties and simulated scenarios.

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The NL5000 [OmniTom] system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.

The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.

The NL5000 CT System is a high resolution, 16 row, 40 cm bore, and 30 cm field of view x-ray computed tomography system. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, Gd2O2S detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch. x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has omni-directional wheels that allow for robust diagonal, lateral, and rotational 360 degree movement and electrical drive system so the system can be moved easily to different locations.

Here's a breakdown of the acceptance criteria and study information for the OmniTom device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the OmniTom as a Computed Tomography (CT) X-ray system. The acceptance criteria are implicitly defined by a comparison against a predicate device (CereTom K051765) and adherence to recognized industry standards. The performance is assessed through various tests, including image quality, safety, and functional parameters.

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

• Test Set Sample Size:
  • Phantom Studies: Not explicitly stated, but "phantom image quality tests" were utilized. Phantoms are typically manufactured objects, not human subjects, so provenance in terms of country of origin is not applicable.
  • Clinical Images: "Clinical images for adult brain exams" were used. The document does not specify the number of adult brain exams used to form the test set.
  • Pediatric Scans: "Phantom image evaluations were performed for pediatric scans," but it's unclear if actual clinical pediatric images were also used for evaluation or just phantoms.
• Data Provenance: The document does not specify the country of origin for any clinical images used. The studies appear to be retrospective clinical data review, as they refer to "clinical images for adult brain exams" being reviewed, which implies pre-existing scans.

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

• Number of Experts: "a board-certified radiologist" (singular) reviewed the clinical images.
• Qualifications of Experts: The expert was "board-certified radiologist." The document does not specify their years of experience.

4. Adjudication Method for the Test Set

• No explicit adjudication method is mentioned. Given that a single "board-certified radiologist" reviewed the images, a formal multi-reader adjudication method (like 2+1 or 3+1) was not employed for the clinical image review described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not performed. This submission is for a CT system itself, not an AI-assisted interpretation or diagnostic software. The focus is on the device's image quality and safety compared to a predicate device, as well as its compliance with relevant standards. Therefore, the effect size of human readers improving with or without AI assistance is not applicable or discussed.

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

• This is not applicable. The OmniTom is a CT scanner, not an independent algorithm or AI diagnostic tool. Its "performance" is its ability to produce high-quality diagnostic images and operate safely, not to autonomously interpret scans.

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

• For image quality, the ground truth appears to be established through:
  • Phantom studies: These use known physical properties of the phantom to assess image metrics like spatial resolution, noise, and contrast.
  • Expert review: A "board-certified radiologist" determined if clinical images were of "diagnostic quality." This could be considered a form of expert consensus, albeit from a single expert, against an internal standard of diagnostically acceptable images.
• For safety and functional performance, the ground truth is established by:
  • Conformance to recognized consensus standards (e.g., IEC, NEMA).
  • Internal verification and validation testing against defined specifications (e.g., electrical, mechanical, radiation hazards).

8. The sample size for the training set

• The document describes a 510(k) submission for a CT hardware system, not a software algorithm that requires a "training set" in the machine learning sense. Therefore, there is no training set sample size mentioned or applicable.

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

• As there is no training set for an AI algorithm in this submission, this question is not applicable.

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The NL4000 BodyTom Elite CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture.

The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.

BodyTom Elite CT system can be used for low dose lung cancer screening. The screening must be performed in compliance with the approved and established protocols as defined by professional medical societies.

*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011: 365:395-409) and subsequent literature, for further information.

The BodyTom Elite is an improved version of BodyTom computed tomography (CT) system providing enhanced functionality. It still has the same high resolution, multi row, 85cm bore and 60cm field of view. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, solid state detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and stepper drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has retractable rotating caster wheels and electrical drive system so the system can be moved easily to different locations.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria and their corresponding performance values in a direct numerical table for the entire device. However, it does list several image quality parameters that are important for Low Dose CT Lung Cancer Screening (LDCT LCS) and the general use of CT, along with reasons for their inclusion. The performance is stated as meeting all image quality criteria used for testing the predicate device.

Image Quality Parameters Relevant to LDCT LCS and General CT Use (Implicit Acceptance Criteria)

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