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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 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 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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