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The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast.

nordicAktiva is a stimulus presentation software intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR maging (fMRI)based on BOLD contrast. In addition, it records responses from the NordicNeuroLab ResponseGrips.

The device is indicated for use during BOLD fMRI examinations of individuals over 2 years of age. It is not intended for the diagnosis of disease or for the direct treatment of conditions.

nordicAktiva would be used in an MRI department of a hospital or clinic, when a functional MRI exam based on BOLD contrast is required involving the provision of visual or auditory stimulation to a subject inside the MRI scanner.

The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast.

nordicAktiva is a stimulus presentation software intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR imaging (fMRI)based on BOLD contrast. In addition, it records responses from the NordicNeuroLab ResponseGrips.

The device is indicated for use during BOLD fMRI examinations of individuals over 2 years of age. It is not intended for the diagnosis of disease or for the direct treatment of conditions.

nordicAktiva would be used in an MRI department of a hospital or clinic, when a functional MRI exam based on BOLD contrast is required involving the provision of visual or auditory stimulation to a subject inside the MRI scanner.

The system presents auditory and visual stimulus to the patient gives feedback through a pair of handheld grips. A synchronizes the stimulus presentation software with the MR scanner. The System consists of five subsystems: AudioSystem, ResponseGrip, SyncBox and nordicAktiva.

The system is used for fMRI studies. fMRI stands for functional Magnetic Resonance Imaging. This technique is primarily used for determining which area of the brain is responsible for specific processes controlling essential functions such as movement, speech, hearing, and vision. This information can form part of the pre-operative planning process in patients with brain tumors, for example. Functional MRI can also be used for research into specific neurological conditions or investigating cognitive function and networks in general.

The System is used to present the stimulus necessary to provoke physiological processes in the brain. Visual [VisualSystem] and auditory [AudioSystem] stimulus and manual responses from the patient [ResponseGrips] are of primary interest. The timing of the visual and auditory stimulation is critical to make sure that the correct MR image of the activated brain is linked to the stimulus presented. A synchronization unit [SyncBox], connected between the MR-scanner and the stimulus presentation software [nordicAktiva], is included in the system to make sure that the synchronization is correct.

The provided text does NOT describe acceptance criteria for a device that involves performance metrics such as accuracy, sensitivity, or specificity. Instead, the document is a 510(k) premarket notification for an fMRI Hardware System where the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device.

The "acceptance criteria" discussed in the document relate to compliance with regulatory standards and software verification, not clinical performance metrics of the device in diagnosing or aiding in diagnosis. The device, nordicAktiva, is a stimulus presentation and response collection system for fMRI, and it is explicitly stated that "It is not intended for the diagnosis of disease or for the direct treatment of conditions."

Therefore, the requested information regarding a table of acceptance criteria and reported device performance (in the sense of diagnostic accuracy), sample size for test sets, expert involvement in ground truth, MRMC studies, and standalone performance is not applicable to this submission, as the device's function does not involve such diagnostic performance evaluations.

The document states that a new version of the software, nordicAktiva, was updated, and the testing performed was focused on verifying that the modified device fulfills its defined characteristics and requirements, maintaining substantial equivalence to its predicate.

Here's a breakdown of what the document does provide regarding "acceptance criteria" and "study":

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

The document does not provide a table with "acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, AUC) and corresponding reported device performance values. The closest information is a comparison of technological characteristics between the modified device and the predicate in Section 1.4.1. The "acceptance criteria" for this submission are more aligned with regulatory compliance and functional verification.

From Section 1.5.1 and 1.5.2, the acceptance criteria are implicit in meeting:

• International and FDA-recognized consensus standards (ISO 14971, IEC 62304, IEC 62366-1).
• Design and performance specifications, as well as user needs, when operated according to instructions.
• Intended use, technological characteristics claims, requirement specifications, and risk management results.

The "reported device performance" is the conclusion that the device "demonstrates compliance" with these standards and "meets the acceptance criteria and is adequate for its intended use and specifications."

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

The document does not specify a "test set" in the context of a clinical performance study with patient data. The testing mentioned (Section 1.5.1) is "non-clinical performance testing" and "verification and validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results." This implies engineering and software testing rather than a clinical study with a patient sample size. Therefore, sample size and data provenance in that context are not relevant or provided.

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

Not applicable. The type of testing performed (non-clinical performance, verification, and validation) would typically involve qualified engineers and testers, but not "experts" to establish "ground truth" for diagnostic performance, as the device is not intended for diagnosis.

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

Not applicable. This is typically used in clinical studies for establishing ground truth, which is not the nature of the testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study is not mentioned. The device is a stimulus presentation and response collection system, not an AI-assisted diagnostic tool.

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

Not applicable. The device's function is to facilitate fMRI by presenting stimuli and collecting responses, not to operate as a standalone diagnostic algorithm.

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

Not applicable. "Ground truth" in the diagnostic sense is not relevant for the type of device and testing described. The "truth" for this device would be its correct functioning according to its design specifications (e.g., stimulus presented correctly, response recorded accurately, synchronization maintained).

8. The sample size for the training set

Not applicable. There is no mention of a training set for a machine learning or AI model, as this is not an AI-based diagnostic device.

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

Not applicable. As there is no training set, this information is not provided.

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The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast.

The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays [VisualSystem HD] or by an in-room LCD monitor.

The system presents auditory and visual stimulus to the patient gives feedback through a pair of handheld grips. A synchronization module synchronizes the stimulus presentation software with the MR scanner. The System consists of five subsystems: AudioSystem, VisualSystem, ResponseGrip, SyncBox and nordicAktiva.

The system is used for fMRI studies. fMRI stands for functional Magnetic Resonance Imaging. This technique is useful when determining certain diseases, gaining more information about a patient's condition or investigating cognitive functions. The technique is also used for examining the area of the brain affected in patients suffering from a brain tumor in both the pre-operative and post-operative stages.

The System is used to present the stimulus necessary to provoke physiological processes in the brain. Visual [VisualSystem] and auditory [AudioSystem] stimulus and manual responses from the patient [ResponseGrips] are of primary interest. The timing of the visual and audio stimulation is critical to make sure that the correct MR image of the brains activity is linked to the stimulus presented. A synchronization unit [SyncBox], connected between the MR-scanner and the stimulus presentation software [nordicAktiva], is included in the system to make sure that the synchronization is correct.

The provided text is a 510(k) summary for a medical device (fMRI Hardware System, specifically an updated VisualSystem HD component) and does not contain the kind of detailed information typically found in a study proving a device meets acceptance criteria for an AI/ML-based diagnostic device.

This document describes a hardware system for presenting stimuli in fMRI studies, and the changes involve technical upgrades (e.g., higher resolution display, HDMI instead of VGA, integrated eye-tracking vs. separate unit). The testing discussed is primarily functional, biocompatibility, and electrical safety, consistent with a hardware device.

Therefore, I cannot extract the requested information from this document because it does not pertain to the performance of an AI/ML algorithm or diagnostic accuracy. The questions about AI model training, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance are not relevant to the described device and the information provided.

The document does contain information about:

• Device Name: fMRI Hardware System (specifically, the VisualSystem HD component).
• Intended Use: "A stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast." (page 4)
• Testing Summary: Functional tests, biocompatibility tests (for a rubber eye guard), and electrical safety/EMC tests. (page 7)
• Sample Size for testing: Not explicitly stated as a "sample size" in the context of diagnostic accuracy, but functional, biocompatibility, and safety tests would have involved specific units or batches of the device.

To answer your specific questions, this document does not provide:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI/ML. The "performance" mentioned is functional, biocompatibility, and safety.
2. Sample sizes for a "test set" in an AI/ML context, nor data provenance.
3. Number of experts or their qualifications for establishing ground truth for a test set.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance effect size.
6. Results of a standalone (algorithm-only) performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

This is a regulatory submission for a hardware component upgrade, not an AI/ML diagnostic software.

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The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast.

The system presents auditory and visual stimulus to the patient gives feedback through a pair of handheld grips. A synchronization module synchronizes the nordicAktiva stimulus presentation software with the MR scanner. The System consists of five subsystems: AudioSystem, VisualSystem, ResponseGrip, SyncBox and nordicAktiva.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the fMRI Hardware System:

The provided document, a 510(k) Summary for a device modification, offers limited details regarding specific quantitative acceptance criteria or a dedicated study report to "prove" the device meets them in the traditional sense of a clinical trial. Instead, the submission emphasizes substantial equivalence to an existing cleared device (K080515) and highlights function and safety testing to confirm the modified device (adding an in-room LCD monitor option) maintains performance.

Therefore, the information below is constructed based on the available text and highlights where specific details are not provided.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) for a device modification (adding an LCD monitor option) and the focus on substantial equivalence, the "acceptance criteria" are implied to be adherence to the original device's functionality and safety, as well as general expectations for such a system. The document does not provide numerical performance metrics or specific criterion thresholds in a table format.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a sample size for a test set in the context of a clinical performance study. The testing mentioned in Section 3.6 ("The fMRI Hardware System has been tested for function and safety...") appears to be internal verification and validation testing of the hardware and software components, rather than a study involving patient data or expert interpretation.

Therefore, there is no explicit data provenance (e.g., country of origin, retrospective/prospective) related to a clinical test set.

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

The document does not mention the use of experts to establish ground truth for a test set. This type of submission, concerning a hardware accessory modification, typically focuses on engineering verification and validation rather than clinical performance studies that require expert-derived ground truth.

4. Adjudication Method for the Test Set

Since there is no mention of a test set requiring expert ground truth or interpretation, there is no adjudication method described.

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

An MRMC comparative effectiveness study was NOT done or reported. The submission is for a hardware system modification, not an AI-powered diagnostic tool where human reader performance would be a primary metric. Therefore, there is no effect size reported for human readers with vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

No standalone performance study was conducted or reported in the context of a diagnostic algorithm. The device is a stimulus presentation and response collection system for fMRI studies, not an algorithm that provides diagnostic outputs.

7. Type of Ground Truth Used

Given that no clinical performance study or diagnostic algorithm evaluation is described, there is no mention of a specific type of ground truth (e.g., expert consensus, pathology, outcomes data) being used. The "ground truth" for the device's function would be its ability to accurately present stimuli and record responses, as determined by engineering tests and adherence to specifications.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This device is a hardware system, not a machine learning or AI model that requires a training set.

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

Since there is no training set, there is no ground truth establishment method for it described.

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The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to evoke physiological processes detectable by the MRI scanner and to collect behavioral responses from the patient. These data, when interpreted by a trained physician, may assist in the diagnosis of brain pathology and may be used in the planning and monitoring of medical treatments.

This is the same intended use as previously cleared for the fMRI Hardware System, K073099.

The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast.

The system presents auditory and visual stimulus to the patient gives feedback through a pair of handheld grips. A synchronization module synchronizes the nordicAktiva stimulus presentation software with the MR scanner. The System consists of five subsystems: AudioSystem, VisualSystem, ResponseGrip, SyncBox and nordicAktiva.

The intended use of the system is to support fMRI studies. fMRI stands for functional Magnetic Resonance Imaging. This technique is useful when determining certain diseases, gaining more information about a patient's condition or investigating cognitive functions. The technique is also used to patients suffering from a brain tumor in both the pre-operative and post-operative stage by examining the area of the brain affected.

The System is used to present the stimulus necessary to provoke physiological processes in the brain. Visual [VisualSystem] and auditory [AudioSystem] stimulus and manual responses from the patient [ResponseGrips] are of primary interest. As the timing of the data is critical to make sure that the correct MR image of the brain activity is linked to the stimulus presented, a synchronization unit [SyncBox] connected between the MR-scanner and the PC running nordicAktiva, a stimulus presentation software, is included in the System to make sure that the synchronization is correct.

The stimulus presentation PC hardware is not a part of the system.

Figure 1 presents the complete configuration of the fRMI Hardware System. All signals entering or leaving the scanner room are received and transmitted by use of fiber optics. The system allows video and audio signals from the stimulus PC to enter the shielded scanner room and to be presented to the subject lying inside the MR. The subject responds to the stimulus by using the handheld grips.

The provided 510(k) summary (K080515) describes modifications to an fMRI Hardware System, specifically the addition of software named nordicAktiva. However, the document does not contain any information regarding specific acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), or a detailed study proving the device meets these criteria in the context of an AI/algorithm-driven medical device submission.

The submission focuses on establishing substantial equivalence for a hardware system with an added software module that provides "the same basic functionality for stimulus presentation and data recording of the software currently used with the system."

Therefore, based solely on the provided text:

1. Table of acceptance criteria and the reported device performance:
Not applicable. The document does not specify quantitative acceptance criteria (e.g., performance metrics like sensitivity, specificity, or accuracy) for the device's diagnostic capabilities or define how the added software module's "performance" was measured against such criteria. The "Summary of Testing" merely states the system "has been tested for function and safety and fulfills all requirement specifications," which is a general statement rather than specific performance numbers against defined acceptance criteria.

2. Sample size used for the test set and the data provenance:
Not applicable. No sample size for a test set (e.g., patient cases, images) is mentioned because no clinical performance study demonstrating diagnostic efficacy against specific metrics for the added software is detailed. The testing described is functional and safety-related for the hardware system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment is described, as no clinical performance study requiring such a process is detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method is 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:
Not applicable. The document does not describe an AI/algorithm for diagnostic interpretation. It is a stimulus presentation and response collection system. Therefore, no MRMC study or AI assistance effect size is discussed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a hardware system with software for stimulus presentation and data collection. It is not an AI algorithm intended for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth for diagnostic purposes is mentioned. The system's function is to present stimuli and collect responses for fMRI studies, which a trained physician then interprets.

8. The sample size for the training set:
Not applicable. There is no mention of a "training set" as the device does not employ machine learning or AI algorithms requiring such a set for its operation.

9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/ML algorithm, there is no description of how ground truth for such a set was established.

Summary based on the document:

The 510(k) submission for the fMRI Hardware System (K080515) is a "Special: Device Modification" focused on integrating a software module (nordicAktiva) into an existing, previously cleared hardware system (K073099). The core claim is that the added software provides "the same basic functionality for stimulus presentation and data recording" as third-party software previously used with the system. The submission relies on establishing substantial equivalence to the predicate device, with functional and safety testing for the hardware system being the primary evidence presented. It does not detail a clinical performance study with quantitative acceptance criteria typically associated with AI/algorithm-driven diagnostic devices.

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The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast.

The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast. The system presents audio and video stimuli to the patient and the patient gives feedback through a pair of handheld grips. A synchronization module synchronizes the Stimuli PC (not a part of the system) to the MR scanner. The System consists of four subsystems: AudioSystem, VisualSystem, ResponseGrip and a SyncBox.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NordicNeuroLab fMRI Hardware System:

Acceptance Criteria and Device Performance Study (K073099)

1. Table of Acceptance Criteria and Reported Device Performance

Unfortunately, the provided 510(k) summary does not explicitly list specific acceptance criteria with numerical targets or thresholds for device performance. It states generally that "The NordicNeuroLab fMRI system has been tested for function and safety and fulfills all requirement specifications." Without access to the full requirement specifications mentioned, precise quantitative acceptance criteria cannot be extracted.

Therefore, the table below reflects the general statement of compliance rather than specific, measurable criteria.

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

The provided document does not specify a sample size for a test set, nor does it describe data provenance (country of origin, retrospective/prospective). The summary indicates "Summary of Testing: The NordicNeuroLab fMRI system has been tested for function and safety and fulfills all requirement specifications." This phrasing suggests internal validation testing rather than a clinical study with a distinct "test set" in the context of AI evaluation.

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

This information is not provided in the document. The device is hardware for fMRI stimulus presentation and response collection, not an AI-driven diagnostic tool that would typically require expert-established ground truth for a test set in the same manner as an image analysis algorithm.

4. Adjudication Method for the Test Set

This information is not applicable/provided. There is no mention of a test set requiring adjudication in the context of this hardware device.

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

This information is not applicable/provided. The NordicNeuroLab fMRI Hardware System is a stimulus presentation and response collection system. It is not an AI algorithm designed to interpret medical images or assist human readers in diagnosis, so an MRMC comparative effectiveness study is not relevant to its stated purpose or evaluation.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable/provided. The device is a hardware system, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.

7. Type of Ground Truth Used

This information is not applicable/provided. As a hardware system, the concept of "ground truth" as it applies to diagnostic algorithms (e.g., pathology, expert consensus) does not directly apply to the evaluation of its functionality. Its performance would be evaluated against engineering specifications for signal integrity, timing accuracy, and safety.

8. Sample Size for the Training Set

This information is not applicable/provided. The device is a hardware system and does not involve machine learning or a "training set" in the conventional sense.

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

This information is not applicable/provided. As explained above, the concept of "training set" and "ground truth establishment" is not relevant for this hardware device.

Summary of Study Information Availability:

The provided 510(k) summary is for a hardware system (fMRI stimulus presentation and response collection), not an AI-driven diagnostic or image analysis software. Therefore, many of the typical evaluation parameters requested for AI/algorithm-based devices (like test/training sets, ground truth, expert adjudication, MRMC studies) are not relevant or applicable to this submission and are consequently not found in the document. The submission focuses on substantial equivalence to a predicate device and basic functional and safety testing for a hardware product.

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