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AccuCTP Pro is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing and analysis of brain images. Data and images are acquired through DICOM compliant imaging devices.

AccuCTP Pro provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CTP), which can visualize and analyze dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

AccuCTP Pro is an extension to legally cleared device AccuCTP (K220663).

AccuCTP Pro is a standalone software package that provides visualization and study of changes of tissue perfusion in digital images captured by CT (Computed Tomography). The software provides viewing, quantification, analysis and reporting capabilities, and it allows repeated use and continuous processing of data and can be deployed on a supportive customer's PC or a virtual platform that meets the minimum system requirements.

AccuCTP Pro works with the DICOM compliant medical image data. AccuCTP Pro provides tools for performing the following types of analysis:

• Volumetry of threshold maps
• Time intensity plots for dynamic time courses
• Measurement of mismatch between rCBF and Tmax threshold volumes obtained from the same scan.

The provided text describes the AccuCTP Pro device, which is an extension of a previously cleared device, AccuCTP. The submission is a "Special 510(k) Summary," indicating that it relies on substantial equivalence to a predicate device and focuses on minor changes.

Based on the provided information, the document does not contain details about a clinical study with acceptance criteria and a human reader performance study (MRMC) to prove the device meets specific performance metrics. Instead, it states that the algorithm and output settings of the AccuCTP Pro are the same as the predicate device (AccuCTP). Therefore, it relies on the previous predicate device's validation and general software verification and validation tests for the updated features.

Here's an analysis of the provided text with respect to your requested information:

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

The document does not provide a specific table of acceptance criteria for clinical performance and reported device performance metrics in the way one might expect for a new or significantly modified device requiring de novo validation. It primarily focuses on software verification and validation for the changes made.

The closest statement regarding "acceptance criteria" for performance is: "All tests met the pre-defined acceptance criteria and were passed." However, these refer to software verification tests, not clinical performance metrics.

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

• Test Set: No specific sample size for a clinical test set is mentioned for AccuCTP Pro's validation. The document explicitly states: "No additional pre-clinical or clinical data is being provided with this submission." It defers to the predicate device's validation.
• Data Provenance: Not applicable as no new clinical data is presented.

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, as no new clinical study data is presented requiring expert ground truth establishment for a test set.

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

Not applicable, as no new clinical study data is presented requiring adjudication.

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 such MRMC study was performed or presented in this submission for AccuCTP Pro. The document focuses on software updates and relies on the predicate device's previous validation.

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

This is implicitly addressed by the statement: "Phantom test and validation study were completed and reviewed as part of the predicate review (K220663), and the results concluded AccuCTP was safe and effective. As all algorithm and output of the subject device AccuCTP Pro is same as the predicate device AccuCTP, it can be concluded that AccuCTP Pro is acceptable for use." This suggests that the predicate device had a standalone evaluation, and since the algorithm hasn't changed, the standalone performance is assumed to be the same.

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

For the predicate device's "phantom test and validation study," the ground truth would likely be established through physical phantom measurements or a gold standard comparison. The document does not specify the type of ground truth for the predicate.

8. The sample size for the training set

Not mentioned. The document describes the device as an "extension" with the "same fundamental scientific technology" and "same operation principle and algorithm embedded in the software" as the predicate. This suggests the training would have occurred for the original AccuCTP, and no new training data is discussed for AccuCTP Pro given that the algorithm is the same.

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

Not mentioned, for the same reasons as in point 8.

Summary of what the document does provide regarding device acceptance and performance:

The acceptance of AccuCTP Pro is based on its substantial equivalence to the predicate device AccuCTP (K220663). The core argument is:

• The intended use, intended user, intended patient population, fundamental scientific technology, operation principle, and algorithm of AccuCTP Pro are the same as the predicate device.
• The changes in AccuCTP Pro are primarily related to data transmission mode, simplified manual operation, and updated software installation environments (e.g., compatibility with Linux and Windows, and virtual platforms like VMware, and basic PACS functions).
• These minor differences were evaluated through software verification and validation tests (import/export of DICOM, automatic selection/calculation, software management, case management, recalculation/adjustment, operating environment tests).
• Cybersecurity testing was performed according to FDA guidance.
• Human factors testing was conducted with fifteen qualified participants to validate usability and the user manual, concluding safe and effective use without residual use-related risks.
• The manufacturer relies on the original phantom test and validation study conducted for the predicate device (AccuCTP), arguing that since the algorithm and output are identical, the conclusions of safety and effectiveness for the predicate device extend to AccuCTP Pro.

In essence, AccuCTP Pro's "acceptance" is not demonstrated by new clinical performance data but by proving that its software updates do not introduce new questions of safety or effectiveness, due to the unchanged core algorithm and the successful completion of software engineering, cybersecurity, and usability tests.

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AccuCTP is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf computer, and can be used to perform image viewing, processing and analysis of brain images. Data and images are acquired through DICOM compliant imaging devices.

AccuCTP provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CT-P), which can visualize and analyze dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue blood volume.

AccuCTP is a standalone software package that provides visualization and study of changes of tissue perfusion in digital images captured by CT (Computed Tomography). The software provides viewing, quantification, analysis and reporting capabilities, and it allows repeated use and continuous processing of data and can be deployed on a supportive customer's PC that meets the minimum system requirements.

AccuCTP works with the DICOM compliant medical image data. AccuCTP provides tools for performing the following types of analysis:

• volumetry of threshold maps .
• time intensity plots for dynamic time courses .
• . measurement of mismatch between rCBF and Tmax threshold volumes obtained from the same scan.

The provided text, a 510(k) Summary for the AccuCTP device, focuses on demonstrating substantial equivalence to a predicate device (RAPID) rather than providing detailed acceptance criteria and the results of a statistically powered clinical study. However, it does outline performance validation activities.

Here's an analysis of the available information regarding acceptance criteria and performance studies, structured according to your request, with limitations noted due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Parameter map and Volume results were quantitatively analysed and met the pre-defined pass/fail criteria." However, the specific numerical pre-defined pass/fail criteria are not explicitly stated in this document. The performance is reported in terms of agreement with a "ground truth" (phantom data) and agreement with the predicate device (RAPID CTP).

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

• Test Set Sample Size: The document mentions a "group of phantoms" for the phantom test and a "calculation performance validation" using data to compare with RAPID CTP. However, the exact numerical sample size (number of CT perfusion studies or phantoms) used in these validation studies is not specified.
• Data Provenance: The document does not specify the country of origin for the data used in the "validation study" that compared AccuCTP to RAPID CTP. It also does not explicitly state whether the data was retrospective or prospective. The phantom study clearly used synthetic data.

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

The document does not mention the use of human experts to establish ground truth for the test sets.

• For the phantom test, the ground truth was inherently known from the design of the phantoms.
• For the "validation study" comparing AccuCTP to RAPID CTP, the ground truth was effectively the output of the predicate device (RAPID CTP), implying a comparison for concordance rather than independent expert adjudication.

4. Adjudication Method for the Test Set

No adjudication method involving human experts is described since the ground truth for the validation was either known from phantoms or based on the predicate device's output.

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

• Was it done? No, the document does not describe an MRMC study. The validation described focuses on the agreement of AccuCTP's output (parameter maps and volumes) with physical phantoms and with the predicate device's output. There is no mention of human readers or AI assistance in diagnostic tasks.
• Effect Size of Human Improvement: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance

Yes, the studies described are standalone performance evaluations of the AccuCTP algorithm. The phantom test directly evaluated the algorithm's accuracy against known physical properties, and the comparison with RAPID CTP assessed the algorithm's concordance with another software's output. The device is described as "a standalone software package."

7. Type of Ground Truth Used

• Phantom Test: The ground truth was known physical properties/measurements derived from the design of the phantoms.
• Validation Study (comparison with RAPID CTP): The "ground truth" for this comparison was effectively the results/output of the predicate device (RAPID CTP). This is a comparison of computational results for substantial equivalence, not a clinical ground truth for diagnostic accuracy (e.g., pathology, clinical outcomes).

8. Sample Size for the Training Set

The document does not specify the sample size of the training set used for developing or training the AccuCTP algorithm. Performance data in this section refers to validation testing, not training data.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set (if supervised learning was used) was established, as it doesn't discuss the training phase of the algorithm development.

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