(58 days)
NeuroQ™ - PET DP Program is indicated to:
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- assist with regional assessment of human brain scans, through automated quantification of mean pixel values lying within standardized regions of interest (S-ROI's), and
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- assist with comparisons of the activity in brain regions of individual scans relative to normal activity values found for brain regions in FDG-PET scans, through quantitative and statistical comparisons of S-ROI's.
The NeuroQ™ - PET DP Display and Analysis Program has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in and your brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database.
This program was developed to run in the IDL operating system environment, which can be rms program any nuclear medicine computer systems which support the IDL software platform. The program processes the studies automatically, nowever, user verification plations. The program processing capability is provided.
Here's a breakdown of the acceptance criteria and study information for the NeuroQ™ - PET DP program, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary (K041022) does not explicitly state quantified acceptance criteria (e.g., minimum sensitivity, specificity, accuracy percentages) or corresponding reported device performance metrics in a readily digestible format. Instead, it relies on demonstrating substantial equivalence to a predicate device (Mirage/NeuroGam™) and general statements about safety and effectiveness.
The closest we get to "performance" is the description of the device's function:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Assist with regional assessment of human brain scans: | The NeuroQ™ program provides automated quantification of mean pixel values lying within standardized regions of interest (S-ROI's). |
| Assist with comparisons of activity relative to normal values: | The program assists with quantitative and statistical comparisons of S-ROI's from individual scans relative to normal activity values found for brain regions in FDG-PET scans (from a database of asymptomatic controls). The output includes quantification of relative activity in brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. User verification of processing capability is provided. The program has been determined safe and effective through "initial design, coding, debugging, testing, software development" and "in-house and external validation." The clibourneous one progific details and results concerning the validation of the NeuroQ™ – PET DP program are listed in Item H, Testing & Validation (not provided in this excerpt). |
| Safety and Effectiveness: | "The program is substantially equivalent to the Mirage NeuroGam™ program which has been in the marketplace for over two years" and "it is intended for the same purpose and raises no new issues of safety or effectiveness." The program has no direct adverse effect on health, as the physician's interpretation remains crucial. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the excerpt. The document mentions "in-house and external validation" and "clibourneous one progific details and results concerning the validation of the NeuroQ™ – PET DP program are listed in Item H, Testing & Validation," but Item H is not included.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the excerpt. The nature of the ground truth (e.g., based on expert consensus for clinical diagnosis) is implied by the software's function to assist physicians, but specific details on expert involvement in validation are missing.
4. Adjudication Method for the Test Set
This information is not provided in the excerpt.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study demonstrating an effect size of human readers improving with AI vs without AI assistance is not mentioned in this document. The device is presented as an aid to the physician, but no formal comparative effectiveness study against unassisted reading is described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The NeuroQ™ is designed as an "aid in the assessment" and "co-register and display brain PET scans and compare the patient's study to a reference database." It explicitly states, "It was not meant to replace or to be used as a primary diagnostic interpretation of a patient's PET brain scan." This suggests that performance was not evaluated in a standalone capacity, and its intended use is always with a human in the loop.
7. The Type of Ground Truth Used
Based on the device's function, the ground truth for the "normal activity values found for brain regions" likely came from a database of "FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC)."
For comparison to patient scans, the implied ground truth would be the physician's final interpretation based on integrating all clinical and diagnostic information, including the NeuroQ™ results, but the document doesn't explicitly detail how this ground truth was established for a test set.
8. The Sample Size for the Training Set
The document mentions "defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC)" as the source of its normal database. However, the sample size for this training (or reference) set is not provided.
9. How the Ground Truth for the Training Set Was Established
The ground truth for the "training set" (referred to as the "AC database" or "reference database") was established by using FDG-PET studies of "defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC)." This implies a clinical assessment of individuals to confirm they are "normal" before their scans contribute to the reference database.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.