(74 days)
Invia's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of reconstructed cardiac emission tomographic studies (SPECT and PET). Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium-scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a risk factor for coronary artery disease. Calcium scoring may be used to monitor the progression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack. Coregistration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.
Corridor4DM is a comprehensive cardiac emission computed tomographic (ECT) application designed to review and quantitatively analyze cardiac ECT (SPECT and PET) nuclear medicine patient studies. The application provides tools for processing and displaying standard ungated and ECG gated cardiac ECT images on both a slice-by-slice basis and as a 3-dimensional surface rendered images in many user selectable formats. Additionally, it provides quantitative assessments of heart function by computing and displaying left ventricular chamber volumes, ejection fraction and transient ischemic dilation (TID) values and provides an assessment of the data set(s) in comparison to a similar patient population with a low likelihood of cardiac disease. The application provides a number of different single or multi-dimensional display(s) to allow the users to select those that best fit their needs. Cardiac CT interpretation and cardiac calcium quantification are optional features that are integrated into Corridor4DM.
This 510(k) summary for the Corridor4DM device does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.
The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technology comparison, and general system performance, rather than providing specific performance metrics, acceptance criteria, or a detailed study design with statistical evidence.
However, I can extract the information that is present and highlight what is missing.
Missing Information Disclaimer
The provided 510(k) summary does not include:
- A table of specific acceptance criteria.
- Quantitative reported device performance metrics against those criteria.
- Details on the sample size used for any test set or the data provenance.
- The number or qualifications of experts used to establish ground truth for a test set.
- Any adjudication method.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used for a test set (e.g., pathology, outcomes data).
- The sample size for a training set.
- How ground truth for a training set was established.
Information Extracted from the Provided 510(k) Summary:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria or reported device performance data against such criteria are provided in this 510(k) summary.
The comparison table provided focuses on features and functionalities to demonstrate substantial equivalence, not performance metrics.
| Feature | Corridor4DM (Intended Performance/Functionality) | Predicate Device (3D-MSPECT) | Predicate Device (Siemens Calcium Scoring) |
|---|---|---|---|
| Computer based templating system | Yes (Present) | Yes | NA |
| Digital image retrieval of patient radiographs | Yes (Present) | Yes | NA |
| Patient Studies Type | ECT, PET, CT (Supported) | ECT, PET | N/A |
| Measurement Tools | Yes (Present) | Yes | NA |
| Overlay of prosthetic templates for proper selection by physician | Yes (Present) | Yes | NA |
| Generation of Parts List | Yes (Present) | Yes | NA |
| Patient files can be saved locally, on a network, or printed. | Yes (Present) | Yes | NA |
| Allows for assessment of wear. | Yes (Present) | Yes | NA |
| Identify and quantify CT data via imaging (Calcium Scoring feature) | Yes (Present) | No | Yes |
Note: The "Reported Device Performance" in this context refers to the affirmation of the presence or absence of a feature, rather than quantitative performance metrics like sensitivity, specificity, accuracy, or statistical equivalency. The submission argues for substantial equivalence based on having similar functionalities as the predicate devices.
2. Sample size used for the test set and the data provenance
Not specified in the provided 510(k) summary. The document does not describe a clinical performance study with a specific test set. The comparison is based on functional equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/specified. A formal test set with expert-established ground truth is not detailed in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/specified. An adjudication method for a test set is not 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
Not applicable/specified. This 510(k) summary does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is a "processing, quantification, and multidimensional review" application, not explicitly an AI-assisted diagnostic tool in the typical sense for MRMC studies as of this submission date (2008). The focus is on providing tools for quantification and review.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/specified. No standalone performance study details are provided. The device is described as an application with processing, quantification, and review tools, implying human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/specified. Since no specific performance study with a test set is detailed, the type of ground truth used is not mentioned.
8. The sample size for the training set
Not specified. The document does not describe an AI/machine learning model development process with a training set.
9. How the ground truth for the training set was established
Not applicable/specified. As no training set is described, the method for establishing its ground truth is also not.
§ 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.