(38 days)
The CSNP-001A is a post processing package that has the capability to perform brain perfusion studies to include whole brain studies, when used by a trained physician, by using data that is acquired on a time sequential basis. This package provides the physician with the following information that can then be measured and analyzed in the assessment of brain trauma or stroke:
TDC (time density curve)
CBF: Blood flow in the capillary vessels of the cerebral tissues.
CBV: Blood volume in the capillary vessels of the cerebral tissues.
MTT: Mean transit time of blood in the capillary vessels f the cerebral vessels.
TTP: Time to peak of the TDCs.
DLY: Delay of each voxel curve from the arterial curves.
This device is a post processing package that allows the user to process dynamic volume sets using a Time Density Curve. The package allows visualization of the data in image map format. Additionally, the software provides numeric data via image analysis software.
The provided text is a 510(k) pre-market notification for the Toshiba America Medical Systems, Inc. CSNP-001A Neuro Package. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a regulatory submission for pre-market notification, focusing on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting raw performance data or a specific clinical study with acceptance criteria.
Therefore, many of the requested items cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated from the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document does not specify quantitative acceptance criteria or provide performance metrics of the device against such criteria. The focus is on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available: The document does not describe a specific test set or clinical study with details on sample size, data provenance, or study design (retrospective/prospective).
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 Available: Since no specific test set or study is described, there's no information about experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available: No test set or adjudication method is 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 Available: The document does not mention an MRMC comparative effectiveness study or the effect size of AI-assisted improvement for human readers. This device is described as "post processing software" that provides visual and numeric data to "assist in the assessment," rather than an AI system designed to improve human reader performance in a controlled study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Available: The document describes the device as a "post processing package" that "allows the user to process dynamic volume sets" and, "when used by a trained physician, will assist in the assessment." This strongly implies a human-in-the-loop system, not a standalone, algorithm-only performance assessment. No such standalone study data is provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available: As no specific study or test set is described, the type of ground truth used is not mentioned.
8. The sample size for the training set
- Not Available: The document does not mention a training set or its sample size.
9. How the ground truth for the training set was established
- Not Available: No training set is mentioned, so how its ground truth was established is not applicable.
Summary of what is available from the document:
The regulatory submission primarily focuses on:
- Description of the Device: "a post processing package that allows the user to process dynamic volume sets using a Time Density Curve. The package allows visualization of the data in image map format. Additionally, the software provides numeric data via image analysis software."
- Intended Uses: "application software that permits cerebral perfusion imaging based upon dynamic volume sets... This device, when used by a trained physician, will assist in the assessment of the type and extent of cerebral perfusion disturbances. Additionally, the software allows for measurement of various values such as mean value, standard deviation, area and distance."
- Technological Characteristics: "similar to the predicate device in uses and applications. The primary difference is in the method used to obtain final results. Both devices are post processing software packages."
- Safety and Effectiveness Concerns: "designed and manufactured under the Quality System Regulations... in conformance with the applicable parts of the IEC 60601-1 international safety standard."
- Substantial Equivalence: Deemed substantially equivalent to the predicate device (CSCP-001A Cerebral Blood Perfusion Analysis Package) based on similar uses, applications, and providing visual and numeric data.
- Indications for Use: To perform brain perfusion studies, including whole brain studies, providing information such as TDC, CBF, CBV, MTT, TTP, and DLY for assessment of brain trauma or stroke.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.