(231 days)
NIVP3 is a computer program which is used with Hokanson vascular diagnostic instruments and an IBM compatible personal computer to produce comprehensive reports. These reports are stored in a computer database and may be sorted, retrieved, and printed. The program allows the user to select and record plethysmographic and Doppler waveforms and blood pressure measurements .. Patient demographics and history are also stored by the program. The user may enter comments to enhance the report.
Safety and effectiveness of NIVP3 are equal or better than for NIVP. The same non-invasive diagnostic instruments are used to provide data inputs to the computer. These are the MD35 Procord (K896034), the TL400 Totalab (K872517), the EC5R Plethysmograph (K932812), and the TD312 Calculating Cuff Inflator K842067). In each case optical isolation is employed to prevent electrical leakage from a computer power supply from reaching the diagnostic instrument, and from there being able to reach a patient. There is no direct electrical connection from the computer to the diagnostic instrument. Data is collected by the computer and incoming waveforms are displayed on the computer screen. The user selects the data to be retained and may edit decision points by moving cursors on the screen. The data is stored in a database using the ACCESS® database engine. A run-time version of ACCESS® is furnished with the program.
No diagnostic decisions are made by the program. The program is not intended to replace the need for a skilled vascular technologist, but is intended to increase the technologist's efficiency by eliminating the need for cutting out chart recordings and writing extensive reports. The advantages of using NIVP3 are that reports are neat and uniform and that patient records are easily stored and retrieved. In some cases tests, like arterial inflow, are semi automated since the program can perform some functions such as inflate a cuff or balance and calibrate the plethysmograph at the correct time to facilitate data collection. Extensive use is made of the Windows® help system to aid the user in operation of the program and give instructions on how to perform certain diagnostic tests.
The provided text describes the 510(k) submission for the NIVP3 Non-Invasive Vascular Program. However, it does not contain specific acceptance criteria or details of a study designed to prove the device meets such criteria.
The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device, NIVP, rather than providing a detailed performance study with acceptance criteria.
Here's how to address each point based on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. The document focuses on substantial equivalence to a predicate device (NIVP) and functional capabilities, not specific performance metrics against pre-defined acceptance criteria. | Functional Capabilities: |
- Uses non-invasive diagnostic instruments (MD35 Procord, TL400 Totalab, EC5R Plethysmograph, TD312 Calculating Cuff Inflator) to collect data.
- Displays incoming waveforms on the computer screen.
- Allows user to select and retain data, and edit decision points by moving cursors.
- Stores data in an ACCESS® database.
- Produces neat, uniform, and easily retrievable reports.
- Semi-automates some tests (e.g., arterial inflow: inflates cuff, balances/calibrates plethysmograph).
- Employs optical isolation to prevent electrical leakage. |
| Device safety (e.g., electrical safety) | "Optical isolation is employed to prevent electrical leakage from a computer power supply from reaching the diagnostic instrument, and from there being able to reach a patient. There is no direct electrical connection from the computer to the diagnostic instrument." |
| Device effectiveness (in terms of increasing technologist efficiency) | "The program is not intended to replace the need for a skilled vascular technologist, but is intended to increase the technologist's efficiency by eliminating the need for cutting out chart recordings and writing extensive reports." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe a specific test set or clinical study with a defined sample size for evaluating the NIVP3's performance against detailed acceptance criteria. The focus is on the device's functional equivalence and safety features.
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 / Not provided. Since no specific test set or clinical study with ground truth establishment is described for NIVP3, this information is not available. The program's design explicitly states: "No diagnostic decisions are made by the program." and "The program is not intended to replace the need for a skilled vascular technologist." This indicates that the program is a data management and reporting tool, not an AI/diagnostic aid that would require ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. As no test set for diagnostic performance is described, there's no adjudication method mentioned.
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 was not done. The NIVP3 is described as a software program to assist vascular technologists with data collection, storage, and reporting, aiming to increase efficiency. It does not perform diagnostic decisions or offer "AI assistance" in the modern sense that would lend itself to an MRMC study comparing human performance with and without an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The NIVP3 is explicitly designed as a human-in-the-loop system. The user selects data to retain, edits decision points, enters comments, and makes diagnostic decisions. The program itself does not make diagnostic decisions in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. As the device is not making diagnostic claims or predictions, there is no discussion of ground truth in the context of diagnostic accuracy. The ground truth for the data it handles would be the measurements and waveforms captured by the connected diagnostic instruments, which are then reviewed and interpreted by a skilled vascular technologist.
8. The sample size for the training set
- Not applicable / Not provided. The NIVP3 is a software application for data management and reporting, not an AI or machine learning algorithm that requires a "training set" in the conventional sense to learn patterns or make predictions. Its functionality is based on predefined logic for data handling, display, and reporting.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No training set is mentioned for this type of software.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).