(205 days)
nVISION® Data Management Software (nVISION) is an optional accessory for compatible Nonin oximeters with memory playback. nVISION Is Indicated for use with the following Nonin oximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and 9840. It is intended for use by healthcare professionals when (1) transferring data from pulse oximeters to computers in order to maintain Individual records of pulse oximetry data, (2) reviewing that data according to user-selected parameters, and (3) generating reports.
nVISION® Data Management Software (nVISION) is an optional accessory for compatible Nonin oximeters with memory playback. nVISION® software is indicated for use with the following Nonin oximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and 9840. nVISION® software runs on a personal computer and provides a graphical display of downloaded oximetry data for review and interpretation by a clinician. This software also allows oximetry data and patient information to be saved in a "library" for future retrieval and analysis. The healthcare professional using nVISION® software is solely responsible for selecting the analysis criteria used to calculate summary statistics included in the reports. nVISION® software is an adjunct system requiring human interpretation of results; it does not suggest a course of treatment or generate a diagnosis.
Here's an analysis of the provided text regarding the acceptance criteria and study for the nVISION® Data Management Software:
Acceptance Criteria and Device Performance for nVISION® Data Management Software (K033307)
Based on the provided documentation, the nVISION® Data Management Software is a Class II medical device (21 CRF 870.2700), classified as Pulse Oximeter Data Management Software. The primary method for demonstrating its acceptance and effectiveness is through a substantial equivalence claim to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) summary for software seeking substantial equivalence, specific quantitative "acceptance criteria" and "reported device performance" in the traditional sense (e.g., sensitivity, specificity, accuracy against a gold standard) are not explicitly detailed in the document. Instead, the acceptance is based on demonstrating equivalence in terms of functionality, safety, and intended use.
| Acceptance Criterion (Based on Substantial Equivalence to Predicates) | Reported Device Performance (Summary of Evidence) |
|---|---|
| Functional Design | nVISION® software successfully underwent performance testing to demonstrate appropriate functional characteristics, which align with the predicate devices. |
| Indications for Use | Intended for use by healthcare professionals for transferring, reviewing (according to user-selected parameters), and generating reports of pulse oximetry data, consistent with the predicates. |
| Principles of Operation | Operates on the same principles as the predicate devices, involving the display and management of downloaded oximetry data. |
| Software Platform | Developed on a software platform comparable to the predicate devices. |
| Hardware Requirements | Compatible with standard personal computer hardware, similar to the predicate devices. |
| Safety Testing | Representative samples successfully underwent performance testing to demonstrate appropriate functional characteristics, ensuring safe operation. |
| Adjunct System Requiring Human Interpretation | Explicitly states it is an "adjunct system requiring human interpretation of results; it does not suggest a course of treatment or generate a diagnosis," mirroring the expected use model of predicate data management software. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a specific "test set" sample size in terms of patient data or clinical cases. The performance testing appears to be functional and safety testing of the software itself rather than a clinical trial with a cohort of patients. The data provenance (country of origin, retrospective/prospective) is therefore not applicable in the context of this software's evaluation as described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given the nature of the software (data management rather than diagnostic interpretation), a traditional "ground truth" derived from expert consensus on patient cases is unlikely to have been the primary method of evaluation. The evaluation focused on the software's ability to accurately handle and display data from the oximeters and match the functionality of predicate devices.
4. Adjudication Method for the Test Set
An adjudication method (e.g., 2+1, 3+1) for a test set is not applicable and therefore not mentioned, as there isn't a stated clinical test set requiring expert adjudication for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted or described in the provided summary. The device is data management software, not an AI interpretation tool intended to directly improve human reader performance on a diagnostic task.
6. Standalone Performance Study
A standalone performance study in the sense of an algorithm's diagnostic accuracy without human-in-the-loop was not performed for this software. The software's role is to present data for human review and interpretation, not to make independent diagnoses. The "performance testing" mentioned refers to functional and safety testing of the software itself.
7. Type of Ground Truth Used
The "ground truth" concept is not directly applicable in the typical clinical sense for this software. The evaluation relied on demonstrating that the software accurately processed and displayed data from compatible Nonin oximeters and performed functions comparable to predicate data management software. The implicit "ground truth" would be the accurate, raw data from the oximeters and the established functionality of the predicate devices.
8. Sample Size for the Training Set
This information is not applicable and not provided. As "nVISION® Data Management Software" is described as a data management tool, not an AI/ML diagnostic algorithm, there isn't a "training set" in the context of machine learning. The software's development likely involved standard software development methodologies and testing, rather than an AI training paradigm.
9. How Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set for an AI/ML algorithm.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).