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510(k) Data Aggregation
(241 days)
OxiScan II Oximetry Data Management Software (OxiScan II) is a central server based software system that uses a personal computer based application written in Microsoft Dot Net protocol to capture oximetry data from an oximeter, and then transmit this data, in a secure encrypted file, via internet, to the central server. At the central server the data is used to render a standard report that is then transmitted via fax and/or email to the prescribing physician. The intended use of the report is to provide a physician with information to help determine the best pulmonary treatment.
The OxiScan II Oximetry Data Management Software is intended to collect, report and archive oximetry trend data to provide information to a medical professional, as a supplemental tool to assist in the timely identification of pulmonary needs.
The OxiScan II Oximetry Data Management Software is intended to (1) transfer oximetry data from a pulse oximeter to a central server data base in order to maintain unique records per patient and test of this pulse oximetry data, and (2) to generate and archive standard reports drawn from this data. A list of approved oximeters appears in the Capture software.
The OxiScan II Oximetry Data Management Software is not a diagnosis tool. It is a decision management support tool that allows medical personnel to securely and accurately upload and view data related to pulse oximetry and to provide output reports as feedback which may be used by a Heathcare professional to form a patient history.
OxiScan II Oximetry Data Management Software is an accessory for use with compatible pulse oximeters. OxiScan II Oximetry Data Management Software collects and stores patient information containing raw oximetery data captured by a pulse oximeter. This information is transferred by a personal computer to an internet Web server where a report which summarizes and graphically presents the data is prepared. This report is delivered to a Healthcare Professional who then uses it along with other information to determine a course of pulmonary treatment. The report may be retrieved, reviewed, and retransmitted via the OxiScan II Oximetry Data Management Software web site.
The OxiScan II Oximetry Data Management Software is a software system intended to collect, report, and archive oximetry trend data from compatible pulse oximeters to provide information to a medical professional. It acts as a supplemental tool for timely identification of pulmonary needs and to form a patient history, but it is not a diagnostic tool.
The acceptance criteria for the OxiScan II Oximetry Data Management Software are primarily focused on its functional characteristics, safety, and effectiveness in meeting its stated intended use, and its substantial equivalence to a predicate device. The study demonstrating that the device meets these criteria is described as "Functional and Safety Testing."
Here's the breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Characteristics: | Representative samples of OxiScan II successfully performance tested to verify compliance to appropriate functional characteristics. |
| - Ability to capture oximetry data from compatible oximeters. | The device uses a PC-based application to capture oximetry data from an oximeter. A list of approved oximeters appears in the Capture software. |
| - Secure and encrypted data transmission to central server. | Data is transmitted "in a secure encrypted file, via internet, to the central server." |
| - Generation of standard reports. | At the central server, data is used to "render a standard report." |
| - Transmission of reports to prescribing physician. | Reports are transmitted "via fax and/or email to the prescribing physician." |
| - Data archiving for unique patient records and tests. | Intended to "maintain unique records per patient and test of this pulse oximetry data." |
| - Accessibility and review of reports by healthcare professionals. | Reports can be "retrieved, reviewed, and retransmitted via the OxiScan II Oximetry Data Management Software web site." |
| Safety: | Representative samples of OxiScan II successfully performance tested to verify compliance to appropriate safety characteristics. |
| Effectiveness: | Representative samples of OxiScan II successfully performance tested to verify compliance to appropriate effectiveness characteristics. |
| Substantial Equivalence: | "OxiScan II Oximetry Data Management Software has been concluded as substantially equivalent to the predicate device [Nonin Medicals "nVISION" software (K033307)]" based on similar intended uses, operation methods, and performance specifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned appears to be software performance testing rather than clinical validation with expert review.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
The document does not describe any adjudication method for a test set. The validation described focuses on functional, safety, and effectiveness testing of the software itself and its equivalence to a predicate device.
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 comparative effectiveness study was not done. The device is data management software, not an AI-assisted diagnostic tool. Its purpose is to collect, report, and archive oximetry data for review by healthcare professionals, not to provide interpretations or assist human readers in making diagnoses in the way an AI algorithm might.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device, OxiScan II, is described as "Oximetry Data Management Software." Its standalone performance would relate to its ability to accurately capture, transmit, process, and report oximetry data as per its specifications. The document states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested to verify compliance to appropriate functional characteristics." This implies standalone testing of the software's data management capabilities. However, it explicitly states it is "not a diagnosis tool" and relies on a "Healthcare Professional" for interpretation, meaning its intended use always involves human-in-the-loop for clinical decision-making.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not detail the type of "ground truth" in the sense of clinical diagnoses or outcomes. Given the nature of the device as data management software, the "ground truth" for its performance testing would likely involve:
- Expected data values/formats: Verifying that captured oximetry data matches the source.
- Report accuracy: Confirming that generated reports correctly reflect the stored data.
- System functionality: Ensuring features like secure transmission, archiving, and retrieval work as designed.
- Compliance with specifications: Testing against pre-defined functional and technical requirements.
8. The Sample Size for the Training Set
The document does not mention a training set, as the device is not described as utilizing machine learning or artificial intelligence that would typically require a training set. The "Functional and Safety Testing" refers to performance verification, not an AI model's training.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned or applicable to this type of software, this information is not provided.
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