(88 days)
BioSign™ is an accessory to a multi-parameter patient monitor (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.
BioSign™ provides the clinician with a trend graph of the patient status index based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The patient status index is a single measure of the patient's condition and represents how different the patient's vital signs are with respect to normality. BioSign™ is an adjunct to and is not intended to replace vital signs monitoring.
BioSign™ is a software accessory to standard multiple parameter physiological patient monitors (bedside or ambulatory) or clinical information systems. It operates on a standard medical grade computer.
BioSign™ is a software device embedded in a standard medical grade computer that through advanced signal processing can combine physiological signals in order to produce a single graph representation of patient condition.
BioSign™ is a computerized analysis system that can accept multiple channels of physiological data (for example heart rate, respiratory rate, temple viauncis of pressure and oxygen saturation as inputs). Through advanced signal procession, BioSign can identify changes in patient status.
The provided document describes the BioSign™ device, its indications for use, and its substantial equivalence to other devices. However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics from a formal clinical study that would allow for a comprehensive description of acceptance criteria and how a study proves the device meets those criteria.
The document mentions "Design verification" and "Design validation" but only provides generic statements about their conclusions. It does not provide the quantitative performance criteria or the results of studies against those criteria.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an analysis of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Hypothetical, as not explicitly stated in document) | Reported Device Performance |
|---|---|
| Device Specifications Conform to User Needs and Intended Use (Inferred from "Design validation") | "Design validation testing of the BioSign™ patient status index model has been conducted and concluded that device specifications conforms with user needs and intended use." |
| Hardware and Software Meet Specified Requirements (Inferred from "Design verification") | "Design verification testing of the BioSign™ hardware and software against the specified requirements has been conducted and the BioSign™ device has been found to meet the specifications." |
| Electrical Safety Compliance | "BioSign™ systems comply with BS EN 60601-1-1:2001, 'Safety requirements for medical electrical systems.'" |
| Accuracy/Reliability of Patient Status Index (Missing) | Not specified or quantified. The document states it produces a "single graph representation of patient condition" and identifies "changes in patient status" but doesn't quantify its accuracy or performance in doing so. |
| Sensitivity/Specificity in Identifying Status Changes (Missing) | Not specified or quantified. |
| User Interface Usability/Effectiveness (Missing) | Not specified. |
Missing Information in the Document: The document does not provide specific acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity, agreement with a gold standard) for the BioSign™ patient status index. It only states that design validation and verification were performed and concluded positively.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. The document vaguely refers to "historic clinical data" in the context of substantial equivalence to another device (Sonicaid System 8002) but does not link this directly to the BioSign™ device's own performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The BioSign™ is described as "decision support" and an "adjunct," but no study is detailed to quantify its assistance to clinicians.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document mentions "Design validation testing of the BioSign™ patient status index model has been conducted..." which implies an evaluation of the algorithm's performance. However, no specific metrics or study details for this standalone performance are provided. It states the system "can identify changes in patient status" and produces an "index and associated trend graph indicative of the patient's state," but without quantification.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated for performance testing. The description of how the BioSign™ model is derived (similar to Sonicaid System 8002) references "a model derived from historic clinical data" and "examination of historical clinical data." This suggests that a form of historical clinical data was used as a basis for establishing "normality" for the patient status index, which could imply expert-defined normal ranges or outcomes from those historical cases. However, no specific ground truth methodology for its own validation study is detailed.
8. The sample size for the training set
- Sample Size for Training Set: Not specified. The document refers to a "model derived from historic clinical data" but does not provide details on the size or characteristics of this data.
9. How the ground truth for the training set was established
- How Ground Truth was Established: Not explicitly detailed. The statement "provides decision support to a clinician in the determination of normality based on a model derived from historic clinical data" (in comparison to Sonicaid System 8002 which had criteria established by "examination of historical clinical data") suggests that the "normality" concept for the patient status index was established through analysis of historical physiological data and likely included clinical interpretation or consensus within that historical dataset. No specific methodology (e.g., expert review, outcome correlation for each case) is provided.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).