(80 days)
The BioSign™ Central Station is an accessory to nulti-parameter patient monitors (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.
The BioSign 146 Central Station provides the clinician with a patient status index (BioSign™ Index) based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The BioSign™ 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.
The BioSign™ Central Station displays BioSign indices for multiple patients.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician
BioSign™ Central Station is a software accessory to standard multiple parameter physiological patient monitors (bedside or ambulatory) or clinical information systems. It operates on a standard PC, or personal computer.
BioSign™ is a software device that through advanced signal processing can combine physiological signals in order to produce a single index (BioSign index) representation of patient condition.
BioSign™ is a computerized analysis system that can accept multiple channels of physiological data (for example heart rate, respiratory rate, temperature, blood pressure and oxygen saturation as inputs). Through advanced signal processing, BioSign can identify changes in patient status.
The provided 510(k) summary for the BioSign™ Central Station discusses design verification and design validation but does not provide specific acceptance criteria or a detailed study report that proves the device meets those criteria.
Here's an analysis based on the provided text, highlighting what's present and what's missing:
Acceptance Criteria and Device Performance
The document states:
- "Design verification testing of the BioSign™ Central Station hardware and software against the specified requirements has been conducted and the BioSign™ device has been found to meet the specifications."
- "Design validation testing of the BioSign™ index model has been conducted and concluded that device specifications conformed with user needs and intended use."
However, the specific acceptance criteria (e.g., performance metrics, thresholds for accuracy, sensitivity, specificity, or correlation) and the reported device performance metrics are NOT provided in this summary. The document broadly states that the device "meets the specifications" and "conformed with user needs," but offers no quantitative data.
Detailed Analysis of Study Information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specifics NOT provided in document) | Reported Device Performance (Specifics NOT provided in document) |
|---|---|
| No specific quantitative acceptance criteria are detailed in the provided text. The document broadly refers to "specified requirements" and "user needs and intended use." | No specific quantitative performance metrics are detailed in the provided text. The document states the device "has been found to meet the specifications" and "conformed with user needs." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The device is said to be based on a "model derived from historic clinical data" (referring to the predicate device, BioSign™ K053112), but no specifics are given for the BioSign™ Central Station's validation.
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 for the test set
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided summary. This device is an accessory that provides an index; it doesn't involve human readers interpreting images, so an MRMC study would be out of scope for its function.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The document states "Design validation testing of the BioSign™ index model has been conducted and concluded that device specifications conformed with user needs and intended use." This implies an assessment of the algorithm's performance. However, no specific details of this standalone performance, metrics, or study design are provided. The device calculates a "BioSign™ index" as a "single measure of a patient's condition."
7. The type of ground truth used
- The summary mentions the BioSign™ Index is based on "a model derived from historic clinical data." This suggests that the ground truth for establishing the "normality" model was based on historic clinical data and potentially clinical outcomes or expert labels within that data. However, how the ground truth for the validation test set was established is not explicitly stated.
8. The sample size for the training set
- Sample Size: Not specified. The predicate device's model was "derived from historic clinical data," but no numbers are given for the volume of this data.
9. How the ground truth for the training set was established
- The ground truth for the model is described as being "derived from historic clinical data." This implies that the 'normality' model and the weighting of the five vital signs were established by analyzing historical patient data, presumably labeled with patient states or outcomes. The precise method of how ground truth was established within this "historic clinical data" (e.g., physician diagnosis, pathology, specific vital sign thresholds indicating certain states) is not detailed.
Summary of Missing Information:
The 510(k) summary provides a high-level overview of design verification and validation, but it significantly lacks specific, quantitative details regarding:
- Acceptance criteria: What performance metrics (e.g., accuracy, reliability measures) did the device need to achieve?
- Device performance results: What were the quantitative results from the verification and validation studies?
- Study design details: Sample sizes for test and training sets, data provenance, ground truth establishment specifics, and expert qualifications.
This level of detail is typically found in more comprehensive study reports submitted to the FDA, rather than the summary provided here.
§ 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).