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Visensia® with alert is an accessory to multi-parameter patient monitors (bedside, ambulatory, or centralized location) or clinical information systems 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.

Visensia® provides the clinician with a patient status index (Visensia® Index) based on a weighted average of five or (four) vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The Visensia® Index is a single measure of a patient's condition and represents how different the patient's vital signs are with respect to normality. Visensia® is an adjunct to and is not intended to replace vital sign monitoring.

When a Visensia® alert has activated, it means that the Visensia® Index has reached and/or surpassed the default threshold and indicates that attention should be brought to the patient.

Visensia® software is a computerized analysis software program designed as an adjunct to standard patient monitors or medical information systems. It operates by forming an aggregate score of patient status based on five vital signs; heart rate; respiratory rate; temperature; noninvasive blood pressure and arterial oxygen saturation. The aggregate score, the Visensia® Index, is displayed on a scale of 0-5, with 0 representing the normal end of the scale and 5 representing extreme physiological deterioration. An audible and visual alert is provided when the Visensia® index exceeds a threshold value for a period of time. The Visensia® Index is calculated whenever new data is received.

The Visensia® display consists of a combination of the following:

• An identifier for each monitored patient and location .
• The Visensia® Index value for each patient (shown as a number, trend or other graphical . representation).
• The vital signs for each patient (shown as a number, trend or other graphical . representation).
• A status bar area showing the state of the system .

Visensia® may also be implemented as a data processing server with no graphical interface.

The provided document is a 510(k) summary for the Visensia® device, which is an adjunct to multi-parameter patient monitors for calculating a patient status index. However, it does not contain the specific details required to answer your request about acceptance criteria and the study that proves the device meets those criteria.

The document states:

• "The Visensia® Index is displayed on a scale of 0-5, with 0 representing the normal end of the scale and 5 representing extreme physiological deterioration."
• "An audible and visual alert is provided when the Visensia® index exceeds a threshold value for a period of time."
• "Visensia® provides the clinician with a patient status index (Visensia® Index) based on a weighted average of five or (four) vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The Visensia® Index is a single measure of a patient's condition and represents how different the patient's vital signs are with respect to normality."

It also mentions "Performance Testing" with "satisfactory results for the release" which involved:

• Unit Testing
• Integration Testing
• System Testing (on the completed product operating on representative hardware and communicating with a Philips MP30 patient monitor and an emulated clinical information system).

The document focuses on demonstrating substantial equivalence to its predicate device (K081140) by describing changes to features like alerts, the algorithm (re-factored but no change to design), data handling, and labelling, and confirming those changes did not alter the intended use.

Therefore, I cannot provide the detailed information requested regarding:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for the Visensia® Index or its alerts, nor does it present specific performance metrics from a study against such criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. The device is an "adjunct" and not replacing human monitoring.
6. If a standalone study was done: The document describes system testing on the "completed product" but does not provide details of a standalone clinical performance study assessing its accuracy against a ground truth.
7. The type of ground truth used: Not mentioned. Given the device provides an "index of patient status," a ground truth would likely involve clinical outcomes, expert assessment of patient deterioration, or some other validated metric of patient health status correlated with vital signs.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

In summary, this document is a Special 510(k) submission, confirming that modifications to an existing device (Visensia®) do not alter its safety or effectiveness compared to the predicate. It does not present new clinical study data with acceptance criteria for the device's diagnostic performance.

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Visensia with Alert is an accessory to multi-parameter patient monitors (bedside, ambulatory, or centralized location) or clinical information systems and is indicated for use by health care professionals with those non-paediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.

Visensia® provides the clinician with a patient status index (Visensia® Index) based on a weighted average of five or four vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The Visensia 9 Index is a single measure of a patient's condition and represents how different the patient's vital signs are with respect to normality. Visensia with Alert is an adjunct to and is not intended to replace vital sign monitoring and as such does not contain alarms, but alerts the physician to changes in the patient's physiological status.

When a Visensia® Alert has activated, it means that the Visensia® Index has reached and/or surpassed the default threshold and indicates that attention should be brought to the patient.

Visensia® is a software accessory to standard multiple parameter physiological patient v benturs (bedside or ambulatory) or clinical information systems. It operates on a standard PC, or personal computer.

Visensia® is a software device that through advanced signal processing can combine physiological signals in order to produce a single index (Visensia® index) representation of patient condition.

Visensia® is a computerized analysis system that can accept multiple channels of Prisonological data (for example heart rate, respiratory rate, temperature, blood pressure and oxygen saturation as inputs). Through advanced signal processing, Visensia® can identify changes in patient status.

The provided text describes Visensia® with Alert, a software accessory that generates a "patient status index" (Visensia® Index) based on vital signs. It also has an alert function to indicate changes in a patient's physiological status.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the device's performance (e.g., a specific sensitivity or specificity for detecting patient deterioration). Instead, it focuses on design verification and validation, and clinical data showing effectiveness.

Therefore, the table will reflect the general statements made about performance:

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Clinical Testing: Clinical data illustrates the effectiveness of Visensia and the usefulness of he alert function. The data correlates patient deterioration with alerting function."

• Sample Size for Test Set: Not specified in the provided text. The document only generally mentions "Clinical data."
• Data Provenance: Not specified in the provided text. It does not mention the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical testing.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided text. The document focuses on the device's standalone performance and its clinical utility rather than comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance assessment was conducted, implied by the "Performance Studies" section.

• "Design verification: Design verification testing of Visensia® hardware and software against the specified requirements has been conducted and Visensia® has been found to meet the specifications."
• "Design validation: Design validation testing of Visensia® index model has been conducted and concluded that device specifications conformed with user needs and intended use."
• "Clinical Testing: Clinical data illustrates the effectiveness of Visensia and the usefulness of he alert function. The data correlates patient deterioration with alerting function."

These statements suggest that the algorithm's performance in generating the index and alerts was evaluated, independently of human interpretation, though the specifics of this evaluation are limited.

7. Type of Ground Truth Used

The document indicates that the "Clinical data illustrates the effectiveness of Visensia and the usefulness of he alert function. The data correlates patient deterioration with alerting function."

This implies that the ground truth for clinical testing was based on observed "patient deterioration" as determined by clinical assessment. However, the specific methodology for defining and confirming "patient deterioration" (e.g., specific clinical outcomes, physician diagnosis, or a composite score) is not detailed.

8. Sample Size for the Training Set

The document makes no mention of a "training set" or its sample size. The description of the device's development implies that the model for the Visensia® Index was developed and refined using historical clinical data, as stated in the substantial equivalence comparison to Sonicaid System 8002: "Visensia®... provides decision support to a clinician in the determination of normality based on a model derived from historic clinical data." However, the size of this historical dataset is not provided.

9. How the Ground Truth for the Training Set Was Established

The document indicates that the model for determining normality was "derived from historic clinical data." Analogous to the predicate device Sonicaid System 8002 where "criteria were established by examination of historical clinical data." This implies that the ground truth for developing the model was based on retrospective analysis of historical clinical data, likely interpreted by experts or defined by established clinical criteria for "normality" or "patient status." However, the specifics of how this ground truth was established (e.g., number of experts, specific criteria) are not detailed.

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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

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.

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