Search Results

The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.

The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated.

The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:

• · Pulse rate
• · Oxygen saturation
• · Temperature
• · Movement

The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, of.

• · Respiration rate
• · Non-invasive blood pressure
• · Lung function & spirometry
• · Weight

The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.

The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.

The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

The Current Wearable Health Monitoring System consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. The Current Wearable Health Monitoring System is also integrated with devices for monitoring of blood pressure, spirometry & lung function, and weight.

The system is intended to continuously monitor adult patient vital signs in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. It is intended to continuously monitor pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). Current is intended for intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP), spirometry & lung function, and weight (WEIGHT).

While the wearable device monitors skin temperature, an additional adhesive axillary sensor can be used to monitor axillary temperature.

In the home environment, the patient will have responsibility for applying the device to their arm, charging the device and plugging in the Homehub to mains power. However, the data will still be made directly available to healthcare professionals. These healthcare professionals will be at a remote location e.g. an office or within the hospital or could be with the patient in their own home.

The provided document does not contain detailed acceptance criteria or the specific study details for validating the device's performance against such criteria. Instead, it lists various "Test Names" and "Test Descriptions" which broadly indicate areas of testing (e.g., electrical safety, EMC, pulse rate testing, SpO2 testing, respiration rate testing, temperature measurement accuracy). However, it does not specify quantitative acceptance thresholds for these performance metrics, nor does it provide the reported device performance in those quantitative terms.

For example, for "Pulse Rate Testing," the description mentions "Validation of the accuracy of pulse rate monitoring of the system in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff. 2007." While this indicates the standards followed, it doesn't state what specific accuracy (e.g., within X beats per minute) was achieved or was the acceptance criterion. The "Results" column consistently states "Passed," but without the specific acceptance criteria, it's impossible to determine the benchmark used for passing.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an attempt to answer based on the absence of the requested information:

1. A table of acceptance criteria and the reported device performance:

   Performance Metric	Acceptance Criteria	Reported Device Performance
   Electrical Safety	Unspecified; adherence to IEC 60601-1	"Passed"
   EMC	Unspecified; adherence to IEC 60601-1-2	"Passed"
   Alarm Testing	Unspecified; adherence to IEC 60601-1-8	"Passed"
   Pulse Rate Accuracy	Unspecified; adherence to ISO 80601-2-61 and FDA Guidance 2007	"Passed"
   SpO2 Accuracy	Unspecified; adherence to ISO80601-2-61 and FDA Guidance 2013	"Passed"
   Respiration Rate Accuracy	Unspecified; comparison to end-tidal CO2	"Passed"
   Temperature Measurement Accuracy	Unspecified; adherence to ISO 80601-2-56	"Passed"
   Battery Life	Unspecified	"Passed"
   PDU Buffering Time	Unspecified	"Passed"
   Usability	Unspecified; adherence to IEC 62366 and IEC 60601-1-11	"Passed"
   Device Ship/Transport	Unspecified; adherence to ASTM D4169	"Passed"
   Biocompatibility	Unspecified; adherence to ISO 10993-1	"Passed"
   Wireless Coexistence	Unspecified	"Passed"
   System V&V	Unspecified	"Passed"
   Software V&V	Unspecified	"Passed"

2. Sample size used for the test set and the data provenance: This information is not provided in the document. The document states "No clinical studies were conducted as part of submission to prove substantial equivalence." The non-clinical tests mention "the system was tested," but do not specify sample sizes for these tests (e.g., how many subjects for pulse rate and SpO2 accuracy, or how many devices for other tests).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.

4. Adjudication method for the test set: This information is not provided.

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: This information is not provided. The device is a "Wearable Health Monitoring System" and the testing described is primarily about the accuracy of its vital sign measurements and compliance with various standards, rather than evaluating AI assistance for human readers in a diagnostic capacity.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes various "non-clinical tests" and "software verification and validation testing" which would fall under standalone performance. However, specific performance metrics quantifying the algorithm's output (e.g., sensitivity, specificity, accuracy %) against a ground truth are not provided. The results are merely "Passed" for general compliance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physiological parameters, the ground truth would typically be established by a reference method. The document mentions "in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff" for pulse rate and SpO2, and "comparison to respiration rate measured via end-tidal CO2" for respiration rate. These represent established reference methods for ground truth, but the details of their application in the study (e.g., specific devices used for reference, blinded measurements) are not given. For other tests like electrical safety or EMC, the ground truth is adherence to the specified standard.

8. The sample size for the training set: This information is not provided. The document does not discuss a training set, as it mainly focuses on verification and validation testing rather than the development of AI/ML models that would require training data.

9. How the ground truth for the training set was established: This information is not provided, as a training set is not discussed.

Ask a specific question about this device

The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.

The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring temperature at the upper arm is clinically indicated.

The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:

• · Pulse rate
• · Oxygen saturation
• · Temperature
• Movement

The Current Wearable Health Monitoring System is intermittent or spot-check monitoring of respiration rate, non-invasive blood pressure and weight in adults.

The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.

The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmas e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.

The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

The Current Wearable Health Monitoring System consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. The Current Wearable Health Monitoring System is also integrated with specific devices for monitoring of blood pressure and weight.

The system is intended to continuously monitor adult patient vital signs in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. It is intended to continuously monitor pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). Current is intended for intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP) and weight (WEIGHT).

In the home environment, the patient will have responsibility for applying the device to their arm, charging the device and plugging in the Homehub to mains power. However, the data will still be made directly available to healthcare professionals. These healthcare professionals will be at a remote location e.q. an office or within the hospital or could be with the patient in their own home.

The provided document is a 510(k) summary for the Current Wearable Health Monitoring System. It details the device's intended use, classification, and comparison to predicate devices, along with non-clinical and software testing. However, it explicitly states:

• No animal studies were conducted.
• No clinical studies were conducted.

Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance. The document primarily focuses on non-clinical performance (bench testing) and software verification/validation to demonstrate substantial equivalence to previously cleared predicate devices.

Given this, I cannot provide acceptance criteria and reported device performance from a clinical study, nor details on sample sizes, ground truth establishment, or expert adjudication as these elements are typically part of clinical studies, which were not performed for this submission according to the document.

The document does, however, list several non-clinical tests performed and their results, which all "Passed." These implicitly serve as the acceptance criteria for those specific tests.

Here is a table summarizing the acceptance criteria (implied by the test description) and reported performance from the non-clinical tests:

1. Table of Non-Clinical Acceptance Criteria and Reported Device Performance

Since no clinical studies were performed, the following information is not available from the provided document:

2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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: Not applicable, as this is a monitoring device and not an AI-assisted diagnostic tool for human readers, and no comparative effectiveness studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The non-clinical tests assess the device's technical performance, which can be seen as "standalone" algorithm/device performance. However, human interpretation of the displayed data is inherent to the intended use.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" was typically established by recognized standards, reference devices, or defined test protocols. For example, for pulse rate and SpO2, the ground truth would be from a reference oximeter or validated physiological simulator. For temperature, it would be a reference thermometer.
8. The sample size for the training set: Not applicable, as no machine learning training data is mentioned.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

snap40 is intended for reusable bedside, mobile and central multi-parameter, continuous and intermittent physiologic patient monitoring of adult patients in environments where patient care is provided by trained healthcare professionals.

snap40 is intended to provide visual and audible physiologic multi-parameter alarms.

snap40 is intended for temperature monitoring temperature at the upper arm is clinically indicated.

snap40 continuously monitors the following parameters in adults:

• · Pulse rate
• · Oxygen saturation
• · Temperature
• · Movement

snap40 is intended for intermittent or spot-check monitoring of respiration rate.

snap40 is not intended for use in high-acuity environments, such as ICU or operating rooms or for use in the home

snap40 is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. snap40 is not a substitute for an ECG monitor.

snap40 is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

snap40 consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station.

snap40 is intended to continuously monitor adult patient vital signs in non-critical areas of the hospital, mainly general medical/surgical units, across pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). snap40 is intended for intermittent or spot-checking monitoring of respiration rate (RESP).

Here's a summary of the acceptance criteria and the studies conducted for the snap40 system, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance specifications rather than explicit acceptance "criteria" in a pass/fail sense, but it does list the accuracy for each monitored parameter. The "Reported Device Performance" column reflects the accuracy achieved in the clinical studies.

2. Sample Sizes and Data Provenance

Oxygen Saturation (SpO2) Test Set:

• Sample Size: 12 participants
• Data Provenance: The document implies these were prospectively collected in controlled desaturation studies. The country of origin is not explicitly stated but is likely the UK, where snap40 Ltd. is located.

Respiration Rate Test Set:

• Sample Size: 37 participants
• Data Provenance: The studies were conducted prospectively, with participants measured in a variety of postures. The country of origin is not explicitly stated but is likely the UK.

3. Number, Qualifications, and Adjudication of Experts for Ground Truth

• The document does not specify the number of experts used to establish ground truth for either the SpO2 or respiration rate test sets.
• The document does not specify the qualifications of these experts.
• The document does not mention any adjudication method used for establishing the ground truth.

4. Adjudication Method

As stated above, the document does not mention any adjudication method used for the test set's ground truth.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any data on how much human readers improve with AI vs. without AI assistance. The clinical studies focused on the accuracy of the device itself against established reference methods.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone (algorithm only) performance studies were conducted for both SpO2 and respiration rate. The "Clinical Studies" section explicitly details these:

• SpO2: "controlled desaturation studies were conducted in compliance with IEC80601-2-61 across 12 participants. This testing demonstrated accuracy of +/- 2 digits across the range of 70-100%."
• Respiration Rate: "snap40 was compared to respiration rate measured by end-tidal CO2. This was conducted on 37 participants in a variety of postures. This testing demonstrated accuracy of +/- 1 respirations per minute across a range of 6rpm to 60rpm."

These are direct measurements of the device's algorithmic performance.

7. Type of Ground Truth Used

• Oxygen Saturation (SpO2): The ground truth was established using "controlled desaturation studies" in compliance with IEC80601-2-61, which typically involves comparing the device's readings against a laboratory co-oximeter or arterial blood gas analysis.
• Respiration Rate: The ground truth was established by comparing snap40 readings against "respiration rate measured via end-tidal CO2," which is a clinical standard for respiratory monitoring.
• Temperature: For the non-clinical temperature accuracy test, "compliance with ISO 80601-2-56" would imply comparison against a calibrated reference thermometer.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for training the device's algorithms. It only describes the clinical validation/test sets.

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

The document does not provide any information on how the ground truth for the training set was established, as details about the training set itself are absent.

Ask a specific question about this device