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510(k) Data Aggregation
(170 days)
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients.
The CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are designed to acquire, process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time with and without arrhythmia detection.
The arrhythmia detection portion of CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but do not provide alarms.
CASE V7.0 Cardiac Testing System and Cardiac Testing System provide the control of external devices (typically a treadmill or bicycle ergometer) and communicate with centralized electronic/digital storage system via data networks.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System provide a user selectable option for printouts of prognostic scores on selected reports. Vector loops are also available.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System can be configured in a network environment for multiple CASE and CardioSoft stations allowing the user to create a central database of patient demographics and collected patient physiological data.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are intended to be used primarily in the hospital but can also be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed.
CASE V7.0 Cardiac Testing System and Cardiac Testing System offer no diagnostic opinion to the user. Instead, it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion.
CASE V7.0 Cardiac Testing System and Cardiac Testing System are not intended to be used as a transport device or for home use.
CASE V7.0 Cardiac Testing System and Cardiac Testing System are not intended for use as a vital signs physiological monitor.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for intracardiac use.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use as an emergency device.
CASE V7.0 Cardiac Testing System and Cardiac Testing System will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulators.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use with high frequency surgical units. Disconnect the patient from CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System before using the high frequency surgical unit.
The CASE V7.0 Cardiac Testing System and the CardioSoft V7.0 Cardiac Testing System are designed to be used for resting ECG, stress test ECG, Spirometry, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CardioSoft V7.0 Cardiac Testing System will be offered as a software only package including a front end for data acquisition. The CASE V7.0 Cardiac Testing System is a turnkey product utilizing the CardioSoft V7.0 Cardiac Testing software.
This FDA 510(k) summary provides information for the CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System. However, it does not contain specific acceptance criteria, reported device performance metrics tied to those criteria, or a detailed study description with sample sizes, expert qualifications, or ground truth methods related to the device's diagnostic or analytical capabilities.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (CASE Cardiac Testing System, CS Cardiac Testing System (K103678)) by comparing features and functions. It mentions compliance with performance standards but does not detail the results of performance tests in terms of specific metrics for the device itself.
Therefore, much of the requested information cannot be extracted from the provided text.
Here's what can be gathered, addressing the points where information is available or noting its absence:
1. Table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with corresponding reported device performance metrics for diagnostic accuracy, sensitivity, specificity, or other analytical capabilities. Instead, it compares the proposed device's features and technical specifications to those of the predicate device, asserting "Identical" or "Equivalent" for most technical aspects.
For example, under "ECG Signal Bandwidth", the proposed device has "0.04 to 150 Hz (CC14)" compared to the predicate's "0.01 to 150 Hz (CAM 14)". The explanation notes that the proposed device complies with IEC60601-2-25:2011 requirement of 0.67 Hz to 150 Hz, implying that 0.04 Hz is within acceptable limits for capturing useful ECG data. This is a comparison to a standard, not a specific performance metric of the device against an internal acceptance criterion.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission states, "The subject of this premarket submission, CASE V7.0 and CardioSoft V7.0 did not require clinical studies to support substantial equivalence." This indicates that no new clinical study was conducted for this 510(k) submission to demonstrate performance with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided as no new clinical study (test set evaluation) was detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as no new clinical study (test set evaluation) was detailed.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed for this submission, as it explicitly states no clinical studies were required. The device provides "interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion," implying human-in-the-loop, but the submission doesn't detail performance with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study of the algorithm (e.g., for arrhythmia detection or ECG analysis) was not detailed as part of this submission. The "arrhythmia detection portion" is described as being "provided to the user for the convenience of automatic detection of arrhythmias but do not provide alarms." The 12SL ECG Analysis Program (V23) is mentioned, which is a previously cleared component (K141963), suggesting its performance was established in its own clearance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided as no new clinical study (test set evaluation) was detailed.
8. The sample size for the training set
This information is not provided. The document describes upgrades to existing software and hardware components and relies on compliance with voluntary standards and substantial equivalence to a predicate device. There is no mention of a new "training set" in the context of machine learning, although software development would involve internal testing.
9. How the ground truth for the training set was established
This information is not provided. As above, there's no mention of a new training set or ground truth establishment. The device incorporates a "12SL ECG Analysis Program (V23) (K141963)" which would have had its own ground truth established during its prior clearance.
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(250 days)
VitalScan ANS is intended for non-invasive measurements of pulse waveforms by photoelectric plethysmography (PPG), heart rate electrocardiograph (ECG), Heart Variability measurements (HRV) and blood pressure (NIBP) in response to paced respiration and controlled testing procedures for physician assessment of the Cardiovascular Systems.
VitalScan ANS also measures/calculates a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assessing development of peripheral arterial disease (PAD).
The device is intended for use on transitional adolescents and adults, including those with unilateral lower limb amputation, in medical clinics, healthcare practices and out-patient departments of hospitals.
The physician has the responsibility of interpreting the significance of the resulting data.
VitalScan ANS system collects multi-parameter patient data including: Electrocardiography (ECG), Plethysmogram (PPG), Pulse Volume Recording (PVR), Blood Pressure, Heart Rate, and Peripheral capillary Oxygen saturation (SpO2).
The system comprises: USB plug and play device hardware and Software installed on a computer.
VitalScan ANS is intended to measure a patient's variations in the heart rate (R-R beat-to-beat intervals from ECG) and perform Heart Rate Variability (HRV) analysis to assess Autonomic Nervous System (ANS) Function;
VitalScan ANS also measure a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assess the risk of developing peripheral arterial disease (PAD).
The results are saved in a backup and can also be printed.
The device does not provide any direct diagnosis rather the device provides information to the physician for inclusion in their decision making process.
The provided document is a 510(k) summary for the VitalScan ANS device. It primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and non-clinical testing.
Here's an analysis of the provided information regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparison table (pages 7-8) that highlights the VitalScan ANS device's specifications against predicate devices. While this table shows performance characteristics, it does not explicitly state "acceptance criteria" in a quantifiable sense for the VitalScan ANS itself. Instead, it demonstrates that the VitalScan ANS either matches or is similar to the established performance of legally marketed predicate devices.
Here's an extracted and summarized table based on the direct comparison for the VitalScan ANS device's performance, using the predicate device values as a proxy for what would be considered acceptable based on substantial equivalence:
| Feature/Parameter | Acceptance Criteria (from Predicate/Reference) | Reported Device Performance (VitalScan ANS) |
|---|---|---|
| ECG | ||
| Method | ECG lead wires attached to disposable electrodes to the skin | ECG lead wires attached to disposable electrodes to the skin |
| Resolution | 16 bit (from ANSHA-QHRV1) | 24 bit |
| Input impedance | > 20 Mohm (from ANSHA-QHRV1) | > 20 Mohm |
| Common mode rejection | -80dB - 100dB (from ANSHA-QHRV1) | -80dB - 100dB |
| Sampling frequency | 800, 400 and 200 Hz (from ANSHA-QHRV1) | 1000, 500, 200 Hz |
| Channels | 3 channels (from ANSHA-QHRV1) | 3 or 12 channels |
| QRS detection | 99.8% (from ANSHA-QHRV1) | 99.8% |
| Permanent Display | Not provided (from ANSHA-QHRV1) | Not provided |
| Applied parts in contact with patient | ECG Electrodes (from ANSHA-QHRV1) | ECG Electrodes |
| HEART RATE | ||
| Method | QRS detection (from ANSHA-QHRV1) | QRS detection |
| Range | 40 - 200 bpm (from ANSHA-QHRV1) | 38 - 250 bpm |
| Accuracy | ± 2 bpm (from ANSHA-QHRV1) | ± 2 bpm |
| BLOOD PRESSURE | ||
| Measurement types | Oscillometric measuring method during deflation of the cuff (from ABPI MD / Tonoport V) | Oscillometric measuring method during deflation of the cuff |
| Measurement ranges (Systolic) | 60 to 260 mmHg (from Tonoport V) | 60 to 260 mmHg |
| Measurement ranges (Diastolic) | 40 to 220 mmHg (from Tonoport V) | 40 to 220 mmHg |
| Measurement ranges (HR) | 35 to 240 min-1 (from Tonoport V) | 35 to 240 min-1 |
| Limit values of measurement errors (ABPI) | ± 0.1 (from ABPI MD) | ± 0.1 |
| Limit values of measurement errors (Systolic) | 4.6 mmHg (Empirical Standard Deviation - from Tonoport V) | 4.6 mmHg (Empirical Standard Deviation) |
| Limit values of measurement errors (Diastolic) | 4.4 mmHg (Empirical Standard Deviation - from Tonoport V) | 4.4 mmHg (Empirical Standard Deviation) |
| Cuffs inflation and deflation | Automatic inflation using an air pump and deflation using an electromagnetic valve. Max 300 mmHg (from Tonoport V) | Automatic inflation using an air pump and deflation using an electromagnetic valve. Max 300 mmHg |
| Pulse Volume / Plethysmography | Pneumo-plethysmography method using the cuffs measuring the blood pressure values: Plethysmography displayed at the inflation and deflation pressure (from ABPI MD) | Pneumo-plethysmography method using the cuffs measuring the blood pressure values: Plethysmography displayed at the inflation and deflation pressure |
| Applied parts in contact with patient | 3 cuffs, tubes and bladders (from ABPI MD) / 1 cuff, tube and bladder (from Tonoport V) | 2 or 4 cuffs, tubes and bladders |
| OXYGEN SATURATION | ||
| Method | Photo plethysmogram on finger. Infrared: 910 nm @ 1.2 mW maximum average, Red: 660 nm @ 0.8 mW maximum average (from ANSHA-QHRV1) | Photo plethysmogram on finger. Infrared: 910 nm @ 1.2 mW maximum average, Red: 660 nm @ 0.8 mW maximum average |
| Range | 70-100% (from ANSHA-QHRV1) | 70-100% |
| Accuracy | ± 2 digits (from 70-100%) (from ANSHA-QHRV1) | ± 2 digits (from 70-100%) |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No Clinical testing was necessary to determine substantial equivalence." (Page 6, section b2). This means there was no test set of patient data used to evaluate the device's clinical performance. The evaluation was based on non-clinical (bench) testing and comparison to predicate devices, not on direct human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since no clinical testing was performed, there were no experts used to establish ground truth for a clinical test set. The substantial equivalence was determined by comparing the device's technical specifications and safety/performance data (from bench testing) to those of already approved predicate devices.
4. Adjudication method for the test set
Not applicable, as no clinical test set was used.
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. This device is not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, if we interpret "standalone" as the device operating according to its technical specifications and algorithms during non-clinical (bench) testing. The document states:
- "Bench testing was carried out on the following characteristics: Electrocardiograph (ECG), Heart rate variability (R-R interval), Heart rate, SpO2 and Plethysmogram, Blood-Pressure Measurement accuracy, Communication, data transmission and storage integrity, Electromagnetic compatibility (EMC), Electrical safety testing, Software verification and validation testing, Biocompatibility verification." (Page 5, section b1)
- And, "The VitalScan ANS device was tested and meets the applicable requirements of following performance Standards and is in accordance with FDA Class II Special Controls Guidance Document" followed by a list of relevant IEC and ISO standards (pages 5-6).
These non-clinical tests demonstrate the device's performance in a standalone capacity against established technical and safety standards.
7. The type of ground truth used
For the non-clinical testing, the "ground truth" would be established by the specifications and measurement accuracies defined in the referenced standards (e.g., IEC 60601-1, AAMI / ANSI 80601-2-30 for blood pressure accuracy). The device's measurements were compared against calibrated instruments or reference signals as part of these bench tests. The substantial equivalence argument also uses the established performance of the legally marketed predicate devices as a form of "ground truth" for acceptable performance.
8. The sample size for the training set
Not applicable. This device is not described as utilizing machine learning or artificial intelligence that would require a "training set" of data. Its functionalities are based on established physiological measurement principles and algorithms.
9. How the ground truth for the training set was established
Not applicable, as there is no training set described for this device.
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(14 days)
It is intended to be used as an aid or support for the initial diagnosis and subsequent treatment's follow-up when it is necessary to measure a patient's blood pressure over a determined period of time. The system does not make any diagnose, it only measures, stores and displays the information. The ABP-2000 G-3 (NIBP) monitor is only intended and designed:
- for measuring the systolic, diastolic and mean blood pressure as well as the heart rate of human beings.
- for recording during a predetermined period of time the above mentioned measurements (up to 250 measurements).
- to be used along with the ABP-2000 G-3 software for programming as well as record keeping and display in a graphical or tabular report.
The ABP-2000 G-3 is an automated, ambulatory, non-invasive blood pressure (NIBP) monitor microprocessor based. The device uses an oscillometric linear deflation technique to determine blood pressure. A cuff is inflated by an internal electrical air pump, and the deflation process is controlled by two internal valves. During deflation, the arterial blood pressure pulses are sensed by the device by means of cuff pressure changes, which are analyzed by the microprocessor in order to determine the blood pressure. The ABP-2000 G-3 can record patient's blood pressure at different and previously determined intervals as clinically scheduled, or can be activated by pressing the Start/Stop button.
The physician can program the measurement intervals as well as the LCD display (it can be disabled to prevent patient from seeing the readings) and then, the device is placed on the patient at the physician's office and is usually worn for 24 hours. The ABP-2000 G-3 software allows the physician to setup the device, the display and to keep all the records. The information is stored on an internal memory that will register each reading. All the data can be downloaded (via serial cable) into the computer software once the study has ended. The information can be analyzed and presented in either graphical or table format, and printed in either format using the PC software.
The provided text describes the ABP-2000 G-3, an Ambulatory Blood Pressure Monitor, and its performance testing in a 510(k) submission. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| AAMI SP-10 compliance | The device complies with all of the requirements of the AAMI SP-10. |
| British Hypertension Society's protocol approval | The ABP-2000 G-3 has been approved according to the British Hypertension Society's protocol. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document refers to compliance with established protocols (AAMI SP-10 and BHS), which typically involve specific testing methodologies, but details about expert involvement in establishing ground truth for this specific device's test set are absent.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This device is an Ambulatory Blood Pressure Monitor, which is a measurement device, not an AI-assisted diagnostic tool for image interpretation or similar. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding human readers and AI assistance is not applicable and was not done for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone automated blood pressure monitor. Its performance, as described by compliance with AAMI SP-10 and BHS protocols, inherently refers to its standalone performance in measuring blood pressure. There is no "human-in-the-loop" aspect to its measurement function, beyond a human initiating the measurement and potentially interpreting the results.
7. The Type of Ground Truth Used
The ground truth for blood pressure measurement devices is typically established through comparison with a reference standard, often involving direct intra-arterial measurement or a highly accurate auscultatory method performed by trained personnel. While not explicitly detailed for this specific study, the compliance with AAMI SP-10 and British Hypertension Society's protocol implies that established methods for determining accurate blood pressure readings were used as the ground truth. These protocols define specific procedures for comparing the device's readings against these reference standards.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The ABP-2000 G-3 is a microprocessor-based device that uses an oscillometric linear deflation technique. It is not an AI/machine learning model in the modern sense that learns from a "training set" of data. Its "training" would be its design, calibration, and validation against established engineering principles and clinical standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated in point 8.
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