(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.
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).