(217 days)
The VasoGuard devices are intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. The devices are not intended to replace other means of evaluating vital patient physiological testing, are not intended to be used in neonatal applications, and are not intended to be used inside the sterile field. The intended use is attended use by trained medical professionals in hospitals, clinics, and physician offices by prescription or on the order of a medical doctor.
The VasoGuard is a family of products designed for non-invasive peripheral vascular diagnostic testing. It uses Doppler probes and photoplethysmography (PPG) sensors positioned on the body to measure physiologic signals and report data to the interpreting clinician. The system consists of up to 10 independent pneumatic pressure channels, up to five PPG ports, up to three Doppler ports that support 4MHz and 8MHz continuous wave (CW) Doppler probes, and a touchless temperature sensor. The V series indicates the products are all made from the same parts with the only differences being that certain parts are not installed when assembled during manufacturing or some features are not enabled.
The VasoGuard family consists of five different configurations of the same device, each varying in the number of pressure channels and sensor ports accessible through one of two available enclosures. The Full-Size enclosure supports Models V6, V8 and V10, and the Mini enclosure supports Models V2 and V4.
All VasoGuard models contain the same main printed circuit board (PCB), manifold PCB(s), built-in power supply, built-in USB hub, and connect to a dedicated Windows-based medical grade PC via USB. Internally the models all utilize the same manifold assemblies and only differ in the quantity installed. The models include physical connections for control of 10 BP cuffs simultaneously, up to five PPG sensors simultaneously, one of up to three Doppler probes (4 MHz or 8 MHz), one USB camera, one IR remote control, and one touch-free infrared skin thermometer.
The VasoGuard software is pre-installed on the Windows PC. It controls all the models and automatically recognizes which model is connected thereby exposing only software capabilities only available on that model.
Each model includes certain components and accessories in addition to the VasoGuard device, including:
- Medical Grade Touchscreen PC
- Windows® 10 Enterprise LTSC
- Washable Keyboard with Trackpad
- Mobile Cart with Height-adjustable Rolling Cart
- Set of Pneumatic Hoses with Articulating Support Arm
- Set of Blood Pressure Cuffs (Shenzhen Vistar Medical Supplies Co., Ltd. K152468)
- Set of PPG Sensors
- Doppler Probes (4 MHz and/or 8 MHz)
- USB Camera
- Infrared Remote Control and Receiver
- Touch-free Infrared Skin Thermometer (Tecnimed SRL - 510(k) K122412)
The VasoGuard software features include patient database management; patient and exam search; importing and exporting of exams; facility management; importing of settings; exam protocol management, custom segment and vessel naming; customizable testing screens, reports, and graphs; backup and restore database; and keyboard shortcuts.
The quantitative measurements are the same for all VasoGuard models. One of the primary measurements is the Ankle Brachial Index (ABI). The ABI uses the Doppler probe to determine the ratio of the highest systolic pressure at the arm to the systolic pressure at the ankle. Another primary measurement of the VasoGuard is segmental blood pressures. Another main measurement of the VasoGuard is recording a waveform representing blood flow for each heartbeat. The system is capable of recording Doppler, PPG (photoplethysmography) and PVR (Pulse Volume Recording) waveforms.
The provided document, an FDA 510(k) summary for the VasoGuard device, does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and non-clinical testing, rather than presenting a performance study with defined acceptance criteria.
However, based on the information available, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for clinical performance nor does it provide reported device performance in a format that would directly fulfill this request from a clinical study standpoint.
Instead, the document focuses on bench testing for comparability to the predicate device. The "acceptance criteria" here are implicitly that the VasoGuard device performs "comparably" to the predicate in terms of waveform quality, sensitivity, and accuracy of reported values.
| Acceptance Criteria (Implied from Bench Testing) | Reported Device Performance (Bench Testing) |
|---|---|
| Comparable waveform quality to predicate | Found to be substantially equivalent in waveform quality |
| Comparable sensitivity to predicate | Found to be substantially equivalent in sensitivity |
| Comparable accuracy of reported values to predicate | Found to be substantially equivalent in accuracy of reported values |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to "bench testing with the predicate device using simulators and live signals" and "unit, design verification, performance, accelerated aging, and validation testing." This indicates the tests were largely non-clinical and involved simulators and controlled signals, not patient data. Therefore, there isn't a "test set" in the sense of clinical patient data, nor is there information on data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Given that the testing described is non-clinical bench testing with simulators and live signals, there wouldn't be "experts" establishing ground truth in the clinical interpretation sense. Ground truth in this context would likely be derived from the known parameters of the simulators or the specifications of the "live signals" themselves, as per engineering and quality control standards. No specific number or qualifications of experts are mentioned for this type of ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is mentioned, as the testing described is non-clinical bench testing, not a clinical study involving human interpretation.
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
No such study (MRMC or AI assistance) is mentioned or implied. The VasoGuard device is described as a diagnostic system for non-invasive peripheral vascular testing (Doppler, PPG, PVR), not an AI-powered diagnostic tool aiding human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as producing quantitative measurements such as Ankle Brachial Index (ABI), segmental blood pressures, and waveforms (Doppler, PPG, PVR). While the device performs calculations and generates data, it explicitly states: "The software automatically places a cursor at the time location which is suspected as being the systolic pressure, yet it is the responsibility of the medical staff to modify the cursor location to define the correct segmental pressure." This indicates a human-in-the-loop design where medical staff are responsible for final interpretation and adjustment, rather than a purely standalone AI algorithm. It's a measurement device, not an AI for diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench testing, the "ground truth" would be the known, controlled inputs from the simulators and "live signals" used during the testing. This is a technical ground truth based on engineering specifications rather than clinical ground truth (expert consensus, pathology, outcomes data).
8. The sample size for the training set
The document does not mention any training set. This suggests that the VasoGuard device is a measurement instrument, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Since no training set is mentioned, this question is not applicable.
§ 870.2880 Ultrasonic transducer.
(a)
Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.(b)
Classification. Class II (performance standards).