(15 days)
The BASIC is a non-invasive diagnostic system to assist in the detection of peripheral vascular disease (arterial or venous).
The BASIC is not intended to be used for fetal monitoring nor for fetal applications. The BASIC is not intended for ophthalmic applications.
The BASIC is not intended for home use.
The BASIC is not intended for use on non-intact skin or eyes.
Photo-plethysmography module.
Pneumo-plethysmography module.
The pneumo-plethysmography module measures volume changes in limbs or digits. Relative limb volume increases with each heartbeat. The pneumo-plethysmography module measures this increase and depicts it as a waveform.
The pneumo-plethysmography is also used in conjunction with the Doppler module or the photo-plethysmography module to measure the systolic blood pressure in limbs or digits. In this case, the pneumo-plethysmography module is used to inflate a cuff to perform the occlusion.
The photo-plethysmography module: the amount of blood in the skin changes with each contraction of the heart. The Photo-plethysmography module measures this change and depicts it in a waveform.
The photo-plethysmography module is also used in conjunction with the pneumo-plethysmography module (blood pressure cuffs) to measure the systolic blood pressure. The photo-plethysmography module detects the return of the blood after the occlusion.
The pneumo-plethysmography module is not intended for neonatal applications.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular
The diagnosis with the BASIC is performed via four separate modalities, each of which can be used to test either the arterial or venous system.
These four modalities are:
- 4 and 8 MHz continuous wave Doppler.
- Photoplethysmography,
- Air plethysmography,
- Systolic pressure examination.
The BASIC's principle of operation is based on:
- Doppler mode: the real time ultrasound measurement of blood velocity in the examined vessel is displayed as a waveform. The time overation of the velocity is made with a 4 or 8 MHz probe.
- Photoplethysmography: The photo plethysmography probe is placed on a digit or taped to the skin surface. The photo plethysmography probe contains an infrared light source and a sensitive photocell. The light source directs infrared light into the skin. The receiving photocell measures in real time the change of the amount of blood in the skin caused by the contraction of the heart. It depicts it in a waveform.
- Air plethysmography: the real time measure of the change of blood volume in a limb. An Air-filled pressure cuff is used to measure these changes. By wrapping a pressure cuff on a patient's leg, arm or digit, the blood flow at these locations can be quickly assessed. Relative limb volume increases with each heart beat. Air plethysmography measures this increase and depict it in a waveform.
- Systolic pressure examination requires a Doppler probe or an arterial photo-sensor and a pressure cuff to measure the patient's systolic pressure at different locations (legs, arms, digits).
The important data are not the absolute value of the pressures but the pressure differences or ratio.
The BASIC consists of the following components:
- The main console,
- The 4 and 8 MHz probes,
- The photo-plethysmography sensors,
- The cuffs (the cuffs are accessories not manufactured by Atys).
The main consoles provides various indicators and controls designed to lead the operator through the sequential procedures needed for the operation of the BASIC. It contains a LCD screen and a thermal printer to display the parameters and charts associated with the tests. The console also houses the electrical and electronical components, the cuff inflate pump, the pressure sensor (that measures the pressure in the cuff). The device operates from 220 V supply.
The 4 and 8 MHz probes are comprised of a sensor tip, a mechanical head, a cable and either two piezo electric transducers.
The transducer transforms the electrical energy into acoustical energy and vice versa.
The photo sensors are non focused sensors with two (arterial sensors) or four (vein sensors) emitters and a center receiver.
The provided text is a 510(k) summary for the BASIC peripheral vascular diagnostic system. It details the device's technical specifications and its substantial equivalence to predicate devices, rather than a clinical study report. Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics in the context of a clinical trial or AI model evaluation is not present in this document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the 510(k) summary. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a clinical study with new performance data (unless specific performance data is required for substantial equivalence, which is not detailed here for a new study). The document states that "technical characteristics are almost identical" and "DIfferences that CAIST Detworld incess and methods of applications do not affect the relative safety or effectiveness of the BASIC" compared to predicates.
2. Sample size used for the test set and the data provenance
This information is not provided. The document does not describe a test set or clinical study.
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. The document does not describe a clinical study or ground truth establishment.
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
There is no mention of an MRMC study or AI assistance. The BASIC device is described as a diagnostic system with various modalities (Doppler, photoplethysmography, air plethysmography, systolic pressure examination), implying direct physiological measurements, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a diagnostic system operated by a human, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided.
8. The sample size for the training set
This information is not provided. The document does not describe a training set as it's not detailing an AI model.
9. How the ground truth for the training set was established
This information is not provided.
Summary of available information from the document related to the device and its clearance:
- Device Name: BASIC (models 1, 2, and 3)
- Common Name: Vascular test system: peripheral Doppler with photo & pneumo plethysmography.
- Regulatory Class: Class II
- Indications for Use: A non-invasive diagnostic system to assist in the detection of peripheral vascular disease (arterial or venous).
- Modalities: 4 and 8 MHz continuous wave Doppler, Photoplethysmography, Air plethysmography, Systolic pressure examination.
- Predicate Devices: HOKANSON, TL 400 TOTALAB (K872517); BIOMEDIX, FLOSTAT VASCULAR LAB (K973644); IMEX MEDICAL SYSTEMS, IMEXLAB 9100 (K973562).
- Performance Standards Conformed To: IEC 601-1, EN 60601-1-2, IEC 801-2,3,4,5 EN55011 (CISPR11). Quality system is ISO 9001 and EN 46001 approved and certified.
- Substantial Equivalence Claim: The device's technical characteristics are "almost identical" to predicate devices, and differences do not affect safety or effectiveness.
- Acoustic Output: Levels are below pre-amendment levels (track 1) for acoustic intensity for the investigation of peripheral vessels.
- FDA Clearance Date: August 10, 2001.
This document serves as a regulatory submission (510(k) summary) demonstrating substantial equivalence based on technical characteristics and existing predicate devices, rather than a report on a clinical performance study with specific acceptance criteria and performance metrics.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.