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The TCD-X is a transcranial Doppler device intended for recording non-invasively Doppler signals from intracranial vessels:

-For the display and measurement of cerebral artery blood flow velocities to determine the presence of hemodynanically significant deviations from normal values.

-For the detection of micro-embolic signals.

TCD-X has the ability to be used as Holter mode on ambulatory patients.

The robotic probe facilitates monitoring use by its ability to track Doppler signal all along recording time. The device is not intended to replace other means of evaluating vital patient physiological processes.

The TCD-X system is a unilateral, non-invasive Transcranial Portable or body-worn Ultrasound Diagnosis Doppler. It is designed to non-invasively measure and display major transcranial vessels blood flow velocities that supply the brain. The system can also provide potential embolic events count.

It is composed by a recorder module, a robotized probe, a hand held probe and associated components (three available sizes for spectacle frames, small carrying bag, SD card, battery charger, USB cable).

TCD-X module needs to be connected to an external computer for its display, processing, archiving records and printing.

All probes are reusable, non invasive and non sterile. TCD-X can be fitted by one probe at a time.

It is fitted with 2MHz PW robotized monitoring probe, and 2MHz PW hand held probe.

The robotized probe has the ability to adjust its angle automatically to search the Doppler signal. When the Doppler signal becomes weaker during its recording, the orientation of the robotized probe can be adjusted automatically to retrieve a good quality signal.

TCD-X can be used in two modes: Holter mode or Desktop TCD mode.

The Holter mode is used on ambulatory patient. During the recording of the transcranial Doppler signal, the TCD-X is placed on the patient in a shoulder bag. The transcranial Doppler signal is recorded on a SD card. The recorded Doppler signal display and processing are made after examination on the computer.

The desktop TCD mode is a common conventional mode used for all TCD ultrasound Doppler. This mode allows the user to display the transcranial Doppler signal in real time. During this mode, the TCD-X remains connected to the PC via an isolated USB, the patient is immobile and the recording is done directly on the PC hard disk. The Doppler signal processing and printing is also possible after the end of real time recording.

The provided documentation describes the TCD-X Transcranial Doppler Ultrasound System. The acceptance criteria and the study proving the device meets them are outlined as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: 97 patients were involved in the clinical trial.
• Data Provenance: The document does not explicitly state the country of origin, but the manufacturer is based in France. The study appears to be a prospective clinical trial comparing the new spectacle frame probe holder to the predicate's headband.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The document mentions "Clinical trials have been conducted with a prototype of TCD-X and points out that: - Fixing the transducer in place with the spectacle frame resulted in recordings of better . quality, and fewer manual adjustments were required compared with fixation with the standard headband." and "No risk for the users or the patients was reported in this study."
• However, the document does not specify the number of experts used to establish ground truth or their specific qualifications (e.g., number of years of experience, specialization), nor does it explicitly state how ground truth was established for the performance evaluation in this 97-patient study (e.g., a formal "ground truth" for a diagnosis, or expert evaluation of recording quality/patient comfort).

4. Adjudication method for the test set:

• The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for the clinical trial results. The findings are reported as observations from the trial.

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 device is a Transcranial Doppler Ultrasound System, which is a diagnostic tool for measuring blood flow velocities and detecting micro-embolic signals. It does not appear to involve "human readers" interpreting images or AI assistance in a way that would fit a typical MRMC study aiming to improve human reader performance. The "robotic probe" automatically tracks the Doppler signal, which is a functional automation, not an AI interpretation aid for a human reader.
• Therefore, an MRMC comparative effectiveness study was not performed in the context of human readers improving with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The document focuses on the hardware and its functional capabilities, including the robotic probe's ability to track the Doppler signal automatically and the Holter mode's ability to record signals for later processing. While these aspects imply automated functions, the evaluation is primarily on the device's ability to acquire good quality Doppler signals and provide measurements, not on a standalone algorithm making diagnostic decisions without human involvement. The indications for use state "The TCD-X is a transcranial Doppler device intended for recording non-invasively Doppler signals... For the display and measurement of cerebral artery blood flow velocities... For the detection of micro-embolic signals." This implies the human operator is still responsible for interpreting the data output by the system.
• The study primarily validates the physical components (probe, frame) and operational modes (Holter).

7. The type of ground truth used:

• The clinical study involving 97 patients primarily assessed the safety and effectiveness of the new spectacle frame probe holder compared to the predicate's headband, focusing on recording quality, need for manual adjustments, patient tolerance, and comfort.
• For the core functional equivalence and performance, the ground truth is implicitly based on comparison to a legally marketed predicate device (EMS-9UA), which itself would have been cleared based on its ability to accurately measure blood flow velocities and detect emboli (likely established through phantom studies and/or correlation with other established diagnostic methods). The TCD-X ensures its measurements are equivalent to the predicate.

8. The sample size for the training set:

• The document does not mention a "training set" in the context of machine learning or AI models. The TCD-X system is described as a medical electrical equipment (ultrasound device) with software (IEC 62304), but not explicitly as an AI/ML powered diagnostic tool that would require a distinct training set for an algorithm.

9. How the ground truth for the training set was established:

• As no "training set" for an AI/ML algorithm is described, this question is not applicable.

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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.

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