(91 days)
The NeuralBot when used with Lucid M1 System is a medical ultrasound device which assists the user in the setup and acquisition of cerebral blood flow velocity via the patient's temporal windows. It is intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the blood stream.
The NeuralBot is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
The NeuralBot System is a cart mounted. robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid M1 System (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) data via the patient's temporal acoustic windows.
The NeuralBot System consists of the following three subsystems mounted on a cart
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- Accessory Control Unit (ACU)
- The main accessory software including the, TCD signal search algorithm, and a. graphical user interface are installed on this subsystem.
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- Robotic Control Unit (RCU)
- Contains the electronics and embedded software that control the robotic actuators of a. the patient headmount unit.
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- Patient Headmount Unit (PHU)
- Comprised of the patient head interface, 2 MHz transducers, and the robotic probe a. positioning mechanism.
The NeuralBot System guides the operator in positioning the transducers in the PHU, one on each side of a patient's head, at their temporal regions. The 2 MHz transducers used in the NeuralBot System are the same transducers previously cleared for use with the Lucid M1 System (K160442). The NeuralBot System's probe positioning is accomplished using robotic actuators that adjust the translational and angular position of each transducer independently using TCD signal search algorithms. The accessory is designed to locate TCD signals at depths between 45 and 60 mm allowing the operator to monitor the CBFV of the vessels via the patient's temporal acoustic windows. The NeuralBot System identifies several candidate TCD signals and displays multiple signals from each side of the patient's head. At the end of the search, the NeuralBot System will then retrieve and track the best located signal.
The NeuralBot System is a robotic transcranial Doppler (TCD) probe positioning accessory that works with the existing Lucid M1 System. It assists users in acquiring cerebral blood flow velocity (CBFV) data by guiding the positioning of transducers at the patient's temporal acoustic windows.
Here's an analysis of the acceptance criteria and supporting studies as described in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not contain a specific table detailing acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) related to the device's primary function of assisting in TCD signal acquisition and tracking. Instead, it focuses on general safety, effectiveness, and substantial equivalence to predicate devices, adhering to recognized standards.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Substantially equivalent to predicate devices with no new questions of safety and effectiveness. | "The NeuralBot System is substantially equivalent to the predicate devices." |
| "There are no new questions of safety and effectiveness concerning the NeuralBot System." | ||
| "The NeuralBot System is designed to be as safe and effective as the predicate devices." | ||
| Performance (General) | Designed to perform as well as the predicate devices. | "The NeuralBot System is designed to perform as well as the predicate devices." |
| Acoustic Output | Conformance to NEMA Standards Publication UD 2-2004(R2009) and UD 3-2004(R2009). | Evaluated for acoustic output per applicable sections of NEMA Standards Publication UD 2-2004(R2009) and UD 3-2004(R2009). (No specific metrics provided in the summary, reliance is on conformance to standards.) |
| Biocompatibility | Conformance to ISO 10993-1:2010. | Evaluated for biocompatibility per ISO 10993-1:2010. (No specific metrics provided in the summary, reliance is on conformance to standards.) |
| Thermal, Mechanical, Electromagnetic Safety | Conformance to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37. | Non-clinical testing conducted per FDA Guidance using applicable sections of IEC 60601-1:2012, IEC 60601-1-2:2014, and IEC 60601-2-37:2015. (No specific metrics provided in the summary, reliance is on conformance to standards.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of clinical performance or algorithm evaluation. The non-clinical testing mentioned focuses on engineering verification and validation against recognized standards for safety and electrical performance. There is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a performance test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The provided document does not describe a study involving expert-established ground truth for a test set related to diagnostic performance. The document focuses on the device's ability to assist in TCD signal acquisition and tracking, rather than providing a diagnostic interpretation.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a clinical test set requiring ground truth adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not described in the provided document. The NeuralBot System is presented as an accessory that assists in probe positioning and TCD signal acquisition, not as an AI interpretation tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes the NeuralBot System as having a "TCD signal search algorithm" and "robotic actuators that adjust the translational and angular position of each transducer independently using TCD signal search algorithms." While an algorithm is at the core of its functionality, the device is explicitly designed as an accessory that "assists the user." Therefore, its performance is inherently tied to a human-in-the-loop interaction for TCD data acquisition, and a standalone algorithm-only performance study (in the sense of diagnostic interpretation without human input) is not discussed. The "device performance" relies on its ability to guide the operator and retrieve and track the best located signal.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not describe a clinical study where ground truth of the type "expert consensus, pathology, or outcomes data" would be used. The "ground truth" implied for the device's functionality would be objective measures of its ability to locate and track TCD signals effectively, likely against established TCD methodologies or physical phantoms, but this level of detail is not provided.
8. The Sample Size for the Training Set
The document does not specify a sample size for a training set. If the "TCD signal search algorithm" utilizes machine learning, the details of its training are not included in this summary.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how ground truth for any potential training set was established.
§ 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.