(221 days)
ImSonic TR-1 Ultrasonic pulsed doppler imaging system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. The system is intended to be used in a hospital or clinic setting. Specific clinical applications and exam types include:
Fetal/obstetric
Gynecological /Pelvic
Abdominal
Renal
Cardiac
Pediatric
Small organ (thyroid, breast, testes, etc.)
Musculoskeletal (conventional & superficial)
Peripheral vascular
Ophthalmic
Modes of operation include B, M, PWD(PW), Color Doppler (C), B+M, B+Color Doppler, B+PWD, Biopsy, Harmonics (Tissue), Contrast Imaging (CPS), Steered Spatial Compounding (SSC).
The ImSonic TR-1 is a general purpose, mobile Ultrasonic Pulsed Doppler Imaging System. The function is to acquire ultrasound data and to display in various modes of operation. The device consists of two parts: the system console and the transducers. The system console contains the user interface, a display, a touch screen, a control panel, system electronics and optional peripherals (barcode scanner, printer). The removable transducers are connected to the system using a standard technology, multipin connectors.
The provided text describes the ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System, which is a general-purpose ultrasound system. However, the document is an FDA 510(k) clearance letter and summary, primarily focusing on demonstrating substantial equivalence to a predicate device.
*Crucially, this document does not contain information about the acceptance criteria or a study that proves the device meets specific performance metrics in a clinical or AI-assisted context, as would be expected for a device incorporating AI/ML.
The document states: "The ImSonic TR-1 Diagnostic Ultrasound System and its transducers did not require clinical data to support the determination of substantial equivalence." This means there was no clinical study performed (or at least, none submitted to the FDA for this clearance) that would establish the type of performance metrics typically associated with AI/ML devices such as sensitivity, specificity, accuracy, or reader improvement.
The non-clinical performance data section refers to compliance with consensus standards for safety, electromagnetic compatibility, usability, software life cycle, and risk management, along with acoustic output limits. These are general device standards, not specific performance metrics against a clinical ground truth for diagnostic accuracy.
Therefore,Based on the provided text, I cannot fulfill your request for the following reasons:
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Acceptance Criteria and Reported Performance (Table): The document does not define specific performance acceptance criteria for diagnostic capabilities, nor does it report device performance against such metrics. It primarily focuses on compliance with general safety and performance standards relevant to ultrasound systems and substantial equivalence to a predicate device.
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Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): The document explicitly states that "The ImSonic TR-1 Diagnostic Ultrasound System and its transducers did not require clinical data to support the determination of substantial equivalence." This signifies that the type of clinical performance study (with test sets, ground truth establishment, expert readers, etc.) typically performed for AI/ML devices to demonstrate diagnostic accuracy was not conducted or presented here.
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Training Set (Size, Ground Truth Establishment): As no clinical study was described for performance evaluation, there is no information about an AI/ML model's training set, its size, or how ground truth for that training set was established.
In summary, the provided document is a regulatory submission for a general-purpose ultrasound system based on demonstrating substantial equivalence to existing devices through compliance with established safety and operational standards. It does not describe the development or validation of an AI/ML component with specific diagnostic performance claims against clinical ground truth.
§ 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.