(259 days)
The Sonara and Sonara/tek Transcranial Doppler are medical ultrasound devices for measuring the blood flow velocities in arteries and in veins noninvasively, consistent with the FDA Ultrasound System and Transducer Indication for Use forms cleared with the 510(k).
The Sonara device is a Transcranial and peripheral vascular Doppler system, which is designed to measure blood flow velocities and other hemodynamic parameters in a non-invasive manner, in intracranial, extracranial and peripheral blood vessels. The Sonara system includes an integrated 15" touch screen color LCD display, integrated PC board and hard disk for data management and display. The Sonara/tek is the same device, utilizing a personal computer for its opcration (via USB connection). The TCD system supports 2MHz, 4MHz and 8MHz ultrasound probe frequencies, either in a unilateral or bilateral configuration. For monitoring purpose, a special 2MHz monitoring probe (which fits into a headset) is provided. Online and Offline modes of operation are available. The system also includes a remote control and footswitch as accessories.
The Sonara and Sonara/tek Transcranial Doppler (TCD) systems are medical ultrasound devices designed to non-invasively measure blood flow velocities and other hemodynamic parameters in intracranial, extracranial, and peripheral blood vessels.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria for device performance (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, the performance assessment focuses on compliance with general safety and functional specifications, and substantial equivalence to predicate devices. The "reported device performance" is summarized as meeting these functional specifications and being comparable to predicate devices.
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Functional Specifications | The device must meet all its functional specifications. (No specific quantitative metrics for these specifications are detailed in the provided text.) | "Final testing of the Sonara device included various performance tests designed to ensure that the device met all its functional specifications." |
| Safety Standards | The device must comply with industry and safety standards, specifically: |
- IEC/EN-60601-1: Medical Electrical Equipment; Part 1: General Requirements for Safety.
- IEC/EN 60601-1-2: Electromagnetic Compatibility.
- IEC/EN 60601-2-37: Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment. | "Tests have been performed to ensure the device complies with industry and safety standards." The design "conforms to the following voluntary standards" listed in the criteria. |
| Acoustic Output | Acoustic output reporting in compliance with FDA Ultrasound Guidance (1997). Maximum acoustic output levels below pre-amendment levels for acoustic intensity and Mechanical Index. Power levels displayed at all times during scanning. | "Acoustic output reporting for the Sonara devices was carried in compliance with 'Information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers', September 30, 1997 (FDA Ultrasound Guidance (1997), Table 6-3, Page 6-9."
"Maximum acoustic output levels are below pre-amendment levels for acoustic intensity for this application, and for Mechanical Index for all applications. Power levels are displayed at all times during scanning." A post-clearance special report for acoustic output measurements on production units is required. |
| Substantial Equivalence | The device must be substantially equivalent to legally marketed predicate devices in safety and efficacy. Features and data provided should be similar. | "The Sonara and Sonara/tek TCD are similar to currently distributed pulsed Doppler Ultrasound systems with 2MHz, 4MHz and 8MHz transducers intended for transcranial and peripheral Doppler applications."
"A standard spectrum display is shown in both viewing display. The device includes an M-mode image. All of the above features are similar to these features in the predicate devices."
"The conclusions drawn from the above Performance Testing and comparison to Predicate devices is that the Sonara and Sonara/tek... are substantially equivalent in safety and efficacy to the predicate devices listed above." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document states: "Final testing of the Sonara device included various performance tests designed to ensure that the device met all its functional specifications." However, no specific sample size (e.g., number of patients, cases, or measurements) for any test set is provided.
The data provenance (e.g., country of origin, retrospective or prospective nature) is not mentioned in the provided summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention using experts to establish ground truth for a test set. The validation appears to be based on engineering performance tests and comparison to specifications and predicate devices, rather than a clinical study requiring expert ground truth.
4. Adjudication Method for the Test Set
Since no specific test set requiring expert interpretation or ground truth is described, an adjudication method is not applicable and not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. The submission is focused on demonstrating substantial equivalence through performance testing and comparison to predicate devices, not on quantifying human reader improvement with or without AI assistance. The device itself is a diagnostic ultrasound system, not an AI-assisted interpretation tool in the context of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a diagnostic ultrasound system intended to be used by a human operator, not an algorithm providing interpretations independently. Therefore, a standalone (algorithm only) performance study as typically understood for AI algorithms was not performed or is not applicable in the context of this submission. The "standalone" performance testing refers to the device's functional integrity.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document extensively refers to "performance testing" and "functional specifications" to ensure the device operates as intended and "acoustic output measurements" to comply with safety standards. The "ground truth" in this context is the adherence to engineering specifications, safety standards, and the capabilities of predicate devices. There is no mention of ground truth established by expert consensus, pathology, or outcomes data as would be typical for studies evaluating diagnostic accuracy against clinical endpoints.
8. The Sample Size for the Training Set
Since the Sonara TCD system is described as a diagnostic ultrasound device designed to measure physical parameters of blood flow, and not as an AI or machine learning model that requires a training set, the concept of a "training set" with a specific sample size does not apply to this submission.
9. How the Ground Truth for the Training Set Was Established
As the concept of a training set is not applicable, the method for establishing its ground truth is also not applicable and not mentioned.
§ 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.