(99 days)
The ECHOTECH 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, obstetrics and gynecology.
The EchoTech 3D FreeScan is a high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards. It incorporates a commercially available image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.
The device records ultrasound transducer spatial position in six degrees of freedom during use. Coordinate tracking is achieved with a miniature magnetic field sensor within a transmitted pulsed magnetic field. This is done by attaching a plastic holding plate to the probe of the host ultrasound system, to which the receiver of an electromagnetic sensor device is attached.
2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is swept across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume.
The provided text does not contain detailed information about specific acceptance criteria, comprehensive study results, or the methodologies for establishing ground truth as requested in the prompt. The document is a 510(k) summary for the EchoTech 3D FreeScan, which primarily focuses on regulatory approval based on substantial equivalence to a predicate device.
However, I can extract the available information and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in quantitative terms. | "Actual device performance satisfies the design intent." |
| "Actual device performance... conforms to the system performance specifications." | |
| "nearly identical in performance and intended use to the TomTec EchoScan" (Predicate Device: TomTec Echo-Scan K963807) |
Missing Information: Specific quantitative acceptance criteria (e.g., accuracy, precision, speed, specific image quality metrics) are not provided. The performance is broadly stated as meeting "design intent" and "system performance specifications" without detailing what those specifications are.
2. Sample Size Used for the Test Set and Data Provenance
Missing Information: The document does not specify the sample size used for the test set. It mentions "software testing and validation" and "additional system testing by a third party standards test house" but does not quantify the data used for these tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Missing Information: The document does not describe the establishment of a "ground truth" for a test set, nor does it mention the involvement or qualifications of experts in this capacity. The testing appears to be internal validation against design specifications rather than clinical performance evaluation against expert-derived ground truth.
4. Adjudication Method for the Test Set
Missing Information: No adjudication method is mentioned or implied, as there is no description of a clinical test set requiring expert consensus.
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
Missing Information: The document does not describe an MRMC comparative effectiveness study. The device is presented as an "add-on accessory" for acquiring and reconstructing 3D ultrasound data, not as an AI-driven diagnostic aid for human readers. Therefore, there is no mention of an effect size related to human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Information Provided (Indirectly): The "Test Discussion" states that "Software testing and validation were done at the module and system level" and "Additional system testing was done by a third party standards test house." This suggests standalone testing of the algorithm (or software components) against its design specifications was performed.
Missing Information: The specific metrics and results of this standalone performance are not detailed beyond a general statement of compliance.
7. The Type of Ground Truth Used
Missing Information: The document does not specify a type of "ground truth" (e.g., pathology, outcomes data, expert consensus) as would be relevant for clinical performance evaluation. The testing described appears to be focused on validating the device's technical functionality and conformity to internal design specifications.
8. The Sample Size for the Training Set
Missing Information: The document does not mention a training set. This device is described as an image acquisition, analysis, storage, and retrieval system for 3D ultrasound, not an AI/ML-based diagnostic algorithm that would typically require a training set.
9. How the Ground Truth for the Training Set was Established
Missing Information: As no training set is mentioned, the method for establishing its ground truth is also not applicable or discussed.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.