(86 days)
The TomTec Echo-Scan is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The Echo-Scan acquires sets of 2D images and stores them digitally in the TomTec standard 3D image file format for subsequent 3D tomographic reconstruction and surface rendering with either the Echo-Scan or Echo-View. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology, The TomTec Freehand Scanning Device is intended for acquiring a sequence of conventional 2D ultrasound images with transducer position recorded for each image acquired. The resulting image data set is intended for storage in the TomTec standard 3D image file format for subsequent 3D tomographic image reconstruction.
The TomTec Echo-Scan is a high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards. It incorporates a proprietary image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The TomTec Freehand Scanning Device records ultrasound transducer spatial position in six degrees of freedom during use. 2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is swept across the patient scan site.
This 510(k) summary for the TomTec Echo-Scan with Freehand Scanning device does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria are met. The document focuses on technological characteristics and internal validation rather than a clinical performance study with specific acceptance criteria.
However, based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a table of performance metrics. Instead, it refers to internal testing and system performance specifications. The "reported device performance" is a general statement about meeting design intent and specifications.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not explicitly stated in the document as quantitative acceptance criteria. The document mentions "system performance specifications" but does not detail them. | Device performance "satisfies the design intent" and "conforms to the system performance specifications." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing described appears to be internal software and system validation, not involving expert-established ground truth for clinical performance.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance
No MRMC study is mentioned. The document describes a device for acquiring, analyzing, and storing 3D ultrasound data, not an AI-assisted diagnostic tool for humans, or a comparative effectiveness study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes internal software and system validation. While this implies standalone testing of the algorithm's functionality (e.g., image acquisition, processing, storage), it does not detail specific performance metrics for the algorithm in isolation in a clinical context. The "Test Conclusions" state that "actual device performance as tested internally conforms to the system performance specifications," suggesting standalone functional validation.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically understood in clinical performance studies (e.g., pathology, expert consensus) is not applicable or described in the context of the internal software testing mentioned. The testing focused on functional validation against design intent and system specifications.
8. The Sample Size for the Training Set
This information is not applicable or provided. The device is an image acquisition and processing system, not a machine learning model that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. As mentioned above, the device does not involve a "training set" in the context of machine learning.
Summary of what is available and what is missing:
- Available: General statements about internal validation and conformance to specifications.
- Missing: Specific quantitative acceptance criteria, clinical study design, sample sizes (for test or training sets), details about ground truth establishment, expert involvement, or any form of comparative effectiveness study.
The provided document describes a 510(k) submission for a device that adds freehand scanning capability to an existing ultrasound image analysis system. The "testing" described is focused on the internal technical performance and functionality of the software and system, rather than clinical performance or diagnostic accuracy. Therefore, many of your questions regarding clinical study design and performance metrics against ground truth are not addressed by this type of regulatory submission document.
§ 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.