(105 days)
The SSA-380A is ready for use with Contrast Agents for their approved uses.
Functionality: This modification will allow the existing SSA-380A system to transmit at one frequency and receive the returning echo at a different frequency.
Scientific Concept: Rayleigh's theory predicts that a bubble in an ultrasonic field will radiate harmonic echoes that are multiples of the incident beam. This theory also stipulates that the second resonated frequency echoed could possibly be higher that the echoed fundamental frequency. This modification equips the SSA-380A to detect and process those harmonic echoes.
Description of Modification: The modification includes the addition of several new/modified circuit boards and modifications to the software to allow two existing transducers to operate in this manner.
Significant Safety Concerns: None. The FDA is currently evaluating the use of contrast agents for their Safety and Effectiveness. This modification does not change the amount of acoustic output required in conventional ultrasonography. The modification is to provide and existing device with the capability of receiving echoes at a frequency different than the transmitted frequency.
The provided text is a 510(k) summary for the Toshiba PowerVision 7000 Ultrasound Imaging System with a modification for Harmonic Imaging and Flash Echo Imaging Function. This document does not describe a study to prove the device meets acceptance criteria in the manner typically expected for AI/ML-driven medical devices.
Instead, this submission is for a modification to an existing ultrasound system, and the acceptance criteria and supporting information are framed within the context of demonstrating substantial equivalence to predicate devices and ensuring the safety and effectiveness of the modified functionality.
Therefore, many of the requested categories (e.g., sample size for test/training set, ground truth experts, MRMC study, standalone performance) are not applicable or explicitly mentioned in this type of submission for a hardware/software modification to an ultrasound system. The focus is on the technical description of the modification and its impact on performance parameters such as acoustic output and image quality.
However, I can extract the relevant information based on the document's content:
Acceptance Criteria and Reported Device Performance
The provided document does not contain an explicit table of acceptance criteria with numerical targets and corresponding reported performance metrics in the way one might typically expect for an AI/ML device. Instead, the "acceptance criteria" can be inferred as demonstrating that the modified device remains safe and effective for its intended use and is substantially equivalent to predicate devices. The performance is reported in terms of functionality and anticipated image quality improvement.
| Acceptance Criteria Category | Description from Document | Reported Device Performance/Claims |
|---|---|---|
| Functional Equivalence/Improvements | The modification will allow the existing SSA-380A system to transmit at one frequency and receive the returning echo at a different frequency. This modification equips the SSA-380A to detect and process those harmonic echoes. This enables "Tissue Harmonics" (n - new indication) and "Harmonics w/Contrast" (n - new indication) functionality for various clinical applications, and "FEI" (Flash Echo Imaging) for Cardiac applications. | The device, as modified, is capable of Harmonic Imaging and Flash Echo Imaging. The FDA granted substantial equivalence on the condition of a post-clearance special report on acoustic output measurements based on production units. This implies the device is expected to perform as described in terms of its new imaging modes. |
| Safety - Acoustic Output | "Significant Safety Concerns: None. The FDA is currently evaluating the use of contrast agents for their Safety and Effectiveness. This modification does not change the amount of acoustic output required in conventional ultrasonography." | The modification does not change the amount of acoustic output required in conventional ultrasonography. A post-clearance special report is required to provide "complete information, including acoustic output measurements based on production line devices" and that values must not be "greater than approved levels." |
| Intended Use | "Intended use remains unchanged from the SSA-380A." However, the "Indications For Use Form" introduces "new" (n) indications for "Tissue Harmonics," "Harmonics w/Contrast," and "FEI" for specific transducers and applications. | The device is deemed substantially equivalent for the indications for use stated in the enclosure which now includes the new harmonic imaging functionalities for the specified transducers and clinical applications. |
| Substantial Equivalence to Predicate Devices | The device is substantially equivalent to four predicate devices: HP Sonos 2500, ATL Level 10 HDI, Diasonics/Vingmed System 5, and Toshiba SSA-380A PowerVision. (This is the overarching "acceptance criteria" for a 510(k) submission, proving that the device is as safe and effective as a legally marketed device). The scientific concept for the modification is "Rayleigh's theory predicts that a bubble in an ultrasonic field will radiate harmonic echoes that are multiples of the incident beam. This theory also stipulates that the second resonated frequency echoed could possibly be higher that the echoed fundamental frequency. This modification equips the SSA-380A to detect and process those harmonic echoes." | The FDA determined "the device is substantially equivalent... to legally marketed predicate devices." This is the ultimate "reported performance" against the primary acceptance criterion, based on the provided technical description and the manufacturer's claims. |
Study Information
For this type of 510(k) submission (a modification to an ultrasound system adding new imaging modes), a clinical study with a "test set" in the context of AI/ML performance evaluation (e.g., sensitivity, specificity for a diagnostic task) is not described. The "study" here refers to the technical evaluation and demonstration of substantial equivalence.
- Sample size used for the test set and the data provenance: Not applicable in the context of a conventional "test set" for an AI/ML algorithm's diagnostic performance. The evaluation is based on technical specifications and demonstration of system capabilities.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would generally refer to established scientific principles of ultrasound physics and engineering standards for device performance, rather than expert clinical annotation of images for a specific diagnostic task.
- Adjudication method for the test set: Not applicable.
- 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: An MRMC comparative effectiveness study was not done or described. This submission predates the widespread regulatory focus on AI/ML in medical devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm in the modern sense but a hardware/software modification to an imaging system.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" implicitly relies on established physics of ultrasound, engineering principles, and the safety and effectiveness track record of the predicate devices. For acoustic output, it would be based on validated measurement techniques and established safety limits.
- The sample size for the training set: Not applicable. This is not an AI/ML system that undergoes a "training" phase with data.
- How the ground truth for the training set was established: Not applicable.
§ 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.