(34 days)
The UGEO PT60A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include:Fetal, Abdominal, Small Organs, Adult Cephalic, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The UGEO PT60A is a general purpose, hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging, PWSpectral Doppler mode, Harmonic imagingor as a combination of these modes. The UGEO PT60A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The UGEO PT60A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided 510(k) Premarket Notification for the UGEO PT60A Diagnostic Ultrasound System does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria in the way that an AI CADe/CADx device submission would. This document is for a general-purpose diagnostic ultrasound system, and the regulatory pathway relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific performance metrics against a defined ground truth through a clinical study.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not typically found in submissions for general ultrasound devices.
Here's a breakdown of the information available based on the provided text, and where gaps exist:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of a general ultrasound system's 510(k) submission.
The submission focuses on demonstrating substantial equivalence in terms of technological characteristics and safety standards to predicate devices. There are no specific performance metrics (e.g., sensitivity, specificity, AUC) for diagnostic tasks defined as "acceptance criteria" for this type of device in the provided document.
The comparison table in section {2} and {3} shows the subject device's features and its predicates, highlighting congruency rather than meeting specific quantifiable performance targets.
- Feature/Characteristic | UGEO PT60A (Subject Device) | Predicate Device (UGEO H60 / MySono U6 / SonoSite Maxx Series) | Equivalence Claim
- Indications for Use | Matches predicate devices for most applications (Fetal, Abdominal, Small Organ, Adult Cephalic, Muscular-Skeletal, Cardiac Adult/Pediatric, Peripheral vessel). | Substantially equivalent in scope of indications.
- Scanhead Types | Linear Array, Phased Array | Matches predicate devices.
- Modes of Operation | B-mode, M-mode, PW Doppler, CW Doppler, Color Doppler, Power Amplitude Doppler, Tissue Harmonic Imaging, 3D/4D imaging, Combined modes | Matches predicate devices.
- Safety & EMC Compliance | IEC60601-1, IEC 60601-2-37, IEC 60601-1-2, NEMA UD-2, NEMA UD-3, ISO10993-1, ISO14971 | Conforms to the same safety and EMC standards as predicate devices.
- Functionality | Quick Scan, Spatial Compound Imaging, SMDR (Dynamic MR Plus), Auto IMT, Needle Mate | Substantially equivalent; some features are present in the subject device and some predicates.
2. Sample size used for the test set and the data provenance
Not applicable. The submission states in section {3}: "Summary of Clinical Tests: Not applicable. The subject of this submission, UGEO PT60A, did not require clinical studies to support substantial equivalence." This means there was no "test set" in the context of a clinical performance evaluation. The device was evaluated against existing standards and predicate devices (as described under 'Technological Characteristics').
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical studies requiring ground truth establishment were conducted for this submission.
4. Adjudication method for the test set
Not applicable. No clinical studies or test sets with ground truth requiring adjudication were conducted.
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
Not applicable. The UGEO PT60A is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The UGEO PT60A is a diagnostic ultrasound system, not an algorithm being evaluated for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical studies requiring ground truth were conducted for this device. The regulatory pathway relied on demonstrating that the device's technical specifications, safety, and intended use were substantially equivalent to existing, legally marketed ultrasound systems.
8. The sample size for the training set
Not applicable. This device is a general-purpose ultrasound system, not an AI or machine learning algorithm that requires a training set in this context.
9. How the ground truth for the training set was established
Not applicable. As above, there was no training set for an AI algorithm.
§ 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.