(98 days)
Pie Medical's 50S Tringa ultrasound system is used by or under the direction of a physician to perform general non-invasive diagnostic ultrasound imaging studies, to include: abdominal, peripheral vascular, fetal, small organ & cardiac applications.
Pie Medical's 50S Tringa ultrasound system
The provided text is a 510(k) summary for the Pie Medical 50S Tringa Ultrasound Imaging System. It focuses on establishing substantial equivalence to predicate devices and detailing the intended uses and technical specifications.
Based on the provided text, there is no information present regarding specific acceptance criteria, a study proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC comparative effectiveness studies, or standalone performance studies.
The document is a regulatory submission for premarket notification (510(k)), which typically demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria and ground truth for an AI/CAD-type device.
The information that can be extracted relates to the device's intended use and technical characteristics compared to predicate devices, but not to performance criteria in the way requested for an AI-enabled device's clinical performance.
Therefore, many of the requested fields cannot be filled from the given text.
Here's a summary of what can be identified from the provided documentation, noting the absence of the requested performance study details:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided in the document. This type of information is typically found in performance studies for AI/CAD devices, not in a 510(k) summary for an ultrasound imaging system where substantial equivalence is the focus.
2. Sample size used for the test set and the data provenance
Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not provided in the document.
4. Adjudication method for the test set
Not provided in the document.
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 provided in the document. This is not an AI/CAD device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not provided in the document. This is not an AI/CAD device.
7. The type of ground truth used
Not provided in the document.
8. The sample size for the training set
Not provided in the document.
9. How the ground truth for the training set was established
Not provided in the document.
Summary of Device and its Intended Use (from the document):
- Device Name: 50S Tringa Ultrasound Imaging System
- Intended Use: "used by or under the direction of a physician to perform general non-invasive diagnostic ultrasound imaging studies, to include: abdominal, peripheral vascular, fetal, small organ & cardiac applications."
- Clinical Applications (for the main system and both mechanical probes): Fetal, Abdominal, Small Organ (Thyroid, Breast, Testicles), Cardiac, Peripheral Vascular. These are listed as "new indications" (N) in the provided tables, meaning they are either new for this specific model or new compared to one of the predicate devices in a specific mode.
- Imaging Modes: 2D / M-Mode (and Combined B+B mode and B+M mode).
- Transducers:
- 3.5/5.0 MHz Mechanical Probe (410047)
- 5.0/7.5 MHz Mechanical Probe (410048)
- Predicate Devices:
- Safety: The device complies with Electrical safety standard EN60601-1 and Ultrasound safety Track 1.
The 510(k) process for this device appears to be based on demonstrating substantial equivalence in terms of intended use, technology, safety, and performance compared to existing predicate devices, rather than a novel AI/CAD device requiring specific performance metrics against established ground truth.
§ 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.