(508 days)
The system is intended for use by a qualified physician for diagnostic ultrasound imaging of the human body in Peripheral Vascular vessels.
The UNEXEF38G ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (A/B-Mode), Color Flow Doppler (CFD), and provides calculations of Flow mediated dilation measurements during reactive hyperemia.
The UNEXEF-38G Ultrasound System is a portable, software controlled ultrasound system used to acquire and display high resolution, real-time ultrasound data in a variety of modes and clinical settings. This system is s Track 3 device that employs an ultrasound probe consisting of ultrasonic transducers arranged in a comb, whereby ultrasound can be generated by supplying electric pulse signals to a group of transducers consisting of multiple adjacent transducers in the single probe.
The provided document is a 510(k) premarket notification for the UNEXEF-38G Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with specific acceptance criteria and detailed performance metrics as would be found in a PMA (Premarket Approval) application.
Therefore, the document does not contain detailed information regarding acceptance criteria, a specific study proving the device meets those criteria, or the other requested information like sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies.
Instead, the submission relies on the common practice of showing that the device is as safe and effective as a predicate device through conformance to applicable standards and consistency with traditional clinical practice.
Here's what can be extracted from the document related to the request, and what is missing:
1. A table of acceptance criteria and the reported device performance
- Not provided. The document does not list specific numerical acceptance criteria or performance metrics for the UNEXEF-38G. Its safety and effectiveness are established through demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. No information on a "test set" in the context of a clinical study or data used to validate specific performance metrics is present. This is typical for a 510(k) where clinical validation in the sense of a new PMA device is not required if substantial equivalence can be shown through other means (e.g., technical performance, conformance to standards, comparison to predicate).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. As there's no clinical test set described in this context, there's no mention of experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. No adjudication method is mentioned for a test set.
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. The UNEXEF-38G is an ultrasound system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not provided. This device is a diagnostic ultrasound system, not primarily an algorithm-driven standalone diagnostic tool. Its performance is inherent to its ability to acquire and display ultrasound data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided. Not applicable as no specific clinical performance study with "ground truth" is described.
8. The sample size for the training set
- Not provided. The document does not mention any "training set" as it is not describing an AI/machine learning device undergoing such a development process.
9. How the ground truth for the training set was established
- Not provided. Not applicable.
Information that is provided, but not directly answering the "acceptance criteria" questions:
- Intended Use: The system is intended for use by a qualified physician for diagnostic ultrasound imaging of the human body in Peripheral Vascular vessels (K131973, Page 2). It performs Imaging (A/B-Mode), Color Flow Doppler (CFD), and provides calculations of Flow-mediated dilation measurements during reactive hyperemia (K131973, Page 2).
- Safety Considerations: The device was tested as a Track 3 device per the FDA Guidance document "Information for the Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. It conforms to applicable acoustic output standards and medical device safety standards (K131973, Page 5).
- Predicate Devices: The UNEXEF-38G Ultrasound System is considered substantially equivalent to:
In summary, this document is a 510(k) notification, which demonstrates substantial equivalence to predicate devices and adherence to recognized standards, rather than providing the detailed clinical study data and acceptance criteria typically seen for novel devices requiring PMA or de novo clearance.
§ 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.