(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intraoperative (vascular/epicardial), Pediatric, Small Organ (thyroid, scrotum and breast), Neonatal Cephalic, Adult Cephalic, Cardiac (Adult & Pediatric), Transesophageal, Transrectal, Transvaginal, Peripheral Vascular.
Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows: Abdominal, Adult Cephalic.
Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows: Fetal, Small Organ (prostate), Transrectal, Transvaginal.
Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows: Intraoperative (vascular/epicardial), Pediatric, Cardiac, Peripheral Vascular.
This premarket notification describes modifications to the indications for the Sonos 5500 M2424A system with the 21330A probe, and the addition of two probes. The common names for these devices are the Phased Array, Endocavity Probe and Intraoperative Probe for Sonos 5500 Ultrasound Imaging System. The classification names for these devices are: Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo imaging System and Diagnostic Ultrasound Transducer.
The provided text is a 510(k) summary for modifications to the Sonos 5500 Ultrasound Imaging System and its transducers. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and performance data for a new AI/CADe device.
Therefore, the document does not contain the information required to fill out the table and answer the study-related questions (items 1 through 9). The approval is based on the devices functioning "in the same way as their predicate devices" and having "no new technological changes" except for patient contact materials. The provided "Indications for Use Form" lists clinical applications and modes of operation, indicating whether they are "new," "previously cleared," or "added under Appendix E," but these are intended use statements, not performance data or acceptance criteria for a study.
Specifically:
- A table of acceptance criteria and the reported device performance: Not available. The document asserts substantial equivalence without providing specific performance metrics or acceptance criteria for the new indications or probes against a defined standard.
- Sample size used for the test set and the data provenance: Not applicable, as there is no mention of a diagnostic performance study, test set, or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, this is not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not mentioned.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as there is no mention of a training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
The 510(k) summary primarily focuses on regulatory compliance, outlining the modifications and asserting that the modified devices are substantially equivalent to existing, legally marketed predicate devices. The "study" mentioned pertains to biocompatibility testing for new patient contact materials, not clinical performance for diagnostic accuracy.
This document is a 510(k) summary for modifications to an existing ultrasound system and its transducers. It *does not contain* information about a study proving a device meets acceptance criteria related to diagnostic performance for a new AI/CADe device. The approval is based on substantial equivalence to predicate devices. Therefore, the requested information cannot be extracted from the provided text.
§ 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.