(91 days)
Diagnostic ultrasound blood flow detection of the human body. The Stethoflux is designed for use by general practitioners or specialists on their own responsibility. It allows dual stethoscopic and doppler peripheral vascular investigation in a simple auscultation. It facilitates: - the detection of blood-flow in the peripheral arteries - Systolic Blood Pressures (SBP) measurements of the lower limb and upper-limb in order to determine the possible PAD ankle Brachial index (ABI) in the concerned limb. when associated with a sphygmomanometer
Acoustic stethoscope with ultrasonic transducer. It operates with 2 modes stethoscopic mode (classical stethoscope) and Doppler mode. Powered by one (6LR61) 9V lenium battery. Doppler frequency: 8 MHz. Operating time 25 h according to use. Mass 331 g.
The provided document is a 510(K) Premarket Notification Submission for the "Acoustic and Doppler Stethoscope Stethoflux®". It states that the device is substantially equivalent to a predicate device (K030466, HandyDop TM, Elcat GmbH) and does not provide detailed acceptance criteria or a dedicated study description with specific performance metrics beyond stating "Similar specifications for the common application with the 8 MHz probe."
The document explicitly states:
- "There are no section 514 performance standards for this class of device for assisting in the determination of its substantial equivalence."
- "Not required for determination of substantial equivalence for this class of device, though publication of some clinical data are contained in this premarket submission." (However, these clinical data are not present in the provided text.)
Therefore, based on the information provided, it is not possible to complete most of the requested sections as the submission relies on demonstrating substantial equivalence rather than meeting pre-defined acceptance criteria through detailed performance studies.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Stethoflux®) |
|---|---|
| Not specified. The submission relies on substantial equivalence to predicate device. | "Similar specifications for the common application with the 8 MHz probe" as the predicate device (K030466, HandyDop TM). |
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 in the document. The text states that performance standards and clinical/non-clinical test data are "Not required for determination of substantial equivalence for this class of device."
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 in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 applicable. This device is a doppler stethoscope, not an AI device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not provided in the document.
8. The sample size for the training set
Not applicable. No algorithm or AI is mentioned, so no training set.
9. How the ground truth for the training set was established
Not applicable. No algorithm or AI is mentioned.
§ 892.1540 Nonfetal ultrasonic monitor.
(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in 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.