(30 days)
The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
The SONOACE R7 is a general purpose, mobile, 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, PW/CW Spectral Doppler mode, Harmonic imaging, 3D imaging mode or as a combination of these modes. The SONOACE R7 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 SONOACE R7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided text is a 510(k) Summary for the SAMSUNG MEDISON CO., LTD. SONOACE R7 Diagnostic Ultrasound System and its various transducers. This type of document is a premarket notification to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. It does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical trial would for an AI/CADe device.
Instead, the document focuses on demonstrating that the SONOACE R7 (and its transducers) has technological characteristics and intended uses substantially equivalent to previously cleared predicate devices (K102065, SONOACE R7 Diagnostic Ultrasound System; K093714, SONOACE X8 Diagnostic Ultrasound System; and K103722 for specific transducers).
Therefore, I cannot populate the table or answer most of the questions as they pertain to a clinical study demonstrating performance against acceptance criteria for a new clinical indication or an AI/CADe device. The regulatory pathway for this device is based on substantial equivalence, not on proving specific diagnostic performance metrics through clinical trials.
Here's what can be extracted based on the provided text, and where information is not available:
1. Table of acceptance criteria and the reported device performance
This information is not available in the provided document. The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing or reporting specific performance metrics against pre-defined acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc. for a new clinical claim. The "acceptance criteria" here implicitly refer to meeting safety and performance standards equivalent to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available. The submission is a 510(k) for an ultrasound system, not a study reporting diagnostic performance metrics. It does not mention any "test set" in the context of diagnostic accuracy evaluation.
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)
This information is not available. There is no mention of a test set with ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available. There is no mention of an adjudication method 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
This information is not available. The device described is a diagnostic ultrasound system (hardware and associated software for image acquisition and display), not an AI/CADe (Computer-Aided Diagnosis/Detection) device that would involve AI assistance for human readers or require MRMC studies in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not available. This is not an AI/CADe device, and therefore "standalone" algorithm performance is not applicable in this context. The device is a tool used by a human operator for diagnostic imaging.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not available. No diagnostic performance study using a ground truth is described.
8. The sample size for the training set
This information is not available. There is no mention of a "training set" as this is not an AI/CADe device.
9. How the ground truth for the training set was established
This information is not available. There is no mention of a "training set" or its ground truth establishment.
§ 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.