(14 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, Adult Cephalic, Transrectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), 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.
This document is a 510(k) summary for the SONOACE R7 Diagnostic Ultrasound System, which is a premarket notification to the FDA for a medical device. This type of submission generally demonstrates substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics against human readers or pathology.
Therefore, the provided document does not contain information related to:
- A table of acceptance criteria and reported device performance for clinical endpoints.
- Sample sizes used for a test set or data provenance in the context of clinical performance evaluation.
- Number and qualifications of experts used to establish ground truth for a test set.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study, effect size regarding human reader improvement with AI, or standalone algorithm performance.
- Sample size for a training set or how ground truth for the training set was established.
Instead, the document focuses on regulatory aspects to demonstrate substantial equivalence to previously cleared devices.
Here's the relevant information that can be extracted from the provided text:
1. Acceptance Criteria and Device Performance:
The document describes the device's adherence to various safety and performance standards rather than clinical acceptance criteria based on disease detection or diagnostic accuracy. The device's "performance" in this context refers to its technical capabilities and compliance with established industry and regulatory standards.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance/Compliance |
|---|---|---|
| Device Safety | UL 60601-1, Safety requirements for Medical Equipment | Designed to meet the standard. |
| CSA C22.2 No. 601.1, Safety requirements for Medical Equipment | Designed to meet the standard. | |
| IEC60601-2-37, Diagnostic Ultrasound Safety Standards | Designed to meet the standard. | |
| EN/IEC60601-1, Safety requirements for Medical Equipment | Designed to meet the standard. | |
| EN/IEC60601-1-2, EMC requirements for Medical Equipment | Designed to meet the standard. | |
| ISO10993-1, Biocompatibility | Designed to meet the standard. | |
| Acoustic Output | NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment | Real-time acoustic output display with mechanical index and thermal index automatically displayed. |
| NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment | Real-time acoustic output display with mechanical index and thermal index automatically displayed. | |
| IEC 61157, Declaration of the acoustic output | Designed to meet the standard. | |
| Functional Equivalence | Substantial Equivalence to Predicate Devices: SONOACE X8 (K093714) and MySono U5 (K100186) | The SONOACE R7 is substantially equivalent in technology (acquires ultrasound data, displays B mode, M mode, Color Doppler, Power Doppler, PW/CW Spectral Doppler, Harmonic imaging, 3D imaging, specialized measurements, and calculations) and intended uses to the predicate devices. |
2. Sample size used for the test set and the data provenance:
Not applicable. The document describes a substantial equivalence submission, which typically relies on comparisons to predicate devices and adherence to recognized standards, rather than new clinical studies with test sets of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no external clinical test set with ground truth was described in this 510(k) summary for device performance evaluation.
4. Adjudication method for the test set:
Not applicable, as no external clinical test set with ground truth was described.
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 is a diagnostic ultrasound system, not an AI-assisted diagnostic device, and no MRMC study or AI performance evaluation is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a diagnostic imaging system, not a standalone algorithm.
7. The type of ground truth used:
Not applicable in the context of clinical performance evaluation against disease. The "ground truth" here is the adherence to safety and performance standards and the functional equivalence to established predicate devices.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning device that would typically involve a specific training set of data.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.