(43 days)
The MySono U6 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdonimal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
The MySono U6 is a general purpose, hand-held, 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, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The MySono U6 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 MySono U6 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided document is a 510(k) Premarket Notification for the MySono U6 Diagnostic Ultrasound System. This type of submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical studies to prove performance against specific acceptance criteria in the same way a novel device might.
The acceptance criteria for this device are primarily based on safety and effectiveness, demonstrated through adherence to various industry standards and comparison to previously cleared predicate devices. There is no study in this document that proves the device meets acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical trial with a test set, ground truth, or expert review.
Instead, the document asserts substantial equivalence by:
- Meeting Recognized Standards: The device has been designed to meet established product safety and acoustic output standards.
- Similar Intended Use: The MySono U6 has comparable intended uses and clinical applications to its predicate devices.
- Similar Technological Characteristics: The system uses similar ultrasound principles and modes of operation as the predicate devices.
Therefore, the requested information components (Sample size for test set, Number of experts, Adjudication method, MRMC study, Standalone performance, Type of ground truth, Sample size for training set, How ground truth was established for training set) are not applicable in the context of this 510(k) submission, as it does not involve a traditional clinical performance study with a test set.
Here's the table of acceptance criteria and reported device performance as can be inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k) requirements) | Reported Device Performance (from document) |
|---|---|
| Safety Standards Adherence: | |
| UL 60601-1 (Safety) | Designed to meet UL 60601-1 |
| CSA C22.2 No. 601.1 (Safety) | Designed to meet CSA C22.2 No. 601.1 |
| IEC60601-2-37 (Diagnostic Ultrasound Safety) | Designed to meet IEC60601-2-37 |
| IEC60601-1 (Safety) | Designed to meet IEC60601-1 |
| IEC60601-1-2 (EMC) | Designed to meet IEC60601-1-2 |
| ISO10993-1 (Biocompatibility) | Designed to meet ISO10993-1 |
| Acoustic Output Standards Adherence: | |
| NEMA UD-2 (Acoustic Output Measurement) | Designed to meet NEMA UD-2 |
| NEMA UD-3 (Real Time Display of Indices) | Designed to meet NEMA UD-3; "real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed." |
| IEC 61157 (Acoustic Output Declaration) | Designed to meet IEC 61157 |
| Functional Equivalence: | |
| Generate B, M, Color Doppler, Power Doppler, PW/CW Spectral Doppler, Harmonic imaging, Tissue Doppler imaging, 3D imaging (real time 4D imaging) | "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, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes." - Functionally equivalent to predicate devices (SONOACE R7, SONOACE X8, MySono U5, SONOACE R5) which "transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body." |
| Measure anatomical structures and provide analysis packages | "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." - Functionally equivalent to predicate devices which "allow for specialized measurements of structures and flow, and calculations." |
| Intended Use Equivalence: | |
| Diagnostic ultrasound imaging and fluid analysis of the human body for specified clinical applications | Intended for "diagnostic ultrasound imaging and fluid analysis of the human body." Clinical applications listed are "Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel." These align with the combined cleared indications of the predicate devices and/or new indications deemed equivalent. |
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented in this 510(k) summary for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware and software diagnostic ultrasound system, not an algorithm being evaluated for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. No training set for a performance algorithm is discussed.
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.