(165 days)
The diagnostic ultrasound system (U50) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
The modifications are listed as below:
Addition of CW mode – the basic system architecture previously supported CW mode.
3 new transducers C5-2b, P5-1b and L15-7b – The C5-2b and the L15-7b are new transducers. The P5-1b is the initial offering of a phased array device on this system.
Addition of HPRF to PW mode
Minor changes to the user interface
Here's an analysis of the provided text regarding the U50 Diagnostic Ultrasound System, structured according to your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in quantitative terms for the device's diagnostic performance (e.g., sensitivity, specificity for specific conditions). Instead, it relies on demonstrating that the device meets safety and performance standards equivalent to predicate devices. The reported device performance is that it "passed all testing" and is "substantially equivalent" to predicate devices.
The tables for each transducer (U50, C352UB, L1042UB, L742UB, E612UB, C612UB, C6152UB, C422UB, L552UB, C5-2b, P5-1b, L15-7b) outline the intended clinical applications and modes of operation supported by each transducer. These can be considered the functional performance criteria ("what it can do").
Here's an example table for the main U50 system based on the "U50 Diagnostic Ultrasound System" table in the document, as it aggregates the general capabilities:
| Feature / Criterion (Implicit) | Reported Device Performance (as stated or implied) |
|---|---|
| Clinical Applications | |
| Abdominal | P (Previously cleared by FDA) |
| Obstetrics | P (Previously cleared by FDA) |
| Gynecology | P (Previously cleared by FDA) |
| Pediatric | P (Previously cleared by FDA) |
| Small Parts (Thyroid, Testes, Breast) | P (Previously cleared by FDA) |
| Urology | P (Previously cleared by FDA) |
| Peripheral Vascular | P (Previously cleared by FDA) |
| Musculoskeletal (Conventional) | P (Previously cleared by FDA) |
| Musculoskeletal (Superficial) | P (Previously cleared by FDA) |
| Endovaginal | P (Previously cleared by FDA) |
| Cardiac (Adult & Pediatric) | P (Previously cleared by FDA) |
| Fetal / Obstetrics (E612UB) | N (New indication) |
| Abdominal (C5-2b) | N (New indication) |
| Other (Urology, Gynecology) (C5-2b) | N (New indication) |
| Adult Cardiac (P5-1b) | N (New indication) |
| Small Organs (L15-7b) | N (New indication) |
| Musculoskeletal (Conventional) (L15-7b) | N (New indication) |
| Musculoskeletal (Superficial) (L15-7b) | N (New indication) |
| Peripheral Vascular (L15-7b) | N (New indication) |
| Modes of Operation | |
| B-mode | Supported (P or N for specific applications) |
| M-mode | Supported (P or N for specific applications) |
| PW-mode | Supported (P or N for specific applications); HPRF added |
| CW-mode | Supported (N for E612UB, C5-2b, P5-1b, L15-7b; added capability for U50 system) |
| Color-mode | Supported (P or N for specific applications) |
| PDI/DPDI (Combined mode) | Supported (Implicitly, as part of "Combined") |
| Biopsy Guidance | Supported (as an "Other" feature) |
| Harmonic Imaging | Supported (as an "Other" feature, no contrast agent) |
| General Performance | |
| Displayed depth | 20-320mm (Probe Dependent) |
| Gray Scales | 256 |
| Dynamic range | 150dB |
| TGC | 8 segments |
| Zoom | Up to 400% |
| Electrical Safety | Passed IEC 60601-1 testing |
| Electromagnetic Compatibility | Passed IEC 60601-1-2 testing |
| Acoustic Output | Passed testing as per FDA guideline |
| Biocompatibility | Passed ISO 10993-1, -5, -10 testing |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical testing is not required." This implies that there was no specific "test set" of patient data used for clinical validation in the traditional sense (e.g., to measure diagnostic accuracy). The evaluation was primarily based on non-clinical performance (safety, EMC, acoustic output, biocompatibility) and a comparison to predicate devices, leveraging their established clinical utility.
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 applicable, as no clinical test set requiring ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was used.
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 submission for a diagnostic ultrasound system (hardware and basic software functions), not an AI-powered diagnostic algorithm. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not an AI algorithm. Its performance is intrinsically linked to human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical test set requiring ground truth was used for evaluation of the system's diagnostic accuracy. The ground truth for safety and performance (e.g., acoustic output, EMC) would be the established international and national standards and their specific test methodologies.
8. The sample size for the training set
Not applicable. This is a medical device (ultrasound system), not an AI/Machine Learning algorithm that requires a "training set" in the computational sense. The design and engineering would have been informed by general ultrasound physics, medical imaging principles, and experience with prior devices.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML algorithm was used.
§ 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.