(114 days)
The diagnostic ultrasound system (DUS-5000) 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), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
The DUS-5000 Diagnostic Ultrasound System, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to11 MHz.
The DUS-5000 Diagnostic Ultrasound System is a medical device intended for diagnostic ultrasound imaging and fluid flow analysis. The acceptance criteria and the study proving the device meets these criteria are outlined below, derived from parts {0} through {15} of the provided text.
Based on the provided information, clinical testing was not required for this device, as stated in section {2}. This implies that the device's performance was evaluated through non-clinical means and comparison to a predicate device. Therefore, details regarding test sets, ground truth establishment, expert adjudication, or MRMC studies for clinical performance are not available in this document. The "acceptance criteria" in this context refer to the successful completion of non-clinical safety and performance standards and demonstrating substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Given that clinical testing was not required, the acceptance criteria are primarily related to non-clinical safety and performance standards, and comparison to the predicate device. The performance is assessed by confirming the device meets these standards and functions identically or equivalently to the predicate.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Non-clinical Safety Standards | IEC 60601-1: Electrical Safety | Subject device has successfully completed these standards. |
| IEC 60601-1-2: Electromagnetic Compatibility | Subject device has successfully completed these standards. | |
| Acoustic Output Testing (per FDA guidance Sep 9, 2008) | Subject device has successfully completed these standards. | |
| ISO 10993-1, ISO 10993-5, ISO 10993-10 (Biocompatibility) | Subject device has successfully completed these standards. | |
| Comparison to Predicate Device (K123249) | Identical Technology Characteristics | Confirmed to be identical. |
| Same Intended Use | Confirmed to be the same. | |
| Same Product Design | Confirmed to be the same. | |
| Same Materials and Manufacturing Process | Confirmed to be the same. | |
| Same Performance Effectiveness | Confirmed to be the same. | |
| Same Performance Safety | Confirmed to be the same. | |
| Same Needle-Guide Bracket Material, Property, Sterilization Methods | Confirmed to be the same. | |
| Functional Equivalence | Acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode across various probes | Confirmed ({"Its function is to acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode."}) |
| Frequency Range | Probes with frequency range of approximately 2.5 MHz to 11 MHz | Confirmed ({"This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to11 MHz."}) |
| Clinical Applications (General) | Abdominal, Obstetrics, Gynecology, Pediatric, Small Parts, Urology, Peripheral Vascular, Musculoskeletal, Transvaginal, Cardiac | All listed applications supported by the device (P = previously cleared) as explicitly or implicitly covered in the Indications for Use forms for the various transducers. Specifically, the DUS-5000 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), transvaginal and cardiac clinical applications" (as per section {1}). |
2. Sample size used for the test set and the data provenance
Since clinical testing was not required (section {2}), there is no mention of a clinical "test set" in terms of patient data or provenance. The "test set" in this context refers to the device itself undergoing non-clinical technical evaluations and comparisons to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as clinical testing was not required (section {2)} and no expert-based ground truth establishment for clinical performance is reported. The "ground truth" for the non-clinical evaluations would be the established engineering and biocompatibility standards themselves.
4. Adjudication method for the test set
Not applicable, as clinical testing was not required (section {2)} and no clinical test set requiring adjudication is 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. The device is a diagnostic ultrasound system and not explicitly stated to be an AI-assisted device. Furthermore, clinical testing was not required (section {2}), so no MRMC study or AI assistance evaluation was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is a diagnostic ultrasound system, not an algorithm-only device. Additionally, clinical testing was not required (section {2)}.
7. The type of ground truth used
For non-clinical evaluation, the "ground truth" is established through adherence to national and international safety standards (e.g., IEC 60601-1, IEC 60601-1-2, Acoustic Output Guidelines, ISO 10993 series) and by demonstrating identical or equivalent performance to the legally marketed predicate device (Model U50 Diagnostic Ultrasound System, K123249).
8. The sample size for the training set
Not applicable, as clinical testing was not required (section {2}). This device is a diagnostic ultrasound system, and the submission does not mention machine learning or AI components that would typically require a training set of data.
9. How the ground truth for the training set was established
Not applicable, as clinical testing was not required (section {2}), and no training set is mentioned.
§ 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.