(103 days)
DP-10/DP-30/DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams.
The DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable/mobile (with mobile ultrasound trolley), software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, Power Mode, THI or the combined mode (i.e. B/M-Mode, B/PW-mode, Power + B, Power + PW +B). This system is a Track 3 device that employs an array of probes that include linear array, convex array.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of performance metrics like sensitivity, specificity, or AUC, which are typical for AI/ML-based diagnostic devices.
Instead, the document is a 510(k) summary for a "DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System," which is a traditional medical imaging device. The "study" referenced in the document is a non-clinical test report demonstrating compliance with various electrical, acoustic, and safety standards, rather than a clinical performance study of the device's diagnostic accuracy.
Here's a breakdown of the available information based on your request, highlighting what is not present:
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A table of acceptance criteria and the reported device performance:
The document does not specify performance acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) for the ultrasonic diagnostic imaging system. Instead, it refers to compliance with safety and performance standards.The performance relies on its ability to "acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, Power Mode, THI or the combined mode" and perform "specialized measurements of structures and flow, and calculations," which is an inherent function of an ultrasonic diagnostic system rather than a measured performance metric against a specific clinical outcome.
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Sample size used for the test set and the data provenance:
This information is not applicable as there was no clinical study evaluating diagnostic performance. The document states: "8. Clinical Studies: Not applicable. The subject of this submission, DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System, does not require clinical studies to support substantial equivalence."The non-clinical tests involved evaluating the device against standards, not a test set of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there was no clinical study with a test set requiring ground truth established by experts. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as there was no clinical study with a test set. -
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 applicable. The device is a diagnostic ultrasound imaging system, not an AI-assisted diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is not an AI algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable as there was no clinical study requiring a ground truth. -
The sample size for the training set:
This information is not applicable as the device is a traditional medical imaging system and not an AI/ML-based device that would require a training set. -
How the ground truth for the training set was established:
This information is not applicable as there was no training set.
In summary, the provided document details a 510(k) submission for a traditional ultrasonic diagnostic imaging system, and therefore, it focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with non-clinical safety and performance standards, rather than clinical performance criteria or studies typical for AI/ML devices.
§ 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.