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510(k) Data Aggregation
(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-sleletal (both conventional and superficial).
The DP-9900 Digital Ultrasonic Diagnostic Imaging System is a general purpose, mobile, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, or in the combined mode (i.e. B/M-Mode). This system is a Track 1 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 8.5 MHz.
The provided document is a 510(k) premarket notification for the "DP-9900 Digital Ultrasonic Diagnostic Imaging System" and its associated transducers. This submission does not describe an AI medical device with specific performance metrics against acceptance criteria in the typical sense of AI algorithm evaluation. Instead, it demonstrates substantial equivalence to a predicate device for market clearance.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set ground truth) are not applicable or cannot be extracted directly from this type of regulatory submission. The document focuses on technological characteristics, safety standards, and intended use as compared to a predicate device.
Here's an attempt to answer the questions based on the information provided, with an emphasis on what is not applicable or not specified for this type of device and submission.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to a legally marketed predicate device (Toshiba SSA-325A JUST VISION 400 Ultrasound Imaging System K990490). This typically involves meeting comparable safety and effectiveness standards, rather than specific numerical performance metrics for an AI algorithm.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (DP-9900 Digital Ultrasonic Diagnostic Imaging System) |
|---|---|
| Safety: | |
| - Conformance to medical device safety standards | - Conforms to IEC 60601-1 (electrical safety) |
| - Conformance to medical device safety standards | - Conforms to IEC 60601-1-2 (electromagnetic compatibility) |
| - Biocompatibility of patient contact materials | - Patient contact materials are biocompatible |
| - Acoustic output within safe limits | - Acoustic output measured and calculated per NEMA UD 2: 1998 |
| - Software controlled device safety issues addressed | - Software safety issues addressed by hazard analysis and system validation |
| Effectiveness: | |
| - Same fundamental technology as predicate | - Incorporates the same fundamental technology as predicate device |
| - Comparable intended use and clinical applications | - Intended for abdominal, gynecologic, obstetric, small parts, cardiac, fetal organ, pediatric, neonatal cephalic, transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial) imaging. Similar to predicate. |
| - Diagnostic imaging capabilities | - Displays in B-Mode, M-Mode, or combined B/M-Mode |
| - Transducer compatibility and function | - Uses linear array and convex linear array probes with frequency range 2.5-8.5 MHz. Transducers are "Track 1" devices. |
| Overall conclusion of substantial equivalence | - Demonstrated to be as safe and effective as the legally marketed predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable and not specified. This submission is for an ultrasonic imaging system, not an AI algorithm evaluated on a dataset. The "testing" mentioned refers to laboratory verification of engineering specifications and safety standards, not an evaluation on clinical cases.
- Data provenance: Not applicable. No clinical data or patient specific data is mentioned as being used for "testing" in the context of performance evaluation against a ground truth.
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. No ground truth for a test set (in the context of image interpretation or diagnosis) was established or used for this regulatory submission.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device. The device itself is an "algorithm only" in the sense that it is a software-controlled ultrasound system, but its performance is judged on its ability to produce images comparable to a predicate, not on a diagnostic algorithm's output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device and compliance with general performance standards for ultrasound systems, rather than a clinical ground truth for diagnostic accuracy.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device that requires a training set.
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