(28 days)
The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a general-purpose, fully digital ultrasound system for abdominal, gynecologic and obstetric, small parts, and cardiac applications.
The system is intended to use for the following type of studies: fetal organ. abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-sletal (both conventional and superficial). This device is intended to adult, pregnant woman, pediatric and neonate. The Device is a prescription device intended to be used by or on the order of a physician or similarly qualified health care professional. This Device is not intended for home use.
The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer 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 10 MHz. The modification will provide users with two new transducers, provide new frequency point, improve imaging enhancement, change system implement protocol by integrating some boards into one and reducing some boards, etc.
The provided document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to existing devices rather than proving specific performance against acceptance criteria in a clinical study. As such, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of regulatory submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating that the modified device remains "as safe, as effective as well as the legally marketed predicate devices."
The reported "device performance" is primarily in the context of compliance with safety and technical standards, and its ability to function as intended.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Confirmed by FDA review, stating the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. |
| Compliance with Design Specifications | Laboratory testing conducted to verify that the DP-9900 system with added transducer met all design specifications. |
| Safety Standards (Thermal, Mechanical, Electrical, Biocompatibility) | Device found to conform to applicable medical device safety standards. |
| Acoustic Output Measurement | Acoustic output measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard. All transducers are "track 1" devices. |
| Biocompatibility of Patient Contact Materials | All patient contact materials are biocompatible. |
| Functionality in specified modes (B-Mode, M-Mode, Combined Mode, PWD, Color Doppler, etc.) for various clinical applications | The device supports the listed modes (B, M, PWD) and clinical applications (Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal, Transrectal, Conventional, Musculo-skeletal Superficial) for the included transducers, as indicated by 'P' (previously cleared by FDA) or 'N' (new indication). |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical testing was required." This indicates that there was no "test set" in the sense of a set of patient data used for clinical performance evaluation. The evaluation appears to be based on technical and safety testing, and a comparison to predicate devices, rather than a prospective or retrospective study on a patient sample.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical testing with a specific "test set" requiring expert-established ground truth was conducted.
4. Adjudication method for the test set
Not applicable, as no clinical testing with a test set requiring adjudication was conducted.
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 and does not describe AI functionality or involve a reader performance study with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not describe AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical testing requiring ground truth for diagnostic accuracy was conducted. The "ground truth" in this context is the established safety and effectiveness of the predicate devices and compliance with technical standards.
8. The sample size for the training set
Not applicable, as there is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set was mentioned.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.