(5 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: fetal, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-skeletal (both conventional and superficial).
The DP-6600 Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable, 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 MHz to 10 MHz.
The provided text is a 510(k) premarket notification for the Mindray DP-6600 Digital Ultrasonic Diagnostic Imaging System. This document asserts the substantial equivalence of the new device to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria for performance in a diagnostic context.
Therefore, many of the requested categories of information related to a diagnostic performance study (e.g., sample size, expert qualifications, ground truth type, MRMC studies, standalone performance) are not applicable or not available from this type of regulatory document.
However, I can extract information related to the technical characteristics and testing performed to demonstrate substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
This document does not describe specific numerical acceptance criteria for diagnostic efficacy (e.g., sensitivity, specificity, accuracy) or clinical performance outcomes. Instead, the "acceptance criteria" appear to be based on demonstrating that the device's technical characteristics and safety meet established standards and are substantially equivalent to a predicate device.
| Acceptance Criteria Category | Reported Device Performance (as described in the document) |
|---|---|
| Technological Characteristics | - Incorporates the same fundamental technology as the predicate device (SSA-320A JUST VISION 200 Ultrasound Imaging System K990490). |
- Designed to project ultrasound waves into body tissue and present returned echo information on the monitor in B-Mode, M-Mode, or combined B/M-Mode.
- Employs an array of probes (linear array and convex linear array) with a frequency range of approximately 2 MHz to 10 MHz.
- Track 1 device (per FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" September 1997). |
| Acoustic Output | - Measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 1998. - All transducers used are Track 1. |
| Material Biocompatibility | - All patient contact materials are biocompatible. |
| Safety Standards Conformance | - Conforms to applicable medical device safety standards in regards to thermal, mechanical, and electrical safety. - Conforms to NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 1998, IEC 60601-1, and IEC 60601-1-2. |
| Software Controlled Device Safety | - Safety issues related to software control are either the same as those addressed by the predicate device or are addressed in the system hazard analysis or system validation. |
| Overall Equivalence | - Found to be as safe and effective as the legally marketed predicate device, the SSA-320A JUST VISION 200 Ultrasound Imaging System (K#990490). |
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: Not applicable. The document states "No clinical testing was required." The testing described is laboratory-based and focused on technical specifications, not patient data in the context of diagnostic performance.
- Data provenance: Not applicable.
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 with associated ground truth was established or described for diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test set with associated ground truth was established or described for diagnostic performance.
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 premarket notification for an ultrasound system, not an AI-powered diagnostic device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to the performance of the entire ultrasound system as a diagnostic tool, which inherently involves a human operator and interpreter. It is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no clinical performance study requiring ground truth for diagnostic accuracy was conducted or reported in this document. The "ground truth" for the technical testing would be the engineering specifications and established standards (e.g., NEMA UD 2).
8. The sample size for the training set
- Not applicable. This document does not describe a machine learning model or a training set for an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Study:
The "study" described in the 510(k) summary is a series of laboratory tests designed to demonstrate the technical performance, safety, and substantial equivalence of the DP-6600 Digital Ultrasonic Diagnostic Imaging System to a predicate device (SSA-320A JUST VISION 200 Ultrasound Imaging System K990490).
- Study Design: Primarily laboratory-based testing of technical specifications and conformance to safety standards.
- Purpose: To show that the new device has "technological characteristics that do not affect the safety or efficacy of the device" and is "as safe and effective as the legally marketed predicate device."
- Key Findings: The device met design specifications and conformed to applicable medical device safety standards (thermal, mechanical, electrical, biocompatibility, acoustic output per NEMA UD 2, IEC 60601-1, IEC 60601-1-2). "No clinical testing was required."
§ 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.