(28 days)
The system 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-skeletal (both conventional and superficial). This device is intended to adult, pregnant woman, pediatric and neonate. The system 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-6600 Digital Ultrasonic Diagnostic Imaging System with added transducers 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. Changing acoustic transducers of probes and addition of some transducers enriches the diversity of the product's configuration and expands the freedom of choices for customers. At the same time, new software functions have been added.
The provided text describes a 510(k) premarket notification for the DP-6600 Digital Ultrasonic Diagnostic Imaging System with added transducers. However, it explicitly states that "No clinical testing was required". This means there is no study detailed in this document that proves the device meets specific acceptance criteria based on human or AI performance.
Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth, experts, and comparative effectiveness studies cannot be fulfilled from the provided text.
Here's what can be extracted based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (if mentioned) | Reported Device Performance (if mentioned) | Met/Not Met/Not Applicable |
|---|---|---|---|
| Safety and Effectiveness | Substantially equivalent to predicate devices (K052113, K992663, K042540) | The device is as safe and effective as the legally marketed predicate devices. | Met (based on manufacturer's conclusion) |
| Design Specifications | Met all design specifications | Verified in laboratory testing | Met (based on manufacturer's statement) |
| Acoustic Output | Measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004 | Measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004. | Met (based on manufacturer's statement) |
| Biocompatibility | Patient contact materials are biocompatible | All patient contact materials are biocompatible | Met (based on manufacturer's statement) |
| Standards Conformance | Conforms to NEMA UD 2, IEC 60601-1, IEC 60601-1-2 | Conforms to NEMA UD 2, IEC 60601-1, IEC 60601-1-2 | Met (based on manufacturer's statement) |
| Clinical Performance | (No specific clinical performance criteria mentioned as no clinical testing was required) | (No clinical performance data reported as no clinical testing was required) | Not Applicable |
2. Sample size used for the test set and the data provenance:
- Not applicable. The document explicitly states "No clinical testing was required," meaning there was no test set of patient data used for performance evaluation.
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 was performed, there was no test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set was used.
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:
- No. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool as described in the context of MRMC studies. The document states "No clinical testing was required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware/software system, not a standalone algorithm. The document states "No clinical testing was required."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical data requiring ground truth was used for performance validation. The device's "ground truth" for demonstrating substantial equivalence relied on its technical specifications meeting existing standards and being comparable to predicate devices.
8. The sample size for the training set:
- Not applicable. As "No clinical testing was required," there's no mention of a training set of data for an algorithm or AI model. The system's "training" would be its development and engineering based on established ultrasound physics and medical imaging principles.
9. How the ground truth for the training set was established:
- Not applicable. No training set requiring ground truth was used as per the document.
§ 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.