(98 days)
The Ultra DCI 5000 System is intended for use by, or on the order of, a qualified physician for ultrasound imaging of the human heart. The cardiac (adult and pediatric) application using Bmode imaging is supported.
The Ultra DC1 Model 5000 is a general purpose, mobile, software-controlled, diagnostic ultrasound system designed to provide the user with the ability to collect standard 2D brightness mode (B-mode) echocardiographic views of the heart, visualize these views and store the collected data for later visualization. The device includes a 4-lead electrocardiograpic (ECG) module and patient connections to collect and display a single ECG trace (PQRST wave) along with the B-mode imagery.
While the provided text describes the "Ultra DCI Model 5000" diagnostic ultrasound system and its intended use, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria.
The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies with acceptance criteria.
Here's what can be inferred from the document regarding the information requested, and what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
- Missing. The document does not provide a table for acceptance criteria for clinical performance or any specific reported performance metrics (e.g., sensitivity, specificity, accuracy). It only states that the device is "substantially equivalent" to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. No information about a test set sample size or data provenance is provided.
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)
- Missing. No information about ground truth establishment or expert qualifications is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. No information about an adjudication method for a test set is provided.
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
- Missing. No MRMC study is mentioned. The device described does not appear to be an AI-assisted device; it is a general-purpose diagnostic ultrasound system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing. As it's a diagnostic ultrasound system operated by a physician, a standalone algorithm-only performance is not applicable in the context described.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Missing. No information about the type of ground truth is provided.
8. The sample size for the training set
- Missing. No mention of a training set or its sample size is made.
9. How the ground truth for the training set was established
- Missing. No information about a training set or its ground truth establishment is provided.
What the document does include that is relevant to device safety and performance:
- Device Description: The Ultra DCI Model 5000 is a general-purpose, mobile, software-controlled, diagnostic ultrasound system for 2D B-mode echocardiographic views of the heart, with a 4-lead ECG module.
- Intended Uses: For use by, or on the order of, a qualified physician for ultrasound imaging of the human heart, supporting cardiac (adult and pediatric) application using B-mode imaging.
- Predicate Devices: K022567 (Sequoia Diagnostic Ultrasound System Signature II) and K024236 (Ultrasound Scanner Type 2400). The current device is considered "substantially equivalent" to these.
- Compliance with Safety Standards: The device has been designed to meet NEMA UD-2 Measurement Standard (1998), IEC 60601-1:1988+A1:1991+A2:1995, IEC 60601-1-2:2001+A1:2004, and IEC 60601-2-37 (2004), (2005) Amendment 2. These are safety and electromagnetic compatibility standards, not specific clinical performance metrics.
- Modes of Operation: Cardiac Adult and Cardiac Pediatric applications use B-mode and B-mode Harmonic imaging (marked as "N" for new indication in the tables). This indicates the specific imaging modalities available.
In summary, the provided text describes a 510(k) submission for a diagnostic ultrasound system seeking substantial equivalence based on its technological similarities and adherence to general safety standards. It does not include the detailed performance study information, acceptance criteria, or ground truth establishment relevant to the specific questions asked.
§ 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.