(17 days)
The Site~Rite® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.
The SiteRite® 6 Ultrasound System is a lightweight, low-output, real-time B-mode ultrasonic pulsed echo imaging system designed primarily to assist physicians in gaining vascular access to major veins and arteries. The SiteRite® 6 Ultrasound System is portable and therefore easy to use at the bedside and in a variety of clinical scenarios, including intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc. In addition, the Site~Rite® 6 Ultrasound System is designed with simple operating controls to facilitate easy operation.
The provided text describes a 510(k) summary for the SiteRite® 6 Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device (SiteRite® 5 Ultrasound System) rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI device.
Therefore, many of the requested categories in your prompt (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set size) cannot be extracted from the given document as they are not applicable to the type of regulatory submission described.
The document indicates that the Site~Rite® 6 Ultrasound System is a conventional ultrasound imaging system, not an AI-powered device. Its approval is based on "Technological Characteristics" being identical to the predicate device and "Safety & Performance Tests" being performed in accordance with Design Controls (21 CFR 820.30). There is no mention of an algorithm or AI.
However, I can provide the information that is present in the document which aligns with some of your points:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document states that the Site
Rite® 6 Ultrasound System "meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, material, principles of operation and indications for use to the current commercially available SiteRite® 5 Ultrasound System." No specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) are provided, as this is a substantial equivalence claim for a non-AI device. - Reported Device Performance: No specific quantitative performance metrics (like accuracy, sensitivity, specificity) are reported. The performance is implied to be equivalent to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
* Not applicable/Not provided. The submission is based on demonstrating substantial equivalence to a predicate device, not on a clinical trial with a test set of data for a new algorithm. Verification and validation tests were performed "in accordance with Design Controls per 21 CFR 820.30," but details on specific sample sizes for performance evaluation are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not provided. This type of information is usually relevant for AI/CAD device submissions based on expert-adjudicated datasets.
4. Adjudication method for the test set:
* Not applicable/Not 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:
* No. This is not an AI device, and therefore no MRMC study comparing human readers with and without AI assistance was conducted or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* No. This is not an AI algorithm.
7. The type of ground truth used:
* Not applicable/Not provided in the context of performance for a novel algorithm. The system's "ground truth" for its intended use (ultrasound guidance for vascular access) is derived from its ability to visualize anatomical structures, which is implied to be equivalent to its predicate.
8. The sample size for the training set:
* Not applicable/Not provided. This is not an AI device that undergoes training.
9. How the ground truth for the training set was established:
* Not applicable/Not provided. This is not an AI device that requires a training set with established ground truth.
In summary: The provided document is a 510(k) summary for a conventional ultrasound system, not an AI-powered medical device. As such, the detailed information requested regarding acceptance criteria and study design for AI evaluation is not present because it does not apply to this type of device and submission. The basis for approval is substantial equivalence to a legally marketed predicate device.
§ 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.