(15 days)
The Site-Rite® 5 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 Site-Rite® 5 Ultrasound System is intended to be used for diagnostic ultrasound imaging of fluid flow analysis of the human body in the following clinical applications.
- Abdominal
- Intraoperative (epiaortic scanning)
- Small Organ (breast, testes, thyroid, etc.)
- Neonatal Cephalic
- Adult Cephalic
- Cardiac
- Peripheral Vascular
- Musculo-skeletal Conventional
The Site-Rite® 5 Ultrasound System is not intended for opthalmic applications.
The Site-Rite® 5 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. It offers high resolution imaging to a depth of 6.0 cm. The Site® 5 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, angiography suites, catheterization laboratories, etc. In addition, the Site® 5 Ultrasound System is designed with simple operating controls to facilitate easy operation.
Key features of the Site~Rite® 5 Ultrasound System are:
- Compact, portable, real-time ultrasound scanner with:
- Intuitive controls allowing for rapid and easy operation
- Choice of battery or line voltage power
- Operating parameters of scanner determined by image depth
- Image freeze frame
- Image printing and saving
- Large screen
This document describes the Site-Rite® 5 Ultrasound System, a Class II diagnostic imaging system intended to assist physicians in gaining vascular access and for general diagnostic ultrasound imaging. The provided text does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or expert involvement.
Instead, the document primarily focuses on establishing substantial equivalence to a predicate device (Site-Rite® IV Ultrasound System) and outlining regulatory compliance with various performance and safety standards.
Here's an analysis based on the provided text, highlighting the absence of the requested detailed study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Performance data must meet predetermined acceptance criteria prior to placing the Site~Rite® 5 Ultrasound System on the market." However, no specific acceptance criteria or an associated table of reported device performance values are provided within this document. The performance is implicitly tied to demonstrating substantial equivalence to the predicate device and compliance with general safety and performance standards.
2. Sample size used for the test set and the data provenance
Not explicitly stated in the document. The document mentions "Performance testing will be completed prior to placing the Site® 5 Ultrasound System on the market," but does not detail the nature of this testing, the sample sizes, or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not stated. This document does not describe a clinical study involving experts establishing ground truth for a test set. The focus is on technical performance and safety standards.
4. Adjudication method for the test set
Not applicable/Not stated. As no detailed clinical test set and ground truth establishment are described, there is no mention of an adjudication method.
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 an ultrasound system, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (ultrasound system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not stated. Given the nature of the device and the regulatory submission, the "ground truth" would likely refer to established physics and engineering principles for ultrasound performance, and the "truth" of safety protocols. However, specific types of ground truth (like pathology or outcomes data from a clinical trial) are not mentioned as being used for performance evaluation within this document. The equivalence claim relies on the predicate device's established performance and safety.
8. The sample size for the training set
Not applicable. This device is a traditional ultrasound system, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this device does not utilize a training set in the AI/machine learning sense.
Summary of Device Acceptance Criteria and Study from the Provided Text:
The provided K052517 submission for the Site-Rite® 5 Ultrasound System focuses on demonstrating substantial equivalence to its predicate device, the Site-Rite® IV Ultrasound System. The "acceptance criteria" discussed are primarily related to compliance with recognized safety and performance standards for medical electrical equipment and diagnostic ultrasound.
The key statements regarding acceptance and performance are:
- "Testing based on the following standards will be completed in order to evaluate the device's performance." A list of IEC, UL, and NEMA standards is provided (page 4 of the submission).
- "Performance testing will be completed prior to placing the Site® 5 Ultrasound System on the market."
- "Performance data must meet predetermined acceptance criteria prior to placing the Site~Rite® 5 Ultrasound System on the market."
- "Performance data must demonstrate that the Site
Rite® 5 Ultrasound System is substantially equivalent to the SiteRite® IV Ultrasound System prior to placement of the Site~Rite® 5 Ultrasound System on the market." - A post-clearance special report is required, containing "complete information, including acoustic output measurements based on production line devices," to be submitted to the FDA (page 6).
In essence, the "study" referred to is the set of engineering and bench testing performed to ensure the device meets the specifications of the standards listed and demonstrates equivalent performance to the predicate device, particularly concerning safety (electrical, electromagnetic compatibility, acoustic output) and basic imaging capabilities. The document doesn't present a clinical study with statistical analysis of a test set, expert readers, or ground truth in the way one might find for an AI diagnostic device.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.