(28 days)
The Site~Rite Vision* II Ultrasound System is intended for diagnostic ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications include: Fetal Abdominal Intra-operative (semi-critical) Pediatric Peripheral Vessel Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary) Musculo-skeletal (conventional and superficial) Cardiac (adult and pediatric)
Typical examinations performed using the Site-Rite Vision* II Ultrasound System include: Vascular, Vascular Access, Abdominal, Interventional and Intraoperative, Superficial.
The Site-Rite Vision* II Ultrasound System is a mobile device that features real-time 2D ultrasound imaging, color-flow Doppler, procedural recordings (cine), patient-information storage, image annotations, and various measurement and calculation tools. The typical environment for ultrasound imaging may include hospitals, outpatient clinics, and long-term care facilities.
The provided text describes a 510(k) premarket notification for the Bard Access Systems, Inc. Site~Rite Vision II Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing details on specific acceptance criteria and a detailed study proving performance against those criteria as would be found for a novel device.
The study presented here is a determination of substantial equivalence study, where the new device is compared to a previously cleared predicate device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for a specific disease or condition detection. Instead, the "acceptance criteria" are broad performance requirements demonstrating that the device is as safe and effective as the predicate device. The performance is reported in the context of meeting these requirements.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance with relevant medical device standards (e.g., electrical safety, EMC, usability, acoustic output, software) | The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device. Specific standards met include: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-6, NEMA UD 2, NEMA UD 3, IEC 62304, ISO 10993-1, and NEMA PS 3.1 – 3.18. |
| Functional equivalence to the predicate device in terms of imaging modes and capabilities (2D, color Doppler) | The device operates identically to the predicate device, using piezoelectric material for ultrasound transmission and reflection, processing signals for 2D images, and displaying Doppler shift for color flow or spectrum analysis. The modes (2D, color Doppler) are the same as the predicate. |
| Substantial equivalence in design, principles of operation, and indications for use to the predicate device | "The Site |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in the context of diagnostic accuracy for medical images or a disease. The performance evaluation appears to be based on engineering verification and validation activities against established standards, rather than a clinical study with a patient dataset. The provenance of the data is therefore not applicable in the sense of patient data origin (e.g., country, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document does not describe a study involving a test set of patient cases requiring expert-established ground truth. The study is an engineering verification and validation against performance standards.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This document describes an ultrasound system, not an AI-powered diagnostic algorithm designed to assist human readers. Thus, there is no mention of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is an ultrasound system, which is a diagnostic imaging tool that inherently requires a human operator and interpreter. It is not an algorithm that performs standalone analysis.
7. The Type of Ground Truth Used
The "ground truth" in this context is the fulfillment of engineering performance requirements and compliance with recognized standards (e.g., IEC, NEMA, ISO). The specific "types of ground truth" listed (expert consensus, pathology, outcomes data) are not applicable because this is not a diagnostic accuracy study based on patient data.
8. The Sample Size for the Training Set
This information is not applicable. The device is a traditional ultrasound system, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as #8.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.