(81 days)
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parotid, submaxillary gland, testes and breast.). Peripheral Vascular, Transvaginal, Transrectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology.
The CHISON iVis20/iVis30/i3/ Q1/Q2/Q3/Q5 ultrasound system is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The CHISON ultrasound system can be configured as a roll-around model on wheels (iVis20/iVis30/i3/ Q1/Q2/Q3/Q5). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years. This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes.
Acceptance Criteria and Study for CHISON iVis Series & Q Series, i3 Diagnostic Ultrasound Systems
This document describes the acceptance criteria and study information for the CHISON iVis Series & Q Series, i3 Diagnostic Ultrasound Systems, extracted from the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) premarket notification summary. For medical devices seeking substantial equivalence, performance characteristics are typically compared against an existing "predicate device" rather than predefined numerical acceptance criteria in the same way as an AI/ML device. The "acceptance criteria" here are implicitly that the new device performs comparably to the predicate device, GE Voluson E6/E8/E8 Expert (K101236), across various imaging modes and clinical applications.
The reported device performance is that the CHISON iVis Models and Q Models and i3 are "substantially equivalent in safety and effectiveness" to the predicate. This equivalence is based on the systems having the "same intended uses and basic operating modes," "same gray-scale and Doppler capabilities," and acoustic output levels "below the applicable FDA limits."
The 510(k) summary itself does not contain specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for image quality or diagnostic effectiveness, as would often be the case for AI/ML devices or novel technologies. Instead, the focus is on demonstrating that the new device meets the same safety and performance standards as the predicate device already on the market.
Table: Comparison to Predicate Device (Implied Acceptance Criteria)
| Feature/Performance Aspect | Acceptance Criteria (Comparable to Predicate: GE Voluson E6/E8/E8 Expert (K101236)) | Reported Device Performance (CHISON iVis Series & Q Series, i3) |
|---|---|---|
| Intended Uses | Same as predicate device | Same as predicate device |
| Basic Operating Modes | Same as predicate device (B-Mode, M-Mode, Pulsed Doppler, Color Doppler, Power Doppler, Directional Power Doppler) | Same as predicate device |
| Gray-scale Capabilities | Comparable to predicate device | Same capabilities as predicate device |
| Doppler Capabilities | Comparable to predicate device | Same capabilities as predicate device |
| Acoustic Output Levels | Below applicable FDA limits | Below applicable FDA limits |
| Product Safety Standards | Compliance with relevant standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1) | Designed to meet listed product safety standards |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective study design).
The submission is for a diagnostic ultrasound system aiming for substantial equivalence to a predicate device. This type of submission typically relies on device design specifications, performance testing (e.g., electrical safety, acoustic output, electromagnetic compatibility), and a comparison of technical features and intended uses to the predicate, rather than a clinical study with a "test set" in the context of AI/ML or novel diagnostic algorithms.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Since the 510(k) summary does not describe a clinical study with a test set requiring ground truth established by experts, there is no information provided regarding the number or qualifications of experts for this purpose.
4. Adjudication Method for the Test Set
As there is no mention of a clinical study or a test set requiring expert adjudication for ground truth, no adjudication method is described in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed, nor does it provide any effect size of human readers improving with or without AI assistance. The device is a diagnostic ultrasound system, not explicitly described as incorporating AI for interpretation.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone (algorithm only) performance study. The device is a complete ultrasound system, and its performance is evaluated in the context of its overall functionality and comparison to a predicate device, not as a standalone algorithm.
7. Type of Ground Truth Used
Given the nature of a 510(k) for a diagnostic ultrasound system (not an AI algorithm or a novel diagnostic modality), the concept of "ground truth" in the context of a clinical test set is not directly applicable or described. The submission focuses on demonstrating that the device's technical specifications, imaging capabilities (B-Mode, M-Mode, Doppler), and safety aspects are equivalent to those of a legally marketed predicate device.
8. Sample Size for the Training Set
The provided 510(k) summary does not contain any information about a training set or its sample size. This is consistent with a traditional medical device submission for substantial equivalence, which does not typically involve machine learning model training as a documented component of the submission.
9. How Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied, there is no information on how ground truth for a training set was established.
§ 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.