(49 days)
Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular applications
The SIUI CTS-7700 is a digital diagnostic ultrasound system capable of the following operating modes: 2D (B mode) and B/M. The system is designed for use in linear and convex scanning modes and supports linear, and convex transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.
Here's an analysis of the provided text regarding the SIUI CTS-7700 Digital Ultrasound Imaging System, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary, which is a premarket notification to the FDA. This type of document primarily focuses on demonstrating substantial equivalence to a previously cleared device, not necessarily providing a detailed study report with specific acceptance criteria and performance metrics as one might find in a clinical trial. Therefore, much of the requested information about formal acceptance criteria, specific studies, sample sizes, and ground truth establishment will not be explicitly present in this type of regulatory submission. The goal of a 510(k) is to show the new device is as safe and effective as a predicate device, often by comparing technical characteristics and intended uses.
Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary, the "acceptance criteria" are implicitly tied to demonstrating that the new device (CTS-7700) is "substantially equivalent" to its predicate device (SIUI CTS-485, K012772) and meets the general controls and classifications for an ultrasonic pulsed echo imaging system (21 CFR 892.1560) and diagnostic ultrasonic transducer (21 CFR 892.1570).
The "performance" isn't reported in quantitative metrics against specific thresholds but rather as a list of features and capabilities that are comparable to or an evolution of the predicate device.
| Acceptance Criteria (Implied from 510(k) Goals) | Reported Device Performance (Characteristics) |
|---|---|
| Substantial Equivalence: Maintain or improve upon the safety and effectiveness of the predicate device. | The device is deemed substantially equivalent to the SIUI CTS-485 (K012772) predicate device. Functionally, it offers 2D (B mode) and B/M modes, supports convex and linear scanning, and includes features like cine review, image zoom, measurements and calculations, image storage, printing, and recording. |
| Clinical Applications: Cover the intended use cases safely and effectively. | System: Abdominal, Pediatric, Small Organ (thyroid, testes, breast), Cardiac (Pediatric), Peripheral Vascular, and "Others" (uterus, ovary, prostate) applications are indicated for B and B/M modes. |
| Transducer Compatibility & Functionality: Ensure transducers operate as intended for specific applications. | C3L60B (Convex Array, 2.5-5.0 MHz): Fetal, Abdominal, Pediatric Cardiac, and "Others" (Uterus, Ovary, Prostate) for B and B/M modes. |
| L7L38B (Linear Array, 5.0-9.0 MHz): Pediatric, Small Organ (thyroid, testes, breast), Peripheral Vascular for B and B/M modes. | |
| Technical Specifications: Meet established standards for ultrasound imaging systems. | Scanning Modes: Convex and linear. |
| Display Modes: B-Mode (B, 2B), B/M-Mode. | |
| Supporting Transducers: C3L60B (2.5-5.0 MHz) and L7L38B (5.0-9.0 MHz). | |
| Focus Mode: Transmit (1-4 selectable, variable depth), Receive (dynamic focus). | |
| Grey Scale: 256. | |
| Pre-processing: 32-channel digital beam-former, 70dB receive gain, 35-66dB dynamic range, edge enhancement (4 steps), image persistence (7 steps), line density (normal, high). | |
| Post-processing: 10 types of grey maps (4 user-definable). | |
| Image Manipulation: Real-time zoom (x4.0 max), frozen image. | |
| B/M-mode speed: 1.2, 2.5, 5.0, 10.0 sec. | |
| Cine: Max. 256 frames. | |
| Image Store/Recall: 32 frames. | |
| Image Orientation: Left/right flip, up/down flip, 90-degree rotation. | |
| Documentation/Storage: 60GB HDD, USB, B&W video printer, Parallel port printer. | |
| Measurements/Calculations: General (Distance, Area, Circumference, Angle, Time, Slope, Heart rate) and Specific (Abdomen, Obstetrics, Gynecology, Cardiology, Small parts, Peripheral Vascular). |
Study Information (Based on 510(k) Summary's Limitations)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not provide information on a specific test set, its sample size, or data provenance. 510(k) submissions typically rely on technical comparisons and performance testing to standards rather than clinical study data from a "test set" in the context of AI/diagnostic accuracy.
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)
- No information is provided regarding experts or ground truth establishment for a test set, as no dedicated clinical study with such a methodology is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No information is provided on an adjudication method, as no formal "test set" requiring expert adjudication is discussed in this summary.
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, an MRMC comparative effectiveness study was not done or reported. This device is an analog/digital ultrasound imaging system, not an AI-powered diagnostic tool. The concept of human readers improving with AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware imaging system, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For an ultrasound imaging system, the "ground truth" for demonstrating performance would typically involve phantom studies (to assess image quality metrics like resolution, penetration, contrast, etc.), biocompatibility testing, electrical safety testing, and comparison of technical specifications to a predicate device, confirming that the images produced are diagnostically acceptable and comparable. Clinical efficacy (diagnostic accuracy) is often implied by demonstrating similar technical performance to a legally marketed equivalent device, rather than a de novo clinical trial with pathology or outcomes-based ground truth. The document does not explicitly describe these ground truth methods.
8. The sample size for the training set
- This device is an ultrasound imaging system, not a machine learning model. Therefore, the concept of a "training set" in the AI sense is not applicable.
9. How the ground truth for the training set was established
- As explained above, the concept of a "training set" (for an AI model) is not applicable to this 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.