(26 days)
Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular applications. Muscular-Skeletal Conventional and Superficial applications. Small organs include: thyroid, testes, breast. Other uses include: Uterus, Ovary, and Prostate.
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.
The SIUI CTS-7700 Digital Ultrasound System is an ultrasonic pulsed echo imaging system intended for diagnostic use. The relevant submission K070982 specifically adds Muscular-Skeletal Conventional and Superficial applications to the system.
1. Acceptance Criteria and Reported Device Performance:
The provided documents do not detail specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) for the addition of Muscular-Skeletal Conventional and Superficial applications. Instead, the "acceptance criteria" appear to be based on demonstrating substantial equivalence to a predicate device (SonoAce 6000, K981510) for these expanded indications.
The device's performance is not presented in quantitative metrics but rather by the FDA's determination of substantial equivalence, which implies that its technological characteristics and intended use for the new applications are comparable to those of the predicate device and meet safety and effectiveness standards.
| Acceptance Criteria (Implied by Substantial Equivalence Review) | Reported Device Performance (as determined by FDA) |
|---|---|
| Device functions as an Ultrasonic Pulsed Echo Imaging System. | The SIUI CTS-7700 is a digital diagnostic ultrasound system capable of 2D (B mode) and B/M modes, supporting linear and convex transducers. |
| System capable of Muscular-Skeletal Conventional imaging. | "N" (New Indication) marked for Muscular-Skeletal Conventional for the system and the L7L38B linear array transducer, indicating the FDA cleared this new application. |
| System capable of Muscular-Skeletal Superficial imaging. | "N" (New Indication) marked for Muscular-Skeletal Superficial for the system and the L7L38B linear array transducer, indicating the FDA cleared this new application. |
| Technological characteristics are largely similar to previously cleared devices. | The technological characteristics (scanning modes, display modes, supporting transducers, focus mode, grey scale, pre-processing, post-processing, image manipulation, cine, image store/recall, image orientation, documentation/storage, measurements/calculations) are described and are consistent with general ultrasound systems. No changes were made that impact the previously cleared applications. |
| Device is safe and effective for the stated indications. | FDA granted substantial equivalence, allowing the device to be marketed for the expanded indications. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided documents do not describe any specific test set, clinical study, or patient data used to demonstrate the performance of the device for the new Muscular-Skeletal Conventional and Superficial applications. The submission primarily focuses on technological characteristics and comparison to a predicate device to establish substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Since no specific test set or clinical study is described, there is no information available regarding experts used for establishing ground truth.
4. Adjudication Method for the Test Set:
As no specific test set or clinical study is described, there is no information available regarding any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study is mentioned or appears to have been conducted as part of this submission. The submission relies on substantial equivalence to a predicate device rather than a direct comparison of human reader performance with and without AI assistance (which is not applicable here as it's an ultrasound system, not an AI-assisted diagnostic tool).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is a digital ultrasound system, not an AI algorithm. Therefore, a "standalone" performance study in the context of an algorithm would not be applicable and is not mentioned. Its performance is inherent to its imaging capabilities, which are assessed for safety and effectiveness in comparison to predicate devices.
7. The Type of Ground Truth Used:
Given the nature of the submission (510(k) for an ultrasound system expansion based on substantial equivalence), the "ground truth" implicitly relies on:
- Engineering and technical specifications: Ensuring the system's output (image quality, measurements, modes) meets industry standards and is comparable to the predicate device.
- Clinical experience and predicate device history: The understanding that similar ultrasound systems with comparable specifications are safe and effective for the stated indications through prior regulatory clearances and medical practice.
There is no mention of specific pathology, expert consensus on case reads, or outcomes data being used to establish a "ground truth" for the clearance of these new indications.
8. The Sample Size for the Training Set:
This device is a hardware/software system, not a machine learning model. Therefore, the concept of a "training set" in the context of AI is not applicable and no training set size is mentioned.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for an AI model, this question is not applicable. The "ground truth" for the system's design and engineering would be based on established ultrasound physics, medical imaging principles, and technical performance standards.
§ 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.