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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.

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.

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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.

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.

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