(28 days)
Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular and muscular-skeletal applications.
The SIUI CTS-900 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.
This document, K081110, is a 510(k) Premarket Notification for the SIUI CTS-900 Digital Ultrasound Imaging System. It focuses on establishing substantial equivalence to previously cleared predicate devices (SIUI CTS-7700, K061083 and K070982) rather than conducting a de novo study with specific acceptance criteria and performance data for new clinical claims. Therefore, the information provided does not contain a study that proves the device meets specific performance acceptance criteria in the manner typically found in a clinical validation study for a new diagnostic claim or AI/CADe device.
Here's an analysis based on the provided text, addressing your points where possible, and noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for substantial equivalence of an ultrasound system, the "acceptance criteria" are implicitly met by demonstrating that the device has the same technological characteristics and intended uses as the predicate devices. The document does not specify quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy) like those for an AI or CADe device. Instead, the performance is assumed to be equivalent to the predicate devices for the listed clinical applications.
| Feature/Criterion | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (as listed in document) |
|---|---|---|
| Intended Use | Equivalent to predicate (K061083, K070982) for: Abdominal, Pediatric, Small organ, Cardiac, Peripheral vascular, Muscular-skeletal. | Confirmed for: Abdominal, Pediatric, Small Organ (thyroid, testes, breast), Cardiac, Peripheral Vascular, Muscular-Skeletal (Conventional, Superficial), Fetal, Uterus, Ovary, Prostate. |
| Operating Modes | Equivalent to predicate (B mode, M mode, combined B/M) | 2D (B mode), B/M mode |
| Transducers Supported | Equivalent to predicate | C3L60B (2.5-5.0 MHz 60R 128e convex), L7L38B (5.0-9.0 MHz 38mm 128e linear) |
| Focus Mode | Equivalent to predicate | Transmit focus (1-4 selectable, variable depth), Receive focus (dynamic) |
| Grey Scale | Equivalent to predicate | 256 |
| Pre-processing | Equivalent to predicate | 32-channel digital beam-former, Receive gain (70dB), Dynamic range (35-66dB), Edge enhancement (4 steps), Image persistence (7 steps), Line density (normal, high) |
| Post-processing | Equivalent to predicate | 10 types of gray maps (4 user-definable) |
| Image Manipulation | Equivalent to predicate | Real-time zoom (x4.0 max), Frozen image |
| B/M-mode speed | Equivalent to predicate | Time for full screen scroll: 1.2, 2.5, 5.0, 10.0 sec |
| Cine Capacity | Equivalent to predicate | Max. 256 frames |
| Image Store & Recall | Equivalent to predicate | 32 frames |
| Image Orientation | Equivalent to predicate | Left/right flip, Up/down flip, 90-degree rotation (0, 90, 180, 270 degrees) |
| Documentation & Storage | Equivalent to predicate | 60GB HDD (BMP), USB memory (BMP), B&W video printer |
| Measurements & Calculations | Equivalent to predicate | General 2D: Distance, Area, Circumference, Angle. General M-Mode: Distance, Time, Slope, Heart rate. Specific: Abdomen, Obstetrics, Gynecology, Cardiology, Small parts, Peripheral Vascular. |
The study that "proves" the device meets these criteria is the substantial equivalence comparison to the predicate devices, not a new clinical study with defined performance metrics. The core argument is summarized in the FDA's letter (K081110): "We have reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This submission relies on substantial equivalence. There is no mention of a dedicated "test set" of patient data for performance evaluation in the context of a new diagnostic claim. The "data" evaluated would have been the technical specifications and clinical indications of the device itself and the predicate devices.
- Data Provenance: Not applicable. The FDA reviewed technical specifications and claims against predicate devices. If any internal testing or demonstrations were performed, their details are not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "ground truth" to establish for a test set in the context of this 510(k) submission. The FDA's determination is based on the comparison of the device's design, technology, and intended use to that of already cleared devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring expert adjudication is mentioned.
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
- Not applicable. This is not an AI/CADe device, and no MRMC study was conducted or referenced in this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is an ultrasound imaging system, not an algorithm, and no standalone performance study in this context was performed.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the sense of a clinical validation study. The "ground truth" for the FDA's decision is the established safety and effectiveness of the legally marketed predicate devices to which the SIUI CTS-900 is compared.
8. The sample size for the training set
- Not applicable. This device is an imaging system and does not involve AI or machine learning that would require a "training set" of data in the manner you're describing.
9. How the ground truth for the training set was established
- Not applicable, for the same reasons as point 8.
§ 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.