(295 days)
Diagnostic ultrasound imaging of the human body as follows: Fetal, Abdominal, Cardiac Adult. Mode of Operation: B mode for Fetal and Abdominal, M mode for Cardiac Adult.
Model CTS-200 is a compact-type linear electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows abdominal organ and fetal images to be observed on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a full keyboard, 9inch video monitor and a special photographic unit.
The provided document K963068 is a Premarket Notification [510(k)] Summary for the SIUI CTS-200 Diagnostic Ultrasound System with EZU-PL21 Transducer. It focuses on demonstrating substantial equivalence to a predicate device, the Hitachi Medical Corporation EUB-240 (K862164), rather than providing detailed acceptance criteria and a study to prove the device meets those criteria in the way one might expect for a novel AI/software device.
Instead of traditional acceptance criteria and a study demonstrating performance against them, the document presents a "Comparison List" of the SIUI CTS-200 and the Hitachi EUB-240, highlighting that the SIUI device's technological characteristics are similar to those of the predicate device. The underlying assumption for 510(k) clearance is that if a new device is substantially equivalent to a legally marketed predicate device, it is as safe and effective as the predicate. The "acceptance criteria" here are essentially the specifications and functionalities of the predicate device.
Here's a breakdown based on the provided text, addressing your questions to the extent possible, and acknowledging what information is not present in a 510(k) summary focused on substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for the SIUI CTS-200 are implicitly the performance specifications and safety standards of the predicate device, the Hitachi EUB-240. The reported device performance for the SIUI CTS-200 is presented next to the predicate's specifications to demonstrate similarity.
| Acceptance Criteria (Predicate: Hitachi EUB-240 Specifications) | Reported Device Performance (SIUI CTS-200) |
|---|---|
| Scanning Mode: Electronic linear scanning (compatible 64 elements linear probe) | Electronic linear scanning (compatible 64 elements linear probe) |
| Display Mode: B, B/B, M, B/M mode simultaneously | B, B/B, M, B/M mode simultaneously |
| Measurement (B mode): Distance, area, circumference | Distance, area, circumference |
| Measurement (M mode): Time interval, velocity, heart rate | Time interval, velocity, heart rate |
| Calculation: Area, circumference, volume, heart rate, pregnant weeks | Area, circumference, volume, heart rate, pregnant weeks |
| Focusing Mode: 4-steps focusing with variable aperture and lens focusing | 4-steps focusing with variable aperture and lens focusing |
| Scanning Width (3.5MHz probe): 102mm | 102mm |
| Transmitting Voltage: Pulse height 120V | Pulse height 120V |
| Transmitting Pulse Width (3.5MHz): 190 us | 190 us |
| Detecting Depth (3.5MHz max): 200mm | 200mm |
| ZOOM Magnification: x1.0, x1.5, x2.0 selectable, depth shift | x1.0, x1.5, x2.0 selectable, depth shift |
| Frame Rate: Maximum 25 frame/second | Maximum 25 frame/second |
| Grey Scale: 16 | 16 |
| Memory: 256x512x4 bit | 256x512x4 bit |
| Video Output: PAL or NTSC system TV signal | PAL or NTSC system TV signal |
| Power Supply: 100V, 110V, 117V, 200V, 220V or 234V, ±10%, 50/60Hz, about 140W | 100V, 110V, 117V, 200V, 220V or 234V, ±10%, 50/60Hz, about 140W |
| Monitor: 9" black and white monitor | 9" black and white monitor |
| Cursor Shift: By 9 cursor shift keys | By 9 cursor shift keys |
| Electrical Safety Standard: Conform to IEC 601-1 Class I, B type apparatus | Conform to IEC 601-1 Class I, B type apparatus |
| Transducer: EZU-PL21: 64 elements 3.5MHz linear probe | EZU-PL21: 64 elements 3.5MHz linear probe |
| Operation Environment: Temperature 5-40° C, relative humidity 30-85% | Temperature 5-40° C, relative humidity 30-85% |
| Storage Environment: Temperature -10-60° C, relative humidity 30-95%, air pressure 700-1060 mB | Temperature -10-60° C, relative humidity 30-95%, air pressure 700-1060 mB |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For ultrasound systems demonstrating substantial equivalence rather than a new clinical claim, extensive clinical "test sets" in the way an AI/software device would have them are typically not required unless there are significant changes in technology or intended use that could affect safety or effectiveness. The comparison is primarily based on technical specifications.
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)
This information is not provided. This type of detail is usually part of a clinical validation study for devices requiring human interpretation, which is not the primary focus of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As above, this is relevant for clinical validation studies involving human interpretation.
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
An MRMC comparative effectiveness study was not done, nor is it applicable here. This document is for a diagnostic ultrasound system, not an AI-assisted interpretation device. The purpose is to show the device is substantially equivalent to an existing ultrasound system, not to show improved human reader performance with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a diagnostic ultrasound system, not an AI algorithm for standalone performance. Its performance is inherent in its imaging capabilities and technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in the context of clinical studies (e.g., for AI devices) is not applicable to this 510(k) submission. The comparison is based on technical specifications and safety standards of the device itself relative to a predicate.
8. The sample size for the training set
This information is not provided and is not applicable to a traditional medical device 510(k) submission for an ultrasound system, which does not involve machine learning "training sets."
9. How the ground truth for the training set was established
This information is not provided and is not applicable to this type of device submission.
§ 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.