(18 days)
The Digi-Lite TCD device is intended for use in the non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children. It is not intended for fetal use. It is not intended for neonatal use.
The Rimed Transcranial Doppler Systems are based on a PC platform system running under Microsoft Windows XP embedded. The product includes a Pentium M or equivalent processor, minimum 60 Gbyte hard disk, USB, RS232, LAN 10/100 RJ-45 network connection, a PC keyboard, mouse, touch screen of 15" TFT color SVGA that provides 1024 x 768 points graphic resolution. In addition to the main PC card, the system hardware contains one Doppler Card that transmits the ultrasound power, translates the received signals to Doppler shift frequencies, and provides the required signal processing functionality. This card contains analog and digital circuits, a FPGA chip for timing and basic hardware digital signal processing, and a DSP chip for performing general control and digital signal processing algorithms. The complete system contains one Doppler card, two 2 MHz probes, a 1 MHz probe, a 4 MHz probe, and an 8 MHz probe. In addition, a Remote Control unit, printer and Foot Switch can be used.
The provided document focuses on the 510(k) premarket notification for the Digi-Lite TCD device and largely attests to its substantial equivalence to a predicate device. It does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, accuracy against a ground truth).
Instead, the "Performance Testing" section (Page 2, Section 7) describes general categories of testing performed to ensure the device meets its specifications and is safe and effective. The conclusion states that "Testing results for all validation tests, demonstrated that the Digi-Lite™ device performs according to its specifications." However, no specific quantitative or qualitative acceptance criteria are provided, nor are the detailed results of these tests.
Therefore, many of the requested details about a study proving the device meets acceptance criteria cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, a table of specific, quantifiable acceptance criteria and reported device performance values cannot be constructed. The document states:
"Testing results for all validation tests, demonstrated that the Digi-Lite™ device performs according to its specifications." (Page 2, Section 7)
However, the "specifications" themselves, or the acceptance criteria for the mentioned tests (Acoustic output testing, Clinical measurement accuracy, Doppler sensitivity testing, Estimate of temperature rise), are not detailed. Therefore, specific metrics like sensitivity, specificity, or accuracy are not present.
2. Sample size 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 document. The performance testing described is largely "bench testing" (Page 2, Section 7.C), implying laboratory-based evaluations rather than extensive clinical studies with human subjects.
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. Given the nature of the described "performance testing - bench," it's unlikely that expert-established ground truth on clinical data was a primary component.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided.
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
This device (Digi-Lite TCD Device) is a TransCranial Doppler (TCD) system used for non-invasive evaluation of vascular flow. It acts as a diagnostic tool rather than an AI-assisted interpretation system for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and not mentioned in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone diagnostic instrument. The performance testing described (Page 2, Section 7) is for the device's inherent performance. While not explicitly termed "standalone algorithm performance" (as it's hardware/software combined), the bench testing assesses the device's technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For "Acoustic output testing," "Clinical measurement accuracy," "Doppler sensitivity testing," and "Estimate of temperature rise," the ground truth would likely refer to established physics principles, calibrated measurement devices, and known standards for ultrasonic performance rather than clinical ground truth like pathology or outcomes data. The document does not specify these "ground truths."
8. The sample size for the training set
This is not applicable and not provided. The document describes a medical device rather than an AI/ML system requiring a training set in the typical sense.
9. How the ground truth for the training set was established
This is not applicable and not provided.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.