(241 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (PWD, CWD), Adult Cephalic (PWD), Peripheral Vascular (CWD).
Not Found
The provided text is a 510(k) clearance letter from the FDA for Rimed Ltd.'s Intra-View and Smart-Lite Transcranial Doppler Devices, along with their respective transducers. The letter primarily focuses on establishing substantial equivalence to previously marketed devices and outlines the intended uses for each transducer based on mode of operation and clinical application.
It's important to note that this document is a regulatory clearance and does not contain details of specific studies, acceptance criteria, or performance metrics in the way a clinical study report would. Instead, it indicates that the device is "substantially equivalent" to legally marketed predicate devices, which implies that the device meets similar safety and effectiveness standards, rather than proving a specific performance against explicit, numerical acceptance criteria within this document.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The document lists the intended uses which define the scope of the device's application, rather than performance metrics.
Based on the provided information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
Cannot be provided directly from the document. The document is a 510(k) clearance letter that states "the device is substantially equivalent" to predicate devices. It does not contain specific performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, etc.) or acceptance criteria that were met, which would typically be found in a detailed validation report. The closest information available is the intended use for each transducer, indicating the modes of operation and clinical applications for which the device is cleared.
Here's a summary of the intended uses for the transducers, which implicitly implies they perform adequately for these applications, but without numerical performance data:
| Clinical Application | Intra-View Transducers (2, 4, 8 MHz) | Smart-Lite Transducers (2, 4, 8 MHz) |
|---|---|---|
| Ophthalmic (PWD) | X (2MHz, 4MHz, 8MHz) | X (2MHz, 4MHz) |
| Ophthalmic (CWD) | X (2MHz, 4MHz, 8MHz) | X (8MHz) |
| Adult Cephalic (PWD) | X (2MHz, 4MHz, 8MHz) | X (2MHz) |
| Peripheral Vascular (CWD) | X (2MHz, 4MHz, 8MHz) | X (8MHz) |
| Peripheral Vascular (PWD) | X (4MHz) |
Note: PWD = Pulsed Wave Doppler, CWD = Continuous Wave Doppler. The tables within the document often use 'X' to mark applicable modes/applications. For the purposes of this table, I am consolidating based on the transducer frequencies listed as being cleared for the system.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Cannot be provided from the document. The 510(k) clearance letter does not include details about specific test sets, sample sizes, or data provenance from any studies conducted by the applicant. This information would typically be part of the detailed submission, not the public clearance letter.
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):
Cannot be provided from the document. The letter makes no mention of expert involvement in establishing ground truth for any test data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Cannot be provided from the document. There is no information regarding adjudication methods.
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:
Cannot be provided from the document. This document predates the widespread regulatory consideration of AI/ML devices in the way described. It does not mention any MRMC studies, human reader improvement with AI assistance, or AI components. The devices are Transcranial Doppler devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Cannot be provided from the document. The devices are physical medical devices (Transcranial Doppler systems with transducers); the concept of a "standalone algorithm" or "human-in-the-loop performance" in the context of AI is not applicable to the information provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Cannot be provided from the document. The document does not describe the methodologies or ground truth used in any studies conducted to support the 510(k) submission.
8. The sample size for the training set:
Cannot be provided from the document. As this is a clearance for a medical device (Transcranial Doppler), not an AI/ML algorithm, the concept of a "training set" in the context of machine learning is not applicable, and no such information is provided.
9. How the ground truth for the training set was established:
Cannot be provided from the document. See the explanation for point 8.
§ 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.