(37 days)
To acquire and display high resolution images of the anterior segment of the eye.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (B-Mode)
The Model P60 UBM is a PC-based digital instrument that utilizes ultrasonic energy to generate various images of the eye. The pulser circuitry is designed to accept information from the user via a graphical user interface provided by the software. The pulser generates signals specific to the probe installed. The signal acquired from the transducer is translated into an image that is displayed on an LCD monitor.
The provided text describes a 510(k) Premarket Notification for the Paradigm Medical Model P60 UBM Ultrasonic Bio-Microscope. The information primarily focuses on the device's technical specifications, intended use, and substantial equivalence to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria.
Therefore, it's not possible to populate all the requested fields as a clinical study with detailed performance metrics, ground truth establishment, or expert adjudication as typically seen for AI/ML devices is not present in this document.
However, based on the available information, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets applicable safety requirements | "meets the applicable requirements of IEC60601-1." |
| Display high-resolution images of the anterior segment of the eye (Implied by Intended Use) | Device is designed to "acquire and display high resolution images of the anterior segment of the eye." |
| Functioning as an Ultrasound System | Substantially equivalent to predicate device, implied to function similarly. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The document describes a technical safety compliance and substantial equivalence claim, not a clinical performance study with a test set of patient data.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no mention of establishing ground truth with experts for a test set in a clinical performance study.
4. Adjudication method for the test set
- Not applicable. No adjudication method is mentioned as there's no clinical test set being evaluated for performance against a ground truth.
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. This device is an ultrasonic bio-microscope, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device; no algorithm-only performance study would be relevant.
7. The type of ground truth used
- Not applicable in the context of clinical performance data. The "ground truth" for this submission appears to be regulatory standards (IEC60601-1) and the performance characteristics of a legally marketed predicate device (Paradigm Medical Model P45 Ultrasonic Bio-Microscope) for establishing substantial equivalence.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.