(396 days)
LIGHTSonic B | UBM is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for measurements inside the ocular structures including orbital, anterior and posterior segment of eye.
The LIGHTMED Ultrasound System is a portable ultrasound biometric ruler intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth. The device is used by coupling the probe / transducer to the eye either through direct contact or immersion methods. Available modes are biometric B-scan and UBM. The B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior-chamber of the eye, particularly when view of the chamber is obscured, such as is the case with cataracts. The UBM mode can be used with a 35 MHz or a 50 MHz transducer. Because of the higher frequency of the transducer, it is expected that its greatest field of application will be in visualizing the anterior segment, because the focus area is about 11 mm from the transducer plane. The system will visualize other parts of the eye, but the resolution is not as high. LIGHTMED Ultrasound System is a stand-alone system that runs on a Windows 10 platform and may be networked (by the user) for interface with electronic medical records systems, printing, and other purposes. The system consists of the LIGHTSonic B|UBM console, ultrasound probe(s) and transducer, and foot pedal.
This document is a 510(k) summary for the LIGHTMED Ultrasound System (LIGHTSonic B | UBM). It focuses on establishing substantial equivalence to a predicate device and does not contain information about the performance criteria or a study proving the device meets acceptance criteria related to a specific clinical task or AI algorithm.
Therefore, I cannot provide the requested information, which typically pertains to the evaluation of an AI/ML-driven medical device. The document primarily details hardware specifications, software validation for general device function (not AI-specific), and safety/EMC standards compliance.
Based on the provided text, here's what I can determine regarding the device validation:
- Acceptance Criteria and Reported Device Performance: This information is not present in the document. The document primarily focuses on establishing substantial equivalence to a predicate device based on technical characteristics, rather than reporting on specific performance metrics against defined acceptance criteria for a clinical task.
- Sample size and data provenance for test set: Not applicable and not provided. The document does not describe a clinical performance study using a test set of patient data to evaluate a measurement or diagnostic outcome.
- Number of experts used to establish ground truth and qualifications: Not applicable and not provided. There is no mention of a ground truth established by experts for a clinical evaluation.
- Adjudication method: Not applicable and not provided.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable and not provided. The document does not describe a study involving human readers or AI assistance.
- Standalone (algorithm-only) performance: Not applicable and not provided. The document describes an ultrasound system, not an AI algorithm evaluated in standalone mode.
- Type of ground truth used: Not applicable and not provided.
- Sample size for the training set: Not applicable and not provided. The document does not describe the development or training of an AI algorithm.
- How the ground truth for the training set was established: Not applicable and not provided.
Summary of what the document does provide regarding validation:
The document focuses on the following types of performance data and compliance:
- Biocompatibility testing: Conducted on patient contact components (B-scan and UBM probes) for cytotoxicity, sensitization, and irritation, in accordance with ISO 10993-1, 10993-5, and 10993-10 regulations. The contact duration is "A-limited."
- Electrical safety and electromagnetic compatibility (EMC) testing: The device complies with AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, ISO 14971, and IEC 62366.
- Software verification and validation testing: Performed according to FDA guidance, with the device software considered a "Moderate Level of Concern."
- Measurement accuracy: The document states that "LIGHTMED Ultrasound System has been validated and is safe and effective for the functions described in the indications for use," but no specific metrics or studies for measurement accuracy are provided in this section. This statement is a general conclusion rather than detailed performance data.
In conclusion, the provided text describes regulatory compliance and safety testing for a medical device (an ultrasound system), but it does not detail the acceptance criteria or a clinical study proving the device meets specific performance criteria related to a diagnostic or measurement outcome in the way an AI/ML device submission would.
§ 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.