(165 days)
To measure dimensions of components of the human eye. To provide tomographic, high-resolution ultrasound images of the anterior portion of the eye. It is also designed to measure these tissues and structures, such as anterior chamber depth, angle to-angle width and sulcus-to-sulcus width. Measurement also may be made of pathologic structures such as solid masses or cysts and it therefore is useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma and hypotony.
The technological characteristics of this device are the same as those for the predicate device except for the models of some of the components, and the method by which the arc-scanning motion is achieved. The materials from which the patient-contact portions of the device are made are the same as in the predicate device. The acoustic output of this device is similar to that of predicate devices and well below the preamendment levels described in the guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."
The provided text is a 510(k) summary for the Artemis™ VHF Ultrasonic Arc-Scan System, an ultrasound bio microscope. It largely focuses on establishing substantial equivalence to a predicate device based on intended use, technological characteristics, materials, and acoustic output. The document does not contain information about specific acceptance criteria or a study proving the device meets them in terms of performance metrics like accuracy, sensitivity, or specificity.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
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Table of acceptance criteria and reported device performance: This information is not present. The document focuses on regulatory equivalence rather than performance metrics.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned. Since no performance study is detailed, there's no test set described.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No ground truth establishment is described for a performance study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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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: Not mentioned. The device is a diagnostic imaging system, and the document doesn't discuss AI assistance or human reader performance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. The document describes an ultrasound system, not an algorithm, and doesn't detail any standalone performance testing.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
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The sample size for the training set: Not applicable. This is a 510(k) for a physical medical device, not an AI/ML algorithm that typically has a training set.
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How the ground truth for the training set was established: Not applicable.
Summary of what the document does state related to capability:
The device's intended use is described as:
- To produce high-resolution ultrasound images of the anterior portion of the eye.
- To measure these tissues such as the thickness of the cornea and its individual layers, the epithelium stroma and surgically induced surfaces.
- To measure pathologic structures such as solid masses or cysts.
- To provide tomographic, high-resolution ultrasound images of the anterior portion of the eye.
- To measure tissues and structures, such as anterior chamber depth, angle-to-angle width, and sulcus-to-sulcus width.
- Measurement also may be made of pathologic structures such as solid masses or cysts, making it useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma, and hypotony.
The basis for clearance is substantial equivalence to an existing predicate device (Artemis™ VHF Ultrasonic Arc-scan System cleared in K003890), not a de novo performance study demonstrating achievement of specific acceptance criteria. The review states that the devices have the same intended use and similar technological characteristics, materials, and acoustic output. The FDA also requested a post-clearance special report containing acoustic output measurements based on production line devices.
§ 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.