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The UBM Plus is designed for imaging the internal structure of the eye including opaque media and anterior segment pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye.

The UBM Plus device is designed as a high frequency ultrasound B-Scan, which uses pulsed echo ultrasound to image the anterior segment of the eye. It utilizes a noncontact probe via a contact Scleral shell to generate and receive the ultrasound pulses, and provides a graphic display of returning pulse echoes to indicate the various structures.

The UBM Plus device's performance data and acceptance criteria are outlined in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the accuracy of the UBM Plus is "less than 1%, well within acceptable limits," which allows for the inference of "<1%" as both the acceptance criteria and the reported performance. The "30mm" for each category appears to indicate the range over which the accuracy was tested.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Accuracy Testing (using a Gammex Lesion Phantom and a proprietary measurement phantom)".

• Sample Size: The specific sample size (number of measurements or phantoms) for the accuracy testing is not explicitly stated.
• Data Provenance: The testing was conducted using phantoms, which are artificial devices designed to simulate biological tissue properties for testing purposes. Therefore, the data is from non-clinical phantom testing, not from human subjects. The country of origin for this testing is not specified but is presumably where Accutome, Inc. (Malvern, PA, USA) or its associated testing facilities operate.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Ground truth for phantom testing is typically established by the inherent design and known physical properties of the phantom itself, rather than by human experts interpreting clinical images. The document does not mention any experts being used to establish ground truth for the phantom testing.

4. Adjudication Method for the Test Set:

Not applicable, as ground truth was established by the known properties of the phantoms, not through human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states that "Since the UBM Plus uses the same technology as existing devices, clinical tests are not required." This implies that no human reader studies, assisted or unassisted, were performed for this 510(k) submission.

6. Standalone (Algorithm Only) Performance:

The "Accuracy Testing" using phantoms represents the standalone performance of the device in terms of its ability to accurately measure lines, areas, and angles. The results (<1% accuracy) are provided, indicating how well the device, on its own (without human interpretation directly affecting the measurement, beyond operating the device), performs these functions.

7. Type of Ground Truth Used:

The ground truth used for the accuracy testing was based on the known physical dimensions and properties of a Gammex Lesion Phantom and a proprietary measurement phantom.

8. Sample Size for the Training Set:

The document does not mention a training set for an algorithm. The UBM Plus is described as an ultrasound imaging system that provides measurements, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a training set or an AI/machine learning algorithm requiring one.

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