(15 days)
The instrument is used for imaging the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye.
The B-Scan Plus device is designed as an ultrasound B- Scan which uses pulsed echo ultrasound to image the internal structure of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides graphic display of returning pulse echoes to image these structures.
Here's a breakdown of the acceptance criteria and study information for the B-Scan Plus device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, resolution). Instead, the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Advent A/B System K960765).
The device performance is described functionally rather than parametrically.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Ability to image internal structure of the eye using pulsed echo ultrasound. | "The B-Scan Plus device is designed as an ultrasound B-Scan which uses pulsed echo ultrasound to image the internal structure of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides graphic display of returning pulse echoes to image these structures." |
| Functional equivalence to predicate device (Advent A/B System K960765). | The FDA determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies it meets the same functional and safety performance expectations. |
| Intended Use: Diagnosing pathological or traumatic conditions in the eye. | "The instrument is used for imaging the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided 510(k) summary does not contain information about experts used to establish ground truth or their qualifications. As there's no mention of a clinical test set in this document, this information would not be present.
4. Adjudication Method for the Test Set
The provided 510(k) summary does not contain information about an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided 510(k) summary does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study would typically be conducted to evaluate the impact of an AI-assisted device on human reader performance, which doesn't seem to be the focus of this 510(k).
6. Standalone (Algorithm Only) Performance Study
The provided 510(k) summary does not describe a standalone (algorithm only) performance study. The device is a B-Scan ultrasound system, which inherently involves human operation and interpretation of images. The concept of a "standalone algorithm" doesn't directly apply in the same way as it would for, say, an AI-powered image analysis software.
7. Type of Ground Truth Used
Given the lack of a detailed performance study in the document, there's no explicit mention of the type of ground truth used. For a B-scan ultrasound system, ground truth in clinical validation would typically involve:
- Clinical Diagnosis: Based on a combination of patient history, physical examination, and other imaging modalities (e.g., MRI, CT, other specialized ophthalmic tests).
- Surgical Confirmation: If pathology is surgically removed.
- Histopathology: Microscopic examination of tissue samples.
- Expert Consensus: Agreement among multiple, highly qualified clinicians (ophthalmologists) on the diagnosis based on the full clinical picture.
8. Sample Size for the Training Set
The provided 510(k) summary does not mention a training set or its sample size. The B-Scan Plus is a traditional medical imaging device, not an AI/ML-driven device that typically requires a discrete training set in the same manner.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.
Summary of Study Information Gaps:
It's important to note that the provided document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data with detailed performance metrics. For devices like the B-Scan Plus, the primary means of demonstrating safety and effectiveness relied on showing that its technological characteristics and indications for use were similar to a legally marketed predicate device, and that any differences did not raise new questions of safety or effectiveness. Therefore, many of the detailed study parameters typically associated with AI/ML device submissions are not present here.
§ 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.