(29 days)
The E-Z scan AB 5500+ ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to mak measurements inside the eye, including the measurement of axial length for determination of IOL power.
The Intended Use of the A_Mode probe for the E-Z scan AB 5500+ ultrasound system is to make measurements inside the eye, including the measurement of axial length for determination of IOL power, and to visualize the eye by means of A-scans.
The intended use of the B-Mode for the E-Z scan AB 5500 is to visualize the interior of the eye by means of ultrasound and to make measurements inside the eye by B-scan ultrasound.
The E-Z Scan AB5500* combines a contact B-scanner used for the visualization by ultrasound of the eye and orbit and an A-scan used for intraocular measurements. The intended use of this system includes the localization and visualization of ophthalmic disorders and measurement of the eye and orbit.
The E-Z Scan AB5500+ is a conventional ophthalmic B-scan system using a motordriven transducer and angle sensor for scanning and a conventional contact A-scan system. The transducer frequency is 10 MHz. It uses a motor-driven 10 MHz transducer with an attached angle encoder. The display is on a video touch screen, also used for controlling the system. The entire device is computer-controlled by an internal microprocessor. The A-scan uses a separate 10 MIIz transducer and its own pulserreceiver.
The provided text describes a 510(k) submission for the Sonomed E-Z Scan AB5500+, an ophthalmic A and B scan system. Here's an analysis of the acceptance criteria and the study information based on the given document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Safety | Determined equivalent to legally marketed predicate device. | Non-clinical tests included ultrasonic emissions tests. Clinical tests were "Not required." |
| Efficacy | Determined equivalent to legally marketed predicate device. | Non-clinical tests included accuracy and validation tests. Clinical tests were "Not required." |
| Intended Use | The device is intended for localization and visualization of ophthalmic disorders and measurement of ocular distances, including axial length for IOL power determination. | This matches the intended use of the predicate devices. |
| Technological Characteristics | The E-Z Scan AB5500+ is a conventional ophthalmic B-scan system using a motor-driven transducer and angle sensor (10 MHz) and a conventional contact A-scan system with a separate 10 MHz transducer. Displays on a video touch screen and is computer-controlled. | This information describes the device's technical specifications and is considered acceptable for demonstrating substantial equivalence to the predicate. |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states "Clinical tests: Not required" for both safety and efficacy. This indicates that no clinical test set was used for this 510(k) submission. The substantial equivalence was based on non-clinical tests (ultrasonic emissions, accuracy, and validation) and comparison to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical test set was used, there is no information on experts establishing ground truth for a test set. Ground truth was not established via expert review of clinical data for this submission.
4. Adjudication Method for the Test Set
As no clinical test set was used, there was no adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was mentioned or performed, as clinical tests were "Not required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an ultrasound system directly operated by a human, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done.
7. The Type of Ground Truth Used
For the safety and efficacy assessment, the ground truth was based on the performance and established safety/efficacy of the legally marketed predicate devices (Sonomed Ophthalmic B-scan B-3000 and Sonomed A-scan A-2000), as well as non-clinical test results (ultrasonic emissions, accuracy, and validation).
8. The Sample Size for the Training Set
There is no mention of a training set in the document. This is common for predicate-based 510(k) submissions for conventional medical devices that do not involve AI/ML algorithms.
9. How the Ground Truth for the Training Set Was Established
As no training set was used, ground truth for a training set was not established.
§ 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.