(12 days)
The POD B-Scan is intended to be used for visualization by ultrasound of the eye and orbit by A-scan and B-scan.
The POD B-Scan System is a multi-purpose computer-based ultrasound diagnostic system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye.
The POD B-Scan is intended to be used for visualization by ultrasound of the eve and orbit by A-scan and B-scan.
The system is PC-based, and can be used with 35 MHz or 50MHz transducers. Because of the higher frequency of the transducers, 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 can visualize other parts of the eye.
Summary of the reaconventional ophthalmic A and B-scan system using a motor-driven transducer and angle sensor for scanning. The A-scan is derived from the B-scan. There is a choice of transducer frequency of 35 MHz or 50 MHz. It uses a motor-driven 10 MHz transducer with an attached angle encoder. The system is PC-based, and the display is on the computer screen.
The provided 510(k) summary for the POD B-Scan ophthalmic ultrasound system (K090884) describes a device seeking clearance based on substantial equivalence to a predicate device. However, it does not present specific acceptance criteria or a detailed study proving the device meets such criteria in terms of clinical performance or diagnostic accuracy.
The summary focuses on:
- Device Description and Intended Use: Visualization of the eye and orbit by A-scan and B-scan, with a focus on the anterior segment due to high-frequency transducers (35 MHz or 50 MHz).
- Technical Characteristics: Conventional ophthalmic A and B-scan system with a motor-driven transducer and angle sensor, PC-based display.
- Testing: Only broadly states "Testing included required ultrasound tests, as well as electrical safety and electromagnetic compatibility tests." This refers to performance and safety standards, not clinical diagnostic accuracy.
- Conclusion: Claims equivalence in safety and efficacy to the predicate device (VuMax High Resolution Ultrasound System, K060626), but does not provide details of how this efficacy was specifically demonstrated.
Given the information provided, here's a breakdown of the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
Accurately filling this table is not possible with the provided document. The 510(k) summary for K090884 does not explicitly state acceptance criteria or report specific performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity, agreement with ground truth for specific pathologies). Instead, it relies on substantial equivalence to a predicate device for safety and efficacy. The "Testing" section broadly mentions "required ultrasound tests," which likely refers to engineering performance, safety (electrical, EMC), and acoustic output parameters, rather than clinical diagnostic performance metrics.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
| Not specified in document | Not specified in document |
| Not specified in document | Not specified in document |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify any clinical test set or data provenance for evaluating diagnostic performance. The testing mentioned is for electrical safety and electromagnetic compatibility, which typically does not involve patient data or test sets for diagnostic accuracy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Since no clinical test set for diagnostic performance is described, there is no mention of experts or ground truth establishment for such a set.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set is described, therefore no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe a MRMC comparative effectiveness study, or any study comparing human readers with or without AI assistance. The device is an ultrasound imaging system, not an AI-driven diagnostic interpretation tool in the context of this submission.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
No. The device is an ultrasound diagnostic system, meaning it generates images for human interpretation. There is no mention of an algorithm performing diagnoses independently.
7. Type of Ground Truth Used
Not applicable for clinical diagnostic performance. The document focuses on showing substantial equivalence based on technical characteristics, safety, and operational performance, not on direct clinical diagnostic accuracy against a defined ground truth like pathology or outcome data.
8. Sample Size for the Training Set
Not applicable. This device is an ultrasound imaging system, and the submission does not describe it as an AI/ML-driven diagnostic algorithm that would typically have a "training set" in the machine learning sense. The "training" for such a device would be its engineering design and calibration, not a data-driven training set for an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As a training set for an AI/ML model is not described, the establishment of ground truth for such a set is also not discussed.
§ 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.