(57 days)
The SSD-5000 Diagnostic Ultrasound System and Transducers be used for diagnostic ultrasound imaging in Cardiac, Gynecological, Neurological, Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological, Abdominal, Gastrointestinal, Trauma, Surgical and Endoscopic applications. The Aloka SSD-5500 is not indicated for ophthalmic applications.
The SSD-5000 makes no changes to the indications for use, the ultrasound generator, transducer(s), controls, or signal processing technologies. There are no new system functions, significant new clinical information provided or significant claims of added effectiveness. In addition, clinical applications/modes of operation provide no new significant interpretation of the predicate device, the SSD-5500.
The provided text is a 510(k) Summary for the Aloka SSD-5000 Diagnostic Ultrasound System. This document primarily focuses on establishing substantial equivalence to a predicate device and outlining the intended uses of various transducers. It does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, data provenance, expert qualifications, adjudication methods, or comparative effectiveness studies of AI.
The tables within the document (from {5} to {28}) list system/transducer models and their intended clinical applications and modes of operation. These tables show whether a particular application/mode is "New" (N), "Previously cleared by FDA" (P), or "Added under Appendix E" (E). This is a description of the device's capabilities and regulatory status, not a report of performance against acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is a summary of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device (SSD-5500) and expanding intended uses of transducers, implying that meeting safety and effectiveness standards comparable to the predicate is the "acceptance criterion" from a regulatory perspective.
- Reported Device Performance: Not reported in terms of specific metrics like sensitivity, specificity, or accuracy. The performance is implied to be equivalent to the predicate device for its stated intended uses.
2. Sample Size Used for the Test Set and Data Provenance
- This information is not provided in the document. The submission is a 510(k) for substantial equivalence, which often relies on comparison to a legally marketed predicate device rather than new clinical outcome studies for performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided in the document.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size of human readers improve with AI vs without AI assistance
- This information is not provided in the document. The device described is a diagnostic ultrasound system, not an AI-powered image analysis tool, making an MRMC study related to "AI vs without AI assistance" irrelevant in this context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- This information is not provided in the document. The device is an ultrasound system, not an algorithm, so this type of study is not applicable.
7. The Type of Ground Truth Used
- This information is not provided in the document.
8. The Sample Size for the Training Set
- This information is not provided in the document.
9. How the Ground Truth for the Training Set was Established
- This information is not provided in the document.
Summary of Device Capabilities (from the tables):
The document details the intended uses for various transducers with the Aloka SSD-5000 Diagnostic Ultrasound System across a wide range of clinical applications. The modes of operation available for these applications include: A (A-mode), B (B-mode), M (M-mode), PWD (Pulsed Wave Doppler), CWD (Continuous Wave Doppler), Color Doppler, Amplitude Doppler, and sometimes Color Velocity Imaging. "Mixed mode operation" is also noted to include combinations like B/M, B/PWD, B/CD, M/CD, and B/CD/PWD, and B/A-SMA.
Clinical Applications for the SSD-5000 System (as listed):
- Cardiac
- Gynecological
- Neurological
- Obstetrical
- Neonatal
- Pediatric
- Perinatal
- Radiological
- Vascular
- Urological
- Abdominal
- Gastrointestinal
- Trauma
- Surgical
- Endoscopic
Note: The system is not indicated for ophthalmic applications.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.