(14 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal /Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo- skeletal Conventional, Urology (including prostate), Transesophageal, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic & vascular). The device is not indicated for ophthalmic applications.
The Aloka SSD-Alpha 7 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a video display. This configuration will provide user enhancements and expanded use.
The Aloka SSD-Alpha 7 Diagnostic Ultrasound System is a medical device that received 510(k) clearance (K072285) for various diagnostic ultrasound imaging and fluid flow analysis applications in the human body. As per the provided documents, no specific acceptance criteria or a dedicated clinical study proving the device meets quantitative acceptance criteria were included in this 510(k) submission.
Instead, the submission states:
- "Clinical Tests: None Required. Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination."
- "Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka SSD-Alpha 7 Diagnostic Ultrasound System and its transducers is substantially equivalent with respect to safety and effectiveness to its predicate and other currently cleared Aloka systems."
This indicates that the clearance for the Aloka SSD-Alpha 7 was based on its substantial equivalence to a predicate device (Aloka SSD-Alpha 10 Diagnostic Ultrasound System K043196), not on a new clinical study demonstrating performance against specific acceptance criteria. The focus was on comparing technical characteristics, safety features, physical design, construction, materials, and intended uses to the predicate device.
Therefore, the following information cannot be provided from the given documents:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
- If a standalone performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any test set.
- The sample size for the training set.
- How the ground truth for the training set was established.
Summary of available information regarding compliance and equivalence:
The device's clearance relies on:
- Non-clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, electrical and mechanical safety. These tests found the device to conform with applicable medical device safety standards.
- Substantial Equivalence: The device is considered technically comparable and substantially equivalent to the Aloka SSD-Alpha 10 (K043196) and other cleared Aloka systems. This substantial equivalence is the primary "proof" of its safety and effectiveness under the 510(k) pathway.
- Quality Systems: The design, development, and quality processes conform with 21 CFR 820, ISO 9001:2000, and ISO13485 quality systems.
- Post-clearance requirement: The FDA requested a post-clearance special report containing complete information, including acoustic output measurements based on production line devices, referencing Appendix G of their "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." This ensures ongoing compliance with approved acoustic output levels.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.