(36 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 Cephalic, Peripheral Vascular, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic & vascular) applications. The device is not indicated for Ophthalmic applications.
The Aloka Prosound 6 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.
Here's a breakdown of the acceptance criteria and study information for the Aloka Prosound 6 Diagnostic Ultrasound System, based on the provided document:
Acceptance Criteria and Device Performance
The provided 510(k) summary for the Aloka Prosound 6 Diagnostic Ultrasound System does not specify quantitative acceptance criteria or provide specific performance metrics in a table. Instead, it relies on substantial equivalence to a predicate device.
The "reported device performance" is implicitly that it performs as safely and effectively as the predicate device (Aloka SSD-1400 Diagnostic Ultrasound System K972465) for the listed indications for use.
Stated Performance / Equivalence Claims:
- Same Technological Characteristics: The Prosound 6 has the same technological characteristics as the Aloka SSD-1400.
- Key Safety and Effectiveness Features: It possesses the same key safety and effectiveness features as the predicate.
- Physical Design, Construction, Materials: Identical to the predicate device.
- Intended Uses and Basic Operating Modes: Same as the predicate device.
- Conformity to Standards: The device and its transducers "have been found to conform with applicable medical device safety standards" (e.g., for acoustic output, biocompatibility, cleaning & disinfection, EMC, electrical and mechanical safety).
- Quality Systems: Design, development, and quality process conform with 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems.
Study Information
The provided documentation explicitly states:
- Clinical Tests: None Required.
This indicates that no clinical study, in the traditional sense of evaluating device performance against specific clinical endpoints or acceptance criteria with patient data, was performed or presented for this 510(k) submission.
Therefore, the following points, which would typically describe such a clinical study, are not applicable based on the given information:
- Sample size used for the test set and the data provenance: Not applicable, no clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set.
- Adjudication method for the test set: Not applicable, no clinical test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an ultrasound system, not an AI-assisted diagnostic tool, and no clinical study was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an ultrasound system, not an algorithm, and no clinical study was performed.
- The type of ground truth used: Not applicable, no clinical test set.
- The sample size for the training set: Not applicable, as this is a medical device clearance based on substantial equivalence, not an AI model being trained.
- How the ground truth for the training set was established: Not applicable.
Summary of Approach:
The Aloka Prosound 6 Diagnostic Ultrasound System gained clearance through the 510(k) pathway by demonstrating substantial equivalence to an already legally marketed predicate device (Aloka SSD-1400). This regulatory pathway often relies heavily on non-clinical testing (such as engineering and safety assessments) and comparison of technical specifications, rather than new clinical trials to establish safety and effectiveness for well-understood device types like diagnostic ultrasound systems.
§ 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.