Search Results

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (liver, pancreas and gall bladder), Intraoperative Neurological, Pediatric, Small Organ (breast, testes and thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.

The Aloka SSD-3500 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-3500 transducer can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.

The Aloka Model SSD-3500 Diagnostic Ultrasound System is substantially equivalent to previously cleared predicate devices (Aloka SSD-4000 and SSD-5500). The submission focuses on demonstrating substantial equivalence rather than presenting a performance study with specific acceptance criteria that would typically be seen for novel devices or AI/CAD systems.

Therefore, the "acceptance criteria" for this submission are primarily met by demonstrating similarity in:

• Intended Use: The device is indicated for the same diagnostic ultrasound applications as the predicate devices.
• Technological Characteristics: The device utilizes essentially the same technologies for imaging, Doppler functions, and signal processing.
• Method of Use: The device has the same method of use as the predicate devices.
• Safety Standards: The device complies with acoustic power output levels below FDA maximums, uses patient contact materials evaluated by the same standards, and meets electrical and physical safety standards (NEMA-UD2: 1992, AUM 1994, IEC-60601-1, UL 2601-1, ISO10993-1:1997).

Since this is a substantial equivalence submission for an ultrasound system, not an AI/CADe device, the typical elements of an AI/CADe performance study (test set, ground truth, expert readers, MRMC study, standalone performance) are not applicable or explicitly provided in the document. The "study" proving acceptance criteria is the comparison to predicates and adherence to established safety standards for diagnostic ultrasound equipment.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. This submission is for a diagnostic ultrasound system, not an AI/CADe device that undergoes clinical performance testing with a specific test set of cases. The acceptance is based on substantial equivalence to existing devices and adherence to engineering and safety standards.
• Data Provenance: Not applicable for a separate "test set" in the context of an AI/CADe submission. The data supporting the submission would be from internal testing and comparisons with the predicate devices, not an independent, annotated clinical dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth establishment by experts for a test set is specific to AI/CADe evaluations. This submission primarily relies on comparisons to already cleared devices and adherence to established engineering and safety standards validated through internal testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are used in AI/CADe studies to establish ground truth from multiple expert opinions.

5. 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:

• No. An MRMC comparative effectiveness study is designed to assess the impact of an AI/CADe device on human reader performance. This submission is for a diagnostic ultrasound system and does not involve AI assistance for image interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No. This device is a diagnostic ultrasound system, which inherently involves a human operator to acquire and interpret images. There is no "algorithm only" performance reported in the context of AI/CADe.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable in the context of a clinical performance study using a test set. The validation of the device relies on demonstrating performance within acceptable limits as defined by engineering standards and functional equivalence to predicate devices, rather than a clinical ground truth regarding disease presence. Performance is measured in terms of image quality, acoustic output, and other technical specifications.

8. The sample size for the training set:

• Not applicable. This device is not an AI/CADe system where a "training set" would be used to develop an algorithm.

9. How the ground truth for the training set was established:

• Not applicable for the same reason as above.

Ask a specific question about this device