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The Aloka SSD-5500, like other marketed diagnostic ultrasound systems, is indicated for imaging body structures and flowing blood to aid in the diagnosis of disease or abnormality.
The subject Aloka SSD-5500 is an all-digital diagnostic ultrasonic scanner with a digital beamformer supporting grav scale, spectral Doppler and Color Flow imaging. Depending on the probe, the Aloka SSD-5500 may be used for diagnostic ultrasound imaging in Cardiac, Gynecological, Neurological, Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological, Trauma and Surgical applications.
The Aloka SSD-5500 is not indicated for ophthalmic applications and there are no other contraindication known.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: N= new indication; P= previously cleared by FDA; E= added under Appendix E

The Aloka SSD-5500 diagnostic ultrasound system. The SSD-5500 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 processed into two-dimensional images. The reflected ultrasound energy is also processed using Doppler principals and displays moving blood as a spectrum or as a color-coded real time two-dimensional image. The Aloka SSD-5500 diagnostic ultrasound system with gray-scale, spectral Doppler and color flow mapping imaging modes is similar in technological characteristics to ultrasound systems marketed by Aloka and others. The subject Aloka SSD-5500 is an all-digital diagnostic ultrasonic scanner with a digital beamformer supporting grav scale, spectral Doppler and Color Flow imaging.

This is a 510(k) premarket notification for the Aloka SSD-5500 diagnostic ultrasound system. This document asserts substantial equivalence to previously marketed diagnostic ultrasound systems and does not contain detailed performance study data against specific acceptance criteria in the manner that would be expected for a novel AI/CAD device.

The information provided describes the device's intended use and technological characteristics compared to predicate devices, and indicates compliance with general safety and performance standards relevant to diagnostic ultrasound equipment at the time of submission (1999).

Therefore, many of the specific details requested regarding acceptance criteria, study methodologies, and performance metrics for AI/CAD devices are not present in this type of submission.

Here's a breakdown based on the provided text, indicating which information is available and which is not:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document in the format of specific acceptance criteria and detailed device performance metrics. The submission focuses on demonstrating substantial equivalence to existing ultrasound systems regarding functionality, indications for use, and compliance with general safety standards rather than quantitative performance against predefined acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to this type of submission. The device is a traditional diagnostic ultrasound system, not an AI/CAD system evaluated on a specific test set of images or data. Performance is implied through comparison to predicate devices and adherence to general safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is a diagnostic imaging system, not an AI/CAD system requiring ground truth established by experts for performance evaluation.

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

This information is not applicable.

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

This information is not applicable. The device is a standalone ultrasound system, not an AI-assisted reading device.

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

This information is not applicable. The device is a diagnostic ultrasound system, not an algorithm being evaluated in a standalone manner.

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

This information is not applicable.

8. The sample size for the training set

This information is not applicable as this is not an AI/CAD device.

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

This information is not applicable as this is not an AI/CAD device.

Summary of available information from the document:

• Acceptance Criteria (Implied): The acceptance criteria are broadly focused on demonstrating substantial equivalence to predicate diagnostic ultrasound systems in terms of:
  • Same diagnostic ultrasound applications.
  • Same gray-scale, spectral Doppler, and Color Flow Mapping abilities.
  • Similar technologies for imaging and signal processing.
  • Same method of use.
  • Acoustic power output levels below maximum allowed by FDA.
  • Compliance with Quality Assurance systems in development and production.
  • Patient contact materials are safe.
  • Compliance with electrical and physical safety standards.
  • Maximum thermal index below 6.0.
  • Compliance with "Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment".
• Study Proving Device Meets Criteria: The entire 510(k) submission serves as the "study." It demonstrates that the Aloka SSD-5500 meets the implied acceptance criteria by asserting its technological characteristics and intended uses are substantially equivalent to legally marketed predicate devices. The document explicitly states:
  • "The Aloka SSD-5500 is substantially equivalent to several previously marketed diagnostic ultrasound systems such as the Aloka SSD-2000. Aloka SSD-1700. Toshiba Power Vision, H.P. Sonos 5500, Vingmed (G.E.) System V and ATL HDI-5000"
  • The submission outlines how the SSD-5500 functions in the same manner, shares similar capabilities, uses similar technologies, and adheres to the same safety standards as these predicate devices.
  • Specific "Indications for Use Forms" for the main system (SSD-2500, likely a typo for SSD-5500) and various transducers (UST-5268P-5, UST-5286-2.5, UST-5536-7.5, UST-5539-7.5, UST-5713T, UST-672-5/7.5, UST-675P, UST-9118, UST-9119, UST-987-7.5, UST-995-7.5) confirm the range of clinical applications where the device is considered safe and effective, aligning with the indications of predicate devices.
• Post-Clearance Requirement: A special report including acoustic output measurements based on production line devices was required to be submitted after clearance but prior to first customer shipment, indicating ongoing verification of safety specifications. This is a form of post-market acceptance criterion verification.

In essence, for a traditional diagnostic ultrasound system like the Aloka SSD-5500 in a 510(k) submission from 1999, the "acceptance criteria" and "study" are intrinsically linked to demonstrating equivalence to predicate devices and adherence to established regulatory and safety standards for the class of device. There are no performance metrics in the context of AI/CAD or specific test set evaluations.

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