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Diagnostic Ultrasound imaging and Doppler analysis of the human body as follows: Fetal, Abdominal, Intra-Operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Transrectal, Transvaginal, Peripheral Vessel, Laparoscopic. Combined Modes: B/M, B/PWD.

The Aloka SSD-1400 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 an image. The Aloka SSD-1400 can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.

This document is a 510(k) summary for the Aloka SSD-1400 diagnostic ultrasound system and associated transducers, submitted in 1997. It explicitly states that the device is "substantially equivalent" to previously cleared devices (Aloka SSD-1700 and Aloka Omniview) and functions in the same manner. This means that the regulatory approval is based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical performance studies against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in this document as it pertains to performance studies that are typically required for novel devices or those that cannot demonstrate substantial equivalence to a predicate.

The document focuses on demonstrating substantial equivalence through:

• Identical intended use (imaging body structures to aid in diagnosis).
• Similar technological characteristics (gray-scale and Doppler abilities, imaging/Doppler functions, signal processing).
• Same method of use.
• Compliance with FDA acoustic power output levels.
• Application of the same Quality Assurance systems.
• Evaluated and safe patient contact materials.
• Compliance with electrical and physical safety standards.

However, to answer as much as possible based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria for device performance in the way a clinical study would for a novel device. Instead, the acceptance criterion for regulatory clearance is "substantial equivalence" to existing predicate devices (Aloka SSD-1700 and Aloka Omniview).

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. No dedicated "test set" in the context of a clinical performance study with patient data is mentioned or implied for this 510(k) submission. The equivalence is based on engineering characteristics and prior regulatory clearances.
• Data Provenance: Not applicable. No new clinical performance data is presented, so there is no country of origin or retrospective/prospective designation for such data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. No ground truth establishment by experts for a test set is described.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This document does not describe an MRMC comparative effectiveness study. The approval is based on substantial equivalence, not on demonstrating improved human reader performance with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: No. This device is a diagnostic ultrasound system, not an AI algorithm. Its performance is intrinsically tied to human operation and interpretation.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. No clinical ground truth (e.g., pathology, outcomes data, or expert consensus) for a performance study is described in this 510(k) submission. The regulatory pathway relies on demonstrating equivalent technical specifications and operational safety to predicate devices.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document is for a traditional diagnostic ultrasound system, not a device incorporating a machine learning algorithm that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable. As there is no mention of a training set or machine learning components, the concept of establishing ground truth for such a set is not relevant to this submission.

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