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Diagnostic Ultrasound imaging of the human body as follows: Fetal, Abdominal, Intra-Operative, Intra-Operative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Transrectal, Transvaginal, Musculo-Skeletal Conventional, Peripheral Vessel, Laparoscopic.

Device Description

The Aloka SSD-900 diagnostic ultrasound system. The SSD-900 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 slice images.

AI/ML Overview

This 510(k) summary for the Aloka SSD-900 diagnostic ultrasound system and its associated transducers (K983879) primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing performance against specific acceptance criteria through clinical studies.

Therefore, the document does not contain the detailed clinical study information typically found for devices requiring performance metrics, ground truth establishment, or human-AI comparison. Instead, the "study" is a comparison to predicate devices, asserting similar technological characteristics, indications for use, gray-scale abilities, signal processing, method of use, acoustic power output, and safety standards.

Here's an attempt to structure the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or inferential due to the nature of a 510(k) substantial equivalence submission for an ultrasound system:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence of a diagnostic ultrasound system (Aloka SSD-900) and its transducers, the "acceptance criteria" are not defined as specific quantitative performance metrics from a clinical study. Instead, the acceptance criteria are met by demonstrating the device is substantially equivalent to predicate devices in terms of:

Acceptance Criterion (Implicit in Substantial Equivalence)	Reported Device Performance (as stated in 510(k) Summary)
Intended Use: Same indications as predicate devices.	"The SSD-900 is indicated for the same diagnostic ultrasound applications as other products currently marketed by Aloka and others." Also, specific Indications for Use tables are provided for the system and each transducer, confirming various clinical applications (e.g., Fetal, Abdominal, Small Organ, Cardiac, Transrectal, Intra-Operative, etc.) and modes of operation (B-mode, M-mode, A-mode, PWD, CWD, Color Doppler, Amplitude Doppler, CVI, Combined).
Technological Characteristics: Similar to predicate devices.	"The SSD-900 uses essentially the same technologies for imaging and signal processing as other products currently marketed by Aloka and others."
Gray-scale Abilities: Equivalent to predicate devices.	"The SSD-900 has the same gray-scale abilities as other products currently offered by Aloka and others."
Method of Use: Similar to predicate devices.	"The SSD-900 has the same method of use as other products currently marketed by Aloka and others."
Acoustic Power Output: Below FDA maximum levels.	"The SSD-900 acoustic power output levels are below the maximum levels allowed by the FDA." (Requires post-clearance special report).
Quality Assurance: Subject to the same QA systems.	"The SSD-900 is subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka."
Patient Contact Materials: Safe for application.	"The patient contact materials used in the probes for the SSD-900 have been evaluated and found to be safe for this application."
Safety Standards: Complies with electrical and physical safety.	"The SSD-900 complies with the same electrical and physical safety standards as other products currently marketed by Aloka."

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

Sample Size for Test Set: Not applicable. This submission does not describe a clinical performance study with a dedicated "test set" in the context of algorithm evaluation. The "test" is the comparison against predicate devices and adherence to safety standards.
Data Provenance: Not applicable for a traditional clinical study test set. The submission relies on existing knowledge of predicate devices and general standards.

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

Number of Experts: Not applicable. No "ground truth" establishment by experts on a test set is described for performance evaluation. The "ground truth" for substantial equivalence is regulatory compliance and comparison to legally marketed devices.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no described test set requiring expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No, an MRMC comparative effectiveness study was not done. The Aloka SSD-900 is a diagnostic ultrasound system from 1999, and the concept of AI assistance in diagnostic imaging, especially for regulatory submissions, was nascent or non-existent at that time for such devices.
Effect Size: Not applicable.

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

Standalone Performance Study: No, this device is an ultrasound system, not an AI algorithm. Its performance is inherent in its imaging capabilities assisted by a human operator, not a standalone AI function.

7. The Type of Ground Truth Used

Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" is primarily regulatory compliance, technical specifications, and the established safety and effectiveness of predicate devices. The submission asserts the new device meets current safety standards (e.g., FDA acoustic power limits, electrical safety) and functions equivalently to already cleared devices.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This document pertains to an ultrasound hardware system, not an AI algorithm requiring a training set.

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

Ground Truth Establishment for Training Set: Not applicable.

In summary: This 510(k) submission demonstrates substantial equivalence for the Aloka SSD-900 diagnostic ultrasound system. It is a traditional medical device submission based on comparison to predicate devices and adherence to relevant safety and performance standards for ultrasound equipment, rather than a submission for an AI-powered device requiring clinical studies with specific performance metrics and ground truth establishment against expert consensus or pathology.

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