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The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative (Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.

Device Description

The SSD-3500 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 type keyboard, specialized controls and a display.

AI/ML Overview

Here's an analysis of the provided information regarding the Aloka SSD-3500 Ver. 7.8 Diagnostic Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) premarket notification for a diagnostic ultrasound system. In a 510(k) submission for a device like this, the "acceptance criteria" are generally that the new device (Aloka SSD-3500 Ver. 7.8) demonstrates substantial equivalence to a previously cleared predicate device (Aloka SSD-3500 Ver. 7.0). This means the new device must have the same intended use, similar technological characteristics, and demonstrate similar safety and effectiveness.

Since this is a substantial equivalence claim for an ultrasound system, the acceptance criteria don't typically involve specific performance metrics like sensitivity or specificity in a diagnostic task, but rather confirmation that the device functions as intended and meets relevant safety standards.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as stated in the submission)
Safety:
- Conformance to applicable medical device safety standards (acoustic output, biocompatibility, cleaning & disinfection, electromagnetic compatibility, electrical, mechanical safety).	"The device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards." Additionally, "The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance."
Effectiveness:
- Same intended uses as the predicate device.	"It has the same... intended uses... as the predicate device." The system's intended uses are: Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative (Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, and Neonatal Cephalic applications. (Ophthalmic applications are excluded).
- Similar technological characteristics and basic operating modes as the predicate device.	"The Aloka SSD-3500 Ver. 7.8 is technically comparable and substantially equivalent to the current Aloka SSD-3500 Ver. 7.0 -(K060059). It has the same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate device." The device description mentions it is a "full feature imaging and analysis system" providing acquisition, processing, and display capability through a "computer type keyboard, specialized controls and a display." The specific operating modes (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined) are listed for each transducer and clinical application.
- No new questions of safety or effectiveness are raised compared to the predicate device.	"Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka SSD-3500 Ver. 7.8 Ultrasound System and its transducers are substantially equivalent with respect to safety and effectiveness to its predicate and other currently cleared Aloka systems."

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

The document explicitly states: "2. Clinical Tests: None Required."
Therefore, there is no test set, sample size, or data provenance related to clinical performance testing for this submission. The device's substantial equivalence is based on technical specifications and comparison to a predicate device, not on new clinical performance data from a specific test set.

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

Since no clinical tests were required, there was no test set and therefore no ground truth established by experts for performance evaluation in this submission.

4. Adjudication Method for the Test Set

As there was no clinical test set, no adjudication method was used for establishing ground truth.

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 MRMC comparative effectiveness study was conducted or required for this 510(k) submission. This device is a diagnostic ultrasound system, not an AI-powered diagnostic application that would typically undergo such a study to evaluate human reader improvement with AI assistance.

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

No standalone algorithm performance study was conducted. This device is a conventional diagnostic ultrasound system, not an artificial intelligence algorithm that would typically have a standalone performance evaluation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

As mentioned above, no specific clinical ground truth was established for performance evaluation in this 510(k) submission because clinical testing was not required. The "ground truth" for the submission is the regulatory acceptance of its predicate device (Aloka SSD-3500 Ver. 7.0) and the demonstrated technical equivalence and adherence to safety standards.

8. The Sample Size for the Training Set

Since no AI/machine learning algorithm is part of this submission, there is no training set mentioned or used.

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

Not applicable, as there is no training set for an AI/machine learning algorithm in this submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Aloka SSD-3500 Ver. 7.8 Diagnostic Ultrasound System meets its acceptance criteria is a technical and regulatory comparison study against a legally marketed predicate device, the Aloka SSD-3500 Ver. 7.0 (K060059).

The manufacturer (Aloka Co., Ltd.) provided documentation and analysis demonstrating that the new version is "technically comparable and substantially equivalent" to the predicate. This involved:

Documentation of Shared Characteristics: Confirming that the Aloka SSD-3500 Ver. 7.8 has the "same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes" as the predicate device.
Non-Clinical Testing: The device and its transducers underwent various non-clinical evaluations to confirm compliance with applicable medical device safety standards. These tests covered:
- Acoustic output
- Biocompatibility
- Cleaning & disinfection effectiveness
- Electromagnetic compatibility
- Electrical safety
- Mechanical safety
Quality System Conformance: The manufacturer confirmed that their design, development, and quality processes align with 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems.

The FDA's review of this submission found that "the device is substantially equivalent... to legally marketed predicate devices," thus confirming it meets the regulatory acceptance criteria for market clearance. Clinical testing was not required because the device was demonstrating equivalence to an already approved device and no new questions of safety or effectiveness were raised.

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