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The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

The ECO Series Diagnostic Ultrasound Systems is a very compact and portable diagnostic ultrasound system having five variations: ECO6, ECO5, ECO3, ECO2, and ECO1, each with options and features suited for its market niche. It has an integrated keyboard, LED display and several interchangeable electronic-array transducers and provides digital acquisition, processing and display capability. The user interface includes a keyboard, an intuitive layout of specialized controls, color GUI display.

This device is a Diagnostic Ultrasound System and therefore does not include acceptance criteria, as one would typically find for an AI/ML powered device. The document provided is primarily an FDA 510(k) summary for the "ECO Series Diagnostic Ultrasound System," submitted by Chison Medical Imaging Co., Ltd.

Instead of acceptance criteria and a study to prove performance, this document focuses on substantial equivalence to a predicate device, which is the standard regulatory pathway for many medical devices.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance in the context of an AI/ML device validating specific metrics (e.g., sensitivity, specificity, AUC). Instead, the document states:

• Acceptance Criteria (Implied): Substantial equivalence to the predicate device in terms of safety and effectiveness, and compliance with applicable safety standards.
• Reported Device Performance: The device performs general-purpose ultrasonic imaging and fluid flow analysis. Its capabilities are outlined by the clinical applications and modes of operation available for each transducer.

The device meets its implied acceptance criteria by being shown to be "substantially equivalent in safety and effectiveness to the predicate systems" (GE LOGIQ i, LOGIQ e, and Vivid e Diagnostic Ultrasound (K102256)). The justification for this equivalence includes:

• Transmits ultrasonic energy into patients.
• Performs post-processing of received echoes to generate on-screen display of anatomic structures and fluid flow.
• Has the same intended uses and basic operating modes as the predicate device.
• Allows for specialized measurements of structures and flow, and calculations.
• Has the same gray-scale (presumably imaging capabilities).
• Acoustic output levels are below FDA limits.
• Designed to applicable electrical and physical safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1).

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

Not applicable. This is not a study evaluating an AI/ML algorithm's performance on a test set. This is a premarket notification demonstrating substantial equivalence.

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

Not applicable. No ground truth was established for a test set in the context of an AI/ML algorithm.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication was used.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The document does not describe human reader performance or improvements with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a general-purpose ultrasound system, not an AI/ML algorithm.

7. Type of Ground Truth Used:

Not applicable. There is no ground truth established for an algorithm. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate device.

8. Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the AI/ML sense.

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

Not applicable. No training set or associated ground truth was established.

Summary of the Study (Substantial Equivalence Justification):

The "study" in this context is the comparison to predicate device(s).

• Predicate Device: GE LOGIQ i, LOGIQ e, and Vivid e Diagnostic Ultrasound (K102256).
• Methodology: The manufacturer presented information demonstrating that the ECO Series Diagnostic Ultrasound Systems share fundamental technological characteristics, intended uses, and operational modes with the legally marketed predicate devices. The comparison highlights similarities in how they transmit and process ultrasonic energy, display anatomical structures and fluid flow, and perform measurements and calculations. The manufacturer also asserts compliance with relevant safety standards and FDA acoustic output limits.
• Conclusion: Based on this comparison, the FDA determined that the ECO Series Models are "substantially equivalent in safety and effectiveness to the predicate systems." This allows the device to be marketed without requiring a more extensive premarket approval (PMA) pathway.

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