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The Scanmate Flex is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The Scanmate Flex is intended for the examination of adult patients.

The Scanmate Flex is a diagnostic ultrasound system that allows eyecare professionals to visualize and measure internal structures of the eye. The technology is based on ultrasonic pulse echo technology, whereby short bursts of ultrasonic energy are transmitted and the resulting echoes are captured, amplified, filtered and processed. The timing of the echoes is analyzed and converted into distance information (when the A-Scan probe is used) or images (when the B-Scan and UBM probes are used). The distance information and images are displayed on a PC screen. The Scanmate Flex consists of an interface module (which is connected to a standard Windows PC, not included with the Scanmate Flex system) and one or more optional ultrasound probes.

The provided text describes the DGH Technology Scanmate Flex, an ophthalmic ultrasound system. However, the document does not contain a detailed study with acceptance criteria and reported device performance in the format requested, specifically for an AI-based system. The information focuses on regulatory approval (510(k) submission) based on substantial equivalence to predicate devices, rather than a prospective study demonstrating specific performance metrics against an acceptance threshold for an AI component.

Here's what can be extracted based on the provided text, while also highlighting what is NOT present:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided document in a quantitative manner for specific performance metrics (like sensitivity, specificity, accuracy). The document focuses on demonstrating substantial equivalence to predicate devices and adherence to medical device standards.
• Reported Device Performance:
  • Acoustic Output: Verified by Acertara Acoustic Laboratories and Sonora Medical Systems. (No specific numerical values or acceptance criteria for acoustic output are provided).
  • Measurement Performance: Verified using precision test blocks and monofilament phantoms. (No specific numerical accuracy, precision, or acceptance criteria are provided).
  • Thermal, Mechanical, and Electrical Performance: Conforms to a list of specified standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD-3 2004). (Compliance with standards is stated, not specific performance values against internal acceptance criteria).
  • Biocompatibility Testing: Patient-contacting materials were found to be biocompatible. (Statement of outcome, not specific performance data against acceptance criteria).
  • Software Verification and Validation Testing: Verified and validated in accordance with internally developed test plans. (Statement of process, not specific performance results).

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

• This information is not provided in the document. The document describes verification and validation using test phantoms and standard-based testing, not clinical data sets with sample sizes or provenance.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This information is not provided as the testing described does not involve expert-established ground truth in a clinical context. Verification was done using physical phantoms and adherence to engineering standards.

4. Adjudication Method for the Test Set:

• This information is not provided as there is no clinical test set adjudication described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done according to the provided text. The device is an ultrasound system for imaging and measurement, and the submission focuses on its technical equivalence to existing predicate devices. There is no mention of AI assistance for human readers or an effect size for human improvement.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• The document describes a standalone ultrasound system. However, there is no mention of an "algorithm only" performance study in the context of AI. The device itself is an algorithm (hardware and software) that performs imaging and measurements. The performance testing (acoustic output, measurement accuracy with phantoms) could be considered standalone performance of the device's measurement capabilities.

7. The Type of Ground Truth Used:

• For acoustic output: Likely measurements from calibrated acoustic sensors and comparison to regulatory limits.
• For measurement performance (Axial Length, ACD, LT, VCD): Likely known dimensions of precision test blocks and monofilament phantoms.
• For thermal, mechanical, electrical, and biocompatibility: Compliance with established industry and regulatory standards.
• For software: Internally developed test plans.

8. The Sample Size for the Training Set:

• This information is not applicable/not provided. The device described is a traditional ultrasound system. There is no indication of an AI model being trained on a dataset.

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

• This information is not applicable/not provided as there is no mention of a training set for an AI model.

In summary, the provided FDA 510(k) summary focuses on demonstrating that the Scanmate Flex ophthalmic ultrasound system is substantially equivalent to legally marketed predicate devices through engineering and safety testing, rather than presenting a clinical study with detailed performance metrics, acceptance criteria, and ground truth establishment for an AI component.

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