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The Quantel Medical COMPACT TOUCH STS is intended to be used for diagnostic imaging and measurement of the eye including:
◆ Visualization of the interior of the eye by B scan
◆ Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber Depth).

The COMPACT TOUCH STS is an ultrasonic system designed for ophthalmic use. It performs B type scans for diagnostic imaging of the eye. It is not intended to be used for determining the power of implanted lenses, but rather is capable of making intra-ocular measurements. The system is composed of a main console controlled by a touch screen. It uses a B-scan probe (LIN50) which is a motor driven 50 MHz transducer.

The provided text describes a 510(k) summary for the Quantel Medical COMPACT TOUCH STS Ophthalmic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, extensive performance data, and detailed study methodologies is not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for performance metrics. Instead, it relies on the concept of "substantial equivalence" to a predicate device.

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

• Sample Size for Test Set: Not applicable. The submission states, "No Clinical testing is required." The evaluation was based on laboratory testing to verify design specifications and demonstrate substantial equivalence, not on a clinical test set with patient data.
• Data Provenance: Not applicable, as no clinical test set data is described. The "laboratory testing" mentioned implies internal testing data, likely from the manufacturer's facilities.

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

• Number of Experts: Not applicable. Since no clinical test set was used and no "ground truth" for patient data was established in the context of this submission, the number and qualifications of experts are not relevant or provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no clinical test set requiring adjudication.

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

• Was an MRMC study done? No. The document explicitly states, "No Clinical testing is required." Therefore, no MRMC study, either with or without AI assistance, was conducted or reported.
• Effect size of human readers improving with AI vs without AI assistance: Not applicable, as no MRMC study was done and the device is a standalone ultrasound system, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Yes, in a sense, but not in the context of an AI algorithm. The device itself, as an ophthalmic ultrasound system, is a standalone diagnostic tool. The "Performance Data" section describes "Laboratory testing following the guidance 'Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers' (Sept 9, 2000)" to verify it met design specifications. This implies testing the device's physical performance, imaging capabilities, and measurement accuracy in a controlled laboratory setting, independent of human interpretation for substantial equivalence purposes.

7. Type of Ground Truth Used

• Type of Ground Truth: For the "laboratory testing," the ground truth would have been established through validated measurement standards, phantoms, and calibrated equipment, rather than clinical ground truth like pathology or expert consensus on patient cases. The goal was to verify the device's technical specifications and ensure it produced accurate ultrasound images and measurements in a controlled environment, consistent with its design.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The COMPACT TOUCH STS is an ophthalmic ultrasound system, not an AI/ML-based device that requires a training set of data.

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

• How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.

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