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The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including:

• Axial Length measurement of the eye by ultrasonic means.
• Implanted IOL power calculation, using the Axial Length measurement. .

The AXIS NANO is an ultrasonic system designed for ophthalmic use. It uses A type scaris for biometric measurements of the eye. The system is composed of a laptop computer connected an acquisition module. The A-scan probe (either TP-01-b or TP-02-las) connects to the acquisition module.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria. Instead, it states that "Laboratory testing... was conducted to verify that the AXIS NANO met design specifications and was substantially equivalent to the predicate devices." No concrete performance metrics or study results are presented.

Therefore, I cannot populate the table or answer most of your detailed questions based on the given information.

However, I can extract the following:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample size: Not specified.
• Data provenance: Not specified (no clinical testing was performed).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no clinical testing was performed and ground truth establishment by experts for a test set is not mentioned.

4. Adjudication method for the test set:

• Not applicable as no clinical testing or adjudication is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC or AI-assisted study was performed or discussed. The device itself is an ophthalmic biometer ultrasound system, not an AI diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• The document implies that laboratory testing of the device (AXIS NANO Ophthalmic Biometer Ultrasound System) was done to verify it met design specifications. This would inherently be a standalone evaluation of the device's physical and functional characteristics. However, no specific "algorithm-only" performance akin to an AI model's standalone performance is detailed.

7. The type of ground truth used:

• Not explicitly defined, as no clinical study for "ground truth" establishment is detailed. The "ground truth" for the device's performance would be against its own design specifications and its measured performance compared to the predicate devices.

8. The sample size for the training set:

• Not applicable; this device is an ultrasound system, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable; this device is an ultrasound system and does not have a training set in the AI sense.

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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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