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The Quantel Medical Cinescan S is intended to be used for: - the Axial Length measurement of the eye by ultrasonic means - the implanted IOL power calculation, using the Axial Length measurement. - Visualization of the interior of the eye by A and B scans.
The intended use of the Cinescan S is for diagnostic imaging of the eye by A and B scans and for biometric measurements of the eye.
The intended use of the Cinescan S 10 MHz B-scan transducer is for diagnostic imaging of the eye by B scans.
The Quantel Medical Cinescan Mhz A-scan transducer is intended to be used with the Quantel Cinescan S A-scans of the eye and for biometric measurements.
The intended use of the Cinescan S is for diagnostic imaging of the eye by B scans and for biometric measurements of the eye.

The Cinescan S is a combined ophthalmic A and B scan system that can also be used for biometric measurements of the eye and for IOL calculations.

The provided documentation for the "Cinescan S" Ultrasonic Ophthalmic A and B scan System (K021683) indicates that no clinical performance studies were conducted to establish acceptance criteria or to prove the device meets such criteria.

The submission explicitly states:
"Since the Cinescan uses the same technology as existing devices, clinical tests are not required."

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: No performance criteria beyond safety and efficacy equivalence to predicates are mentioned, and no specific performance metrics are reported from the Cinescan S.
• Sample size used for the test set and the data provenance: No test set was used for clinical performance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set was evaluated.
• Adjudication method for the test set: Not applicable.
• 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: Not applicable, as this is an ultrasound system, not an AI diagnostic device, and no clinical studies were performed.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of Device Acceptance:

The device's acceptance was based on a Special 510(k) submission which asserts substantial equivalence to legally marketed predicate devices:

1. "B-SCAN", K926521 (manufactured by Biovision and then B.V.I, predecessor to Quantel Medical)
2. Axis II, K000554 (manufactured by Quantel Medical, a modification of the "B-scan")

The justification for not requiring clinical tests was that the Cinescan S uses the "same technology as existing devices." This implies that the performance of the predicate devices implicitly serves as the "acceptance criteria" for the Cinescan S, and the direct comparison of technology is the "study" proving it meets these criteria.

Non-Clinical tests reported for the Cinescan S include:

• Electrical Security (IEC 601-1)
• Electromagnetic Compatibility (IEC 601-1-2)
• FDA transducer emissions tests

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