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The instrument is used for measuring the corneal thickness of the eye, and calculating a corrected intraocular pressure based on those measurements.

The AccuPach V device is designed as an ultrasound pachymeter which uses pulsed echo ultrasound to measure the corneal thickness of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides a numeric display of returning pulse echoes to indicate the thickness of the cornea.

The provided 510(k) K042752 for the AccuPach V does not contain information about acceptance criteria or a study proving the device meets said criteria.

The 510(k) submission generally describes the device, its intended use, and claims substantial equivalence to a predicate device (Accutome Kremer Corneometer K810660). It mentions that the AccuPach V is an ultrasound pachymeter that measures corneal thickness of the eye using a 10.5 MHz A-Mode probe.

The document includes the FDA's clearance letter, which confirms substantial equivalence but does not detail performance specs or the studies conducted to establish them. It primarily focuses on regulatory compliance and administrative details.

Therefore, I cannot provide the requested information based on the provided text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size for test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Information about MRMC comparative effectiveness studies or effect sizes.
6. Results of a standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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