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The Ocular Response Analyzer is intended to measure intra-ocular pressure of the eye and biomechanical response of the cornea.

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The provided text is a 510(k) clearance letter for the Ocular Response Analyzer (ORA). It confirms that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device.

Critically, this document DOES NOT contain the acceptance criteria or a study proving the device meets those criteria.

510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring the submission of new clinical efficacy or performance studies with detailed acceptance criteria in the same way a PMA (Premarket Approval Application) would.

Therefore, I cannot extract the requested information from the provided text. The document states the "Indications for Use" but does not detail performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

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The ORA is intended to measure intra-ocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma.

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The provided text is a 510(k) clearance letter from the FDA for a device called the "Ocular Response Analyzer (ORA)." This document primarily focuses on the regulatory clearance process, indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.

Crucially, this document does not contain the detailed information necessary to describe acceptance criteria, a specific study proving those criteria were met, or any of the other requested information related to AI/algorithm performance, ground truth establishment, or sample sizes for testing and training datasets.

The 510(k) clearance process, as exemplified here, is about demonstrating substantial equivalence to a predicate device, not necessarily providing a de novo clinical study with specific performance metrics against pre-defined acceptance criteria in the manner typically required for novel AI/ML medical devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided FDA letter. The letter confirms substantial equivalence but doesn't detail performance metrics against specific acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable or mentioned for this type of device and clearance. This is more relevant for AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable or mentioned. The ORA is a physical device that measures properties of the eye.
7. The type of ground truth used: Not available in this document.
8. The sample size for the training set: Not applicable or mentioned, as this is not an AI/ML device in the context of the training sets typically discussed for such algorithms.
9. How the ground truth for the training set was established: Not applicable or mentioned.

The document states the device's Indications for Use: "The ORA is intended to measure intra-ocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma." This is the primary functional statement provided.

To obtain the information you're asking for, you would typically need to refer to the 510(k) Summary or the full 510(k) Submission for K032799, which would contain detailed information about the design verification and validation studies performed, including any performance data used to demonstrate substantial equivalence to the predicate device. These documents are often publicly available through the FDA's 510(k) database.

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