Search Results

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

Not Found

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.

Ask a specific question about this device

An AC-Powered slitlamp biomicroscope is intended for use in eye examination of the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Not Found

The document provided is a 510(k) clearance letter from the FDA for a device called "Xcel 255 Slit Lamp". This type of document confirms that a new medical device is substantially equivalent to a legally marketed predicate device, rather than providing a detailed technical study or specific performance metrics.

Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information on standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as a regulatory clearance, indicating equivalence to an existing device, but does not detail the technical performance testing that would typically be described in a study report.

Ask a specific question about this device

ATP is intended to measure intra-ocular pressure and comeal thickness of the eye for the purpose of aiding in the diagnosis and monitoring of glaucoma.

Not Found

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the "ATP (Auto Non-Contact) Tonometer/Pachymeter)" and an "Indications for Use Form" for a diagnostic ultrasound.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance
• Sample sizes and data provenance for the test set
• Number and qualifications of experts for ground truth establishment
• Adjudication method
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study
• Results of a standalone performance study
• Type of ground truth used
• Sample size for the training set
• Method for establishing ground truth for the training set

Ask a specific question about this device

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.

Not Found

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.

Ask a specific question about this device