Search Results

To clean soft (hydrophilic), rigid gas permeable (silicone acrylate, fluoro-sillcone acrylate) and hard (PMA) contact lenses.

The device is currently marketed as a cleaner for rigid gas permeable (RGP) and hard (PMMA) contact lenses. The current notification is for the added indication of cleaning soft (hydrophilic) contact lenses.

The provided text does not contain detailed acceptance criteria for the device's performance, nor does it describe a study specifically designed to prove the device meets such criteria in terms of quantitative measures. The document is a 510(k) summary for a contact lens cleaner, focusing on demonstrating substantial equivalence to a predicate device for an expanded indication (cleaning soft contact lenses).

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria (e.g., specific percentage reduction in protein deposits, a certain level of comfort score, or a defined visual acuity improvement). Therefore, a table with such criteria and corresponding device performance cannot be generated.

The document mentions:

• "Non-clinical testing supports the safety and effectiveness of the device from microbiology, toxicology, chemistry and manufacturing perspectives." (No specific criteria or performance data provided.)
• "Clinical data were obtained from a multi-center study involving a hydrophilic contact lens consisting of 72 eyes followed for 3 months." (No specific performance outcomes or acceptance criteria for this clinical data are detailed in this summary.)

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: 72 eyes.
• Data Provenance: The document does not specify the country of origin. It indicates it was obtained from a "multi-center study," suggesting multiple locations, but not specific countries. The study appears to be prospective, as it involved following the 72 eyes for 3 months.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The study described is a clinical trial, and the "ground truth" would likely refer to clinical outcomes (e.g., lens cleanliness, adverse events, comfort). The adjudication method for these clinical outcomes is not described.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This type of study is not applicable to this device. The Lobob Universal Contact Lens Cleaner is a consumer product (contact lens solution), not an AI-powered diagnostic or interpretive device that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is not applicable. The device is a physical product (contact lens cleaner), not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context would likely be clinical outcomes related to contact lens use, such as:

• Lens cleanliness (visual inspection or lab analysis)
• User comfort
• Presence/absence of adverse events (e.g., corneal staining, infection)
• Visual acuity (though less likely to be directly impacted by a cleaner unless significant deposits were present)

The document does not specify how these outcomes were measured or adjudicated.

8. The Sample Size for the Training Set:

This information is not applicable as the device is not an AI algorithm requiring a training set. The clinical study described involved 72 eyes, which would be for evaluation/testing of the device's performance, not for "training" an algorithm.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable as there is no training set for an AI algorithm.

Ask a specific question about this device