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510(k) Data Aggregation
(24 days)
The Luxvision Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eye 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 segments.
The Luxvision Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination There are 3 models LS880, LS1100, and LS1400. These models differ only in the supplied accessories. All models have the same operating characteristics and intended use.
The Luxvision Slit Lamp is a Class II medical device (regulated under 21 CFR 886.1850) that was cleared through the 510(k) pathway, asserting substantial equivalence to a predicate device rather than providing de novo performance criteria or a detailed clinical study demonstrating its effectiveness.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ISO 10939:1998, Ophthalmic instruments -- Slit-lamp microscopes | The USOphthalmic Luxvision Slit Lamp "complies with the requirements of listed FDA Recognized Consensus Standards", specifically mentioning ISO 10939:1998. |
| Compliance with IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety | The USOphthalmic Luxvision Slit Lamp "complies with the requirements of listed FDA Recognized Consensus Standards", specifically mentioning IEC 60601-1. |
| Substantial Equivalence to Predicate Device (66 Vision-Tech YZ Slit Lamp K033190) | "This has been demonstrated through an 8-point technological comparison of features." The document states: "The devices were found to be substantially equivalent." |
| Intended Use (eye examination of the anterior eye segment to aid in diagnosis of diseases/trauma) | The device's technological characteristics are "essentially identical" to the predicate, leading to the belief that it "performs as well as or better than the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
No specific "test set" or clinical data is mentioned for the Luxvision Slit Lamp. The clearance is based on technological comparison and compliance with standards, not performance against a specific dataset.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. Ground truth establishment by experts for a test set is not described as part of this 510(k) submission.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. An MRMC comparative effectiveness study was not done. The submission focuses on technological equivalence to a predicate device, not on measuring human reader improvement with AI assistance (as this is not an AI device).
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a traditional medical device (slit lamp), not an algorithm or AI. Standalone performance for an algorithm is not a relevant criterion.
7. The Type of Ground Truth Used:
The "ground truth" for the Luxvision Slit Lamp's acceptance is based on adherence to recognized consensus standards (ISO 10939:1998 and IEC 60601-1) and technological characteristics being substantially equivalent to a legally marketed predicate device. There is no mention of expert consensus, pathology, or outcomes data being used to establish device performance.
8. The Sample Size for the Training Set:
Not applicable. This is a traditional medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned for this device.
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