Search Results

The D.O.R.C. HEXON Illumination System is indicated for intraocular illumination in vitreoretinal surgery.

The D.O.R.C. HEXON Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a metal halide discharge lamp and utilizes an internal focusing system to focus the light into the end of the optical fiber. Accessories to the Illumination Unit include adapters and color filters. Accessories to the system include single use and reusable fiberoptic probes, fibers, and microinstruments which require storilization prior to use.

The provided text is a 510(k) premarket notification summary for the D.O.R.C. HEXON Illumination System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel performance or efficacy. Therefore, much of the requested information regarding acceptance criteria, specific study design, expert involvement, and detailed performance metrics as would be found in a clinical trial for a new therapeutic or diagnostic device is not applicable or not provided in this document.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with specific thresholds. Instead, it demonstrates performance by comparing the device's characteristics to those of predicate devices to establish substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This is not a study assessing device performance on patient samples. The "test set" here refers to the characteristics of the device itself and its comparison to predicate devices, not data from patients.
• Data Provenance: Not applicable in the context of clinical data. The data provenance relates to the specifications and characteristics of the D.O.R.C. HEXON Illumination System and the predicate devices (Grieshaber Light Source and Escalon VitLite I), derived from engineering specifications and existing market information.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. Ground truth in a clinical or diagnostic sense is not being established. The "truth" here is the stated technical specifications of the devices being compared.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There is no expert adjudication of clinical findings in this type of submission. The comparison is based on documented device specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is an ophthalmic illumination system, not an AI or diagnostic tool that would involve "human readers" or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this 510(k) submission is the technical specifications and intended use of the legally marketed predicate devices. The D.O.R.C. HEXON Illumination System demonstrates substantial equivalence by showing that it has similar technological characteristics and the same intended use as these predicates.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of device development for a 510(k) involving an illumination system.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

Ask a specific question about this device