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The iScience Surgical Fiberoptic Illuminator is indicated for illumination during anterior and posterior segment ophthalmic surgery.

The iScience Surgical Fiberoptic Illuminator (FI) is a portable light source intended to provide illumination during anterior and posterior segment ophthalmic surger. It is designed to be used only with the iScience Surgical iTrack Ophthalmic Microcannula to illum nate tissues during advancement into intraocular structures of the anterior and posterior segment.

The FI consists of a splash proof sheet metal enclosure with panel mounted rocker switches for operational control, and a custom light output connector. The FI houses a laster dionel illumination source, and is specific for the iScience Surgical iTrack Ophthalmic Microcannula. The FI is not intended to be sterilized or placed in a sterile enclosure.

The FI has a custom designed light output connector that contains two redundant safety interlock switches. These switches, in conjunction with electronic circuitry in the Fly ensure that laser light can only emanate from the laser aperture when an iScience Surgical iTrack Ophthalmic Microcannula is installed in the connector. The interlock switches independently detect the proper insertion of the iScience Surgical iTrack Ophthalmic Microoannulaipe into thre connector, ensuring that the microcannula is fully engaged and retained in the connector before laser output is enabled.

The provided 510(k) summary for the iScience Surgical Fiberoptic Illuminator (K062259) does not contain the level of detail typically found in a clinical study for medical device clearance. This submission primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and a limited in-vitro test rather than a full clinical study with acceptance criteria and statistical analysis of performance.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not explicitly provided in the text. I will extract the information that is available and note when details are missing.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" as applied to a quantitative performance metric is not explicitly stated in the document. The study's conclusion is qualitative, focused on the sufficiency of illumination.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The study states "enucleated cadaver eyes," implying more than one, but no specific number is given.
   • Data Provenance: Retrospective (cadaveric eyes), country of origin not specified.

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

   • Not specified. The statement "demonstrated equivalent results" implies an assessment was made, but the number or qualifications of individuals performing this assessment are not provided.

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

   • Not specified.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This study is an in-vitro comparison of two illumination devices, not an AI-assisted diagnostic device study. The concept of "human readers improve with AI" is not applicable here.

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

   • This is not an AI algorithm. The study was an in-vitro comparison of two illumination devices, one of which (the subject device) uses a different light source technology than its predicate.

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

   • The "ground truth" was the qualitative assessment of "sufficient illumination" for the task of advancing the microcannula into intraocular structures. This would likely be assessed by an expert (e.g., an ophthalmic surgeon), but this is not explicitly stated.

7. The sample size for the training set:

   • Not applicable. This is an in-vitro operational test, not a machine learning model.

8. How the ground truth for the training set was established:

   • Not applicable. This is an in-vitro operational test, not a machine learning model.

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