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Vortex Surgical Laser Probes and Illuminated Laser Probes are indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm. Vortex Surgical Illuminated Laser Probes, Endoilluminator, and Chandelier are indicated for illumination during vitreoretinal surgery with visible light.

Vortex Surgical Illuminated Laser Probe is a sterile, single used for delivering laser endophotocoagulation with illumination into the posterior segment of the eye.

Vortex Surgical Laser Probe is a sterile, single use medical device used for delivery laser endophotocoagulation into the posterior segment of the eye.

The laser probe is a cable made fiberoptic, one laser connector, one handle for surgeon manipulation, nitinol, PEEK, or stainless steel tubing extending from the handle which penetrates the surgical site, and protective sheath over the fiber. The MAXReach model device also contains a slide button allowing the surgeon to bend the nitinol, PEEK, or stainless steel tubing once inside the eye to direct output into the periphery of the eye. On the proximal end the fiberoptic is terminated by a connector that attaches to the distal side, the fiberoptic is terminated by nitinol, PEEK, or stainless steel tubing which penetrates the eye. The probe can be either 23ga, 25ga, or 27ga. The fiber for laser transmission is made from silica glass and is restricted for use with the wavelength of 500nm to 1100mm. In illuminated laser probes, the illumination fiber is made of PMMA. The total length of the device is 90 ± 6 inches.

Vortex Surgical Endoilluminator and Chandelier are sterile, single use medical devices used for delivering illumination into the posterior segment of the eye.

The endoilluminator is an illuminators made from one fiber optic cable, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates the surgical site, and the protective sheath over the fiber. On the proximal side the fiberoptic is terminated by a connector that attaches to the illumination console. The endoilluminator utilizes a needle. The illumination fiber is made of PMMA. The total length of the devices is 90 ± 6 inches.

The chandelier is an illuminator made from one fiber optic cable and the protective sheath over the fiber. The illumination fiber is made of PMMA. The total length of the devices is 90 ± 6 inches.

The provided text describes a 510(k) premarket notification for Vortex Surgical's Laser Probes, Illuminated Laser Probes, Endoilluminators, and Chandeliers. As a medical device submission, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving novel clinical efficacy or conducting a multi-reader multi-case (MRMC) study. Therefore, the details requested in points 5, 8, and 9 (related to AI-assisted human reader improvement, training set size, and training set ground truth establishment) are not applicable in this context, as the device is not an AI/ML software or diagnostic tool that requires such studies.

Here's an analysis based on the information provided for the other points:

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

The document does not present explicit "acceptance criteria" in a table format with specific quantitative thresholds. Instead, the performance evaluation focuses on demonstrating that the subject devices are substantially equivalent to their predicates across various non-clinical bench tests and material assessments. The criteria are implicitly met if the test results show equivalence and do not raise new safety or effectiveness concerns.

The document concludes: "The performance of the Vortex Surgical Laser Probes, Illuminated Laser Probes, Endoilluminators, and Chandeliers show that the instruments are substantially equivalent to their predicates. Vortex Surgical had demonstrated through Ethylene Oxide (EO) sterilization EU residual testing, endotoxin testing, biocompatibility testing, shelf-life testing, and nonclinical bench test results that the Vortex Surgical instruments are safe and effective as their predicate devices and any difference between the two raise of safety or effectiveness."

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

The document does not specify a "sample size" in terms of number of patients or cases. The tests described are primarily non-clinical bench tests (e.g., laser output, mechanical actuation, biocompatibility assessments) and material characterization. Therefore, the data provenance is from laboratory testing of the devices themselves, not from patient data. There is no indication of country of origin for such non-clinical test data, nor is it classified as retrospective or prospective in the clinical sense.

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

This question is not applicable as the device is not a diagnostic tool requiring expert interpretation of medical images or data for ground truth establishment. The "ground truth" for the non-clinical tests would be defined by engineering specifications, recognized standards (e.g., IEC 60601-2-22, ANSI Z80.36-2016, ISO 10993-1, ISO 11135), and the performance characteristics of the predicate device.

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

This point is not applicable as there is no human interpretation or subjective assessment of data that would require an adjudication method. The testing involves objective, measurable physical and chemical properties and performance characteristics against established standards or predicate device performance.

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

This is not applicable. The device is not an AI-assisted diagnostic tool. It is a surgical instrument (laser probes, illuminators). MRMC studies are typically performed for diagnostic devices, especially those incorporating AI, to evaluate human reader performance with and without AI assistance. This document describes a submission for a substantially equivalent predicate device, not an AI-powered one.

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 surgical instrument, not an algorithm. Standalone performance evaluation (without human-in-the-loop) would refer to the performance of a software algorithm on its own, which is not relevant here.

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

As explained in point 3, the "ground truth" for this type of device and submission is based on engineering specifications, recognized international standards (e.g., ISO, IEC, ANSI), and the established performance characteristics of the predicate device. For biocompatibility, it's about meeting the safety thresholds defined by ISO 10993-1. For performance, it's about meeting the requirements of electro-optical and mechanical standards and demonstrating equivalence to a legally marketed predicate. There is no clinical "ground truth" derived from patient outcomes, pathology, or expert consensus on interpretations.

8. The sample size for the training set

This question is not applicable. The device is not an AI/ML model, so there is no "training set."

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

This question is not applicable. The device is not an AI/ML model, so there is no "training set" or ground truth establishment for such a set.

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MAXReach Laser Probe is indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm to 1100nm. The MAXReach Laser Probe is compatible with the following lasers: Alcon Constellation/Pure Point Lasers, Iridex GL Laser and Ellex Solitaire Laser

MAXReach Laser Probe is a sterile, single use medical device used for delivering laser endophotocoagulation into the posterior segment of the eye. The laser probe is a cable made from one fiberoptic, one laser connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates the surgical site, and protective sheath over the fiber. On one side, the fiberoptic is terminated by a connector that attaches to the laser console. On the other side, it is terminated by Nitinol tubing which penetrates the eye. It can be either 23ga or 25ga. The fiber for laser transmission is made from glass and is restricted for use with the wavelength of 500nm to 1100nm. The total length of the device is 101 inches. The total length of the fiber is 96 inches.

The provided text is a 510(k) summary for the Vortex Surgical MAXReach Laser Probe. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain information related to software-driven device performance, clinical study acceptance criteria, or a study proving device performance against such criteria.

The document primarily focuses on:

• Regulatory information: 510(k) number, regulation details, classification, and general controls.
• Device description: Physical characteristics, materials, and compatibility with laser systems.
• Comparison to a predicate device: Highlighting similarities in indications for use, intended use, wavelength, optical fiber, and other technical characteristics.
• Non-clinical bench testing: This testing involved laser output, laser spot size, laser compatibility, ophthalmic cannula interface, and handle actuation testing. The conclusion states these tests indicate the device operates similarly to the predicate and is safe and effective.
• Risk management: Compliance with ISO 14971.
• Biocompatibility, sterilization, and shelf-life testing.

Therefore, I cannot provide the requested table of acceptance criteria and study details because the provided text does not describe a study proving the device meets acceptance criteria. The document focuses on showing substantial equivalence to a predicate device through engineering and bench testing, not through a clinical performance study with human subjects, which would typically involve the type of acceptance criteria and study design elements you've asked about.

The "study" referenced in the text is "Non-Clinical Bench Testing," which is distinct from a clinical study assessing reader performance.

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