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The EVA NEXUS™ Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic subretinal microinjection of gases or aqueous fluids.

In addition, the optional laser is indicated for the following:

The EVA NEXUS™ Ophthalmic Surgical System (EVA NEXUS) is a combined anterior and posterior procedure ophthalmic system that is modular in design and is identical in most respects to the recently cleared predicate EVA Ophthalmic Surgical System (K190875). EVA NEXUS (see Figures 1, and 2 for external views) is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification and fragmentation, cautery, diathermy as well as photocoagulation.

This document describes the EVA NEXUS™ Ophthalmic Surgical System, a combined anterior and posterior procedure ophthalmic system. The submission (K213467) seeks to demonstrate substantial equivalence to its predicate device, the EVA Ophthalmic Surgical System (K190875), and other components cleared under different K numbers.

The device includes several modifications and new components compared to its predicate, such as a redesigned infusion pole, a second infusion/irrigation port, "Smart IOP" functionality, microinjection capability, a digitally controlled phaco board, increased cutter speed, and a video overlay device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative thresholds for efficacy or safety endpoints. Instead, it relies on demonstrating substantial equivalence to predicate devices through a combination of bench testing, compliance with international standards, and verification/validation testing. The performance aspects are primarily evaluated by comparison to the predicate device and relevant standards.

However, based on the "Comparison of Technological Characteristics with the Predicate Devices" (Table 5 and subsequent detailed comparisons for individual components like vitrectomy probes, tubing, and laser probes) and "Performance (Bench) Testing" sections, we can infer some performance requirements and reported outcomes:

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The EVA Ophthalmic surgical system is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery.

In addition, the optional laser is indicated for the following:

The EVA Ophthalmic Surgical System (EVA) is a combined anterior and posterior procedure ophthalmic system that was cleared by FDA in March, 2015 (K142877). The EVA is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification and fragmentation, cautery, diathermy as well as photocoagulation.

The purpose of this 510(k) is to obtain clearance for minor improvements to the cleared device. These changes include:

• Footswitch: The footswitch of the EVA has been modified to improve ergonomics and simultaneously integrate the laser pedal functionality. An optional separate laser footswitch will remain available if surgeons prefer.
• Illumination: Due to quality improvements in the LED output, the light output has been increased to improve illumination with small gauge fibers. However, the system controls the absolute output of the module to 40 lumens as previously cleared. As an example, the illumination output for a 27 gauge fiber has been improved from 5 lumens as cleared to 7 lumens in the proposed system. However, the maximum output, and maximum exposure to patient, remains at 40 lumens for any fiber as previously cleared. Thus there are no risks introduced with this change.
• The Posterior Module (Air Functionality): To support use of EVA for fluid/air exchanges (F-AX), independent of the compressed air / gas supply available, the hardware design of the Posterior (VFIE, Air, Proportional Scissors) module has been modified to provide air through two independent circuits, instead of one as previously cleared. As a result, the air for F-AX is provided by a separate circuit that draws air from the environment (with appropriate filtration), whilst the compressed gas drive for other EVA functions is provided from the pneumatic input (supplied by the surgical setting - typically compressed air or Nitrogen) as per the current design. With this improved design, the compressed gas input of the system will only be used for internal system operation while air needed for surgical use will be derived from filtered, ambient air. Thus, the consumption of compressed gas used to operate the EVA is reduced.
• Software: To support these changes the EVA software was upgraded as well as anomaly/bug fixes. A complete detail of these minor improvements can be found in the Software portion of this 510(k) (Section 16 and Annex 5).
• Sterilization of Reusable Accessories: Minor changes to the conditions recommended in the labeling have been made and are supported by validation and performance testing included in this 510(k).
• Shelf life of Disposable Accessories: The shelf-life of peel pouch packed disposable accessories has been extended to 5-years and is supported by validation and performance testing included in this 510(k).
• Accessory Changes: Some packs (combinations of accessories) were discontinued and new configurations added. No new accessories that were not previously cleared were added.

The provided text is a 510(k) summary for the D.O.R.C. EVA Ophthalmic Surgical System. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through modifications to ergonomic features, illumination, air functionality, software updates, and accessory sterilization/shelf-life.

Based on the available information, the document does not describe a study involving an AI/machine learning component that generates performance metrics (e.g., sensitivity, specificity, AUC) against acceptance criteria. Instead, it details various performance tests to ensure compliance with standards and functionality.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them in the context of an AI/ML-based performance evaluation. The document does not contain information about:

1. A table of acceptance criteria and reported device performance (in terms of AI metrics).
2. Sample sizes used for a test set (for AI evaluation).
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication methods for a test set.
5. MRMC studies or effect sizes for human readers with/without AI assistance.
6. Standalone (algorithm-only) performance evaluations.
7. Type of ground truth used for AI evaluation.
8. Sample size for a training set (for AI).
9. How ground truth for a training set was established (for AI).

The performance data section in the 510(k) summary focuses on biocompatibility, electrical safety/EMC, software verification/validation (for general software functionality, not AI performance), and bench performance testing related to physical and functional aspects of the surgical system (e.g., illumination, pneumatic system, compliance with IEC/ISO standards).

In summary, the provided document does not contain the information requested about AI performance testing or a related study with acceptance criteria for such a system.

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