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:
| Condition | Treatment |
|---|---|
| Diabetic Retinopathy | |
| • Proliferative Diabetic Retinopathy | Panretinal Photocoagulation |
| • Clinically Significant Macular Edema | Focal or Grid Laser |
| Retinal Tear and Detachments | Laser Retinopathy |
| Lattice Degeneration | Retinal Photocoagulation |
| Sub-retinal (choroidal) Neovascularization | Focal Laser |
| Retinal Vascular Occlusion | |
| • Neovascularization secondary to Brand or Central retinal | |
| vein occlusion | Scatter Laser |
| Photocoagulation | |
| • Chronic macular edema secondary to Branch or Central | |
| retinal vein occlusion | Focal or Grid Laser |
| Glaucoma | |
| • Primary Open-angle | Trabeculoplasty |
| • Closed Angle | Iridotomy or Iridoplasty |
The EVA Ophthalmic Surgical System (EVA) is a combined anterior and posterior procedure ophthalmic system that is modular in design and serves as an enhanced version of the currently cleared Associate (K081877). 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 provided text describes the "EVA Ophthalmic Surgical System." It discusses various performance data, including biocompatibility, electrical safety, electromagnetic compatibility (EMC), and software verification and validation. However, the document does not contain information about specific clinical performance studies where the device's efficacy is measured against defined acceptance criteria using patient data. Instead, it focuses on demonstrating the device's safety and equivalence to predicate devices through engineering and laboratory tests.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) cannot be sourced from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format for device performance in clinical use, nor does it report patient-centric performance in such a table. It states that "animal and clinical performance testing was not required for the EVA to demonstrate efficacy, safety and substantial equivalence to predicate devices."
Instead, it lists various engineering and laboratory tests and states that the device "complies" or "will not fail."
| Acceptance Criteria (Implied from tests) | Reported Device Performance |
|---|---|
| Biocompatibility: No cytotoxicity, irritation, or sensitization for patient-contacting components (cartridges and vitrectomy handpieces). | Biocompatibility was evaluated and confirmed acceptable by cytotoxicity, Kligman maximization, and intracutaneous irritation testing, in compliance with ISO 10993-1, 10993-5, 10993-10, and 10993-12. |
| Electrical safety: Compliance with applicable standards. | The system complies with IEC 60601-1, EN 60601-2-2, and EN 80601-2-58 standards for safety. |
| EMC: Compliance with applicable standards. | The system complies with EN 60601-1-2 and 47 CFR Part 15 Subpart B for EMC. |
| Software: Software verification and validation ensure safety and intended performance (categorized as "major" level of concern). | Software verification and validation testing were conducted and documentation provided as recommended by FDA guidance. The device's software was considered to be of "major" level of concern. |
| Vitrectomy cutters: Will not fail at normal working pressure (41 PSI). | Testing confirmed that vitrectomy cutters will not fail at the normal working pressure (41 PSI). |
| EVA Pump module: Durability. | Testing determined the durability of the EVA Pump module. (Specific metrics not provided). |
| Light probe tips: Will not melt at maximum output of LED illumination module. | Testing confirmed that the light probe tips will not melt at the maximum output of the LED illumination module. |
| Waste bags: Will not rupture when full. | Testing confirmed that the waste bags will not rupture when full. |
| Vitrectomy cutters: Will not generate particulate matter at highest cut speed. | Testing confirmed that the vitrectomy cutters will not generate particulate matter at the highest cut speed. |
| Reusable accessories: Withstand repeat sterilization without impact to device characteristics. | Testing confirmed that reusable accessories can withstand repeat sterilization without impact to device characteristics. |
| Compliance with specific standards for lens removal/vitrectomy, high-frequency surgical equipment, and light hazard protection (e.g., IEC 80601-2-58). | Testing ensured compliance to IEC 80601-2-58 "Medical electrical equipment, Part 2: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery," IEC 60601-2-2, and ISO 15004-2: 2007 "Illuminator Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable. The document states that "animal and clinical performance testing was not required." The performance data provided are from laboratory/bench testing on device components and the system itself, not from a clinical test set with patient data.
- Data provenance: Not explicitly stated, but the testing appears to be internal lab/bench testing for device compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable, as no clinical test set with human-established ground truth was used for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test set requiring adjudication was used.
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 surgical system, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a surgical system, not an algorithm. The software verification and validation are for the embedded software controlling the surgical system, not for a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The ground truth for the "performance testing" described is based on engineering specifications, physical properties, and compliance with recognized standards (e.g., whether a pump is durable, if a tip melts, if a waste bag ruptures, if a cutter generates particulates, compliance with electrical safety standards).
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is not an AI/machine learning product for performance evaluation.
9. How the ground truth for the training set was established
- Not applicable.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.