(193 days)
The VISALIS V500 and VISALIS S500 Surgical System is indicated for surgical treatment of the eye by performing irrigation /suction, phacoemulsification of the crystalline lens, anterior vitrectory and coagulation techniques using bipolar diathermy.
The VISALIS V500 is indicated for use in vitreo-retinal surgery such as retinal detachment and other pathologies of the vitreous body and the posterior segment of the human eye.
The VISALIS V500 / VISALIS S500 Surgical System has been designed to be used in surgical theaters by qualified medical personnel (eye surgeon) for surgical methods of treatment of the anterior and posterior segment of the human eye. The equipment has been designed for the performance of irrigation, irrigation/suction, phacoemulsification of crystalline lens, anterior and posterior vitrectomy, bipolar diathermy coagulation techniques, air and silicone oil tamponade, endoocular illumination. The system is intended for use in clinics, hospitals or other human medicine institutions.
The provided text describes a 510(k) submission for the Carl Zeiss Meditec AG VISALIS V500 / VISALIS S500 Surgical System. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing data on an AI/Algorithm-only device or an MRMC study.
Therefore, many of the requested criteria cannot be extracted from this document, as they are not relevant to a traditional 510(k) for a surgical system and its accessories demonstrating equivalence to an existing device. The document primarily details compliance with various medical device standards (e.g., safety, EMC, software, biocompatibility, sterilization) to show that the new device is as safe and effective as the predicate.
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 doesn't provide specific quantitative acceptance criteria or performance metrics in a table format for the device's surgical functions (e.g., phacoemulsification efficiency, aspiration rates). Instead, it states compliance with a large number of recognized standards. The "performance data" summary lists these compliance tests, implying that meeting these standards constitutes the acceptance criteria.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ISO 14971:2007 (Risk Management) | Compliance demonstrated. |
| ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Basic safety and essential performance) | Found to be in compliance. |
| IEC 60601-1-2:2014 (Electromagnetic compatibility (EMC)) | Found to be in compliance. |
| IEC 60601-2-2:2017 (High frequency surgical equipment and accessories) | Found to be in compliance. |
| IEC 80601-2-58:2008 (Lens removal devices and vitrectomy devices) | Found to be in compliance. |
| IEC 62304:2006/A1:2015 (Software lifecycle processes) | Software documented and tested; found to be in compliance. |
| IEC 62366-1:2015 (Usability engineering) | Compliance demonstrated. |
| IEC 15752:2010 (Endoilluminators and optical radiation safety) | Found to be in compliance. |
| ISO 10993-1:2009 (Biocompatibility - Part 1: Evaluation and testing) | Applicable accessories found to be in compliance. |
| ISO 10993-5:2009 (Biocompatibility - Part 5: In vitro genotoxicity tests) | Applicable accessories found to be in compliance. |
| ISO 10993-10:2010 (Biocompatibility - Part 10: Tests for irritation and skin sensitization) | Applicable accessories found to be in compliance. |
| ST72:2011/(R)2016 (Sterilization, Industrial) | Applicable accessories found to be in compliance. |
| ISO 17665-1:2006 (Sterilization of health care products - Moist heat) | Applicable accessories found to be in compliance. |
| ISO 11135:2014 (Sterilization of health care products - Ethylene oxide) | Applicable accessories found to be in compliance. |
| ISO 10993-7:2008-10 (Biocompatibility - Part 7: Ethylene oxide sterilization residuals) | Applicable accessories found to be in compliance. |
| ISO 11737-2:2009 (Sterilization of medical devices - Microbiological methods - Sterility tests) | Applicable accessories found to be in compliance. |
| F88/F88M-15 (Standard Test Method for Gross Leakage of Packaging by Internal Pressurization (Bubble Test)) | Applicable accessories found to be in compliance. |
| F1929-2015 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration) | Applicable accessories found to be in compliance. |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a 510(k) for a conventional medical device, not an AI/ML algorithm that would typically have a test set of data. The "testing" refers to compliance with performance and safety standards, often done on prototype devices or components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There is no "ground truth" derived from expert consensus in the context of this 510(k). The evaluation is against established standards and equivalence to a predicate device, not diagnostic performance of an AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. See point 3.
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 a surgical system, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-only device. It is a physical surgical system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this submission are the established performance and safety standards (e.g., ISO, IEC) and the functional specifications of the predicate device. The study demonstrates performance based on engineering tests and compliance, not clinical diagnostic accuracy.
8. The sample size for the training set:
Not applicable. There is no AI/ML model for which "training data" would be collected.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML model.
§ 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.