(134 days)
The Legion™ System is indicated for emulsification, separation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof™ intraocular lenses into the eye following cataract removal.
The AutoSert™ IOL Injector Handpiece achieves the function of intraocular lenses. The AutoSert™ IOL Injector Handpiece is indicated for use with AcrySof™ lenses SN60WF, SN6AT3 through SN6AT9, as well as approved AcrySof™ lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
The LEGION™ System is intended for use in anterior segment ophthalmic surgery procedures that require simultaneous lens extraction via phacoemulsification, irrigation and aspiration, and associated procedures such as anterior vitrectomy, coagulation and intraocular lens (IOL) insertion.
The LEGION™ System consists of a standalone tabletop console, which performs the core functionalities for cataract lens extraction. The LEGION™ System's console provides two electrical connector ports that support the CENTURION™ series of ultrasound handpieces, an electric vitrectorny cutter, the Alcon AutoSert™ IOL Injector and a Coagulation accessory port on both sides of the Fluidics module. The OZIL torsional technology of Alcon's phacoemulsification handpieces and tips operates with ultrasonic torsional oscillations which can be used exclusively. combined or alternated with traditional longitudinal phacoemulsification. The traditional modalities of ultrasonic power control including continuous, pulsed, and burst application of ultrasonic power, as well as duty cycle management are available.
The same fluidics module and overall fluid management system (FMS) design of the predicate device (CENTURION™ Vision System) is used on the LEGION™ System. The FMS is an interface between the LEGION™ System Console (Fluidics Module) and the surgical handpieces, used to regulate irrigating fluid to the handpiece, aspirate fluid and debris from the handpiece, monitor irrigation and aspiration pressure and deposit the fluid and debris in a sealed drainage bag This single assembly contains a rigid plastic fluidic chamber, non-invasive pressure/vacuum sensor, drain bag, irrigating fluid administration line, as well as irrigation and aspiration handpiece tubing.
Two types of FMS can be used with the LEGION™ System: Single Use and MultiPak FMS. The MultiPak FMS is intended to be a day-use cassette for up to 12 consecutive procedures (patients). The primary difference between the single use and MultiPak FMS is the ability to replace the single use sterile irrigation (1/A) manifold and drain bag. Several design aspects have been implemented to reduce the risk of cross-contamination when using the MultiPak FMS.
The LEGION™ System utilizes gravity-based irrigation (i.e. irrigation pressure derived from the height of the irrigation fluid bag or bottle). The LEGION™ System can be used in conjunction with a manual IV pole, or can be used with the optional LEGION™ cart, which is equipped with a powered IV pole.
The LEGION™ System supports anterior vitrectomy procedures via compatibility with the reusable LEGION™ anterior vitrectomy handpiece and consumable vitrectomy probe. The reusable anterior vitrectomy handpiece drives the guillotine-style consumable vitrectomy probe to achieve anterior vitrectomy functionality.
The LEGION™ System provides bipolar coagulation capability via support for Alcon coagulation handpieces and tips, with a power rating identical to the predicate device.
The provided text is a 510(k) Summary for the Alcon LEGION™ System, a phacofragmentation unit used in ophthalmic surgery. It outlines the device's purpose, comparison to a predicate device, and performance data. However, it does not explicitly state acceptance criteria or provide a study with detailed results in the format requested.
The document lists performance tests conducted, but it doesn't give specific numerical acceptance criteria (e.g., "Aspiration rate must be within X +/- Y%") or the quantitative results from these tests to compare against such criteria. It generally states that the device's performance is "in accordance with design requirements" or "consistent with the predicate device," which are qualitative statements of meeting criteria without providing the specifics.
Therefore, I cannot populate the table or answer all sub-questions as the detailed quantitative acceptance criteria and study results are not present in the provided text. I will answer based on what can be inferred or directly stated from the text.
Acceptance Criteria and Device Performance
Based on the provided text, specific numerical acceptance criteria and their corresponding reported device performance values are not explicitly stated. The document broadly indicates that the device met its design requirements and performed consistently with the predicate.
| Acceptance Criterion (Inferred from Performance Data) | Reported Device Performance (Qualitative Description) |
|---|---|
| Compatibility with Alcon phacoemulsification handpieces and tips | Demonstrated compatibility |
| Ultrasound frequency (longitudinal and torsional) | Consistent with the predicate device |
| Compatibility with Alcon I/A handpieces and tips | Demonstrated compatibility |
| Peristaltic aspiration | In accordance with design requirements |
| Vacuum range | In accordance with design requirements |
| Accuracy of Aspiration rate | Demonstrated accuracy |
| Accuracy of Pressure sensing (irrigation and aspiration) | Demonstrated accuracy |
| Accuracy of Vacuum control | Demonstrated accuracy |
| Occlusion Break Surge performance | Verification performed |
| Effectiveness of design aspects preventing cross-contamination (FMS MultiPak) | Verification performed |
| Anterior vitrectomy probe cut rate and quality | Verification performed |
| Coagulation power rating | Verification performed |
| Compatibility with Alcon IOL injection handpiece | Demonstrated compatibility |
| Biocompatibility of patient-contact aspects | In accordance with the intended use of the devices |
| Sterility and performance of Anterior Vitrectomy Kit and FMS Paks over shelf life | Verification performed |
| Electromagnetic compatibility and electrical safety | In accordance with FDA-recognized standards |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document primarily refers to "Performance Data" which includes various verification tests (e.g., compatibility, accuracy, safety). It does not specify sample sizes for these tests (e.g., number of units tested, number of simulated cases, etc.).
- The data provenance (country of origin, retrospective/prospective) is not mentioned. These appear to be laboratory and engineering test results rather than clinical study data.
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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)
- This question is not applicable to the type of performance data presented. The document describes engineering and safety tests for a medical device (phacofragmentation system), not diagnostic performance based on human expert interpretation or ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable. The performance data listed (e.g., accuracy of aspiration rate, electromagnetic compatibility) are objective measurements from device testing, not expert-adjudicated clinical outcomes or readings.
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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 MRMC study was described. The LEGION™ System is a surgical instrument, not an AI-powered diagnostic tool. The document focuses on its mechanical, electrical, and fluidic performance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable in the context of an AI algorithm. The performance data provided relates to the standalone operational characteristics of the surgical device itself (e.g., aspiration, vacuum, coagulation capabilities), not an AI algorithm's performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The concept of "ground truth" as typically applied to diagnostic AI models (e.g., pathology for cancer detection) is not applicable here. The "ground truth" for the performance data would be the established engineering specifications and physical principles against which the device's mechanical, electrical, and fluidic outputs were measured. For example, "accuracy of aspiration rate" would be compared to a known, calibrated standard.
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The sample size for the training set
- This is not applicable. The LEGION™ System is a hardware medical device with specific functionalities, not a machine learning model developed with a training set.
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How the ground truth for the training set was established
- This is not applicable for the same reason as in point 7.
§ 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.