(156 days)
Either the DK7786 or DK7791 handpiece is used in combination with the ONE SERIES Ultra Cartridge, Model 1VIPR30 to fold and assist in inserting AMO intraocular lenses that allow use of this injector in the approved IOL labeling, ONLY into the capsular bag.
The Model DK7796 handpiece is used in combination with the Model 1MTEC30 cartridge to fold and assist in inserting AMO intraocular lenses that allow use of this injector in the approved IOL labeling, ONLY into the capsular bag.
The One Series ULTRA Cartridge, Model 1VIPR30, remains unchanged with respect to the predicate device that was cleared on October 2, 2008 under 510(k) K081545. The only modification to the 1VIPR30 device in comparison to the predicate device is with the coating material on the inside of the cartridge. The 1MTEC30 Cartridge is a smaller version of the 1VIPR30 and was assessed under a 510(k) Note-To-File. Both the 1VIPR30 and the 1MTEC30 Cartridges are used to fold and assist in the insertion of AMO Intraocular lenses that allow use of this 1VIPR30 and 1MTEC30 in the approved IOL labeling, ONLY into the capsular bag following cataract extraction: the tip of the cartridge has direct contact with the eye. They are both single-use devices composed of injection-molded polypropylene. The coating of the cleared 1VIPR30 Cartridge (predicate device) is biologically-derived material. The new coating will be made of synthetic materials that meets the same functional specifications of the predicate 1VIPR30 Cartridge.
This document describes a 510(k) premarket notification for two intraocular lens (IOL) cartridges, the One Series ULTRA Cartridge, Model 1VIPR30, and the UNFOLDER Platinum 1 Series Cartridge, Model 1MTEC30. The primary change in these new cartridges compared to the predicate device (Model 1VIPR30 cleared in K081545) is the replacement of a biologically-derived internal coating with a new synthetic coating.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format. Instead, it describes the objective of the non-clinical tests as evaluating "IOL recovery properties following simulated surgical manipulation (ISO 11979-3:2012) of the TECNIS 1-Piece Soft Acrylic Lens under worst-case conditions." The ultimate acceptance criterion is that the new cartridges with the synthetic coating "perform to the same specifications as the predicate device" and are "as safe and as effective as the legally marketed predicate device."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| IOL recovery properties after simulated surgical manipulation (per ISO 11979-3:2012) | Demonstrated good IOL recovery properties after simulated surgical manipulation. |
| Functional equivalence to the predicate device (1VIPR30 with biological coating) | Performed to the same specifications as the predicate device. |
| Safety and effectiveness equivalent to the predicate device | Deemed as safe and as effective as the legally marketed predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Design verification and validation testing was performed on the 1MTEC30 Cartridge" and "Design verification was also performed on the 1VIPR30 Cartridge." However, it does not specify the sample size (i.e., the number of cartridges or IOLs tested) used for these tests.
Regarding data provenance:
- The tests were non-clinical (simulated surgical manipulation).
- The location where the tests were conducted is not explicitly stated, but the manufacturer is Abbott Medical Optics Inc., based in Santa Ana, CA, USA.
- The study appears to be prospective in nature, as new testing was performed on the modified devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. As this was a non-clinical, performance-based study, the "ground truth" would likely be established by adherence to the ISO 11979-3:2012 standard and objective measurements rather than expert consensus on a test set.
4. Adjudication Method for the Test Set:
This information is not applicable/not provided as the study was non-clinical and did not involve human interpretation or subjective assessment that would require an adjudication panel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:
An MRMC study was not conducted, and this section is not relevant as the device is an IOL cartridge, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This section is not relevant as the device is an IOL cartridge, not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth for the non-clinical tests was established through objective measurements of IOL recovery properties in accordance with the ISO 11979-3:2012 standard under simulated worst-case surgical manipulation. This standard dictates the methods and parameters for evaluating IOLs and their delivery systems.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. As this is not an AI/machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not provided as there is no training set for this device.
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.