(13 days)
The Royale® AE-9036 LSP Injectors are reusable instruments to assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery. They are designed to incorporate Monarch III cartridges D and Monarch II cartridge C for foldable intraocular lenses. The cartridges are loaded into the injector body. By pushing the piston, the lens will be removed out of the cartridge and delivered to the desired position.
The injectors are autoclavable, reusable titanium hand pieces which are used to deliver folded intraocular lenses into the eye for replacement of the human crystalline lens. They are a modification to the previously cleared Injector Royale AE 9045 K023737. The injector reusable hand piece accepts the cartridges with a sterile single use cartridge which incorporates the folded lens and delivers the lens by using a plunger to express the lens. The plunger's head is contoured to provide a good contact to the lens as well as an adequate clearance for the trailing haptic. The plunger is advanced by direct forward motion applied to the syringe type plunger. Due to the ball bearing technology a smooth and well controlled lens delivery is ensured.
The provided text describes a 510(k) submission for the "Royale AE 9036 LSP" intraocular lens injector. It includes information about tests performed to demonstrate the device's performance, but it does not provide a table of acceptance criteria with corresponding performance metrics in a defined quantitative format, nor does it detail a study that directly proves the device meets specific quantitative acceptance criteria.
The document primarily focuses on verifying the device's functionality and safety through mechanical, optical, and cleaning tests, largely in comparison to a predicate device and relevant international standards.
However, I can extract the relevant information based on the request, even if it's not presented in the exact requested format:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table. Instead, it describes passing various tests to ensure the integrity of the IOL and the cleanliness and safety of the injector. The "reported device performance" is generally stated as "the instrument has passed all the necessary tests successfully."
| Acceptance Criteria (Inferred from tests performed) | Reported Device Performance |
|---|---|
| IOL Integrity (Mechanical & Optical) | IOLs remained mechanically and optically undamaged after manipulation with the AE-9036LSP injector (in combination with one-piece ACRYSOF® acrylic foldable IOLs (SN60WF) and Alcon III Monarch Cartridges). |
| Compliance with ISO 11979-2 (Optical properties) | Passed |
| Compliance with ISO 11979-3 (Mechanical properties) | Passed |
| Compliance with FDA IOL Guidance Document | Passed |
| Device Cleanliness & Biocompatibility | Passed all tests successfully. |
| Acrinol Test (cleanliness by Acrinol staining and light microscopy) | Passed |
| Bio-Burden Test (cleanliness by microbiological methods and light microscopy) | Passed |
| Intra-ocular Irritation Test | Passed |
| Functionality (Lens Delivery) | Smooth and well-controlled lens delivery ensured due to ball bearing technology. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the precise sample size (number of lenses, number of injectors, or number of tests) used for the performance tests. It refers to "the IOLs" and "the instrument" generally.
Data Provenance: Not explicitly stated, but given the manufacturer (ASICO LLC, USA) and the context of a 510(k) submission to the FDA, it is highly probable the testing was conducted in a controlled laboratory environment, likely in the US or by a recognized testing facility. The data appears to be prospective as it describes tests performed specifically for device qualification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. The ground truth in this submission is established through objective laboratory testing (e.g., optical property measurements, mechanical property tests, microbiological analysis, irritation tests) based on recognized international standards (ISO 11979-2, ISO 11979-3) and internal protocols (Acrinol test, Bio-Burden test, Intra-ocular irritation test). It does not involve human interpretation or consensus for establishing the ground truth of a diagnostic outcome.
4. Adjudication Method for the Test Set
Not Applicable. As the tests are objective, laboratory-based evaluations against specified standards or criteria, there is no need for an adjudication method by experts in the typical clinical sense (like 2+1, 3+1). The "adjudication" is inherent in passing or failing the defined test protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The Royale AE 9036 LSP is an intraocular lens injector, a surgical instrument. The evaluation focuses on its mechanical, optical, and biological safety performance, not on human interpretation.
6. Standalone Performance Study (Algorithm Only)
Not Applicable. This device is a manual surgical instrument and does not incorporate an algorithm in the sense of AI or automated analysis. Its "standalone performance" is its functional performance as an injector for IOLs, which was evaluated as described in the "Tests Performed" section.
7. Type of Ground Truth Used
The ground truth used for performance evaluation is based on:
- International Standards: Compliance with ISO 11979-2 (optical properties) and ISO 11979-3 (mechanical properties) for IOLs.
- FDA Guidance Document: Compliance with the FDA IOL Guidance Document.
- Objective Laboratory Test Results: Outcomes of Acrinol staining, microbiological burden assessment, and intraocular irritation tests.
- Visual Inspection/Assessment: For damage to IOLs after manipulation.
8. Sample Size for the Training Set
Not Applicable. This device is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI algorithms. The tests performed are for device verification and validation.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.
§ 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.