(99 days)
The disposable single-use soft tipped injector (model number R-INJ-04) is intended to be used to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling.
The disposable single-use soft tipped injector (model number R-INJ-04) is intended to be used to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling. It is designed to mechanically fold the lens and insert it into the eye during normal, small-incision cataract surgery.
The soft tipped injector (model number R-INJ-04) is a plastic, single-use disposable device.
The injector components barrel, flap, nozzle and bush are made of polypropylene. The plunger is a polypropylene with a soft tip made from a Thermoplastic Elastomer (TPE). The injector is transparent and the plunger has a blue tip.
The provided 510(k) summary for the Rayner Single Use Disposable soft Tipped Injector R-INJ-04 focuses on demonstrating substantial equivalence to a predicate device (Rayner Single Use Disposable Injector R-INJ-02) based on non-clinical performance data. It does not describe a study involving human readers, AI assistance, or expert consensus on image analysis. Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document in the context of AI/human reader studies.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes various non-clinical tests rather than specific acceptance criteria with quantifiable pass/fail values directly linked to a table. However, the overall conclusion of these tests serves as the "reported device performance," aiming to demonstrate that the device delivers IOLs without significant impact on their properties.
| Acceptance Criteria (Implied) | Reported (Implied Device Performance) |
|---|---|
| IOL Integrity (Visual) | No optic lens tears for properly loaded lenses. No haptic damage. Absence of 'Fold lines' and/or deposits/debris on the lens surface. Evaluation of haptic fixation recovery time, to 11 mm diameter dimension. |
| IOL Optical Performance | Satisfactory Modulation Transfer Function, Dioptric power, and Spectral transmittance. (Compliance with applicable optical requirements was demonstrated at 24+/-2 hours post folding/injection). |
| IOL Mechanical Performance | Satisfactory Dimensions (overall diameter, sagittal dimension), Haptic compression force, Dynamic fatigue durability, Limb/loop pull strength, Optic decentration, Optic tilt, Axial displacement. (Compliance with applicable mechanical requirements was demonstrated at 24+/-2 hours post folding/injection). Testing was performed on 10 lenses each of both the highest and lowest powers. The IOL was allowed to return to its original and designed configuration after being folded for a minimum of 3 minutes. The study performed as per FDA IOL Guidance document Oct 10th 1997 and ISO 11979-3, section 4.1. |
| Injector Biocompatibility | The materials (nozzle, plunger tip) were found to be biocompatible/toxicologically safe for the intended clinical application, as per ISO 10993-1 and US Blue Book Memorandum G95-1 (Cytotoxicity, Maximization Test, Intracutaneous Reactivity, Acute Systemic Toxicity). |
| Injector Integrity (Visual/Production) | Satisfactory Surface finish & dimensional check. |
| Injector Integrity (Mechanical) | Satisfactory Nozzle tip detachment from barrel/main body of injector, Tensile testing on bond of the TPE tip to the shaft of the plunger. |
| Packaging Performance | Passing Sterility test, Dye penetration, and Burst Test. |
| Overall conclusion regarding IOL models | The device delivers those IOL models, that allow use of this injector in their approved labeling, without significantly impacting the optical performance, the dimensions or the cosmetic appearance of the lens. |
2. Sample Size Used for the Test Set and Data Provenance:
- IOL Mechanical and Optical Testing: "10 lenses each of both the highest and lowest powers" for mechanical testing (Dioptric power). For other IOL tests (visual, optical, mechanical), the specific sample size is not explicitly stated.
- Biocompatibility Testing: Not specified for individual tests, but conducted on the nozzle and plunger tip materials.
- Injector Visual/Mechanical Testing: Not specified.
- Packaging Performance Testing: Not specified.
- Data Provenance: The studies were conducted by the manufacturer, Rayner Intraocular Lenses Ltd., in the UK (East Sussex, England). The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is an injector, and the testing involves physical and optical properties of the IOL and the injector itself, not interpretation of medical images by experts.
4. Adjudication Method for the Test Set:
Not applicable. This type of adjudication method (e.g., 2+1) is relevant for studies involving human interpretation or clinical endpoints, not for the non-clinical engineering and materials testing described here.
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 document describes a non-clinical study for a medical device (IOL injector), not an AI-assisted diagnostic or interpretative system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests was established by adherence to recognized standards and validated test methodologies:
- IOL Integrity: Based on visual inspection, mechanical measurements (e.g., dimensions, force, recovery time), and optical assessments against established IOL specifications and performance criteria (e.g., FDA IOL Guidance document Oct 10th 1997, ISO 11979-3).
- Biocompatibility: Based on results from standardized tests (Cytotoxicity, Maximization Test, Intracutaneous Reactivity, Acute Systemic Toxicity) according to ISO 10993-1 and the US Blue Book Memorandum G95-1, with findings interpreted against established safety thresholds.
- Injector Integrity & Packaging: Based on visual inspection, dimensional checks, mechanical strength tests, and sterility/integrity tests against defined product specifications and industry standards.
8. The Sample Size for the Training Set:
Not applicable. There is no AI model or training set described in this document.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no AI model or training set described in this document.
§ 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.