(105 days)
The single-use small incision disposable injector (model number R-INJ-06) is intended to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling.
The single-use small incision disposable injector (model number R-INJ-06) is intended 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 small incision injector (model number R-INJ-06) is a plastic, single-use disposable device. The injector components barrel, flap, nozzle, bush and sleeve are made of polypropylene. The plunger is made of polycarbonate. The injector is transparent and the plunger is white.
The provided document is a 510(k) Summary for a medical device (Rayner Single Use Small Incision Disposable Injector R-INJ-06) seeking substantial equivalence to a predicate device. It details non-clinical performance data but does not describe a study to prove acceptance criteria in the typical sense of a clinical trial or a statistically powered study with acceptance criteria for clinical outcomes.
Instead, the "acceptance criteria" discussed are implicitly met by the successful completion of various non-clinical tests. The "study that proves the device meets the acceptance criteria" refers to a series of non-clinical tests outlined in the document, which are used to demonstrate that the new device performs comparably to the predicate and meets safety and performance standards for its intended use.
Here's an breakdown based on the information provided, keeping in mind the limitations of a 510(k) summary for non-clinical data:
1. Table of Acceptance Criteria and Reported Device Performance
Since formal acceptance criteria values (e.g., "tear rate less than X%") are not explicitly stated with numerical targets, the table below lists the performance aspects tested and the general conclusion provided in the summary. The performance is "reported" as meeting these implicit criteria by the statement "The performance data indicates that the Rayner Single Use Disposable Soft Tipped Injector R-INJ-06 delivers those IOL models...without significantly impacting the optical performance, the dimensions or the cosmetic appearance of the lens."
| Acceptance Criteria (Performance Aspect Tested) | Reported Device Performance |
|---|---|
| Biocompatibility | Materials biocompatible/toxicologically safe for intended clinical application (limited exposure duration with device in contact with breached/compromised surface). |
| - Cytotoxicity (ISO 10993-5) | Passed |
| - Maximization Test (ISO 10993-10) | Passed |
| - Intracutaneous Reactivity (ISO 10993-10) | Passed |
| - Acute Systemic Toxicity (ISO 10993-11) | Passed |
| Visual Testing on Injected IOL | No significant impact on IOL visual integrity. |
| - No optic lens tears | Demonstrated |
| - No haptic damage | Demonstrated |
| - Absence of 'Fold lines' / deposits/debris | Demonstrated |
| - Haptic fixation recovery time (11 mm) | Demonstrated |
| Optical Testing on Injected IOL | No significant impact on IOL optical performance. |
| - Modulation Transfer Function (MTF) | Compliance demonstrated |
| - Dioptric power | Compliance demonstrated |
| - Spectral transmittance | Compliance demonstrated |
| Mechanical Testing on Injected IOL | No significant impact on IOL mechanical properties. |
| - Dimensions (per ISO 11979-3 & FDA IOL Guidance) | Compliance demonstrated |
| - Lens sagittal dimension | Compliance demonstrated |
| - Lens overall diameter | Compliance demonstrated |
| - Haptic compression force | Compliance demonstrated |
| - Dynamic fatigue durability | Compliance demonstrated |
| - Limb/loop pull strength | Compliance demonstrated |
| - Optic decentration | Compliance demonstrated |
| - Optic tilt | Compliance demonstrated |
| - Axial displacement | Compliance demonstrated |
| Visual/Mechanical on Injector (Self) | Functionally sound. |
| - Surface finish & dimensional check | Demonstrated |
| - Nozzle tip detachment from barrel/body | Demonstrated |
| Packaging Performance Testing | Maintained sterility and integrity. |
| - Sterility test | Passed |
| - Dye penetration | Passed |
| - Burst Test | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- IOL Testing (Optical and Mechanical): "performed on 10 lenses each of both the highest and lowest powers." This means 20 IOLs were tested for optical and mechanical properties after injection.
- Biocompatibility: The specific sample sizes for each test (Cytotoxicity, Maximization Test, Intracutaneous Reactivity, Acute Systemic Toxicity) are not provided in this summary, only that these tests were undertaken.
- Packaging Performance: Specific sample sizes for Sterility, Dye Penetration, and Burst Tests are not provided.
- Data Provenance: The data is non-clinical, originating from laboratory testing (in vitro/ex vivo). No country of origin for the testing itself is explicitly stated, but the manufacturer is Rayner Intraocular Lenses Ltd. (England). The context is a 510(k) submission to the US FDA, so the tests likely adhere to international standards (e.g., ISO, US Blue Book Memorandum). The data is retrospective in the sense that it was generated prior to submission for regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable for this type of non-clinical device submission. "Ground truth" in this context refers to objective measurements and adherence to established standards (e.g., ISO, FDA guidance documents) rather than expert consensus on subjective observations or diagnoses.
4. Adjudication Method for the Test Set
Not applicable for this type of non-clinical testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases, often involving human interpretation of medical images or symptoms. Here, the tests involve objective measurements and observations against pre-defined engineering and biological criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is an injector for intraocular lenses, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a mechanical injector, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on:
- International Standards: ISO 10993 (biocompatibility), ISO 11979-3 (IOL mechanical and optical properties).
- Regulatory Guidance: US FDA Blue Book Memorandum G95-1 (biocompatibility), FDA IOL Guidance Document Oct 10th 1997.
- Objective Measurements: Visual observations (e.g., absence of tears, haptic damage, fold lines), optical measurements (MTF, dioptric power, spectral transmittance), mechanical measurements (dimensions, compression force, durability, pull strength, decentration, tilt, axial displacement), and standard packaging tests (sterility, dye penetration, burst).
- Predicate Device Comparison: Implicitly, the performance is also compared against the known performance characteristics of the predicate device (Rayner Single Use Soft Tipped Disposable Injector R-INJ-04) to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not a machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no training set for this type of 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.