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The disposable single-use injector (model number R-INJ-02) 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 injector (model number R-INJ-02) 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 injector is designed to mechanically fold the lens and insert it into the eye during normal, small-incision cataract surgery. The disposable single-use injector is a plastic, single-use disposable device. The injector components barrel, flap, nozzle and bush are made of polypropylene, and the plunger is polycarbonate. The Spring is stainless steel. The injector is transparent and the plunger white in color.

The provided text describes a 510(k) premarket notification for a medical device called the Rayner Single Use Disposable Injector R-INJ-02. The document focuses on demonstrating substantial equivalence to a predicate device and outlines non-clinical performance data.

Crucially, the document does not detail specific "acceptance criteria" for the device's performance in terms of numerical thresholds or metrics that would be compared to reported device performance in a table. Instead, the non-clinical performance data section describes the types of tests conducted to ensure the device performs as intended and does not negatively impact the intraocular lens (IOL) it injects.

Therefore, I cannot generate a table of acceptance criteria and reported device performance as it is not present in the provided text.

Here's an analysis of the other requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, the document does not provide a table with explicit numerical acceptance criteria and corresponding reported performance values. It describes categories of tests and general conclusions about successful performance.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: For "Optical Testing" and "Mechanical Testing" of the injected IOL, the document states: "Testing as per FDA IOL Guidance document Oct 10th 1997, was performed on 10 lenses each of both the highest and lowest powers." This suggests a test set of 20 lenses for these specific tests. Other tests (biocompatibility, visual, packaging) do not specify sample sizes, but mention "testing on the final packaged and terminally sterilized Single Use Disposable Lens Injector" for biocompatibility.
• Data Provenance: Not explicitly stated, but the submission is to the US FDA and references US FDA guidance documents, implying the testing was conducted in a manner compliant with US regulations. There's no mention of specific countries of origin for the data itself or whether it was retrospective or prospective. Given the nature of a 510(k) for a new device, the testing would generally be prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. This device is an injector, not a diagnostic tool that relies on expert interpretation of imaging or other medical data to establish ground truth. The "ground truth" for its performance relates to objective physical, optical, and biological parameters (e.g., IOL integrity, successful injection, biocompatibility).

4. Adjudication Method for the Test Set:

Not applicable. Since the device does not involve subjective interpretation or diagnosis, there is no mention of adjudication methods like 2+1 or 3+1. Performance is assessed against objective physical and chemical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. An MRMC study is designed for evaluating the performance of diagnostic devices often involving human readers. This document describes a medical device for injecting IOLs and focuses on non-clinical performance data. No human-in-the-loop performance or comparison with human readers is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an AI/algorithm-based diagnostic device. The performance evaluated is of the physical injector device itself.

7. The Type of Ground Truth Used:

• Biocompatibility: Established through standard ISO 10993 series and US Blue Book Memorandum G95-1 tests (Cytotoxicity, Maximization Test, Intracutaneous Reactivity, Acute Systemic Toxicity). The "ground truth" is that the materials are "biocompatible/toxicologically safe."
• Visual, Optical, and Mechanical Testing on Injected IOL: The "ground truth" is established by comparing the injected IOLs to "non-injected lenses" (control lenses). The goal is "without significantly impacting the optical performance, the dimensions or the cosmetic appearance of the lens."
  • Visual: No optic lens tears, no haptic damage, absence of 'fold lines'/deposits/debris, evaluation of haptic fixation recovery time. This implicitly compares to an undamaged, clean IOL.
  • Optical: Modulation Transfer Function, Dioptric power. Compared to the expected optical properties of the IOL.
  • Mechanical: Dimensions, Optic decentration, Optic tilt, Dynamic fatigue durability, Limb/loon pull strength, Compression force, Axial displacement. Compared to the expected mechanical properties and integrity of the IOL. Compliance was demonstrated "at 24+/-2 hours post folding/injection" with "applicable mechanical and optical requirements" (referenced ISO 11979-3 and CDRH IOL Guidance Document Oct 10th 1997).
• Visual and Mechanical Testing on the Injector: Surface finish & dimensional check, no nozzle tip detachment, no bush detachment. The "ground truth" is that the injector maintains its structural integrity and specified dimensions.
• Packaging Performance Testing: Sterility, dye penetration, burst test. The "ground truth" is that the packaging maintains product sterility and integrity.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The performance evaluation is based on non-clinical testing of the physical device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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