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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."

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.

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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.

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.

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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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