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The Rayner Injectors (Models STW01 and RSP01) are intended to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labeling.

The Rayner Injectors are devices for folding and delivering Rayner C-flex intraocular lenses (models 570C and 970C), and other IOLs indicating the use of the Rayner Injectors in their approved labeling into the eye. The Rayner Injectors consist of a syringe shaped body and nozzle, with a soft tipped plunger, and a loading bay closed in use with a mobile flap. The Rayner Injectors are sterile, disposable plastic devices, with a narrow diameter circular lumen through which the IOL can be introduced into the eye in a single continuous action. Rayner Injectors are designed for single use only.

This document describes the Rayner Injectors (Models STW01 & RSP01), which are intraocular lens (IOL) folders and injectors. The submission is a 510(k) premarket notification, indicating the intent to market the device by demonstrating its substantial equivalence to a legally marketed predicate device.

The information provided does not include details of a clinical study or detailed performance acceptance criteria in the way one might expect for an AI algorithm or a diagnostic device. Since this is an intraocular lens guide (Class I device), the evidence for substantial equivalence primarily relies on design, material, and functional comparisons to a predicate device, along with verification and validation testing, usually non-clinical.

Therefore, many of the requested points regarding acceptance criteria and study details (like sample size for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable (N/A) in the context of this 510(k) submission for a Class I medical device like an IOL injector. These types of detailed studies are more common for higher-risk devices or software as a medical device (SaMD) where clinical performance or diagnostic accuracy is the primary concern.

However, I will extract and present the relevant information that is available in the document.

Acceptance Criteria and Reported Device Performance

The document states that the Rayner Injectors are substantially equivalent to the predicate device (Single Use Soft Tipped Disposable Injector, Model R-INJ-04). Substantial equivalence itself serves as the overarching "acceptance criterion" for a 510(k) submission.

The specific characteristics compared, which inherently function as acceptance criteria for demonstrating equivalence, are detailed in the "Comparison of Devices" table. The device meets these criteria by being identical or having minor differences that do not raise new questions of safety or effectiveness.

Study Information (Based on the provided document):

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical performance evaluation. For devices like this, testing typically involves mechanical, material, and sterilization validation, which would involve samples but not in the same way as a diagnostic test.
   • Data Provenance: The submission is from Rayner Intraocular Lenses Ltd., located in the United Kingdom. The testing data would likely originate from their internal R&D and quality assurance processes, conducted in the UK. This is prospective for the device's development but not a retrospective analysis of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. For a mechanical device like an IOL injector, "ground truth" as it applies to diagnostic accuracy from expert interpretation is not relevant. Performance is established through engineering and material testing standards.

3. Adjudication method for the test set:

   • N/A. Adjudication methods are relevant for subjective interpretations by experts (e.g., image reading). This device's performance is objectively measured.

4. 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:

   • N/A. This is a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not applicable.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. This is a physical medical device, not an algorithm. Therefore, standalone algorithm performance is not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the aspects considered in this submission (material compatibility, sterility, shelf-life, and mechanical function), the "ground truth" is derived from established engineering standards, biocompatibility testing, sterilization validation protocols, and physical testing (e.g., force required for injection, IOL integrity after injection). It's not based on expert clinical consensus or pathology in the diagnostic sense, but rather objective measurement against predefined specifications.

7. The sample size for the training set:

   • N/A. There is no "training set" in the context of AI or machine learning for this device. Device development involves iterative design, prototyping, and testing, but not in a "training set" paradigm.

8. How the ground truth for the training set was established:

   • N/A. As there is no training set, this is not applicable.

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The RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model R-INJ-10) is intended to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labeling.

The RaySert PLUS Small Incision Single Use Soft-Tipped Injector is a device for folding and delivering Rayner C-flex intraocular lenses (models 570C and 970C), and other IOLs indicating the use of the RaySert PLUS in their approved labeling into the eye. The RaySert PLUS consists of a syringe shaped body and nozzle, with a soft tipped plunger, and a loading bay closed in use with a mobile flap. The RaySert PLUS is a sterile, disposable plastic device, with a narrow diameter circular lumen through which the IOL can be introduced into the eye in a single continuous action. RaySert PLUS is designed for single use only.

This document describes a 510(k) premarket notification for the RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model R-INJ-10). The submission aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative performance metrics with defined thresholds. Instead, it focuses on demonstrating substantial equivalence by comparing characteristics of the subject device to a legally marketed predicate device (K132002). The "reported device performance" is implicit in the statement of equivalence for each characteristic.

2. Zonular insufficiency. | 1. Vitreous in the anterior chamber.
3. Zonular insufficiency. (Identical to predicate) |
   | Materials | Barrel: Polypropylene
   Flap: Polypropylene
   Nozzle: Polypropylene
   Plunger tip: TPE, Santoprene
   Plunger shaft: Polypropylene
   Guide Bush (x 2): Polypropylene | Barrel: Polypropylene
   Flap: Polypropylene
   Nozzle: Polypropylene
   Plunger tip: TPE, Santoprene
   Plunger shaft: Polypropylene
   Guide Bush (x 2): Polypropylene (Identical to predicate) |
   | Number of Uses | Single Use | Single Use (Identical to predicate) |
   | Sterility | Supplied Sterile | Supplied Sterile (Identical to predicate) |
   | Sterilization Method | Ethylene Oxide | Ethylene Oxide (Identical to predicate) |
   | Sterility Assurance Level | 10^-6 | 10^-6 (Identical to predicate) |
   | Shelf Life | 5 Years | 2 Years (with protocol in place to extend to 5 years as testing is completed) (Subject device has temporary shorter shelf life with plans to extend upon further testing) |

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

The document does not describe any specific clinical or performance test set, sample size, or data provenance (e.g., country of origin, retrospective or prospective) for demonstrating efficacy or safety. The submission focuses on demonstrating substantial equivalence through comparison of device characteristics and intended use with a predicate device.

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

This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set. The submission is based on a comparison to a predicate device's existing regulatory approval.

4. Adjudication Method for the Test Set

This information is not applicable as the document does not describe a study involving adjudication of a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned in this submission. This type of study would be relevant for assessing the impact of AI on human readers, which is not the subject of this 510(k) submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study of an algorithm was not done and is not mentioned in this submission. This device is a manual, single-use surgical instrument, not an AI or algorithmic medical device.

7. The Type of Ground Truth Used

The concept of "ground truth" as it relates to expert consensus, pathology, or outcomes data is not applicable to this 510(k) submission. The "truth" or basis for approval here is the previously established substantial equivalence and safety/efficacy profile of the predicate device, to which the subject device is being compared.

8. The Sample Size for the Training Set

This information is not applicable as the document does not describe any machine learning or AI algorithm development that would involve a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set mentioned in the document.

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The single use disposable injectors (Model R-INJ-04 and Model R-INJ-04/18) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling.

There are two types of Rayner disposable single use soft tipped injectors (Model R-INJ-04 and Model R-INJ-04/18). They are the same except Model R-INJ-04 has a 2.0 mm diameter nozzle and Model R-INJ-04/18 has a 1.8 mm nozzle. The size is indicated on the barrel flap of the respective injectors by 1.8 or 2.0 embossed texts. The injectors are assembled from a nozzle, barrel, flap, guide bushes and plunger components which are made of polypropylene material. The plunger has a thermoplastic elastomer soft tip at one end. The injectors are supplied sterile.

The provided document describes the non-clinical performance data for the Rayner Injectors (Model R-INJ-04 and Model R-INJ-04/18), comparing them to a predicate device. This is a 510(k) submission, focused on demonstrating substantial equivalence, and therefore the study design is centered on confirming that the new devices perform as well as the predicate and meet established specifications.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Description:

The study conducted was a series of non-clinical performance tests designed to demonstrate that the Rayner Injectors (Model R-INJ-04 and Model R-INJ-04/18) are safe, effective, and perform as well as (or better than) the predicate device. The focus was on comparing the technical characteristics and test results of the new devices with a previously cleared predicate device (K091507).

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

• Sample Size for Test Set: The document does not explicitly state the exact sample sizes for each individual test (e.g., number of injectors or lenses tested for mechanical integrity, optical performance, etc.). It generally states that "tests were completed" and "pre and post injection tests have been completed."
• Data Provenance: The data is non-clinical performance data, generated from laboratory testing of the devices. The document does not specify the country of origin for the testing, but the manufacturer is based in the UK. The studies are prospective in the sense that they were designed and executed to evaluate the new devices.

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

This type of study does not involve human experts establishing ground truth in the way a clinical study would (e.g., expert radiologists reviewing images). The acceptance criteria (ground truth) for mechanical, visual, and optical performance are established by pre-determined specifications based on international standards (ISO 11997-3) and internal engineering/quality requirements. The "experts" involved would be the engineers, technicians, and quality control personnel who perform and analyze these tests, ensuring adherence to the established protocols and standards. Their qualifications would be in engineering, materials science, optics, and quality assurance, but specific details are not provided.

4. Adjudication Method for the Test Set

Not applicable for this type of non-clinical, specification-based testing. Performance is measured against objective, quantitative, or qualitative (e.g., "no visible damage") criteria as defined by standards and internal procedures, not through expert adjudication of subjective findings.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not conducted. This is a non-clinical 510(k) submission, which focuses on device performance and substantial equivalence rather than comparative clinical effectiveness with human readers.

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

This question is not applicable. The device is a medical injector, not an algorithm or AI system. The performance evaluated is the physical function and characteristics of the injector and its impact on the intraocular lens.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on engineering specifications, international standards (specifically ISO 11997-3), and predefined performance criteria. For example, biocompatibility is based on passing specific biological tests, sterility on achieving a defined SAL, and optical/mechanical performance on meeting specified tolerances for MTF, power, dimensions, and visual integrity.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

Not applicable, as there is no training set.

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The disposable single use soft tipped small incision injector (model number R-INJ-04/18) is intended to be used to compress and insert into the capsular bag only those IQL models that allow use of this injector in their approved labelling.

The single use small incision disposable injector (model number R-INJ-04/18 is intended to be used to compress and insert into the capsular bag only those intraocular Lenses that allow use of this injector in their approved labelling. It is designed to mechanically fold the lens and insert it into the eye during normal, small incision (1.8mm) cataract surgery. The small incision injoctor (model number R-1NJ-04/18 is a plastic single use disposable device. The injector components harrel, flap, nozzle, bush and sleeve are made of polypropylene. The plunger is made of polycarhonate. The injector is transparent and the plunger is white.

Here's an analysis of the provided text regarding the Rayner Single Use Small Incision Disposable Injector R-INJ-04/18, structured to answer your questions about acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document states: "Mechanical testing was completed to ensure that the injector functioned according to the requirements."

• Sample Size: The document does not specify the sample size used for the mechanical testing or any other tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the manufacturer's location (Hove, East Sussex, UK) and the submission to the FDA, the testing was likely conducted in the UK or a facility approved by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not provide any information on the involvement of experts for establishing ground truth. The testing described is "mechanical testing," which implies objective, measurable parameters rather than expert-derived ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not mention any adjudication method for test results. Mechanical testing typically involves predefinedPass/Fail criteria for objective measurements, rather than subjective agreement among adjudicators.

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

This section is not applicable to the provided document. The device is a mechanical injector for intraocular lenses, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study regarding AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable to the provided document. The device is a mechanical injector. There is no algorithm involved to perform in a standalone capacity. The "performance" described is the physical interaction of the device with an IOL and its insertion into a model or cadaveric eye as part of mechanical testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "mechanical testing," the "ground truth" would likely be:

• Engineering specifications/measurements: Confirmation that the injector could successfully compress and insert the specified IOL models through a 1.8mm incision without deforming the IOL or encountering excessive resistance, as per design requirements.
• Visual inspection: "Visually observe that the lens is symmetrically folded within the loading bay" and for any trapped parts of the optic or haptics.
• Functional outcome: Successful insertion of the IOL into a model or cadaveric capsular bag.

The document does not explicitly state these as "ground truth" but these are inferred based on the description of mechanical testing and device function.

8. The sample size for the training set

This section is not applicable. The device is a mechanical injector, not a machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an AI model. The device underwent design, development, and testing according to established procedures.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

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