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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. 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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