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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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