Search Results

The Visian® nanoPOINT™ 2.0 Injector System is a device intended to fold and insert STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses, Model Visian® ICL, for surgical placement in the human eye.

The Visian® nanoPOINT™2.0 Injector System is a sterile, single-use device intended to fold and insert a STAAR Surgical Collamer® Phakic One Piece Intraocular Leas. Model Visian® ICL through surgical procedure in a human eye. The system provides, a tubular pathway through a corneal incision allowing delivery of a phakic IOL into the human eye. This device has 3 basic components: a syringe type injector with a silicone cushion tip plunger, a 33º bevel down cartridge tip and a loading block.

This submission describes a medical device, the Visian® nanoPOINT™ 2.0 Injector System, and its substantial equivalence to a previously cleared device. Therefore, a traditional acceptance criteria and study section as seen with AI/ML devices or novel technologies is not fully applicable. However, I can extract the relevant information from the provided text to structure an answer that addresses your requested categories based on the nature of this 510(k) submission.

Nature of the Device and Submission:

The Visian® nanoPOINT™ 2.0 Injector System is an intraocular lens injector system, a Class I medical device. This 510(k) submission (K101134) is a declaration of substantial equivalence to a predicate device (K092023, Naviject Sub2-1P Injector Set) rather than a novel device requiring extensive de novo clinical trials to prove efficacy against specific acceptance criteria. The key argument for substantial equivalence is that the new device is identical to the predicate device in its technological characteristics, design, materials, and operating principle, with only a modification to the indications for use to specifically name the lens model it is intended for.

Given this, the "acceptance criteria" and "study" are framed around demonstrating that the new device is as safe and effective as the predicate device because it is essentially the same device.

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

The "acceptance criteria" for the Visian® nanoPOINT™ 2.0 Injector System were met by demonstrating its substantial equivalence to the predicate device (K092023, Naviject Sub2-1P IOL Injector Set). The performance reported is that the device is identical to the predicate device in all critical aspects.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical or performance test set. The submission relies on the established performance and safety of the legally marketed predicate device (K092023).
• Data Provenance: The "data" primarily comes from the regulatory clearance of the predicate device (K092023) and an earlier device (K070669) from which the biocompatibility data was carried forward. This is retrospective in nature, drawing from previous approvals and pre-existing validation reports. The country of origin for the earlier validation studies is not specified in this document, but Medicel AG is based in Switzerland.

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

Not applicable. The ground truth for this type of submission is based on regulatory precedent and the established safety and effectiveness of a predicate device, as determined by the FDA. It does not involve expert consensus on new data for this specific submission, beyond the FDA's regulatory review process itself.

4. Adjudication method for the test set

Not applicable. There was no "test set" in the context of clinical or performance testing requiring adjudication. The adjudication was the FDA's regulatory review process determining substantial equivalence.

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 device is not an AI/ML diagnostic tool, nor does it involve "human readers" or "AI assistance." It is a mechanical device for implanting intraocular lenses.

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

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this substantial equivalence determination is regulatory precedent and established safety/effectiveness data of the predicate device. Specifically:

• The Visian® nanoPOINT™ 2.0 Injector System is declared "identical" to the K092023 Naviject Sub2-1P IOL Injector Set.
• Biocompatibility data was inherited from the previously cleared K070669 IOL injector, which was deemed substantially equivalent to K092023.
• Mechanical safety was validated for the specific lens model, building on validations done for the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set with established ground truth.

Ask a specific question about this device