(22 days)
The Naviject Sub2-1P IOL Injector and Cartridge Set for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.
The Naviject Sub2-1P IOL Injector and Cartridge Set is a sterile, single-use device intended to fold and insert a STAAR Surgical Visian ICL phakic intraocular lens through surgical procedure in a human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the human eye.
The provided document describes a 510(k) premarket notification for the Naviject™ Sub2-1P IOL Injector Set. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance data in the traditional sense of a clinical trial for a novel AI device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, AI assistance effect size, standalone performance, training set details) are not applicable to this type of submission.
The "acceptance criteria" in this context are the demonstration of substantial equivalence to a legally marketed predicate device, as outlined in the comparison table, rather than quantifiable performance metrics against a predefined threshold. The "study" proving acceptance criteria is the comparison analysis itself.
Here's the information that can be extracted or inferred from the provided text:
1. A table of acceptance criteria and the reported device performance:
| Feature/Acceptance Criteria (Demonstrated Substantial Equivalence To) | Reported Device Performance (Naviject Sub2-1P IOL Injector Set) |
|---|---|
| Product Description: Sterile, single-use device intended to fold and insert a STAAR Surgical Visian ICL phakic intraocular lens through surgical procedure in a human eye, providing a tubular pathway for IOL delivery. | Same as predicate, except for use with different IOLs. |
| Intended Use: Indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling. | Same as predicate, except for use with different IOLs. |
| Design: Syringe type injector with a silicone cushion tip plunger, a cartridge tip, and a loading block. | Device has 3 basic components: a syringe type injector with a silicone cushion tip plunger, a 33° bevel down cartridge tip, and a loading block. (Predicate had a 40° bevel up cartridge tip). |
| Materials: Plastic materials: ABS, Polydimethilsiloxane (Silicone) and Polypropylene with GMS additive. | Same as predicate. |
| Mechanical Safety: Validated for STAAR Surgical phakic Visian ICL intraocular lenses. | Same as predicate, except with different IOLs. |
| Manufacturing: Per internal operating procedures. | Same as predicate. |
| Operating Principle: IOL loaded into cartridge, pushed through cartridge and delivered into human eye through surgical incision. | IOL is loaded into the cartridge, then pushed through the cartridge and delivered into a human eye through a 2.2 mm surgical incision. (Same as predicate). |
| Packaging: Labeled blister trays with Tyvek material lids and boxes. | Same as predicate. |
| Sterility: Sterile (EO). | Same as predicate. |
| Manufacturer: Medicel AG | Same as predicate. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission is based on a comparison analysis to a predicate device, not a performance study involving a patient or clinical test set. The validation for mechanical safety (mentioned in the table) would involve testing the device with the specific IOLs, but no details on sample size or provenance are provided in this regulatory document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth established by experts for a test set is discussed. The "ground truth" for this type of submission is the legally marketed status and characteristics of the predicate device.
4. Adjudication method for the test set:
- Not Applicable. No test set or adjudication method described.
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 is not an AI device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI device.
7. The type of ground truth used:
- Primarily comparison to a legally marketed predicate device's characteristics and intended use. The mechanical safety aspects would have involved bench testing against defined specifications, but the specifics of that "ground truth" are not detailed here beyond "Validated for STAAR Surgical phakic Visian ICL intraocular lenses."
8. The sample size for the training set:
- Not Applicable. This is not an AI device.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI device.
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.