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510(k) Data Aggregation
(14 days)
The Crystalsert™ Crystalens® Delivery System is intended to be used to fold and deliver the Crystalens® (AT-50SE, AT-52SE, HD520 and HD500) accommodating intraocular lens into the capsular bag.
The Crystalsert consists of a plunger, body, drawer and inserter tip. All of the components are manufactured with medical grade polypropylene. There is also a stainless steel spring for the plunger return. The plunger tip is 2.8 mm that requires the lens to be folded when delivered. The body has a loading dock area for placement of the lens with forceps with an additional notch to allow for correct haptic placement. Once the lens is placed in the loading dock, the drawer is pressed closed and then the plunger can be depressed to deliver the lens. Finger flanges are also built onto the body to assist in the deliver.
The provided document describes the Crystalsert™ Crystalens® Delivery System, an intraocular lens inserter. It is a 510(k) submission, which means it aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials.
Therefore, the study information requested (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) is not applicable or not provided in this type of submission. 510(k) clearances typically rely on performance testing that demonstrates the device meets its design specifications and functions as intended, aligning with the predicate device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the sense of performance metrics with specific thresholds that would be used in a clinical study to quantify device efficacy (e.g., sensitivity, specificity for a diagnostic device). Instead, it focuses on demonstrating substantial equivalence to a predicate device (MPort (MP-30)) by comparing technological characteristics and intended use. The "performance" assessment is implied through validation activities.
| Feature/Characteristic | Predicate Device (MPort (MP-30)) | Subject Device (Crystalsert Inserter) | Comparison/Assessment |
|---|---|---|---|
| Operating Principle | Lens loaded through loading deck, pushed into position by closing drawer. Lens lays flat. Haptic puller used. Delivered by direct forward motion of syringe-type plunger. Single lens inserted through 3 mm tip, folded when pushed. | Lens loaded into loading dock in unfolded flat state. Put in proper position by closing drawer. No haptic puller necessary. Delivered by direct forward motion of syringe-type plunger. Single lens inserted through 2.8 mm tip, folded when pushed. | Substantially Equivalent: Both operate on the principle of folding and delivering an IOL via a plunger. The Crystalsert has a slightly smaller tip (2.8mm vs 3mm) and eliminates the need for a haptic puller by having a notch in the loading area for correct haptic placement, which could be considered an enhancement while maintaining the core operating principle. |
| Design | Plunger, inserter body, drawer, haptic puller. Loading dock attached to end of body. | Plunger, inserter body, drawer. Loading dock attached to end of body. Additional notch cut in loading area for correct haptic placement. | Substantially Equivalent: Core components are the same. The Crystalsert removed the haptic puller and added a notch in the loading area, a design modification to improve usability while achieving the same function. |
| Material | Medical Grade Polypropylene with PA-208 lubricant. Stainless steel plunger return spring. Silicone plunger O-ring. | Body and drawer: Medical Grade Polypropylene (Huntsman) with 1% InCon GMB#2 Lubricant. Plunger: medical grade polypropylene (BP Amoco). Stainless steel plunger return spring. No plunger O-ring. | Substantially Equivalent: Both use medical-grade polypropylene and stainless steel springs. Differences in specific lubricant, polypropylene supplier, and absence of an O-ring for the Crystalsert are considered minor material differences for a 510(k) submission, likely supported by biocompatibility and performance testing (not detailed here). |
| Intended Use/Indications for Use | The Mport Foldable Lens Placement system is indicated for compressing and inserting a Soflex™ series multi-piece intraocular lens into the eye during small incision cataract surgery. | The Crystalsert™ Crystalens delivery system is intended to be used to fold and deliver the Crystalens® (AT-50SE, AT-52SE, HD520 and HD500) accommodating intraocular lens into the capsular bag. | Substantially Equivalent: Both are IOL delivery systems for cataract surgery. The specific IOL models differ, as the Crystalsert is designed for Crystalens, but the fundamental function (folding and delivering an IOL) is the same. |
| Cleaning/Sterilization Information | EtO sterilized to SAL of 10-6. Single use. 6-month shelf life. | Same | Identical: No differences reported. |
| Validations (IOL/Viscoelastic compatibility) | Validated for use with LI61U, LI51U, C31UB and Silens6/Soflex 2. Bausch & Lomb Ocucoat Viscoelastic and Amvisc viscoelastics can used. | Validated with Crystalens models AT-50SE or AT-52SE and validated with Bausch & Lomb Viscoelastic Amvisc Plus. | Functionally Equivalent: Both are validated for specific IOLs and viscoelastics. The specific models differ, as expected, given the Crystalsert's intended use with Crystalens. This indicates internal testing was performed to ensure compatibility and proper function for its indications. |
2. Sample size used for the test set and the data provenance
- Not applicable / Not provided. As a 510(k) submission for an IOL delivery system, the "test set" would typically refer to the various IOLs and viscoelastic materials validated for use with the device and performance testing to ensure the device consistently delivers these IOLs without damage. Specific sample sizes for such tests are not detailed in this summary. Data provenance is also not specified as there are no clinical trials mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. Ground truth, in the context of diagnostic device validation, is not relevant here. For a device like an IOL inserter, the "truth" is whether it successfully delivers the IOL undamaged, which is determined through engineering and performance testing.
4. Adjudication method for the test set
- Not applicable / Not provided. Adjudication methods are typically used in clinical studies with human readers/assessors. For a mechanical device, performance is evaluated against defined specifications.
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 / Not provided. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of results. This device is an IOL delivery system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is also relevant for AI-powered diagnostic devices. The Crystalsert is a mechanical delivery system. Its "standalone performance" would be assessed by its ability to reliably fold and insert an IOL, which is implied by the "Validations" section.
7. The type of ground truth used
- Not applicable / Not provided. For this type of device, ground truth would be synonymous with demonstrable mechanical performance and successful, undamaged IOL delivery, established through bench testing and engineering validation, rather than expert consensus, pathology, or outcomes data from a clinical trial.
8. The sample size for the training set
- Not applicable / Not provided. Training sets are used for machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable / Not provided. Training sets are used for machine learning algorithms.
In summary, this 510(k) submission focuses on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics, materials, and intended use, supported by internal validation testing (e.g., IOL compatibility). It does not involve the types of clinical studies or AI-related assessments that would provide the requested information about sample sizes, expert ground truth, or reader studies.
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