(29 days)
The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lens identifying the Crystalsert Delivery System in their approved labeling.
The Crystalsert Delivery System is a device used for folding and delivering the Crystalens accommodating intraocular lens (AT-52SE, AT-50SE, HD520, HD500, AT50AO, AT52AO), Trulign™ Toric, and other IOLs indicating use of the Crystalsert Delivery System in their approved labeling into the eye. The Crystalsert Delivery System consists of a syringe shaped body and tip with a plunger and drawer. The Crystalsert Delivery System is a sterile, disposable plastic device, with a small tubular pathway in which the lens can be placed into the eye with one continuous motion, designed for single use only.
The provided document describes the Bausch & Lomb Crystalsert Delivery System, an intraocular lens guide. It outlines the device's description, indications for use, and a comparison to a predicate device. However, the document does not contain a study that proves the device meets specific acceptance criteria in the format typically expected for clinical or performance studies with quantitative results.
Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (K123736, Crystalsert Delivery System) based on similar indications for use, contraindications, materials, single-use nature, sterility, sterilization method, sterility assurance level, and shelf life.
The "Brief Summary of Nonclinical Test and Results" section states: "The Crystalsert Delivery System has successfully undergone functional and biocompatibility testing and was found in conformance with the requirements set forth in respective standards." However, it does not provide specific acceptance criteria or the reported device performance from these tests. The details of these tests (e.g., sample sizes, methodology, and quantitative results) are not included in this summary document.
Therefore, most of the requested information regarding acceptance criteria and a study demonstrating the device meets these criteria cannot be extracted from the provided text.
Here's an attempt to answer the questions based only on the information available in the provided text, with explicit notes where information is missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit, quantified acceptance criteria with corresponding performance data from a specific study. Instead, it relies on demonstrating equivalence to a predicate device by matching various characteristics.
| Characteristic | Predicate (Acceptance Basis - assumed "meets predicate") | Proposed Device Performance (Reported as equivalent) |
|---|---|---|
| Indications for use | The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert Delivery System in their approved labeling. | The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert Delivery System in their approved labeling. |
| Contraindications | None | None |
| Materials | Body, drawer, plunger: polypropylene; Spring: stainless steel | Body, drawer, plunger: polypropylene; Spring: stainless steel |
| Single use | Single use | Single use |
| Sterile | Sterile | Sterile |
| How sterilized | Ethylene oxide | Ethylene oxide |
| Sterility assurance level | 10-6 | 10-6 |
| Shelf life | 12 months | 12 months |
| Functional and biocompatibility testing | "successfully undergone functional and biocompatibility testing and was found in conformance with the requirements set forth in respective standards." (Specific criteria and results not provided) | "successfully undergone functional and biocompatibility testing and was found in conformance with the requirements set forth in respective standards." (Specific criteria and results not provided) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified in the provided summary. The summary only states that "functional and biocompatibility testing" was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The document describes a medical device (an IOL delivery system), and the testing mentioned (functional, biocompatibility) typically involves engineering and laboratory assessments against standards, rather than expert-derived ground truth as might be seen in diagnostic AI.
4. Adjudication method for the test set
Not applicable and not provided, as the tests mentioned are functional and biocompatibility, not expert-based assessment requiring adjudication.
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 a delivery system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical delivery system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the functional and biocompatibility testing, the "ground truth" would be adherence to established industry standards or internal specifications for mechanical performance and biological safety. The specific standards or specifications are not detailed in this summary.
8. The sample size for the training set
Not applicable. This device is a physical product, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a physical product, not an AI algorithm.
§ 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.