(28 days)
The Crystalsert Delivery System is intented 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 a device used for folding and delivering the Crystalens accommodating intraocular lens 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 is a 510(k) summary for the Bausch & Lomb Crystalsert Lens Delivery System (Model CI-26). It primarily focuses on demonstrating substantial equivalence to a predicate device (Model CI-28) through nonclinical bench and laboratory tests.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly "Pass" for all tests, indicating that the device met the established benchmarks for each test. The document emphasizes that the proposed device demonstrated equivalence to the predicate device.
| Item | Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Function Performance | (Before and after insertion) IOL surface & bulk homogeneity | Pass | Pass |
| (Before and after insertion) IOL lens power | Pass | Pass | |
| (Before and after insertion) IOL image quality | Pass | Pass | |
| (Before and after insertion) IOL dimensions | Pass | Pass | |
| IOL delivery outcome | Pass | Pass | |
| Damage to insertion device | Pass | Pass | |
| Coating transfer study | Pass | Pass | |
| Particle counting study | Pass | Pass | |
| Sterilization Verification | Evaluation and rationale for inclusion in "family grouping" of similar devices per ISO11135:2014 and AAMI TIR 28:2009 | Pass | Pass |
| Packaging Verification | Evaluation and rationale for inclusion in "family grouping" of similar devices. | Pass | Pass |
| Product Shelf Life | Evaluation and rationale for inclusion in "family grouping" of similar devices for a one-year shelf life. | Pass | Pass |
| Biocompatibility | Evaluation and rationale was performed per ISO 10993-1:2009 and ISO 10993-18:2005. Components are either the same part or considered to be materially equivalent to parts in the predicate device. As such, no additional biocompatibility testing was warranted or conducted. | Pass | Pass |
| EO/ECH Residuals Transfer Test | Lab testing per ISO 10993-7:2008 with protocols and acceptance criteria previously reviewed by FDA. | Pass | Pass |
| Bacterial Endotoxin Validation | Lab testing per EN ISO 13485:2012 | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Bench tests, laboratory tests, and evaluations were completed on the proposed B+L Crystalsert Lens Delivery System (Model Cl-26). No animal or clinical testing was required for this submission."
- Sample Size: The exact sample sizes for each nonclinical test are not specified in the provided text.
- Data Provenance: The data provenance is from nonclinical bench and laboratory testing. The country of origin of the data is not explicitly stated, but the submitter (Bausch + Lomb) is based in St. Louis, Missouri, USA, implying the testing likely occurred within the US or by US-affiliated labs. The nature of the testing is prospective as it was conducted for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this submission relies solely on nonclinical bench and laboratory testing, the concept of "ground truth" established by human experts in the way it applies to diagnostic or prognostic devices is not directly applicable. The "ground truth" for these tests would be defined by the technical specifications, standards (e.g., ISO, AAMI), and predefined acceptance criteria for each test. The individuals performing and evaluating these tests would be laboratory technicians and engineers, whose qualifications are not detailed but are assumed to be appropriate for conducting such tests.
4. Adjudication Method for the Test Set
As the evaluation is based on objective nonclinical tests against predetermined acceptance criteria, there is no human adjudication method in the sense of a 2+1 or 3+1 design. The results are binary (Pass/Fail) based on direct measurement and comparison to specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No animal or clinical testing was required for this submission." This type of study is relevant for diagnostic imaging or AI devices involving human interpretation, which is not the case here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not an algorithm or AI device. It's a medical device for delivering intraocular lenses. Therefore, a standalone algorithm performance study is not applicable and was not done.
7. The Type of Ground Truth Used
The "ground truth" for the nonclinical tests is based on engineering specifications, established industry standards (ISO, AAMI), and predefined acceptance criteria for each test (e.g., IOL surface homogeneity, lens power, dimensions, sterility, biocompatibility). It is objective and measurable, rather than expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or therapeutic efficacy studies in clinical settings.
8. The Sample Size for the Training Set
Not Applicable. This device is not an AI or machine learning algorithm, so there is no "training set" in the conventional sense. The device itself is manufactured, and its performance is evaluated against engineering and safety standards.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. (See point 8).
§ 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.