(200 days)
The Foam Tip™ Injector is a device used to fold and insert STAAR Surgical UV-ELASTIC™ silicone lenses for surgical placement in the human eye.
STAAR Surgical Company's Foam Tip™ Injector is used to fold and insert STAAR Surgical UV-ELASTIC™ silicone intraocular lenses for surgical placement into the human eye. The new Foam Tip™ Injector utilizes the same design principles (i.e. a plunger pushing or threaded mechanism) to push the IOL through a cartridge for injection into the eye as the existing MicroSTAART™ injectors. The new injector system differs from the MicroSTAART™ injector in that it contains a disposable Foam Tip™ plunger insert which may be attached to the sterilized injector body prior to lens loading. This attachable Foam Tip™ plunger insert is encapsulated inside a holder that protects the sponge from damage. The holder acts to guide the plunger as it slides into the injector body and performs as a wrench to remove the plunger from the injector once the lens has been implanted. Once the sponge portion of the foam plunger insert is hydrated, it enables the surgeon to have greater control in ejecting the lens properly through the cartridge and into the eye. Like the existing MicroSTAAR™ injectors, the new Foam Tip™ Injector body is provided sterile and can be resterilized for multiple use. The new Foam Tip™ plunger insert is also provided sterile but is intended for single use only.
Here's an analysis of the acceptance criteria and study detailed in the provided text for the Foam Tip™ Injector System (K980696):
Acceptance Criteria and Device Performance for Foam Tip™ Injector System (K980696)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional Testing) | Reported Device Performance (Functional Testing) |
|---|---|
| No lens tears | No evidence of lens tears |
| All post-ejected lenses meet STAAR's minimum resolution efficiency requirements | All 40 functional test lens ejections passed minimum resolution testing |
| No haptic damage | No evidence of haptic damage |
| Gross particulate evaluation | Particulates were noted in both the Test and Control samples. None appeared to be greater than 10 microns in size. |
Additional Acceptance Criteria and Performance (Accelerated Aging Studies)
| Acceptance Criteria (Accelerated Aging Studies) | Reported Device Performance (Accelerated Aging Studies) |
|---|---|
| Acceptable microbial barrier | Results of Microbial Challenge Dust Drum Test, Dye Penetration and Burst tests indicate both sample groups (baseline versus six month) provided an acceptable microbial barrier and kept product sterile within. |
| Maintained product sterility | Results of Microbial Challenge Dust Drum Test, Dye Penetration and Burst tests indicate both sample groups (baseline versus six month) kept product sterile within. |
| Acceptable seal strength (slight variations) | Slight variations in seal strength were within an acceptable range and did not appear to have compromised the sterile barriers or the integrity of the product. |
| Material non-toxicity | Cytotoxicity tests showed that the material was non-toxic. |
| E-Beam sterilization as an acceptable method | FTIR demonstrated that E-Beam sterilization was an acceptable method of sterilization. |
| Bacterial endotoxins not above FDA limits | LAL testing was performed which indicated that bacterial endotoxins were not above FDA limits, thereby providing acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 40 functional ejection tests were conducted for the functional testing.
- Data Provenance: The text does not explicitly state the country of origin or whether the study was retrospective or prospective. It describes laboratory or in-house testing performed by or for STAAR Surgical Company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the use of "experts" to establish ground truth in the traditional sense of clinical opinion or image interpretation. The ground truth for functional performance (lens tears, haptic damage, resolution efficiency, particulates) was established through direct observation and measurement in a controlled testing environment, likely by trained technicians or engineers.
4. Adjudication Method for the Test Set
Not applicable. The criteria for functional testing were objective and directly observable/measurable (e.g., presence/absence of tears, adherence to resolution requirements). There was no "adjudication" between multiple expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This document describes non-clinical functional and accelerated aging tests of the device itself, not a comparative effectiveness study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical injector system, not an algorithm or AI. The tests performed are standalone in the sense that they evaluate the physical device's performance directly.
7. The Type of Ground Truth Used
The ground truth was established through objective physical measurements and observations within a controlled laboratory setting (e.g., visual inspection for tears/damage, resolution testing, particulate analysis, microbial challenge results, chemical analysis).
8. The Sample Size for the Training Set
Not applicable. This is a non-AI/algorithm device. The concept of a "training set" does not apply to the development and testing of a mechanical injector system in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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.