(87 days)
The Disposable MicroSTAAR™ Injector (Model MSI-P1) is a device used to fold and insert STAAR Surgical UV-ELASTICT™ silicone lenses for surgical placement in the human eye.
The Disposable MicroSTAAR™ Injector is a device used to fold and insert STAAR Surgical Company UV-ELASTIC™ single-piece silicone lenses for surgical placement in the human eye.
The Disposable MicroSTAART™ Injector (Model MSI-P1) is used to fold and insert STAAR Surgical UV-ELASTICTM silicone intraocular lenses for surgical placement in the human eye. Like other MicroSTAAR injectors it provides a sterile tubular pathway through a surgical incision, over the iris and into either the ciliary sulcus or the capsular bag of the eye. The Disposable MicroSTAART™ Injector (Model MSI-P1) is made from plastic and the inner dimensions of the delivery pathway, as well as the outer dimensions of the portion that contacts the eye tissues are identical to STAAR Surgical Company's currently marketed injection systems. The Disposable MicroSTAART™Injector (Model MSI-P1) is provided sterile and is designed for single use.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Premarket Notification [510(K)] Summary for the Disposable MicroSTAAR™ Injector System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Functional Testing) | Reported Device Performance |
|---|---|
| No optic zone lens tears for properly loaded lenses. | No lens tears were observed. |
| All post-ejected lenses to meet a minimum resolution > 3.6. | All post-ejected lenses met the minimum resolution requirements. |
| Acceptance Criterion (Accelerated Aging Study - Microbial Challenge Dust Drum) | Reported Device Performance |
|---|---|
| All samples and negative controls to be "NEGATIVE". | All samples and negative controls were "NEGATIVE". |
| Positive controls to be "POSITIVE". | Positive controls were "POSITIVE". |
| Acceptance Criterion (Accelerated Aging Study - Dye Penetration) | Reported Device Performance |
|---|---|
| All samples to "Pass". | All samples "Passed". |
| Acceptance Criterion (Accelerated Aging Study - Peel Strength) | Reported Device Performance |
|---|---|
| Sample means and variances for baseline and one-year accelerated samples to be statistically similar (T-test and F-test). | Results indicate sample means and variances are statistically similar. |
| Acceptance Criterion (Accelerated Aging Study - Burst) | Reported Device Performance |
|---|---|
| For large pouch, sample means and variances for baseline and one-year accelerated samples to be statistically similar (T-test and F-test). | Results indicate sample means and variances for the large pouch are statistically similar. |
| For small pouch, no failures. | No failures observed. |
2. Sample Size Used for the Test Set and Data Provenance
- Functional Testing:
- Sample Size: Thirty (30) sterile Disposable MicroSTAAR™ Injectors (Model MSI-P1).
- Data Provenance: Not explicitly stated but implies laboratory testing done by the manufacturer (STAAR Surgical Company) as part of their validation. It is a prospective test, as it's a validation performed for the device.
- Accelerated Aging Study:
- Sample Size: "Baseline (zero time) and one year accelerated samples" were used. The exact number of samples for each specific test (Microbial Challenge, Dye Penetration, Peel Strength, Burst) is not explicitly stated, but it would have been a subset of the manufactured devices.
- Data Provenance: Similar to functional testing, this was likely a prospective laboratory study conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to mechanical device testing like an IOL injector. The "ground truth" here is objective physical measurements and performance thresholds (e.g., absence of tears, resolution measurements, integrity assessments). No human experts were used to establish a ground truth in the sense of image interpretation or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements against predefined criteria, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
Not applicable. This device is a mechanical injector, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a mechanical injector, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests was based on objective, measurable physical characteristics and performance criteria for the device and its packaging. This includes:
- Absence of physical damage: Lens tears.
- Performance metrics: Optical resolution post-ejection.
- Sterility integrity: Microbial challenge results, dye penetration, peel strength, burst strength.
- Statistical similarity: For aging studies, comparing mechanical properties of new vs. aged samples.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a mechanical 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.