(71 days)
The MicroSTAAR® Injector System (MSI) is a device intended to fold and insert STAAR® Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement into the human eye.
The MicroSTAAR® Injector System Cartridge (MSI Cartridge) is designed to facilitate the loading, folding and delivery of Collamer® phakic and aphakic intraocular lenses (ICL/IOL) into the human eve through a small incision. There is one model of MSI Cartridge in this submission, SFC-45 cartridge. The SFC-45 Cartridge is designed to lock into a corresponding MicroSTAAR® Injector System. The cartridge has a loading area on one end and a tapered tip on the other. The SFC-45 has a funnel shape, with exposed flat loading areas, and was designed to work with the Collamer® 1piece lenses manufactured by STAAR Surgical.
The provided document is a 510(k) summary for the MicroSTAAR® Injector System Cartridges, specifically concerning a change in the polypropylene material used for manufacturing. The document describes several performance tests conducted to demonstrate that the device, with the new material, is substantially equivalent to its predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Cytotoxicity Test (ISO 10993-5) | Passed. "No evidence of causing cell lysis or toxicity." |
| - Sensitization Test (ISO 10993-10) | Passed. "No evidence of causing delayed dermal contact sensitization in the guinea." |
| - Intraocular Irritation Test (ISO 10993-10) | Passed. "No differences in ocular observations between eyes treated with test article extract and those treated with the control vehicle." |
| Feasibility Test (Device Function/Integrity): | Passed. "Successfully delivered the lenses without any damage to the cartridge." Concluded to be "substantially equivalent to the cartridges manufactured using the current material." |
| Fourier-transform infrared spectroscopy (FTIR) (Material Composition): | Performed. "FTIR resulting spectra showed the typical makeup for the polypropylene copolymer material. The main difference between all materials was related to the amount of additives." (This is a characterization, not a pass/fail, but supports material identity). |
| Shelf-Life (Accelerated Aging): | Passed (1 month accelerated aging). "Comparable to the cartridges manufactured using the current material and passed within the manufacturer's specifications. The delivery of the lenses was smooth and there was no damage to the cartridges or lenses." |
| Sterilization (Sterility Assurance Level - SAL): | Achieved a minimum sterility assurance level of 1 x 10^-6 (probability of less than one non-sterile unit out of each one million units sterilized). Biological indicators indicated no bacteriostatic characteristics. EO/ECH residuals negligible. (Indicates successful sterilization, which is a required characteristic for this medical device type). |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the sample sizes for each individual test (biocompatibility, feasibility, shelf-life, sterilization).
- Data Provenance: The biocompatibility study was performed by "Namsa Laboratory." No country of origin is explicitly mentioned for the data, but the company (STAAR Surgical) is based in the USA, and the material supplier is in Japan. The study is retrospective in the sense that these tests were performed on a device with a modified material to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable to the type of device and studies described. The tests performed are engineering and laboratory-based assessments (e.g., cytotoxicity, material analysis, mechanical function, sterility), not clinical evaluations requiring expert interpretation of diagnostic images or patient outcomes. Therefore, "ground truth" in the sense of expert consensus on clinical data is not relevant here.
4. Adjudication Method for the Test Set:
- Not applicable. As the tests are objective laboratory and functional evaluations, there is no need for an adjudication method as would be used in expert consensus for clinical image interpretation.
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 an intraocular lens injector cartridge, a mechanical device used in surgery, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI effect size are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For biocompatibility, the ground truth is established by standard biological assays and the absence of cytotoxic, sensitizing, or irritating effects as per ISO 10993 standards.
- For feasibility, the ground truth is successful delivery of the lenses without damage, as determined by visual inspection and functional assessment.
- For FTIR, the ground truth is the chemical fingerprint of polypropylene copolymer.
- For shelf-life, the ground truth is the continued functional performance and integrity of the cartridge after accelerated aging, meeting manufacturer's specifications.
- For sterilization, the ground truth is the achievement of the specified Sterility Assurance Level (SAL), demonstrated by biological indicators.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model that requires a training set. The "training" in this context refers to the development and manufacturing processes that establish the device's characteristics.
9. How the ground truth for the training set was established:
- Not applicable. See point 8. The "ground truth" for the device design and manufacturing is established through engineering specifications, material science principles, and adherence to quality system regulations (e.g., 21 CFR 820). The studies described here are verification and validation activities against those established specifications.
§ 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.