(30 days)
The MicroSTAAR® Injector System Cartridge, Model CQ is a device intended to fold and insert STAAR Surgical Company Collamer® aphakic 3-piece Intraocular Lenses for surgical placement in the eye.
The MicroSTAAR Injector System Cartridge, Model CQ (also referred as "MicroSTAAR Injector CQ Cartridge" or "CQ Cartridge") is intended to facilitate the loading, folding and insertion of the STAAR Surgical Collamer® 3-piece Intraocular Lens (IOL) into the human eye following cataract extraction. The model CQ Cartridge is a single use device designed specifically to be used with the reusable MicroSTAAR MSI-PM or MSI-TM injector to deliver the STAAR Surgical Collamer® 3-piece (IOL). The CQ Cartridge is composed of polypropylene and is terminally sterilized using Ethylene Oxide.
The provided text describes a 510(k) premarket notification for a medical device called the "MicroSTAAR Injector System Cartridge, Model CQ." This submission is a "Special 510(k) Notification" for a design modification of an already cleared predicate device (K101782). The key modification is in the polypropylene formulation composing the device.
Therefore, the studies and acceptance criteria presented focus on demonstrating that this material change does not negatively impact the device's performance, safety, and effectiveness compared to the predicate.
Here's an analysis of the acceptance criteria and the studies, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric/Condition | Reported Device Performance (Subject Device) | Met? |
|---|---|---|---|
| Material Performance | Lenses must recover to specifications after being folded and deformed by the cartridge (per ISO 11979-3:2012, Section 5). | The change in material formulation does not impact the performance characteristics of the cartridge or lens. Intraocular lenses recovered to specifications. | Yes |
| Shelf-Life Stability | Cartridge performance maintained over stated shelf-life under real-time and accelerated conditions (per ISO 11979-6:2014). | The change in material formulation does not impact the performance characteristic of the cartridge over the stated shelf life. (Study initiated and ongoing) | Yes |
| Biocompatibility | The new material formulation must meet requirements for biological evaluation of medical devices (per ISO 10993-1:2009 and FDA Guidance). | The biocompatibility tests performed on the modified formulation model CQ cartridge met all acceptance criteria. | Yes |
| Intended Use | Device folds and inserts STAAR Surgical Company Collamer® aphakic 3-piece Intraocular Lenses for surgical placement in the eye. | Implicitly met by design; primary focus of studies is on material change, not a change in fundamental function. | N/A* |
| Device Configuration/Usage | Single-use, sterile, Ethylene Oxide (EtO) sterilized, specific packaging. Same as predicate. | Claimed to be identical to predicate beyond material; therefore, implicitly met. No specific performance criteria stated for these aspects. | N/A* |
* N/A here means these were claimed as "same" or design specifications rather than performance metrics requiring specific numeric acceptance criteria and measurement after the material change. The primary focus of the studies was to confirm the material change did not alter the existing performance.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the exact sample sizes (number of cartridges or IOLs) used for each non-clinical test (Recovery of Properties, Biocompatibility, Shelf-Life). It only mentions "validation testing" and "tests performed."
Regarding data provenance:
- The studies were non-clinical (laboratory/bench testing).
- There is no mention of country of origin of data or whether it was retrospective or prospective in the context of human data, as these are bench tests. For the shelf-life study, it states it was "initiated and on-going" for "real time and accelerated conditions," indicating a prospective study design for that specific test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is an intraocular lens injector cartridge, and the studies described are non-clinical (bench testing) to verify material performance, shelf-life, and biocompatibility. There is no "ground truth" established by human experts in the way it would be for diagnostic AI/CADe devices. The "ground truth" is based on established ISO standards and performance specifications for the mechanical and biological properties of the device and lens interaction.
4. Adjudication Method for the Test Set
Not applicable. As described above, the studies are non-clinical, involving physical and chemical testing against established standards. There is no human adjudication process involved.
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 is a physical medical device (an injector cartridge), not an AI/CADe system designed for image analysis or diagnosis. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to this submission.
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 (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for these non-clinical studies is defined by:
- Performance Specifications: The intraocular lenses must recover to their intended specifications after being folded and deformed by the cartridge, as mandated by Section 5 of ISO 11979-3:2012.
- Standard Requirements: The modified material must meet the biocompatibility requirements laid out in ISO 10993-1:2009 and relevant FDA Guidance.
- Stability Standards: The device must demonstrate stability over its stated shelf-life according to ISO 11979-6:2014.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set.
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.