Search Results

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

* 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.

Ask a specific question about this device

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:

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.

Ask a specific question about this device