(180 days)
The MicrSTAAR™ MSI Injector System is a device intended to fold and insert STAAR™ Surgical Company Collamer phakic and aphakic one-piece and three-piece Collamer® intraocular lenses for surgical placement in the eye.
The injector system is designed to facilitate the loading, folding and delivery of an intraocular lens (IOL) into the human eye through a small incision. The MicroSTAAR™ MSI injector System Cartridge utilizes three different cartridges for the insertion of an IOL lens. The three cartridges; CQ cartridge, SFC-45 cartridge and the SFC-25 cartridge are designed to facilitate a folded IOL lens for delivery. Each cartridge has a loading area which tapers down to a small tip, for the SFC-45 and SFC-25 cartridges, the lens loading area is flat and for the CQ cartridge the loading area is hinged. It is a component that is fabricated from polypropylene mixed with Glycerol Monostearate (GMS). Currently, the cartridge is cleared for fabrication from polypropylene mixed with GMS and is supplied sterile.
The provided text describes the MicroSTAAR™ (MSI) INJECTOR SYSTEM CARTRIDGES, a Class I device (Intraocular Lens Injector Cartridge). The submission is a 510(k) premarket notification, which seeks to establish substantial equivalence to predicate devices, rather than prove efficacy through extensive clinical studies with acceptance criteria based on performance metrics like sensitivity, specificity, or reader improvement.
Therefore, the requested information regarding detailed acceptance criteria, specific study designs (like MRMC or standalone), sample sizes for test and training sets, and expert-established ground truths for performance evaluation of a diagnostic or AI-driven device is not applicable to this submission.
This document focuses on demonstrating substantial equivalence based on technological characteristics, intended use, and materials.
Here's an attempt to answer the questions based on the available information, highlighting where the requested details are not present for this type of device submission:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission for a Class I device like the MicroSTAAR™ (MSI) INJECTOR SYSTEM CARTRIDGES, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to predicate devices. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Performance is evaluated in terms of meeting functional requirements and material specifications comparable to the predicate.
General "acceptance criteria" for demonstrating substantial equivalence for this type of device would typically revolve around:
- Identical Intended Use: The device must have the same intended use as the predicate.
- Similar Technological Characteristics: The device must have similar design, materials, operating principles, and manufacturing processes as the predicate.
- No New Questions of Safety or Effectiveness: Any differences in technological characteristics must not raise new questions of safety or effectiveness.
- Functional Equivalence: The device must perform its intended function equivalently to the predicate.
The provided document extensively details the "Comparison Analysis" which serves as the "study" to prove the device meets these substantial equivalence criteria.
| Acceptance Criteria Category | Reported Device Performance (vs. Predicate Devices) |
|---|---|
| Intended Use | Same: Intended to fold and insert STAAR Surgical Company 1-piece and 3-piece Collamer intraocular lenses for surgical placement in the human eye. (Compared to predicate K940593, K980696, K073586 having the same intended use for 1-piece or 3-piece Collamer IOLs, and K090161 for 3-piece Silicone IOLs, with the MSI aligning more closely with the Collamer IOLs). |
| Product Description | Same: System is designed to facilitate the loading, folding and delivery of an IOL into the human eye through a small incision. |
| Design | Same: Single cartridge to be used in conjunction with appropriate injector system and 1-piece or 3-piece Collamer lenses for surgical placement of lens into eye. |
| Materials | Same: Cartridge is manufactured from Polypropylene MG05 and Polypropylene MG03 purchased from Japan Supplier. (While predicate K940593, K980696, K073586 used US Supplier material, the new device uses the same material and supplier as predicate K090161). The document states "Cartridge is fabricated from polypropylene mixed with Glycerol Monostearate (GMS)." |
| Operating Principle | Same: The IOL is either placed into the loading area and folded shut or pressed forward towards the tip, then the cartridge is loaded onto the injector. (Similar to predicate devices). |
| Manufacturing | Similar: Utilization of contract manufacturers and in-house processing at STAAR Japan facility, while molding process is still done by a US contractor. (Similar to predicate K090161 which used STAAR Japan facility, and predicate K940593, K980696, K073586 which used US contract manufacturers and Monrovia facility). |
| Packaging | Similar: Cartridge is placed in tray, sealed with Tyvek lid and labeled. Tray is placed in Kraft paper pouch. Japanese Packaging supplier. (Similar to predicate K090161 which used Japanese Packaging Supplier; differing from predicate K940593, K980696, K073586 which used US Packaging Supplier and included a foil pouch). Differences are not deemed to raise new questions of safety/effectiveness as sterility is maintained. |
| Sterility | Same: Sterile Ethylene Oxide (EtO) by STAAR Japan. (Similar to predicate K090161; differing from predicate K940593, K980696, K073586 which used Subcontractor EtO. The method (EtO) is the same, only the facility differs, which is typically controlled by validated processes). |
| Manufacturer | Same: STAAR Japan (Similar to predicate K090161; differing from predicate K940593, K980696, K073586 which was STAAR Surgical. The critical point is that the processes are controlled/validated). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) submission for a Class I medical device, particularly for an IOL injector cartridge, does not typically involve a "test set" in the context of clinical performance data or AI model evaluation. The submission relies on comparative analysis of technological characteristics and safety data, often through bench testing (not detailed here) and biocompatibility, rather than human subject testing to establish performance metrics. The data provenance is generally from the device manufacturer or its suppliers as outlined in the "Manufacturing" and "Materials" sections.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As explained above, there is no "test set" or "ground truth" established by experts in the context of diagnostic accuracy for this type of device submission. The FDA reviews the technical documentation and comparison to predicates.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no "test set" requiring adjudication in this context.
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 not an AI-driven or diagnostic device. Therefore, MRMC studies and AI assistance effect sizes are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For this type of device, "ground truth" is not established in the clinical diagnostic sense. Instead, the "truth" is whether the device meets its design specifications, performs its intended function reliably, and is safe for use when compared to already-marketed predicate devices. This is typically established through engineering tests, material analyses, and biocompatibility assessments, which are not detailed in this summary document beyond the characteristics comparison.
8. The sample size for the training set
- Not Applicable. This is not an AI-driven device, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI-driven device, so there is no training set and therefore no ground truth for it.
In summary, this 510(k) notification focuses on demonstrating that the MicroSTAAR™ MSI Injector System Cartridges are "substantially equivalent" to existing legally marketed devices. The "study" that proves the device meets the acceptance criteria is the detailed "Comparison Analysis" presented in the document, which systematically compares the new device's intended use, technological characteristics, and safety aspects against predicate devices. The approval letter from the FDA confirms that this comparison was deemed sufficient to establish substantial equivalence.
§ 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.