(310 days)
The Collamer 3 Piece IOL Injector, is an intraocular lens guide used to ford and into the capsular bag or ciliary sulcus following cataract extraction.
The Collamer 3 Piece Injector is made of titanium alloy designed for inserting intraocular lenses into the human eye following cataract extraction. The Collamer 3 Piece Injector materials and mechanical behavior are similar to those used with the predicate device.
The provided document is a 510(k) summary for the STAAR Surgical Collamer 3 Piece Injector, and it describes a medical device (injector), not an AI/ML powered device, therefore most of the requested information (like acceptance criteria for an AI model, sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this document.
However, I can extract the information relevant to the device's performance based on the provided text, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's the relevant information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical performance equivalent to predicate device | The Collamer 3 Piece Injector was found to perform equivalently to the predicate device, the MS1-P Elastic Lens Injector, with respect to mechanical performance. |
| Mechanical behavior equivalent to predicate device | The Collamer 3 Piece Injector was found to perform equivalently to the predicate device, the MS1-P Elastic Lens Injector, with respect to mechanical behavior. |
| Designed and tested in accordance with applicable safety standards | The Collamer 3 Piece Injector has been designed and tested in accordance with applicable safety standards. |
2. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing an AI/ML algorithm's performance on a dataset. The testing described is non-clinical mechanical performance testing of a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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/ML device.
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 AI algorithm.
7. The type of ground truth used: Not applicable. The "ground truth" in this context would be the objective measurements and observations of the physical device's mechanical performance and behavior, compared to a predicate device and safety standards.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Summary of the Study:
The study described is a non-clinical test to demonstrate the substantial equivalence of the Collamer 3 Piece Injector to its predicate device, the MS1-P Elastic Lens Injector (K861085). The study focused on validating the mechanical performance and mechanical behavior of the new injector.
The device meets the (implicit) acceptance criteria because the non-clinical tests showed that it performs equivalently to the predicate device in terms of mechanical performance and behavior, and it was designed and tested in accordance with applicable safety standards. The FDA's clearance letter (K032412) confirms that the device is substantially equivalent, allowing it to be marketed.
§ 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.