(234 days)
The Medicel IOL Injector Set and Cartridge for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.
The Medicel IOL Injector Set for intraocular lenses is intended to insert foldable intraocular whose labeling specifies this injector. The injector is available as reusable or single-use. The cartridge is single-use and is provided sterile. The device has two basic components: an injector (available either reusable or single use) and a disposable cartridge, sold sterile. The single-use injector is made of plastic and is sold sterile. The re-usable injector is made of titanium and can be autoclaved. The cartridge is made of lubricated polypropylene.
The provided document is a 510(k) summary and FDA clearance letter for a medical device: the Medicel A.G. IOL Injector Set. This submission is for a traditional medical device, not an AI/ML-enabled device. Therefore, the questions regarding acceptance criteria, study details, and performance metrics related to AI/ML are not directly applicable to this document.
However, I can extract the information relevant to the device's performance testing as described in the document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It indicates that the device was tested for biocompatibility and compatibility with recommended intraocular lenses.
| Acceptance Criteria (Inferred from document) | Reported Device Performance |
|---|---|
| Biocompatibility | All contact materials have been tested for biocompatibility. |
| Compatibility with IOLs | The device was tested with each of the recommended intraocular lenses. |
| Safety and Efficacy (vs. predicate) | The IOL Injector Set is equivalent in safety and efficacy to the legally marketed predicate devices. |
Regarding the other questions, they are not applicable or cannot be answered from the provided document as it concerns a traditional medical device, not an AI/ML product.
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 for this traditional medical device. The document mentions "The device was tested with each of the recommended intraocular lenses" but does not specify a sample size for these tests or data provenance.
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. This is not an AI/ML device relying on expert-established ground truth.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The performance is based on physical testing and comparison to predicate devices, not medical ground truth.
8. The sample size for the training set
Not applicable. There is no training set for a non-AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.