(138 days)
The Epiphany Injector System is a device intended to fold and insert STAAR Surgical Company aspheric three piece Collamer®, Model CQ2015A, and aspheric three piece silicone intraocular lenses, Model AQ2015A, for surgical placement in the human eye.
The single use, disposable Epiphany Injector System is a delivery system for intraocular lenses (IOLs) for surgical placement in the human eye. The two main materials used in the manufacturer of this injector system will be polycarbonate and polypropylene. All product is also supplied "STERILE."
The provided text describes the Epiphany Injector System, a disposable intraocular lens injector. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the way requested by the prompt.
Instead, the document serves as a 510(k) summary for regulatory submission, primarily focusing on demonstrating substantial equivalence to predicate devices. It references "test results" for "Mechanical Safety" but does not elaborate on these results or the acceptance criteria used.
Therefore, I cannot fulfill many of the requested sections as the information is not present in the provided text. I will indicate where information is missing.
Epiphany Injector System
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list specific performance acceptance criteria for the Epiphany Injector System. It largely relies on a comparison to predicate devices to establish substantial equivalence.
| Feature | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (From "Mechanical Safety" - Test Results) |
|---|---|---|
| Mechanical Safety | (Implied to be "Similar" to predicate devices) | "See test results" (Details not provided in the document) |
| Product Description | A delivery system for intraocular lenses (IOLs) | "Same" as predicate devices |
| Intended Use | As described in Directions for Use | "Similar" to predicate devices |
| Design | As per prints | "Similar" to predicate devices |
| Main Materials | Polypropylene and polycarbonate | "Similar" to predicate devices |
| Manufacturing | Per internal operating procedures | "Similar" to predicate devices |
| Operating Principle | An injector system that utilizes delivery mechanism for the insertion of an IOL | "Similar" to predicate devices |
| Packaging | Labeled pouches and a tray with Directions for Use | "Similar" to predicate devices, except MSI-P1 model is "Same" |
| Sterility | Sterile | "Same" as predicate devices, but different sterilization method for one |
2. Sample size used for the test set and the data provenance
The document states, "A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration." This indicates that no clinical test set was used. The brief mention of "Mechanical Safety: See test results" implies some form of engineering or bench testing, but the sample size and data provenance are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical studies or human expert-based test sets are described.
4. Adjudication method for the test set
Not applicable. No clinical studies or human expert-based test sets are described.
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 a mechanical injector system, not an AI or imaging device that would typically involve MRMC studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical injector system, not an algorithm. Bench testing would be analogous to "standalone" performance for a mechanical device, but details are not provided.
7. The type of ground truth used
The primary "ground truth" for this submission appears to be the established performance and safety of legally marketed predicate devices, against which the Epiphany Injector System demonstrated "substantial equivalence." For "Mechanical Safety," internal test results are referenced, implying engineering specifications or performance benchmarks as ground truth, but these are not detailed.
8. The sample size for the training set
Not applicable. This device is a mechanical injector system, not an AI system requiring a training set in the conventional sense.
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.