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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.

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.

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