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The epithelial scrubber is intended for deepithelialization of the cornea in preparation for subsequent surgical procedures on the denuded cornea.

The Amoils Epithelial Scrubber ("epithelial scrubber") is a small, powered handheld device to which is attached a single use brush with Tynex microfilaments. The microfilaments of the brush tip are encased in a retaining ring such that the diameter of the brush is 6.3mm. When being operated, the brush rotates in a circular fashion at approximately 1500 revolutions per minute.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Amoils Epithelial Scrubber:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define formal, quantitative acceptance criteria for the Amoils Epithelial Scrubber. Instead, it relies on comparison to a predicate device and qualitative assessments based on an eye bank study and a human study. Here's a table summarizing the implicit "acceptance criteria" (based on predicate device characteristics and desired outcomes) and the reported device performance:

2. Sample Size Used for the Test Set and Data Provenance

• Test Set 1 (Eye Bank Study):

  • Sample Size: "eyes drawn from an eye bank" - The exact number of eyes is not specified.
  • Data Provenance: Not explicitly stated, but likely from a local eye bank given the manufacturer's location in South Africa. This would be retrospective in terms of using donated eyes for laboratory testing.

• Test Set 2 (Human Study):

  • Sample Size: "500 human eyes"
  • Data Provenance: Conducted in South Africa. This was a prospective study where the device was used on human patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Eye Bank Study:

  • Number of Experts: Not specified.
  • Qualifications: Not specified, but the ground truth was established by SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscopy) photos. These analyses would typically be performed and interpreted by highly trained specialists (e.g., histologists, pathologists, or researchers with expertise in microscopy), but the document does not name them or their specific qualifications.

• Human Study:

  • Number of Experts: Not specified.
  • Qualifications: "surgeon" is mentioned as visualizing the epithelial removal. The assessment of "quick healing" and "equivalence to reported speed" would have been made by the operating surgeons and/or clinical researchers. No specific qualifications beyond "surgeon" are provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1).

• For the eye bank study, the "ground truth" was derived directly from the physical characteristics observed via SEM and TEM.
• For the human study, the observations (removal time, quick healing) were likely made by the operating surgeons and recorded. There's no mention of a separate adjudication process for these clinical observations.

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

No, an MRMC comparative effectiveness study was not done. This device is a mechanical surgical tool, not an AI-assisted diagnostic or therapeutic system. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This is a mechanical device, not an algorithm. The performance described is of the device as used by a human surgeon.

7. The Type of Ground Truth Used

• Eye Bank Study:

  • Pathology/Histology (Microscopy): The ground truth for surface smoothness and damage to Bowman's layer was established by SEM and TEM photos. This is a direct physical assessment at a microscopic level.

• Human Study:

  • Clinical Observation/Outcomes Data: The ground truth for removal time and healing was based on clinical observation by the surgeons and subsequent patient outcomes (e.g., rapid central epithelium regrowth).

8. The Sample Size for the Training Set

The document describes pre-market studies for a medical device and does not mention any "training set." This type of device does not involve machine learning or AI that would require a training set in the conventional sense. The studies described are validation studies.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

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