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The ESSTECH® MULTI Aspheric (multifocal) (hioxifilcon B) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and/or presbyopia) in not-aphakic persons with non-diseased eyes. The lens may be worn by persons who may exhibit astigmatism of 1.50 diopters or less that does not interfere with visual acuity.

The lens may be disinfected using either heat (thermal) or chemical (not heat) disinfection systems.

The ESSTECH® MULTI Aspheric (multifocal) (hioxifilcon B) Soft (hydrophilic) Contact Lens is available as a lens with an aspheric front surface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The lens is constructed to provide optimum edge thickness and contour, with the central area providing the reading power in the equivalent of a 2.00 diopter near addition. The aspheric front curve undergoes a progressive power change, resulting in intermediate and distance power outward from the center. The lens is a flexible transparent shell of the following dimensions:
Chord diameter: Baber: steps)
The lens material, hioxifilcon B, is a hydrophilic co-polymer of glycerol methacrylate (GMA) and 2-hydroxyethyl methacrylate (2-Hema), crosslinked with ethylene glycol dimethacrylate. The lens is swollen to equilibrium state in sterile buffered saline solution, and contains 48% water by weight when fully

1. Acceptance Criteria and Reported Device Performance:

There are no specific quantifiable acceptance criteria or reported device performance metrics presented in the provided document regarding efficacy or safety directly related to the ESSTECH® MULTI Aspheric (multifocal) contact lens. The approval is based on a determination of substantial equivalence to previously cleared devices.

The document states: "Ten (10) ESSTECH® MULTI Aspheric (multifocal) (hioxifilcon B) Soft (hydrophilic) Contact Lenses were manufactured according to prescription, and shown to be within acceptable standards by the ordering clinician." This implies an implicit standard of clinical acceptability but doesn't specify measurable criteria or a performance table.

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

• Test Set Sample Size: 10 lenses.
• Data Provenance: The document does not explicitly state the country of origin for the "ordering clinician" who evaluated the 10 lenses. The study appears to be prospective, as lenses were "manufactured according to prescription" and then evaluated.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

• Number of Experts: One ("the ordering clinician").
• Qualifications: "Ordering clinician." No specific qualifications like "radiologist with 10 years of experience" are provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: None. A single "ordering clinician" evaluated the 10 lenses.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was done. The document does not describe any study involving human readers or AI assistance to measure improvement in performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable. This is a physical medical device (contact lens), not an algorithm or AI. Therefore, no standalone algorithm performance study was conducted.

7. Type of Ground Truth Used:

• Ground Truth: "Acceptable standards by the ordering clinician." This is a form of expert consensus or clinical judgment from a single expert, demonstrating that the manufactured lenses met the prescription and were clinically acceptable.

8. Sample Size for the Training Set:

• The document does not describe a separate "training set" in the context of an algorithmic or AI device. The submission refers to a small manufacturing run of 10 lenses that were evaluated. The basis for approval is primarily substantial equivalence to previously cleared devices and materials.

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

• Not applicable as there is no training set described in the context of AI or algorithmic development. The "acceptable standards" for the 10 manufactured lenses were established by a single "ordering clinician."

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