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Sereine Extra Strength Daily Cleaner is indicated for use as a daily cleaner for removal of film, deposits and other debris which accumulate on soft (hydrophilic) and hard (PMMA) contact lenses during wear. Sereine Extra Strength Daily Cleaner may be used with either thermal (heat) or chemical (cold) disinfection systems. Follow the recommendation of your eye care practitioner when disinfecting your lenses.

Sereine Extra Strength Daily Cleaner is a sterile, viscous, aqueous solution with an alkaline pH. The cleaner contains an amphoteric surfactant to aid in the removal of proteins, lipids and other debris which accumulate on contact lenses during wear. The cleaner is not meant for use in the eye and must be rinsed from the lenses. Sereine Extra Strength Daily Cleaner is packaged in a 1 FL OZ plastic bottle (polyethylene) with red dropper tip (polyolefin) and over-cap (polypropylene). It has an outside cardboard carton. It has an expiration date of two years from the date of bottling.

This document describes the Sereine Extra Strength Daily Cleaner, a contact lens cleaning solution, and outlines its similarity to a predicate device, MiraFlow Extra Strength Daily Cleaner. The submission focuses on demonstrating substantial equivalence rather than conducting a separate clinical study with distinct acceptance criteria for novel performance.

Here's an breakdown of the information provided, tailored to your request:

Acceptance Criteria and Device Performance (Demonstrated Equivalence)

The acceptance criteria for Sereine Extra Strength Daily Cleaner appear to be based on demonstrating close similarity in key physical and chemical properties to the legally marketed predicate device, MiraFlow Extra Strength Daily Cleaner. The reported performance demonstrates that Sereine meets these criteria by matching the predicate's values.

The "study" that proves the device meets (or, more accurately, is substantially equivalent to) the acceptance criteria is a series of laboratory tests comparing the Sereine Extra Strength Daily Cleaner to the MiraFlow Extra Strength Daily Cleaner.

Study Details

Due to the nature of this 510(k) submission for a contact lens cleaning solution, the provided document does not describe a clinical study with human participants, expert ground truth, or an MRMC comparative effectiveness study in the context of diagnostic AI tools. Instead, it focuses on laboratory bench testing and non-clinical performance.

1. Sample size used for the test set and the data provenance:

   • pH: Three different lots of Sereine Extra Strength Daily Cleaner were tested. Data provenance is internal laboratory testing.
   • Viscosity: Three lots of Sereine Extra Strength Daily Cleaner were tested. Data provenance is internal laboratory testing.
   • Total Solids: Three samples of Sereine Extra Strength Daily Cleaner were tested. Data provenance is internal laboratory testing.
   • Sterility: Sereine Extra Strength Daily Cleaner was tested for sterility by randomly sampling bottles from the lot. The exact number of samples is not specified beyond "randomly sampling bottles." The testing was performed by Nelson Laboratories, Inc., Salt Lake City, UT. (Provenance: US, prospective testing for the submission).
   • UV-visible spectrum: One sample of Sereine Extra Strength Daily Cleaner was compared. Data provenance is internal laboratory testing.
   • Stability Study (pH, Viscosity, Active Ingredients, Physical Appearance, Sterility, Preservative Effectiveness): Three lots of Sereine Extra Strength Daily Cleaner were stored at ambient temperature for two years and tested periodically. (Provenance: US, prospective testing for the submission).
   • Solution Compatibility:
     • 10 Metrotint (hydrophilic) lenses
     • 10 Horizon 55 (hydrophilic) lenses
     • 10 PMMA (hard) lenses
       (Provenance: US, prospective testing for the submission).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable as the study involved physical and chemical characterization of a cleaning solution, not a diagnostic task requiring expert interpretation. The ground truth was established by laboratory measurements and adherence to specified testing procedures (e.g., USP 24 for sterility, FDA Guidelines for preservative effectiveness).

3. Adjudication method for the test set:

   • Not applicable. The tests involved objective measurements (pH, viscosity, total solids, UV-Vis spectra, sterility) and direct observation for physical appearance and solution compatibility. There was no human interpretation or adjudication method described in the context of expert consensus.

4. 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 is a 510(k) submission for a contact lens cleaning solution, not a diagnostic AI device. Therefore, no MRMC study with human readers assisting AI was conducted or is relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable, as this is not an AI algorithm. The performance described is that of the cleaning solution itself.

6. The type of ground truth used:

   • Objective Laboratory Measurements: For pH, viscosity, total solids, and UV-visible spectrum, the "ground truth" was established by direct measurement using calibrated equipment (Piccolo pH meter, Gilmont Falling Ball Viscometer, Shimadzu UV-visible Spectrophotometer).
   • Sterility: The ground truth for sterility was established by culturing methods as per USP 24, performed by a third-party laboratory (Nelson Laboratories, Inc.).
   • Preservative Effectiveness: Ground truth was established by microbiological challenge testing according to FDA Guidelines documented in the "Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products," performed by a third-party laboratory (Northview Pacific Laboratories, Inc.).
   • Solution Compatibility: Ground truth was based on objective measurements of optical parameters (before and after 30 cycles) and visual inspection for physical changes (e.g., discoloration, cracks, precipitates) by laboratory personnel.

7. The sample size for the training set:

   • Not applicable. This is not an AI device that requires a training set. The term "training set" is typically used in machine learning.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this device.

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