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The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a cleaner for removal of film, deposits and other accumulated debris, which accumulate on Silicone Hydrogel soft contact lenses during wear.

Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is to be used with a Multipurpose Solution indicated for Silicone Hydrogel soft contact lenses. Follow the recommendation of your eye care practitioner when disinfecting your lenses.

Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a sterile, viscous, aqueous solution with an alkaline pH. The cleaner contains no added preservatives. The cleaner contains an amphoteric surfactant to aid in the removal of film, deposits and other debris that accumulates on contact lenses during wear. The cleaner is not meant for use in the eve and must be thoroughly rinsed from the lenses.

Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is packaged in a 1 FL OZ plastic bottle (polyethylene) with red dropper tip (polyethylene) and white over-cap (polypropylene). It has an outside cardboard carton. It has an expiration date of two years from the date of bottling.

The provided text is for a 510(k) premarket notification for a soft contact lens cleaning solution. It is not an AI/ML device, therefore, the requested information about acceptance criteria, study details, and AI-specific metrics are not applicable.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and includes pre-clinical performance data to support the safety and effectiveness of the Sereine Extra Strength Daily Cleaner.

However, I can extract the information that is available regarding the performance of the device and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated as a numerical sample size. The compatibility study tested "Four Silicone Hydrogel contact lens types," namely: senofilcon A (Oasys), lotrafilcon A (Night & Day), comfilcon A (Biofinity), and balafilcon A (Purevision). For cytotoxicity, it refers to "the four Silicone Hydrogel lenses" cleaned over 30 days.
• Data Provenance: The studies appear to be pre-clinical, conducted by the applicant or a contract research organization in support of the 510(k) submission. No information on country of origin of data or whether it was retrospective/prospective is provided.

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

• This information is not applicable. The studies referenced are laboratory-based compatibility and cytotoxicity tests, not expert-adjudicated clinical studies for AI/ML performance. The "ground truth" here is determined by objective physical and biological measurements against established standards (e.g., ISO standard 81369-2 for lens parameters, ISO requirements for Cytotoxicity).

4. Adjudication Method for the Test Set:

• This information is not applicable. There was no human adjudication process described, as the tests involved objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a contact lens cleaning solution.

6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done:

• This information is not applicable. The device is a physical cleaning solution, not an AI algorithm.

7. The Type of Ground Truth Used:

• For compatibility: Objective measurements of lens parameters and visual inspection for discoloration/clarity changes, compared against a baseline and established ISO standards (ISO standard 81369-2).
• For cytotoxicity: Laboratory assessment of cytotoxicity, meeting "ISO requirements."

8. The Sample Size for the Training Set:

• This information is not applicable. The device is not an AI/ML algorithm that requires a training set.

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

• This information is not applicable. There is no training set for this type of medical device submission.

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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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