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3N Contact Lenses Adjunct Cleaner is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses with only either OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution or Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution.

The proposed device, 3N Contact Lenses Adjunct Cleaner, Model TN083 is an electrical cleaner which is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses using approved contact lens solutions.

The 3N Contact Lenses Adjunct Cleaner adopt the principle of protein electrophoresis, take advantage of the characteristics that negatively charged protein in certain environment and swarm towards positive pole in electric field, then the tear protein will be removed from the surface and air holes of contact lens and absorbed by anodic cleaning probe to achieve the goal of cleaning contact lenses.

The cleaning components of the 3N Contact Lenses Adjunct Cleaner (Model: TN083) consist of a cleaning unit (Power Base) and a partitioned fluid reservoir functioning as the cleaning chamber.

The cleaning chamber is detachably connected to the cleaning unit (power base). In the cleaning chamber, there are two independent cleaning tanks; and there is a cleaning probe on each side of the cleaning tank, namely electrode. In the cleaning unit, the circuit board is fixedly provided with electrode connectors electrically connected to the circuit board. The end of the electrode connector can be stretched and elastically connected with the bottom of the electrode.

The document describes the submission of a 510(k) premarket notification for the "3N Contact Lenses Adjunct Cleaner" (K211361). The study provided is a non-clinical performance test (bench test) to demonstrate the device's deproteinization efficiency and physical compatibility.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample size:
  • Deproteinization efficiency and Service life testing: Four kinds of contact lens materials (Johnson and Cooper Optics, Ocufilcon D, Etafilcon A, Comfilcon A, and Senofilcon A). The service life test specifically mentions "151 times" for the Ocufilcon D lens.
  • Physical compatibility testing: "3 low modulus high water SCLs (>50wt% water, for example 3 commercial lenses from any of these SCL materials, hioxifilcon A, nelfilcon A or nesofilcon A, or other high water materials)".
• Data Provenance: The document does not specify the country of origin for the test data directly. It is a submission by "Suzhou 3N Biological Technology Co., Ltd" from China. The tests are described as "Non-Clinical Data" and "Performance Testing - Bench." It is a retrospective analysis of test data conducted on the device.

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

Not applicable. This study is a bench test assessing the physical performance and deproteinization efficiency of the device on contact lenses, not a study involving human interpretation or expert ground truth for medical imaging/diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is a physical performance bench test, not a human reader study.

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 MRMC comparative effectiveness study was done. The submission explicitly states: "This submission does not include any clinical performance testing. It was determined that no such testing was required to demonstrate substantial equivalence."

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

Yes, this was a standalone device performance test. The tests (deproteinization efficiency, service life, physical compatibility) were conducted solely on the device and contact lenses, without human intervention in the performance measurement itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on measurable physical and chemical properties of the contact lenses before and after treatment by the device. Specifically:

• Protein removal: Measured by quantifying protein adsorption/removal percentage.
• Physical compatibility: Assessed against the requirements of ISO 18369-2:2017, which defines standards for contact lens physical properties.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI or software algorithm that requires a training set. The "Software Verification and Validation" section refers to software contained within medical devices, but there's no indication of an AI/ML component requiring a "training set" in the context of typical AI model development.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML model for this device.

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