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The Purilense System is indicated for the cleaning and disinfection of soft (hydrophilic) contact lenses by means of subsonic agitation to remove lens deposits and microorganisms, and ultraviolet irradiation of the surrounding storage solution for disinfection. The lenses may be stored in the disinfected solution for a period of 24 hours following the cleaning and disinfection cycle.

The device is a cleaning and disinfection unit for contact lenses. It consists of the Purilens Unit and Purilens Solution. The Purilens Unit is compact, with an upper housing containing a germicidal UV light, and a lower housing which contains a removable, clear cleaning chamber with a lens holder for the contact lenses. A mechanism in the lower portion of the cleaning chamber creates the cleaning turbulence activity. Within the lower housing unit is an electronic control unit which operates the UV light and turbulence vibrating mechanism. The lower unit contains an internal automatic timing device which shuts the unit after its 15 minute cycle. The lens holder consists of a removable basket which houses the contact lenses in separate chambers and is suspended within the cleaning chamber in the lower housing. The removable basket assembly is shielded from the UV light. The cleaning chamber contains an unpreserved saline medium as a storage solution for the contact lenses. The Purilens Solution is a preservative free saline solution which is used to fill the cleaning chamber. The turbulence mechanism is a magnetic pedal suspended on the end of a flexible spring located in the bottom of the cleaning chamber. When activated by the electronic connection, the pedal osillates in a subsonic range of 50 - 120 cycles per second creating a whirlpool effect that swirls the Purilens Solution surrounding the lens baskets and removes debris and microorganisms from the lenses during the 15 minute cycle. UV radiation energy from the upper housing disinfects loosened microorganisms in the solution. Disinfection is accomplished without heating, preservatives, or chemicals. The unit cannot function unless the electrical interlock is complete between the upper and lower housings. An electrical transformer is located on the power cord. The transformer converts house current of 110 VAC to 14 VAC for the purpose of operating the device.

The PuriLens System is a cleaning and disinfection unit for soft (hydrophilic) contact lenses. It uses subsonic agitation to remove lens deposits and microorganisms, and ultraviolet (UV) irradiation of the surrounding storage solution for disinfection.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria in a dedicated table. Instead, it describes various studies and their successful outcomes as evidence of performance. The implicit acceptance criterion for all studies described is "successfully performed all tests" or "no negative affect" or "performs equally as" or "superior to" a comparable control.

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

• Clinical Study: The document states that a clinical study was performed.
  • Sample Size: Not explicitly stated for subjects. Each subject experienced both the Purilens System and the control for three months each, implying a paired or crossover design. The number of lenses examined for cleaning analysis is also not explicitly stated but involved "all lenses worn in the clinical study."
  • Data Provenance: Not specified (e.g., country of origin). The study design is described as "clinical study," implying a prospective study.
• Pre-clinical Studies (Toxicology, Solution Compatibility, Microbiological):
  • Sample Size: Not explicitly stated for toxicology tests (e.g., number of mice, rabbits) or for microbiological challenge tests (e.g., number of test repetitions or organisms). Solution compatibility was tested "after 180 cycles of the device on Groups I, II, III, and IV soft contact lenses."
  • Data Provenance: Not specified. These are laboratory-based pre-clinical studies.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical or pre-clinical test sets.

• For the clinical study, the "results of the clinical study indicate..." suggests a clinical assessment, likely by ophthalmologists or optometrists, but their number and qualifications are not provided.
• For the lens cleaning analysis, "computer image processing quantification of visible light reflections of hydrogel contact lens deposits was performed." While this is an objective measure, expert interpretation of the images or the results might have occurred, but is not detailed.
• For pre-clinical studies, laboratory personnel with relevant expertise in toxicology, microbiology, and materials science would have been involved, but specific details are not given.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the clinical or pre-clinical studies.

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

No. The clinical study described is a crossover design comparing the Purilens System to a comparable multipurpose contact lens cleaning and disinfection system. It evaluates the device's effectiveness rather than the effect of AI assistance on human readers.

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

The device itself is a standalone system for cleaning and disinfection; it does not involve AI or human-in-the-loop performance in the context of diagnostic interpretation. The studies assessed the standalone performance of the device in cleaning and disinfecting contact lenses.

7. The Type of Ground Truth Used

• Toxicology: Biological response in animal models (mice, rabbits) and in vitro assays (MEM Elution Method, cytotoxicity).
• Solution Compatibility: Objective measurements of lens parameters after cycling.
• Microbiological Efficacy: Laboratory culture-based methods (e.g., "D" value test, multi-item challenge test) to quantify reduction of microorganisms.
• Cleaning Efficacy: Objective quantification of deposits using "computer image processing quantification of visible light reflections."
• Clinical Analysis: Clinical observations and outcomes from subject use over time, comparing the device to a control system.

8. The Sample Size for the Training Set

This question is not applicable. The Purilens System is a mechanical/UV device, not a machine learning or AI-based system that requires a "training set" in the computational sense.

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

This question is not applicable for the same reason as point 8.

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