(59 days)
ACU-CLENS™ Cleaning Accessory is indicated for use with recommended contact lens cleaning solutions for cleaning soft (hydrophilic) and rigid gas permeable contact lenses in accordance with directions for use in the solution labeling. The device ands in cleaning by minimizing hand contact with lenses.
ACU-CLENS™ Cleaning Accessory for Contact Lens Cleaning is a method of cleaning contact lenses that mimics the figure-eight hand-in-palm motion. The ACU-CLENS™ Cleaning Accessory can be used with hard (gas permeable) and soft (hydrophilic) lenses. ACU-CLENSTM Cleaning Accessory features a durable plastic case and disposable foam pads for use with professionally recommended daily cleaning solutions. The hinge mounted base and cover contain right and left lens receptacles and four mounting posts which secures the disposable pad to the base. The cover provides a motion plate, cleaning head domes and a hinged latch to secure the disposable pad to the cleaning head domes. Daily cleaning solution (recommended by an eye care professional or physician) is applied to the disposable pad secured to the cleaning head domes and the right and left receptacle and the lenses are placed on the disposable pad above the right and left receptacle. After closing the case the motion plate on the cover is moved in a figure-8 motion to create the scrubbing effect necessary to clean both top and bottom of each lens simultaneously. Lenses should be thoroughly disinfected using solution recommended by physicians or eye-care professionals. The disposable pad should be removed and the Cleaning Case disinfected after each use.
This document describes a 510(k) summary for the ACU-CLENS™ Cleaning Accessory, a device for cleaning contact lenses. It focuses on demonstrating substantial equivalence to a predicate device. The information provided is insufficient to answer most of the questions related to sophisticated acceptance criteria, quantitative performance evaluations, and detailed study methodologies typically associated with modern medical device clearances, especially software-driven AI algorithms.
The 510(k) is from 1996, and the device is a mechanical cleaning accessory, not an AI or software-driven diagnostic tool. Therefore, many of the requested details (like AI effect size, training data, expert ground truth for specific metrics) are not applicable or not provided in this type of submission for this kind of device.
However, I can extract what is available and explain why other information is missing.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are primarily related to safety, non-toxicity, non-irritation, and effectiveness in cleaning contact lenses. The performance is described qualitatively and visually.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | Biocompatibility: |
| - Non-cytotoxic (for foam pads) | The foam pads used in the ACU-CLENS™ Cleaning Accessory have been tested for cytotoxicity and eye irritation and have been found to be non-toxic. |
| - Non-eye irritating (for foam pads) | The foam pads used in the ACU-CLENS™ Cleaning Accessory have been tested for cytotoxicity and eye irritation and have been found to be non-irritating. |
| Effectiveness (Cleaning): | Cleaning Action: |
| - Able to clean contact lenses (hard and soft) | Mimics the figure-eight hand-in-palm motion, creating a scrubbing effect to clean both top and bottom of each lens simultaneously. The CLENSER Corporation has tested lenses with the ACU-CLENS™ Cleaning Accessory, the results of which are represented by Scanning Electron Microscope photographs. (Specific quantitative measures of cleanliness are not provided, but SEM photos are offered as evidence). The device "aids in cleaning by minimizing hand contact with lenses." |
| Functionality: | Ease of Use/Minimizing Contact: |
| - Minimizes hand contact with lenses during cleaning | The ACU-CLENS™ Cleaning Accessory has been designed to minimize the hand contact with lenses normally associated with cleaning instructions. |
| - Disposable pads used as intended (not reused) | Labeling instructs for a fresh pad each use, addressing a difference from the predicate. |
| Substantial Equivalence (Implicit overall criterion): | Comparable to Predicate: Described as "SUBSTANTIALLY EQUIVALENT TO: The CLEANER™ Accessory by Easy Eyes, Eaton Medical Corporation." The differences (disposable vs. reusable pads) are addressed as not raising new safety or effectiveness concerns, and superior in that the ACU-CLENS™ does not recommend reuse. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The text mentions "The CLENSER Corporation has tested lenses with the ACU-CLENS™ Cleaning Accessory," but provides no numerical count of lenses or tests performed.
- Data Provenance: Not specified. Given the company is in Minnesota, USA, it's highly likely the testing was conducted in the USA, but this is not explicitly stated. The study type (retrospective/prospective) is not mentioned, but it would have been a prospective lab study to generate the SEM photographs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for cleaning effectiveness appears to be based on visual inspection via Scanning Electron Microscope (SEM) photographs. While SEM analysis requires expertise, the number and specific qualifications of the evaluators are not mentioned, nor would they typically be for this type of device and submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is usually associated with human-expert review of diagnostic findings, often in medical imaging or pathology. The primary evidence for this device is physical testing (cytotoxicity, irritation, cleaning effectiveness via SEM).
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
Not applicable. This is a mechanical contact lens cleaning accessory, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for cleaning effectiveness was based on Scanning Electron Microscope (SEM) photographs. For biocompatibility, it was based on cytotoxicity and eye irritation testing (standardized in-vitro and/or in-vivo tests to assess material biological response).
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”