(57 days)
The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.
The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.
The VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning Systems are cleaning systems for contact lenses. Both devices consist of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens. The systems are designed to mimic human hand rubbing. This is done by the 3D multi-frequency modulated stereo power source and corresponding intelligent control circuit, which make a uniform three-dimensional relative movement between the damping heads and cleaning cushion.
The proposed device consists of two versions:
- For Rigid Lenses, VueSonic Advance 2 Contact Lens Cleaning System; and
- For Soft and Hybrid Lenses, VueSonic One Contact Lens Cleaning System.
The provided document describes the VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning System. It does not contain a study explicitly proving the device meets acceptance criteria. Instead, it relies on a battery of non-clinical tests and a comparison of technological characteristics with predicate devices to establish substantial equivalence.
Therefore, many of the requested details about a specific study, acceptance criteria for performance, and ground truth establishment cannot be extracted directly from this document.
However, I can provide the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" for device performance in the form of specific thresholds or metrics for cleaning effectiveness. Instead, it lists the non-clinical tests performed, implying that satisfactory results from these tests constitute meeting the requirements for substantial equivalence. The "reported device performance" in terms of cleaning effectiveness is described through the successful completion of a "Protein and Lipid Removal Test."
| Test Category | Specific Test | Relevant Standard/Guidance | Implied Acceptance: Satisfactory Result |
|---|---|---|---|
| Cleaning Performance | Protein and Lipid Removal Test | Citation (specific not provided) | The test results demonstrate adequate protein and lipid removal, supporting the device's cleaning function (implied by "test results show that the devices are substantially equivalent"). |
| Biocompatibility | Ocular Irritation | ISO 10993-10, 12 | Device materials are not ocular irritants. |
| In Vitro Cytotoxicity Test | ISO 10993-5 | Device materials are not cytotoxic. | |
| Sensitization | ISO 10993-10 | Device materials do not cause sensitization. | |
| Systemic Toxicity | ISO 10993-11, 12 | Device materials do not cause systemic toxicity. | |
| Electrical Safety and EMC | General Requirements electromagnetic compatibility | IEC 60601-1-2 | The device meets electromagnetic compatibility requirements. |
| General Requirements electrical safety | IEC 60601-1 | The device meets general electrical safety requirements. | |
| General Requirements home healthcare environment | IEC 60601-1-11 | The device meets safety requirements for home healthcare use. | |
| Usability | Human Factor Engineering and Usability Engineering Evaluation Report | IEC62366-1:2015 | The device is user-friendly and safe for its intended use, based on human factors principles. |
| Material Safety | Total Extractive Residues | FDA 21 CFR 177.2600 | The device's materials do not release unacceptable levels of extractive residues. |
| Software | Software Validation | FDA Guidance | The software components of the device are validated and function as intended. |
| Lens Compatibility | Lens Compatibility Test | ISO 18369-2:2017 | The device is compatible with the specified types of contact lenses (soft, hybrid, rigid) without causing damage. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the "Protein and Lipid Removal Test" or any other non-clinical test. It also does not explicitly state the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The document describes non-clinical tests, which typically rely on standardized protocols and laboratory measurements rather than expert consensus for ground truth.
4. Adjudication method for the test set
This information is not provided.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a contact lens cleaning system, not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a contact lens cleaning device. The "algorithm" in this context refers to the device's mechanical cleaning mechanism (3D sonic vibration technology), which operates in a "standalone" manner in that it performs its cleaning function without human intervention during the cleaning cycle. However, the overall process requires human interaction for placement of lenses and solution.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Protein and Lipid Removal Test," the ground truth would likely be established through quantitative laboratory measurements of protein and lipid levels on the contact lenses before and after cleaning, using standardized analytical methods. For other non-clinical tests (e.g., biocompatibility), the ground truth is based on the adherence to specified ISO standards and the absence of adverse biological reactions or safety failures.
8. The sample size for the training set
This information is not applicable and not provided. The device is a mechanical cleaning system and does not employ a machine learning model that would require a training set in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no mention of a machine learning model or a training set.
§ 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.”