(211 days)
The LENSERVER Automatic Contact Lens Cleaning Accessory is intended for use as an adjunct in cleaning both soft hydrophilic and rigid gas permeable contact lenses using approved contact lens cleaning solutions.
Examples of approved cleaning solutions indicated for use with the LENSERVER Automatic for soft hydrophilic lenses are the Allergan Soft Mate Consept-1 Cleaning and Disinfecting Solution, Allergan Soft Mate Consept-2 Neutralizing and Rinsing Solution, or Spray. The LENSERVER Automatic is indicated for cleaning rigid gas permeable lenses in conjunction with approved solutions such as Allergan Gas Permeable Daily Cleaner and Allergan ComfortCare Gas Permeable Wetting and Soaking Solution.
The LENSERVER Automatic Contact Lens Cleaning Accessory is an electro-mechanical contact lens cleaning device designed to be used in conjunction with approved contact lens cleaning solutions. The cleaning components of the LENSERVER Automatic consist of a motorized cleaninq unit and a partitioned fluid reservoir functioning as the cleaning beaker.
The motorized unit is manufactured from a polymer and houses the battery compartment. motor and control circuits. The fluid reservoir or lens receptacle/cleaning beaker is partitioned and injection molded from medical grade polymer. Fill marks are engraved on the outer wall of the beaker indicating a fluid volume sufficient to completely submerge contact lenses. Each contact lens would be placed into the appropriate compartment. designated "L' or 'R'.
The base of the fluid reservoir or cleaning beaker fits snugly onto a vibrating platform on the motorized cleaning unit. When placed on the vibrating platform and the power button is actuated, the cleaning beaker vibrates, and after a predetermined period the timing mechanism halts rotation of the motor.
The provided 510(k) summary describes the LENSERVER Automatic Contact Lens Cleaning Accessory and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria with quantifiable metrics. Instead, the study focuses on demonstrating safety and compatibility with contact lenses, which are indirect measures of "performance" in this context.
However, based on the information provided, we can infer some "acceptance criteria" and describe the study that addresses them.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device Safety | Acute Ocular Irritation: Solutions cycled through the LENSERVER Automatic (LENSERVER test solution) showed no acute ocular irritation, concluding that materials used in the device were safe. |
| Lens Compatibility | No Detectable Damage/Changes to Lenses: No detectable damage or changes were demonstrated in test lenses (soft hydrophilic: FDA groups I and IV; rigid gas permeable) following the evaluation program. Parameters measured (power, base curve, diameter, clarity) for new lenses before and after cleaning cycles showed no significant alterations. The device was deemed safe and compatible with both soft hydrophilic and rigid gas permeable contact lenses. |
| Cleaning Efficacy (Implied) | "Assist in cleaning": While not directly quantified in terms of bacterial reduction or debris removal, the device is intended to "assist in cleaning" in conjunction with approved solutions. The electro-mechanical agitation is presented as functionally equivalent to the cleaning mechanisms of predicate devices. The study doesn't provide a direct metric for the effectiveness of cleaning, but rather the safety of the cleaning process on the lenses. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Acute Ocular Irritation Test: The document mentions "saline cycled through the device" and "LENSERVER test solution," but does not explicitly state the number of samples or animal subjects used for this test.
- Lens Compatibility Test:
- 10 lenses of each lens type.
- Total of 30 cleaning cycles for each individual lens.
- Lens types: 2 types of soft hydrophilic lenses (FDA groups I and IV) and 2 different rigid gas permeable lenses of different manufacture.
- "Ten different LENSERVER Automatic devices" were used.
- Data Provenance: The tests were conducted by:
- An independent testing facility for the acute ocular irritation test.
- Highly trained and expert investigators at a recognized college of optometry (specifically, Southern California College of Optometry, Fullerton, California) for the lens compatibility test.
- Retrospective or Prospective: These appear to be prospective studies specifically conducted for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Acute Ocular Irritation Test: Performed by an "independent testing facility" according to USP XXII guidelines. The specific number or qualifications of experts are not detailed, but the reference to USP XXII suggests adherence to recognized standards for such tests.
- Lens Compatibility Test: "Highly trained and expert investigators" at the Southern California College of Optometry. The document does not specify the exact number of investigators or their detailed qualifications (e.g., "radiologist with 10 years of experience"), but their affiliation with a recognized optometry college implies relevant expertise.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in either test.
- For the Acute Ocular Irritation Test, results were determined by the "independent testing facility" according to USP XXII guidelines, which would have defined assessment criteria.
- For the Lens Compatibility Test, the "trained investigators" at the optometry college measured lens parameters ("power, base curve, diameter and clarity") before and after cleaning cycles. The determination of "no detectable damage or changes" would likely have been based on established clinical or optical tolerances for these parameters, not necessarily inter-expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a cleaning accessory, not an diagnostic imaging tool where human readers assess cases. The studies performed focused on the device's safety and compatibility with lenses.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical electro-mechanical accessory, not an AI algorithm. Its performance is inherent in its physical operation. The "standalone" performance refers to the device's ability to clean without causing harm to the lenses or eyes.
7. The Type of Ground Truth Used
- Acute Ocular Irritation Test: The ground truth for safety was based on the biological response observed in the test (e.g., lack of irritation) compared to established toxicity standards (USP XXII guidelines). This could be considered a form of outcomes data in a controlled biological setting.
- Lens Compatibility Test: The ground truth for lens compatibility was established through objective measurements of lens parameters (power, base curve, diameter, clarity) before and after cleaning cycles, and the absence of visually detectable damage or changes. This is a form of objective measurement data interpreted by experts.
8. The Sample Size for the Training Set
This device does not involve an AI algorithm; therefore, there is no training set in the context of machine learning. The device's design and operation are based on engineering principles comparable to predicate devices.
9. How the Ground Truth for the Training Set Was Established
As there is no AI algorithm or training set, this question is not applicable.
§ 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.”