(74 days)
The New Comfort Contact Lens Care Accessory is intended for use in conjunction with contact lens solutions as an accessory in the cleaning of contact lenses.
The New Comfort Contact lens Care Accessory is indicatod as aid for cleaning as an accessory for soft hydrophilic lenses and gas pormoablo lonsos whon usod with the appropriate Allergan® Soft Mate® solutions such as the Consept® Cleaning and Disinfoction Systom which is comprisod of the Allergan® Soft Mato® Consept®-1 Cleaning and Disinfecting solution and Allergen® Soft Mate® Consept - 2 Neutralizing and Rinsing Solution or Spray. The New Comfort Contact Lens Care Accessory is indicated for use for gas permeable solutions such as Allergan® Gas Permeable Daily Cleaner and Allergan® ComfortCare GP Wetting and Soaking Solution. The New Comfort Contact Lens Care Accessory may be used for a receptacle for chemical disinfection.
The New Comfort Ultrasonic Contact Lens Care Accessory uses a piezo-electric crystal to generate a wave form, in a reservoir containing a specific volume of fluid. Cavitation in fluid results in the generation of microscopic bubbles that implode upon the lens surface. The matrix of frequency, duration of ultrasound, and the control of temperature rise in the fluid medium leads to cleaning when a specific contact lens solution is present. The New Comfort device uses standard power (110 v/120 v). There is a four (4) foot cord and a UL approved wall transformer.
The New Comfort device consists of the housing, lens baskets, a reservoir, electronics and a transducer. All components that come in contact with contact lenses or solutions are of medical grade composition and have been used in legally marketed predicate devices in the United States. The housing is injection molded of ABS. The baskets and supporting structure are injection molded from ABS. The reservoir is deep drawn stainless steel, is passivated and electropolished. The electronic circuitry has been used in other cleaning applications in other industries for years. The single crystal is affixed directly to the bottom of the reservoir with an epoxy generally used in cleaning applications in the ultrasound industry.
Acceptance Criteria and Device Performance for "The New Comfort Contact Lens Care Accessory"
This document describes the acceptance criteria and the study that demonstrates the "New Comfort Contact Lens Care Accessory" meets these criteria, based on the provided 510(k) summary (K974724).
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list "acceptance criteria" in a formal, quantifiable manner. Instead, the demonstration of substantial equivalence is based on the device performing comparably to legally marketed predicate devices, particularly regarding its impact on contact lenses during cleaning cycles. The acceptance criteria can be inferred from the study's objective: to ensure no adverse changes to the contact lenses after prolonged use with the device.
| Acceptance Criteria (Inferred from Study Objective) | Reported Device Performance (New Comfort) |
|---|---|
| No changes in contact lens color after 30 cleaning cycles. | No changes noted in color. |
| No changes in contact lens clarity after 30 cleaning cycles. | No changes noted in clarity. |
| No changes in contact lens power after 30 cleaning cycles. | No changes noted in power. |
| No changes in contact lens diameter after 30 cleaning cycles. | No changes noted in diameter. |
| No changes in contact lens base curve after 30 cleaning cycles. | No changes noted in base curve. |
| No deposits or residue observed on contact lenses after 30 cleaning cycles. | No deposits or residue noted on any of the lenses. |
| No damage to contact lenses observed after 30 cleaning cycles. | No damage noted on any of the lenses. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Lenses were selected from "Group 1, Group 3, Group 4 and the Gas Permeable class." The exact number of lenses used is not specified in the document, but it includes representatives from key contact lens types.
- Data Provenance: The study was conducted by an optometrist in a large ophthalmology practice, strongly suggesting prospective data collection. The country of origin is not explicitly stated, but given the 510(k) submission to the FDA, it is highly likely to be the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: One expert.
- Qualifications of Expert: The study was conducted by "an optometrist who is director of optometric services in a large ophthalmology practice." This indicates a qualified eye care professional with clinical experience relevant to contact lenses.
4. Adjudication Method for the Test Set
- Adjudication Method: None explicitly stated. The evaluation was conducted by a single optometrist. There's no mention of a consensus process or multiple reviewers for the ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This device is an accessory for cleaning contact lenses, not an diagnostic imaging tool where MRMC studies are typically performed. The evaluation focuses on the physical effects of the device on lenses, not on human interpretation or diagnostic accuracy.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done: Yes, in essence. The described study evaluates the device's performance (its effects on contact lenses) in isolation from human intervention in the cleaning process itself. The optometrist observes and measures the lens characteristics after the device has completed its function.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established through expert observation and measurement by a qualified optometrist. This involves physical and optical parameter measurements (color, clarity, power, diameter, base curve) and visual inspection for deposits, residue, or damage.
8. Sample Size for the Training Set
- The 510(k) summary describes a performance study for the device, not a machine learning model. Therefore, there is no concept of a "training set" as would be applicable to AI/ML devices. The device operates mechanistically based on physics (ultrasound), not learned patterns.
9. How the Ground Truth for the Training Set Was Established
- As stated above, this is not applicable as there is no training set for this type of device.
§ 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.”