(10 days)
ULTRACARE Neutralizing Tablets are part of the ULTRACARE System, a disinfecting, neutralizing and storage system for daily and extended wear soft (hydrophilic) contact lenses in a chemical (not heat) lens care system.
The ULTRACARE Neutralizing Tablets are indicated for use to neutralize the ULTRACARE Disinfecting Solution in the ULTRACARE System. ULTRACARE Neutralizing Tablets are added at the beginning of the disinfection cycle so that disinfection and neutralization occur without any additional steps.
ULTRACARE Neutralizing Tablets are smooth, round, beige to pale pink tablets that contain catalase, hydroxypropyl methylcellulose, and cyanocobalamin (Vitamin B12) as a color indicator, with buffering and tableting agents.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ULTRACARE® Neutralizing Tablets:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes a submission for a 510(k) premarket notification, which usually focuses on demonstrating "substantial equivalence" to a predicate device rather than setting explicit, quantifiable acceptance criteria for novel performance claims. However, we can infer performance targets based on the comparison to the predicate and the types of studies conducted.
| Aspect of Performance | Acceptance Criteria (Implied/Predicate-based) | Reported Device Performance |
|---|---|---|
| Lens Compatibility | Comparable to predicate device; no significant changes in lens parameters (power, diameter, basecurve, spectral transmittance, surface) after 30 regimen cycles. | "The results indicated that ULTRACARE Neutralizing Tablets used in combination with ULTRACARE Disinfecting Solution and ULTRAZYME Enzymatic Cleaner are compatible with hydrogel contact lenses and perform comparably to the predicate device." |
| Antimicrobial Efficacy | Meet FDA criteria for "stand-alone" contact lens disinfecting products (against FDA's recommended panel of microorganisms). | "The test results showed that the disinfection system using ULTRACARE Neutralizing Tablets met the criteria for 'stand-alone' contact lens disinfecting products." |
| Ocular Safety (Toxicology) | No clinically significant ocular discomfort, irritation, or toxicity. | "The results of this study showed no clinically significant ocular discomfort, irritation or toxicity." |
| Clinical Safety & Acceptability (Overall) | Safe and acceptable for intended use; no apparent difference in key safety (corneal staining) and acceptability (lens comfort) variables compared to predicate. | "The results of the study showed that the ULTRACARE lens care regimen is safe and acceptable for its intended use based on: - Successful use by 96.7% (55/59) of evaluable subjects. - No apparent difference in the key safety variable of corneal staining compared to the predicate device. - No apparent difference in the key acceptability variable of lens comfort compared to the predicate device." |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Clinical Study: 59 evaluable subjects.
- Lens Compatibility: Representative lenses from FDA Lens Groups 1 and 4. (Specific number not provided, but implies multiple lenses per group to demonstrate compatibility).
- Microbiology/Toxicology: Not explicitly stated, but these are typically in-vitro and in-vivo lab tests (e.g., animal models for toxicology), not human subjects.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly probable the studies were conducted prospectively with data relevant to US regulatory standards.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a "ground truth" in the way it might be stated for, say, an imaging AI device. The ground truth for this medical device is established directly through clinical outcomes, objective measurements, and established microbiological standards:
- Clinical Study: Evaluated "corneal staining" and "lens comfort." These would be assessed by ophthalmologists or optometrists associated with the clinical trial, though their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.
- Microbiology: Comparison to "FDA's recommended panel of microorganisms" and "criteria for 'stand-alone' contact lens disinfecting products." This implies adherence to established regulatory standards, not expert consensus on individual cases.
- Toxicology: Assessment of "clinically significant ocular discomfort, irritation or toxicity" would be made by clinical investigators/ophthalmologists.
- Lens Compatibility: Objective measurements (power, diameter, basecurve, spectral transmittance) and material surface changes, likely performed by laboratory technicians and assessed by material scientists or optical engineers.
4. Adjudication Method
Not applicable in the conventional sense for this type of medical device study. There isn't a "test set" of images or cases needing independent review for classification. Clinical endpoints (e.g., corneal staining, comfort) were likely assessed by investigators in the clinical trial.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a contact lens care product, not an imaging AI device where multiple readers evaluate cases. The clinical study compares the new device regimen to a predicate device regimen, but it's not described as an MRMC study designed to measure human reader improvement with AI assistance.
6. Standalone Performance Study
Yes, in a conceptual sense. The "Microbiology" testing evaluated the "antimicrobial efficacy of the ULTRACARE® System...met the criteria for 'stand-alone' contact lens disinfecting products." This indicates the system (inclusive of the neutralizing tablets) performs its primary function (disinfection and neutralization) without human intervention beyond the user following instructions.
7. Type of Ground Truth Used
The ground truth is a combination of:
- Clinical Outcomes/Observations: For the clinical study, this includes successful use rate, corneal staining, and lens comfort.
- Regulatory Standards: For microbiology, adherence to "FDA's recommended panel of microorganisms" and "criteria for 'stand-alone' contact lens disinfecting products."
- Objective Measurements: For lens compatibility, changes in physical and optical properties of the lenses.
- Toxicological Assessment: For ocular safety, absence of clinically significant discomfort, irritation, or toxicity.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device where a "training set" is used to develop an algorithm. The development of the ULTRACARE® Neutralizing Tablets would involve formulation science, chemical engineering, and manufacturing processes, not data training in an AI context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI algorithm. The "ground truth" for the development of the product itself would be based on established scientific principles, chemical efficacy, material science, and prior regulatory experience with similar products.
§ 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.”