(113 days)
Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to lubricate and rewet soft and rigid gas permeable contact lenses (silicone acrylate lenses and fluorosilicone acrylate lenses). Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to help relieve dryness, discomfort and irritation that may be associated with lens wear. Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to cushion lenses by placing a drop on the lens prior to application on to the eye.
REFRESH® CONTACTS™ Lubricating and Rewetting Drops is a sterile, buffered, isotonic preserved solution containing sodium carboxymethylcellulose as the demulcent and preserved with PURITE® (stabilized oxychloro complex 0.005%). Boric acid, sodium chloride, potassium chloride, calcium chloride and magnesium chloride act as buffering and tonicity agents. REFRESH® CONTACTS™ Lubricating and Rewetting Drops is supplied sterile, packaged in plastic bottles with controlled dropper tips and labeled with lot number and 24 month expiration date.
Here's an analysis of the provided text regarding the acceptance criteria and study for REFRESH® CONTACTS™ Lubricating and Rewetting Drops:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Non-toxic to ocular tissue | Demonstrated by in-vivo preclinical testing in laboratory animals. |
| Safety: Compatibility with soft (hydrophilic) contact lenses | Demonstrated by in-vitro lens compatibility testing. |
| Safety: Compatibility with RGP contact lenses | Demonstrated by in-vitro lens compatibility testing. |
| Safety (Clinical): Safety comparable to predicate devices (COMPLETE® for hydrogel, CLARIS® for RGP) as measured by slit lamp findings. | Clinical study results showed safety comparable to predicate devices. |
| Acceptability (Clinical): Acceptability comparable to predicate devices (COMPLETE® for hydrogel, CLARIS® for RGP) as measured by symptoms of discomfort. | Clinical study results showed acceptability comparable to predicate devices. |
| Effectiveness/Successful Use (Clinical): One month successful use by hydrogel lens wearers. | 100% of hydrogel lens wearers (25/25) had successful use for one month. |
| Effectiveness/Successful Use (Clinical): One month successful use by RGP lens wearers. | 100% of RGP lens wearers (25/25) had successful use for one month. |
| Substantial Equivalence: Physical, chemical, and microbiological properties substantially equivalent to predicate devices. | Preclinical studies indicate physical, chemical, and microbiological properties are substantially equivalent to REFRESH® CL, COMPLETE®, and CLARIS®. |
| Substantial Equivalence: Action, indications for use, safety, and effectiveness substantially equivalent to predicate devices. | Clinical study and overall assessment determined substantial equivalence in terms of action, indications for use, safety, and effectiveness to REFRESH® CL, COMPLETE®, and CLARIS®. Any differences between the new device and its predicates do not affect the use of this product. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study):
- 25 hydrogel lens wearers
- 25 RGP lens wearers
- Total: 50 subjects
- Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective, as it describes a "one month clinical study conducted to evaluate the safety and acceptability."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts, their qualifications, or their role in establishing ground truth for the clinical study. The "ground truth" for safety was determined by "slit lamp findings" and for acceptability by "symptoms of discomfort," presumably assessed by the clinical investigators or study staff, but specific details on expert involvement are not given.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study data or assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for a lubricating and rewetting drop, not an imaging device that would typically involve human readers interpreting cases. The comparison was between the new device and predicate devices in terms of patient safety and acceptability.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable to a lubricating and rewetting drop. There is no "algorithm" or standalone performance for this type of medical device. Its performance is assessed through its direct interaction with the eye and contact lenses in human subjects.
7. The Type of Ground Truth Used
The ground truth for the clinical study appears to be:
- Clinical Observations: Slit lamp findings for safety assessments.
- Patient-Reported Outcomes/Symptoms: Symptoms of discomfort for acceptability assessments.
- Successful Use: Defined as 100% of subjects having successful use over one month.
For preclinical testing, ground truth was established through:
- In-vivo preclinical animal testing for ocular tissue toxicity.
- In-vitro lens compatibility testing for compatibility with different lens types.
- In-vitro chemical, toxicological, and microbiological studies to assess properties.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an AI/ML algorithm. This device is not an AI/ML product. The preclinical and clinical studies described are for safety and efficacy evaluation of the physical product itself.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for an AI/ML algorithm. The ground truth for the product's performance was established through the various preclinical and clinical tests outlined above.
§ 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.”