(50 days)
Karats Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.
Karats Multi-Purpose Solution is a sterile aqueous solution containing sorbitol, tromethamine, pluronic F127, sodium phosphate dihydrogren, dexpanthnol, edetate disodium dihydrate and preserved with polyhexanide 0.0001
The provided text describes the 510(k) summary for KARATS Multi-purpose Solution, a contact lens care product. It details various studies conducted to demonstrate its safety and substantial equivalence to other marketed solutions. However, the document does not present specific acceptance criteria in a table format alongside device performance data for each claim. Instead, it generally states that the product meets guidelines or demonstrates substantial equivalence.
Here's an attempt to extract and infer the information based on the provided text, acknowledging that specific acceptance values are not explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Guidelines/Substantial Equivalence) | Reported Device Performance |
|---|---|
| Silicone Hydrogel Lens Compatibility: No significant difference in optical and physical changes compared to saline control. | "no significant difference between KARATS and the saline control solution, with respect to optical and physical changes in the measured properties of the lenses." |
| Surface Analysis (XPS): No significant changes to the lens surface. | "no significant changes to the surface of the Focus NIGHT & DAY lens as analyzed by XPS testing." |
| In Vitro Cleaning Efficacy: Substantially equivalent to currently marketed products in daily protein removal. | "KARATS is substantially equivalent to currently marketed products in terms of daily protein removal." |
| Cytotoxicity: Non-cytotoxic and non-irritant. | "KARATS is non-cytotoxic and is a non-irritant." |
| Microbiological Efficacy: Meets stand-alone criteria of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products. | "KARATS meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products." |
| Clinical Performance: Substantially equivalent to predicate solutions. | "Data from the clinical studies supported the substantial equivalence of KARATS." |
Note: The document frequently refers to "substantial equivalence" and meeting "guidelines" without providing the specific numerical or qualitative targets for these criteria. The "reported device performance" directly quotes or paraphrases the document's findings.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Silicone Hydrogel Lens Compatibility: Not explicitly stated, but implies multiple lenses were tested for "measured properties."
- Surface Analysis (XPS): Not explicitly stated, but mentions "lens samples were processed and analyzed."
- In Vitro Cleaning Efficacy: Not explicitly stated.
- Cytotoxicity: Not explicitly stated.
- Microbiology: Not explicitly stated.
- Clinical Testing: Not explicitly stated.
- Data Provenance: The document does not specify the country of origin of the data. The studies were pre-clinical and clinical, indicating both laboratory and human subject studies. No information is given about whether the studies were retrospective or prospective, though clinical studies are generally prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- The document does not mention using experts to establish ground truth for any of the studies described. The assessments appear to be based on laboratory measurements (e.g., optical/physical changes, XPS, in vitro efficacy, cytotoxicity, microbiological testing) and clinical observations, not expert consensus on an annotated dataset.
4. Adjudication Method for the Test Set
- None stated or implied. As ground truth was not established by human experts, there would be no need for an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document describes studies for a contact lens solution, not an AI-assisted diagnostic device. A MRMC study with human readers and AI assistance is not applicable here.
6. Standalone Performance Study
- Yes, for microbiological efficacy. The document explicitly states: "These studies demonstrate that KARATS meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products." This indicates the solution's performance was assessed independently against established criteria. Other pre-clinical studies (e.g., cytotoxicity, in vitro cleaning) also represent standalone assessments of the product's properties.
7. Type of Ground Truth Used
The "ground truth" for KARATS Multi-purpose Solution appears to be:
- Laboratory Measurements/Analytical Standards: For silicone hydrogel compatibility (optical/physical changes), XPS (surface changes), in vitro cleaning efficacy (protein removal), cytotoxicity (cell viability/irritation), and microbiology (disinfection efficacy against specific organisms). These are typically quantitative or qualitative outcomes measured in a controlled lab setting against predefined success criteria (e.g., "no significant difference," "non-cytotoxic," "meets stand-alone criteria").
- Clinical Observations/Outcomes: For clinical testing, data likely involved patient reported outcomes, adverse event rates, and physician assessments to demonstrate "substantial equivalence."
8. Sample Size for the Training Set
- Not applicable / Not stated. This is a pre-AI era medical device submission (2003) for a chemical solution, not an AI/ML algorithm. Therefore, there is no concept of a "training set" in the context of machine learning. The studies involved testing the solution directly.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided document.
§ 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.”