(252 days)
The Soft K (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring Keratoconia management and for the correction of myopia and hyperopia in aphakic and nonaphakic persons that may exhibit refractive and/or corneal irregularity such as irregular astigmatism up to 2.00 D that does not interfere with irregular astigmatism and may be disinfected with a chemical or heat disinfection system.
The Soft K Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring Keratoconia management and for the correction of myopia, hyperopia and astigmatism in aphakic and non-aphakic persons that exhibit refractive and/or post-refractive surgery corneal irregularity corneal astigmatism. The lens may be disinfected with a chemical or heat disinfection system.
Not Found
This is a 510(k) premarket notification for a medical device (contact lenses). These types of documents do not typically include detailed studies with acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies as might be found for AI/ML device submissions.
Instead, the FDA determines "substantial equivalence" to legally marketed predicate devices based on similarities in intended use, technological characteristics, and safety/effectiveness data. The document confirms that the device has been found substantially equivalent.
Therefore, the specific information requested in your prompt for acceptance criteria and a study proving device performance (as would be applicable for AI/ML or novel devices) is not present in this document. The "performance" in this context refers to the device meeting the same standards as existing, legally marketed contact lenses through non-clinical or clinical data that demonstrates similar design and performance characteristics.
The document does include:
- Trade/Device Name: Soflex Soft K (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear and Soflex Soft K Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear
- Indications for Use: Detailed in the "Page 1 of 1" section (document {2}).
- Regulatory Class: Class II
- Product Code: LPL
To answer your specific questions in the context of this document:
- A table of acceptance criteria and the reported device performance: This document does not contain such a table. The "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to a predicate device, which would involve showing that the new device is as safe and effective as the predicate.
- Sample size used for the test set and the data provenance: Not applicable/not provided in this document. Information on clinical or non-clinical testing would have been submitted in the 510(k) application, but the summary letter does not detail these aspects.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. This type of information is more relevant for diagnostic devices requiring expert interpretation of results.
- Adjudication method for the test set: Not applicable/not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a contact lens, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical contact lens.
- The type of ground truth used: Not applicable/not provided. Performance data would relate to lens fit, vision correction, comfort, and safety, typically compared to predicate lenses.
- The sample size for the training set: Not applicable/not provided. Training sets are relevant for AI/ML models, not for physical medical devices like contact lenses.
- How the ground truth for the training set was established: Not applicable/not provided.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.