(36 days)
The Soft-55 daily wear lenses have the same intended use as the predicate Softcon® DW lens; they are fit on the comea to correct the vision acuity of the patient. The lenses have identical indications, warnings, contra indications and produce the same effect on the eye.
The Soft-55 daily wear contact lens design is substantially equivalent to the designs of the predicate lens currently in commercial distribution (Softcon® Daily Wear lens). The Soft-55 lens also has light transmission, refractive index and physical characteristics comparable to the predicate Softcon® Daily Wear lens.
The provided text describes a premarket notification (510(k)) summary for the Soft-55 Vifilcon A Daily Wear Plastic Contact Lens. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study with quantifiable performance metrics against specific acceptance criteria.
Therefore, many of the requested details, such as specific acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity), sample sizes for test sets, expert qualifications, or detailed study designs for AI algorithms, are not applicable to this document. The summary explicitly states that equivalence is established based on design, lens properties, and manufacturing processes.
Here's an attempt to address your request based on the provided information, noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate) | Reported Device Performance (vs. Predicate) |
|---|---|---|
| Design | Substantially equivalent to Softcon® Daily Wear lens | Equivalent |
| Material Properties | Light transmission comparable to Softcon® Daily Wear lens | Comparable |
| Material Properties | Refractive index comparable to Softcon® Daily Wear lens | Comparable |
| Physical Characteristics | Physical characteristics comparable to Softcon® Daily Wear lens | Comparable |
| Intended Use | Same as Softcon® Daily Wear lens | Same |
| Indications | Identical to Softcon® Daily Wear lens | Identical |
| Warnings | Identical to Softcon® Daily Wear lens | Identical |
| Contraindications | Identical to Softcon® Daily Wear lens | Identical |
| Effect on Eye | Produces same effect on the eye as Softcon® Daily Wear lens | Same |
| Safety and Effectiveness | As safe and effective as Softcon® Daily Wear lens | As safe and effective |
Note: The "acceptance criteria" here are implicit in the comparison to the predicate device. The performance is reported as being "equivalent" or "comparable" to the predicate, rather than meeting specific quantitative thresholds.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This document does not describe a clinical test set in the traditional sense of a study collecting data from a sample of patients. Equivalence is established through comparison of design, material specifications, and manufacturing processes.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There is no mention of a test set with ground truth established by experts.
4. Adjudication Method for the Test Set
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a 510(k) submission for a physical medical device (contact lens), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant or performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No. This is not an AI-powered device.
7. The Type of Ground Truth Used
- Not applicable. The basis for safety and effectiveness is substantial equivalence to an already marketed device, not ground truth derived from clinical pathology or outcomes for the new device.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 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.