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The material from which the lens will be manufactured is FDA approved polymacon (2-HEMA) which, when fully hydrated, is 38% water. This polymer is the original soft (hydrophilic) contact lens material and has been tested for performance, comfort and oxygen transmissibility since 1972. It is the most widely employed polymer in the contact lens industry. There are over four FDA approved manufacturers of polymacon polymer.
The equipment and processes which Unilens Corp., USA uses to manufacture polymacon lenses are identical to those which are used to manufacture their other hydrophilic lenses.
The FreeSoft (polymacon) Soft (Hydrophilic) Aspheric Contact Lens is an aspheric lens design the same as many other lenses on the market, such as the Unilens 38 (polymacon) Aspheric Contact Lens (510(k) K941836), Ideal Optics PS (polymacon) Aspheric Contact Lens (PMA No. P830012-S003), the Fulfocus (polymacon) Aspheric Contact Lens manufactured by Contact Lens Corporation of America (PMA No. P830006-S005), the Allvue (polymacon) Aspheric Contact Lens manufactured by Salvatori Ophthalmics (PMA No. P840006-S007) and the VX Soft Lens (polymacon) Aspheric Contact Lens manufactured by GBF Contact Lens (PMA No. P780013-S004 approved August 13, 1991).
The FreeSoft (polymacon) Aspheric Contact Lens is a front surface asphere with a base curve consisting of multiple radii. The front asphere creates the most plus power in the center of the lens, with the power becoming more minus towards the periphery. The multiple radii in the base curve produce increased plus power in the lens. This is a similar design as the other aspheric lenses listed above and the Unilens (hefilcon A) Soft (Hydrophilic) Aspheric Contact Lens which has been manufactured at this facility since our approval June 6, 1990 under PMA No. P850002-S005. The lenses have been designed so as to allow about 1 mm movement on the blink. This movement of the lens provides tear exchange to increase the oxygen under the lens and will assist in the removal of corneal metabolic wastes.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
It's important to note that the provided text is a "Summary of Safety and Effectiveness for the FreeSoft (polymacon) Soft (hydrophilic) Aspheric Contact Lens" from a 510(k) submission in 1996. This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with quantitative acceptance criteria and detailed performance metrics as one might find for a new AI/ML-driven medical device.
Therefore, many of the requested fields regarding detailed study methodologies (like sample sizes for test sets, data provenance, ground truth establishment, MRMC studies, or standalone algorithm performance) are not present in this type of regulatory document for a contact lens. The "acceptance criteria" here are largely implicit, relating to safety and effectiveness demonstrated through the long-standing use of the material and similar designs.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Safety & Effectiveness: Based on established use of polymacon. | The lens is made from FDA-approved polymacon (2-HEMA) which is 38% water, a material safely used for over 20 years, with a record of healthy wear and good movement on the eye. |
| Manufacturing Process Equivalence: Identical to previously approved processes. | Equipment and processes are identical to those used for other approved hydrophilic lenses by Unilens Corp., USA. |
| Design Equivalence/Functionality: Similar to existing FDA-approved aspheric contact lenses, providing good movement and tear exchange. | The FreeSoft lens is an aspheric design (front surface asphere with multiple radii base curve) similar to numerous other FDA-approved aspheric lenses from various manufacturers (e.g., Unilens 38, Ideal Optics PS, Fulfocus, Allvue, VX Soft Lens, Unilens (hefilcon A)). Designed to allow ~1mm movement on blink for tear exchange and removal of metabolic wastes. |
| Water Content: Slightly lower water content polymacon for daily wear. | 38% water content polymacon for Daily Wear, similar to previously approved lower water content lenses manufactured by Unilens since 1985. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. The submission relies on the established safety and effectiveness of the polymacon material and the aspheric design rather than a new comparative clinical trial with specific test sets. Data provenance would primarily be from general clinical use and post-market surveillance of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. "Ground truth" in the context of an AI/ML device for diagnostic purposes does not apply to this contact lens submission. The "truth" here is established by regulatory approval of similar materials and designs over decades of clinical use.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. No specific "test set" and adjudication method as defined for an AI/ML diagnostic device's performance study is detailed in this submission.
5. 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
This information is not applicable/provided. This is a contact lens submission, not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or effect size for AI assistance would be present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This is a physical medical device (contact lens), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's safety and effectiveness is primarily established through:
- Decades of clinical experience and regulatory approval of the polymacon material (since 1972).
- Clinical experience and regulatory approval of similar aspheric contact lens designs from various manufacturers (PMA numbers cited).
- Manufacturing experience and FDA inspections of the manufacturing facility (last inspected Feb 22, 1993).
- Clinical understanding of contact lens physiology, specifically movement for tear exchange and corneal health.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" in the context of an AI/ML device for this contact lens submission. The "training" here refers to the accumulated knowledge and clinical performance of the material and design over many years.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, there is no "training set" in the AI/ML sense. The "ground truth" related to the material and design's safety and effectiveness was established through extensive historical clinical use and regulatory review processes over several decades, involving ophthalmologists, optometrists, and regulatory bodies.
§ 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.