ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES

• K Number: K091327
• Device Name: ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES
• Manufacturer: ALDEN OPTICAL LABS., INC.
• Date Cleared: 2010-06-25 ( 416 days)
• Product Code: LPL
• Regulation Number: 886.5925
• Type: Special
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

The Alden HP 54 Spherical soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The Alden HP 54 Toric soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes, with refractive ametropia (myopia or hyperopia), and/or possess refractive astigmatism not exceeding 10.00 diopters. The Alden HP 54 Multifocal soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and presbyopia, with add powers not exceeding 4.00 diopters. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not . interfere with visual acuity. The Alden HP 54 Toric Multifocal soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes, with refractive ametropia (myopia or hyperopia), and/or possess refractive astigmatism not exceeding 10.00 diopters, and presbyopia with add powers not exceeding 4.00 diopters. The lenses are available for either conventional wear or planned replacement modalities.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for contact lenses. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a detailed 510(k) summary.

The document primarily focuses on:

• Substantial Equivalence: Stating that the Alden HP 54 contact lenses are substantially equivalent to legally marketed predicate devices.
• Regulatory Information: Details regarding the device's classification, applicable regulations, and responsibilities of the manufacturer.
• Indications for Use: Describing what the lenses are intended to correct (e.g., myopia, hyperopia, astigmatism, presbyopia) and in what patient populations (aphakic/not aphakic, non-diseased eyes).

Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from this document. This kind of information is typically found in the clinical data section of a 510(k) submission, which is not included in this clearance letter.

Regulation Number and Section

§ 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.