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The iO2 Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with nondiseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D.

The ASTERA Multifocal iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or nonaphakic patients with non-diseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D and have near add requirements up to 3.25 D.

The iO2Toric (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or non- aphakic persons with non diseased eyes in a spherical power range of +30.00 to -30.00 D and a cylinder power range up to -10.0D.

The ASTERA Multifocal Toric iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic or non- aphakic patients with non-diseased eyes in a spherical power range of +30.00 to -30.00 D, a cylinder power range up to -10.00 D and an add requirement up to 3.25 D.

iO2 lenses may be disinfected using chemical (not heat) disinfecting systems.

The iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in spherical, multifocal, toric, and toric-multifocal designs. Specifically, the iO2 Sphere, iO2 Toric, ASTERA Multifocal iO2, and ASTERA Multifocal Toric iO2 models are hemispheric flexible shells. All iO2 lenses are plasma treated in the dry state prior to initial hydration. The lens material (mangofilcon A) is a non-ionic hydrophilic copolymer that consists of 51% mangofilcon A and 49% water by weight. Mangofilcon A is available clear (no tint) with or without a UV absorber to block a significant amount of the UV radiation occurring between 200 and 400 nm (UVA and UVB). Mangofilcon A is also available in Blue or Aqua visibility tints to assist with handling. Both colors are available with or without the UV absorber.

This 510(k) summary (K133079) details the substantial equivalence of the Alden Optical Laboratories' iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear to a predicate device. The information provided outlines non-clinical performance data for the device but does not include any clinical study data involving human subjects or experts to prove the device meets specific acceptance criteria.

Therefore, I cannot populate the requested sections regarding acceptance criteria, reported performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from this document. The submission relies solely on a comparison of physicochemical properties and manufacturing processes to a legally marketed predicate device.

However, based on the provided text, I can infer the acceptance criteria are implicitly aligned with demonstrating physicochemical and safety characteristics equivalent to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicitly defined by the characteristics of the predicate device, K120756 (LSH mangofilcon A). The "study" proving the device meets these criteria is the non-clinical analysis and testing performed by the manufacturer, which showed identical or equivalent physicochemical properties to the predicate.

The following information is NOT available in the provided document:

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set (i.e., human subjects) was used for safety and effectiveness comparison in this submission. The "test set" here refers to material samples for non-clinical analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as expert evaluation of clinical performance is not mentioned. The "ground truth" for the non-clinical tests is based on established scientific measurement methods for material properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a contact lens, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For the non-clinical characterization, the "ground truth" is the scientifically measured physiochemical properties of the material and the finished lenses, compared directly to the predicate device.
8. The sample size for the training set: Not applicable, as there is no mention of a training set as would be used for an AI/ML device. For manufacturing, quality control involves testing batches, but this isn't designated as a "training set" in this context.
9. How the ground truth for the training set was established: Not applicable.

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The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with otherwise non-diseased eyes. 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 NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) and astigmatism in aphakic and not aphakic persons with otherwise non-diseased eyes and who possess refractive astigmatism not exceeding 10 Diopters.
The lenses may be prescribed for either conventional wear or planned replacement modalities, and may be disinfected with a chemical or heat disinfection system.

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Here's an analysis of the provided text regarding acceptance criteria and supporting study information.

IMPORTANT NOTE: The provided document is a 510(k) clearance letter from the FDA. Its purpose is to state that the device is "substantially equivalent" to legally marketed predicate devices, not typically to present original clinical study data or detailed acceptance criteria for a new device. Therefore, much of the requested information (especially specific performance metrics, sample sizes, expert qualifications, etc.) is not present in this type of document. The letter refers to the "premarket notification" which would contain such details, but the letter itself does not include them.

As such, I will extract what can be found and explicitly state when information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Breakdown of Missing Information and Assumptions Based on Document Type:

Regarding the remaining points, this document (a 510(k) clearance letter) does not typically contain the detailed study information you're asking for. Such information would be submitted to the FDA in a Pre-Market Notification (510(k)) application by the manufacturer, but is not present in the clearance letter itself.

Here's a breakdown of the requested information and why it's not in this document:

• 2. Sample size for the test set and data provenance:

  • Missing from document. Clinical study sample sizes and data provenance (e.g., country of origin, retrospective/prospective) are not included in this FDA clearance letter. These would have been part of the manufacturer's 510(k) submission.

• 3. Number of experts used to establish the ground truth for the test set and qualifications:

  • Missing from document. For soft contact lenses, performance is typically assessed through clinical trials involving patient wear rather than expert image interpretation. If any expert evaluation was performed (e.g., grading of ocular health), the number and qualifications of those experts would not be listed in this type of FDA letter.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

  • Missing from document. This is typically relevant for image-based diagnostics where there's a need to resolve discrepancies between readers. Contact lens studies focus on physiological responses and visual acuity, which are measured directly or by an ophthalmologist/optometrist during follow-up visits.

• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size:

  • Not applicable / Missing from document. MRMC studies are primarily for evaluating diagnostic imaging devices where human readers interpret images. This device is a soft contact lens. Its effectiveness is assessed by factors like visual acuity, comfort, and ocular health outcomes in wearers, not by human interpretation of its "output" aided by AI. There is no indication of AI assistance in this traditional contact lens clearance.

• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

  • Not applicable / Missing from document. This device appears to be a physical medical device (contact lens), not an algorithm or AI system. Therefore, "standalone algorithm performance" is not relevant.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

  • Missing from document, but can be inferred for contact lenses. For contact lenses, "ground truth" often refers to clinical outcomes (e.g., measured visual acuity, slit lamp examination findings for ocular health, patient-reported comfort, incidence of adverse events). This information would be collected during clinical trials described in the 510(k) submission.

• 8. The sample size for the training set:

  • Not applicable / Missing from document. As this is a physical contact lens, there isn't a "training set" in the context of machine learning or AI models. Clinical trials for contact lenses involve a "study population" or sample size.

• 9. How the ground truth for the training set was established:

  • Not applicable / Missing from document. Similar to point 8, the concept of a "training set" and "ground truth establishment" for an algorithm does not apply to a physical contact lens. Clinical trial data collection methods would describe how outcomes (the closest equivalent to "ground truth" here) were established for the study population.

Summary regarding this particular document:

The provided document is an FDA 510(k) clearance letter confirming that the NOVAKONE Spherical and NOVAKONE Toric contact lenses are substantially equivalent to legally marketed predicate devices. It focuses on the regulatory aspects and indications for use. It does not present any specific data, acceptance criteria, or details of clinical studies that would contain the performance metrics or ground truth information you've requested. Those details would be found in the original 510(k) premarket notification submitted by the manufacturer.

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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.

Not Found

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.

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The Alden Classic (polymacon), Alden Classic 55 (methafilcon A), Alden HP 49 (hioxifilcon B) and Alden HP 59G (hioxifilcon A) Multifocal (Spherical and Toric) soft contact lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia. The lenses are available for either conventional or planned replacement modalities.

Alden Classic (polymacon) Multifocal Contact Lens (Spherical and Toric designs); Alden Classic 55 (methafilcon A) Multifocal Contact Lens (Spherical and Toric designs); Alden HP 49 (hioxifilcon B) Multifocal Contact Lens (Spherical and Toric designs); Alden HP 59G (hioxifilcon A) Multifocal Contact Lens (Spherical and Toric designs).

The provided text is a 510(k) premarket notification letter from the FDA to Alden Optical Laboratories, Inc. regarding their multifocal contact lenses.

**This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI detection algorithms.

Therefore, I cannot provide the requested information based on the given input text. The document is a regulatory approval letter for a medical device (contact lenses), not a study report or technical specification for an AI-powered diagnostic device.

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The Alden HP 55 (methafilcon A) and Alden HP 59G (hioxifilcon A) Sphere and Toric Soft Contact Lenses For Daily Wear, are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, and/or possess refractive astigmatism not exceeding 10 Diopters. They are available for either conventional wear or planned replacement modalities.

Alden HP 55 (methafilcon A) and Alden HP59G (hioxifilcon A) Sphere & Toric Soft Contact Lenses

The provided document is a 510(k) premarket notification letter for soft contact lenses. It does not contain information about the acceptance criteria or a study proving that a device (in the context of AI/software as a medical device) meets acceptance criteria.

The document discusses the substantial equivalence of Alden HP 55 (methafilcon A) and Alden HP59G (hioxifilcon A) Sphere & Toric Soft Contact Lenses to legally marketed predicate devices. The focus is on the regulatory pathway for these contact lenses, which fall under 21 CFR 886.5925, Soft (hydrophilic) contact lens, and are classified as Class II.

Therefore, I cannot extract the requested information about acceptance criteria and a study from this document, as it pertains to contact lenses and not a device that would typically have the kind of performance study details requested (e.g., sample sizes for test/training sets, ground truth establishment by experts, MRMC studies, standalone performance).

The information provided in the prompt is specific to a type of medical device (like an AI algorithm) that would undergo performance evaluation against explicit acceptance criteria, often involving clinical studies with human readers, ground truth, and statistical analysis. This document simply confirms the FDA's decision regarding the substantial equivalence of ophthalmic contact lenses based on their regulatory classification.

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The OXYLENS PROSTHETIC (hioxifilcon B), Tinted Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prostheric contact leases for cosmetic management of conditions such as comeal, ins or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with either a chemical or a heat disinfection system.

The OXYLENS TINTED (hioxifilcon B) Spherical Soft Contact Lenses for daily wear, are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with 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 lens may be disinfected with either a chemical or a heat disinfection system.

The OXYLENS TINTED (hioxifileon B) Toric Soft Contact Leases for daily wear, are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected with either a chemical or a heat disinfection system.

The leases are available within a planned replacement program with frequency of replacement determined by the practitioner.

The OXYLENS TINTED, PROSTHETIC (hioxifilcon B), Soft Contact Lens is fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. A tint mixture containing; Blue 7,16-Dichloro-6, 15-dihydro-5,9,14,18-anthrazinetetrone, Green 16,17 -Dimethoxydinaphtho [1.2.3 -cd:3'.2'.1' -lm] pervlene-5,10-dione, and Brown 16,23 -Dihydrodinaphtho [2,3-a.2 ] 3 ' -i] napth [2',3' ; 6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone is added to the lens.

The tint mixture (BLACK) is processed into the contact lens to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.

Tint Patterns Available:

• 1. Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm.
• 2. Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
• 3. Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0.5 mm increments. Clear Pupil diameter range 2.0 mm to 7.5 mm in 0.5 mm increments.
• 4. Tinted lens with Black Pupil. Uses the Alden Classic Tinted (polymacon 38%) contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.

The OXYLENS TINTED may contain a single listed color additive, or may contain a combination of color additives in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. The color additives are added to the contact lens for enhancing and/or altering the apparent color of the eve.

In the hydrated state, the OXYLENS TINTED, PROSTHETIC lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a color altering optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped, however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The provided text is a 510(k) summary for the OXYLENS TINTED, PROSTHETIC (hioxifilcon B) Soft Daily Wear Contact Lens. This document demonstrates that the device is substantially equivalent to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested elements about acceptance criteria, clinical studies, sample sizes, ground truth, and expert involvement are not applicable as this type of submission relies on demonstrating substantial equivalence to existing devices with established safety and effectiveness.

Here's a breakdown of the applicable and non-applicable information based on the provided text:

1. A table of acceptance criteria and the reported device performance

There are no explicit "acceptance criteria" presented in the format of a clinical study or performance goals that the device had to meet. The submission focuses on demonstrating substantial equivalence to predicate devices based on material characteristics and intended use. The table below summarizes the characteristics of the proposed device and its predicates, serving as the basis for the substantial equivalence claim.

Table of Device Characteristics and Predicate Comparison

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This 510(k) submission does not include a clinical study with a test set of data. The submission demonstrates substantial equivalence based on the device's design, materials, and intended use being similar to already approved predicate devices. It references "pre-clinical toxicology and manufacturing/chemistry data" but does not detail any specific human clinical testing for this submission.

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)

Not Applicable. No ground truth establishment by experts for a test set is described, as no specific clinical study data is presented for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As no clinical study or test set is described, there is no adjudication method.

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

Not Applicable. This is not an AI-assisted device, and no MRMC study or comparative effectiveness study is presented in the 510(k) summary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a contact lens and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No explicit ground truth based on expert consensus, pathology, or outcomes data is mentioned as there is no specific clinical study for this 510(k) submission. The "ground truth" for demonstrating safety and effectiveness relies on the established safety and effectiveness profiles of the predicate devices and the similarity of the new device to them.

8. The sample size for the training set

Not Applicable. This involves a physical medical device (contact lens), not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established

Not Applicable. See response to item 8.

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The ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or nonsighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with either a chemical or a heat disinfection system.

The ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Leas is fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. A tunt mixture containing: Blue 7,16-Dichloro-6, 15-dihydro-5,9,14,18-anthrazinetetrone, Green 16,17-Dimethoxydinaphtho [1,2,3 -> 1' - Im] perylene-5,10-dione, and Brown 16,23 -Dibydrodinaphtho [2,3-a:2',3' -i] napth [2',3';.6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone is added to the lens.

The tint mixture (BLACK) is processed into the contact lens to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or leas abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occhisive therapy for conditions such as diplopia, amblyopia or extreme photophobia.

Tim Patterns Available:

• 1. Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12,5 mm.
• 2. Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
• 3. Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0,5 mm increments. Clear Pupil diameter range 2.0 mm to 7,5 mm in 0.5 mm increments.
• 4. Tinted lens with Black Pupil. Uses the Alden Classic Tinted (polymacon 38%) contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.

In the hydrated state, the leas conforms to the curvature of the eye covering the cornes and extending sightly beyond the limbus forming a color altering optical surface. The (polymacon) soft hydrophilic contact leas a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the leas dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies, formatted as requested:

1. A table of acceptance criteria and the reported device performance

Based on the provided document, the device's acceptance criteria and performance are primarily established through substantial equivalence to predicate devices rather than explicit performance metrics against predefined thresholds. The document compares various material and functional characteristics.

Note: The document explicitly states: "The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the Alden Classic, and Alden Classic Tinted (polymacon), 510(k)'s #K973967 and #K980554." This implies that the device's safety and effectiveness are established by showing equivalence to previously cleared devices through shared material and manufacturing characteristics rather than new, independent clinical performance studies with specific numerical acceptance criteria.

The provided document describes a 510(k) submission for a soft contact lens. In the context of 510(k) submissions, the "study that proves the device meets the acceptance criteria" is typically a demonstration of substantial equivalence to a legally marketed predicate device, rather than a clinical trial proving specific performance metrics against predefined acceptance criteria.

Here's the breakdown of the information requested, based on the provided text:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. This submission is for a 510(k) premarket notification demonstrating substantial equivalence. It does not refer to a "test set" in the sense of clinical trial data with patient samples. The "testing" involves comparing the device's characteristics to a predicate device.
• Data Provenance: Not applicable in the context of a clinical test set. The data provenance relates to the characteristics and historical clearances of the predicate devices (WESLEY-JESSEN PROSTHETIC and BENZ-38) and the applicant's previously cleared devices (Alden Classic and Alden Classic Tinted), which would have been marketed in the USA. The submission itself is to the US FDA.

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)

• Not applicable. There is no mention of expert consensus being used to establish a ground truth for a "test set" in this type of submission. The "ground truth" for substantial equivalence is derived from the characteristics and regulatory history of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This is not a clinical study involving human judgment or image analysis requiring adjudication.

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

• Not applicable. This is a contact lens medical device submission for substantial equivalence, not an AI-based diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a contact lens medical device, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate devices (WESLEY-JESSEN PROSTHETIC and BENZ-38) and the applicant's previously cleared devices (Alden Classic, and Alden Classic Tinted), as defined and accepted by the FDA when those predicate devices were brought to market. Substantial equivalence means the new device is as safe and effective as a legally marketed device.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. As noted above, this is not a machine learning or AI device.

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The OXYLENS (hioxifilcon B) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or byperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters of less where the astigmatism does not interfere with visual acuity.

The OXYLENS (hioxifileon B) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 Diopters.

The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.

The OXYLENS (bioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eve. If the lens dries out, it will become hard and appear somewhat warped, however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 48% water by weight.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Oxylens:

Based on the provided 510(k) summary, the device (Oxylens soft contact lenses) is seeking substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria for device performance in a clinical trial. The "acceptance criteria" here refer to demonstrating that the Oxylens device is functionally and materially equivalent to already-approved devices, meaning it meets the same safety and effectiveness profile.

The document primarily focuses on demonstrating equivalence through comparison of physical properties and manufacturing methods, rather than presenting a clinical study with performance metrics like sensitivity, specificity, or reader improvement.

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the characteristics of the predicate devices. The device "performance" is the Oxylens' material and manufacturing properties matching or being similar to those of the predicate.

Study that proves the device meets the acceptance criteria:

The "study" proving equivalence is a comparison of the physical, chemical, and manufacturing characteristics of the Oxylens with those of the identified predicate devices ("Alden Classic" series, "Satureyes" and "Satureyes Toric" manufactured by Metro Optics, and "BENZ-G 3X" manufactured by Benz Research and Development). The document explicitly states: "The following matrix illustrates that the production method, lens function and material of the OxyLens (hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathecut from Lens Blank), are substantially equivalent to the predicate device(s). In addition, the water content, polymer, Dk value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate device."

This is a technical and material comparison, not a clinical efficacy or safety trial in the typical sense. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 3X (hioxifilcon B), 510(k) #K964528.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. This submission relies on material and manufacturing equivalency testing and existing data from predicate devices, not on a new clinical test set of patients or images.
• Data Provenance: The data provided relates to the physical and chemical properties of the lens material. The "established safety profile" is linked to a predicate device (BENZ-G 3X) which would have undergone its own review. The provenance of that underlying data is not detailed here. It is not a clinical study with patient data provenance.

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)

• Not applicable. This submission does not involve expert review for a "test set ground truth" in the context of an AI or diagnostic device. The ground truth for material properties is established through standard laboratory testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There is no clinical "test set" and thus no adjudication method for establishing ground truth from multiple readers/experts.

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

• No MRMC clinical study was done. This device is a contact lens, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a contact lens, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" here is based on standard material science properties and manufacturing characteristics (e.g., water content, Dk value, refractive index) as determined by established laboratory methods, and the functional characteristics of existing, legally marketed contact lenses. This is a technical equivalency, not a medical "ground truth" derived from patient outcomes or pathology.

8. The sample size for the training set

• Not applicable. This submission does not involve machine learning or an AI algorithm, so there is no training set.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set.

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The ALDEN CLASSIC TINTED (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with 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 CLASSIC TINTED (polymacon) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 Diopters.

The ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. A Blue tint (transparent/enhancing), 7,16-Dichloro-6, 15-dihydro-5, and 9,14,18anthrazinetetrone is added to the lens.

In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight.

The provided text is a 510(k) summary for a medical device (soft contact lenses) and focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the way envisioned by the prompt.

Therefore, many of the requested elements for describing an acceptance criteria study (like sample size, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in the provided document.

Here's an attempt to structure the information based on the prompt's request, noting where information is absent:

Acceptance Criteria and Device Performance Study Summary

This submission for the ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted relies on demonstrating substantial equivalence to predicate devices rather than a de novo performance study against specific acceptance criteria. The "acceptance criteria" in this context are interpreted as the critical physical and material properties that allow the device to be considered substantially equivalent to already approved devices.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implied by the characteristics of the predicate device, which the new device must match to demonstrate substantial equivalence.

Note on Dye Color: The device differs in the specific dye color used compared to the predicate, but this is acknowledged and presumably deemed non-critical for substantial equivalence in safety and effectiveness regarding the overall functionality of a tinted contact lens.

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not applicable. The submission relies on comparing material properties and manufacturing processes, not a clinical test set with patient data for performance evaluation.
• Data Provenance: Not applicable.

3. Number of Experts for Ground Truth and Qualifications

• Not applicable. Ground truth, in the sense of expert consensus on clinical outcomes, is not established for this type of submission. The 'ground truth' for comparison is the established properties of the predicate devices.

4. Adjudication Method for Test Set

• Not applicable. There was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is not a diagnostic imaging device involving interpretation by multiple readers.

6. Standalone Performance Study

• Not applicable in the typical sense of algorithm-only performance. The "performance" is demonstrated through the equivalence of physical and chemical properties to already approved devices.

7. Type of Ground Truth Used

• The "ground truth" for this substantial equivalence argument is derived from the known and approved specifications and performance characteristics of the predicate devices (Metro Tint and BENZ-38) and established scientific measurements of material properties.

8. Sample Size for Training Set

• Not applicable. There is no AI/machine learning component requiring a training set.

9. How Ground Truth for Training Set Was Established

• Not applicable.

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The ALDEN CLASSIC (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with 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 CLASSIC (polymacon) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual aculty in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 Diopters.

The ALDEN CLASSIC (polymacon) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eve. If the lens dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight.

The Alden Optical Laboratories ALDEN CLASSIC (polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Tinted, Lathe-cut from Lens Blank) is a medical device for correcting visual acuity. This summary outlines its acceptance criteria and the study that demonstrates compliance.

1. Acceptance Criteria and Reported Device Performance:

The device's acceptance criteria are based on its substantial equivalence to predicate devices (Co Soft 38 Toric, Metrolite, and BENZ-38) regarding material properties, production method, and lens function. The table below presents these characteristics:

2. Sample Size for Test Set and Data Provenance:

The provided document does not describe a clinical study with a "test set" in the traditional sense of evaluating device performance on a new cohort. Instead, the "study" demonstrating the device meets acceptance criteria is a substantial equivalence comparison to existing, legally marketed predicate devices.

Therefore, there is no explicit sample size for a "test set" or data provenance from a prospective or retrospective study of human subjects with the ALDEN CLASSIC lens itself to be reported in this context. The core of the submission relies on the established safety and effectiveness profile of the predicate devices and the identical material and design specifications.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This 510(k) submission is based on demonstrating substantial equivalence through material and design comparison, not a diagnostic or performance test requiring expert review of specific cases or images to establish ground truth. The "ground truth" here is the established performance and safety of the predicate devices.

4. Adjudication Method for Test Set:

Not applicable, as there was no traditional "test set" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This submission focuses on material and design equivalence, not on comparing human reader performance with or without AI assistance. The device is a contact lens, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study in the context of an algorithm's performance without human intervention was not done. The device is a soft contact lens, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" used for this submission is the established safety and effectiveness profile of predicate devices that have already been legally marketed and deemed safe and effective by the FDA. This is based on pre-clinical toxicology and manufacturing/chemistry data of the predicate devices (specifically BENZ-38) and the demonstration that the ALDEN CLASSIC maintains identical specifications.

8. Sample Size for the Training Set:

Not applicable. There is no training set for an algorithm as this is a contact lens submission based on substantial equivalence to existing lenses.

9. How Ground Truth for the Training Set was Established:

Not applicable, as there was no training set.

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