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P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) for daily wear are spherical lenses indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia ranging from -0.00 diopters to -10.00 diopters.

The lenses 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 lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. The lenses are intended for daily wear and are to be replaced every three months (quarterly). When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

The P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in 0.9% saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).

The P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is available clear or tinted for visibility using phthalocyanine blue, tinted in unique pattern to enhance or alter the apparent color of the eye. Each unique patterns may be distributed under unique or "private label" trade names. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: C.I Reactive Black 5, Titanium Dioxide (TiO2), Carbazole Violet (i.e.,C.I Pigment Violet 23), Phthalocyanine green (i.e.,C.I PIgment Green 7), D&C Yellow No. 10, D&C Red No. 17, [Phthalocyaninato (2-)] Copper (i.e.,C.I PIgment Blue 15).

When producing the color lenses, the manufacturing process changes the specifications of the clear lens by pad-printing the color pigment(s)—entrapping the colorants in the interpenetrating network of the contact lens material—in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the clear, pre-tinted lens.

Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

The provided text is a 510(k) clearance letter for contact lenses. While it details the device, its intended use, and substantial equivalence to a predicate device, crucial information regarding acceptance criteria for AI/algorithm performance and the study that proves the device meets the acceptance criteria (specifically in the context of AI/algorithm evaluation) is not present.

The document focuses on the physical and biological properties of contact lenses and manufacturing processes, not on an AI or algorithmic component that would require a study with an AI-specific acceptance criterion, ground truth establishment, or MRMC studies. The "Non-Clinical Test Conclusion" section primarily refers to biocompatibility, shelf life, and physicochemical/mechanical properties testing, all of which are standard for contact lenses and do not involve AI performance evaluation.

Therefore, I cannot fulfill the request as the input document does not contain the necessary information about AI/algorithm performance.

If this were a document for an AI-powered medical device, the information would typically be found in dedicated sections detailing "Clinical Performance Study," "Software Verification and Validation," or similar.

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Sphere/ Asphere
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D

Toric
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D and astigmatic corrections from -0.25D to -3.50D.

Multifocal
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) with presbyopia in aphakic or non-aphakic person with non-diseased eyes who may have +0.25D to +3.00D of ADD powers or less. The lens may be prescribed in spherical powers ranging from +6.00D to -12.25D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.

Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are clear and visibility tint with UV blocker are available as a spherical lens. The lens material, Toufilcon B is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA), N-Vinyl-2-Pyrrolidinone (NVP), N,N-Dimethylcarylamide (DMA), Methacrylic Acid (MAA), (3-Methacryloxy-2-hydroxypropoxy)propyl-bis(trimethylsiloxy)methylsilane (SiGMA) and Polydimethylsiloxane macromer (monofunctional Polydimethylsiloxane) (PDMS macromer), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and
Triallyl isocyanurate (TAIC) via photo-polymerization. The copolymer consists 50% Toufilcon B and 50% water by weight when immersed in buffered borate solution. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Toufilcon B name has been adopted by the United States Adopted Names Council (USAN).

This document describes the regulatory clearance of contact lenses, not a medical AI device requiring the kind of rigorous AI-specific validation outlined in your request. The provided text is a 510(k) clearance letter for contact lenses, which focuses on demonstrating substantial equivalence to a predicate device through physicochemical, biocompatibility, and clinical performance in human subjects, rather than AI model performance metrics.

Therefore, many of the requested elements for an AI device's acceptance criteria and accompanying study (e.g., sample size for test set, data provenance for AI, number of experts for ground truth, adjudication method, MRMC studies, standalone AI performance, training set details) are not applicable to this document as it does not relate to an AI device.

However, I can extract the relevant information from the provided document concerning the contact lens study and present it in a similar structured format, adapting where necessary.

Device: Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

Nature of Study: Clinical trial demonstrating substantial equivalence of a new contact lens product to an existing predicate device, focusing on safety and effectiveness for vision correction. This is not an AI device study.

1. Table of Acceptance Criteria (for Contact Lenses) and Reported Device Performance

Given this is a contact lens, the "acceptance criteria" are related to clinical efficacy (visual acuity) and safety (adverse events, slit lamp findings), and various physicochemical properties. The study aims to show non-inferiority or comparability to the predicate device rather than meeting specific numerical thresholds for many of the elements you'd expect in an AI performance table (e.g., sensitivity, specificity).

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Screened: 75 subjects
  • Enrolled: 56 subjects (39 wore test lenses, 17 wore control lenses)
  • Completed Study: 54 subjects (2 subjects in test group discontinued)
• Data Provenance: Prospective, randomized, double-blind, parallel, active-controlled clinical trial conducted in Taiwan.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not explicitly stated for establishing "ground truth," as this was a clinical trial involving patient outcomes and examinations. Clinical assessments were likely performed by eye care professionals involved in the study (e.g., ophthalmologists, optometrists), but a specific number or their detailed qualifications are not provided in the summary. The "ground truth" for contact lenses is physiological response, visual acuity, and safety outcomes from direct patient observation.

4. Adjudication Method for the Test Set

Not explicitly stated. Clinical trials typically have protocols for adverse event reporting and assessment, often by an independent safety committee or study investigators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is specifically designed for evaluating diagnostic performance of imaging modalities or AI systems where multiple readers interpret cases. This document describes a clinical trial for a contact lens, comparing direct patient outcomes between a new lens and a predicate.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not Applicable. This is a physical medical device (contact lens), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this contact lens study was based on:

• Clinical Outcomes Data: Corrected visual acuity measurements.
• Safety Data: Adverse event reporting, assessment of slit lamp findings (direct observation of ocular health by clinicians).
• Physicochemical and Biocompatibility Test Results: Objective laboratory measurements demonstrating material properties and biological safety.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning study, so there is no training set in that context. The "training" for the device would be the manufacturing process and quality control.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. See point 8.

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The contact forte Alpha is a Processor and is intended for use with the Sophono Headband or Softband (no age limitations), or with the Sophono Magnetic Implant (patients 5 years of age and up) for the following patients and indications:

• Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1.2, and 3 kHz).

• Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 4 kHz, or less than 15 dB at individual frequencies.

• Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear, who for some reason will not or cannot use an Air Conduction Contralateral Routing of Signal (AC CROS). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

The contact forte Alpha Processor is a sound processor that converts sound into mechanical vibrations. The sound processor is magnetically connected to a Sophono Headband, Sophono Softband or Sophono Attract Magnetic Spacer by the integrated metal disk. Sound enters the audio processor through the microphones, which then goes through a DSP chip for signal processing. The output of the DSP chip drives an electromechanical transducer, which converts the signal into mechanical vibrations. These vibrations are transferred to the patient's skin through the Sophono Headband, Sophono Softband or the Sophono Attract magnetic spacer. The vibrations are carried through the patient's skin and skull to the cochlea where they are perceived as sound. The device is designed for use on either the right or left side application. The device has a "oval" housing with a symmetrical design ( for right or left side application). The material used: Plastic contact with intact skin;

The FDA 510(k) Clearance Letter for the "contact forte Alpha" bone-conduction hearing aid (K243041) outlines performance data demonstrating the device's substantial equivalence to its predicate, the Sophono Alpha 2.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal table of quantitative acceptance criteria with corresponding performance numbers for the contact forte Alpha versus the Sophono Alpha 2. Instead, it relies on qualitative statements of equivalence and "good concordance" for certain measurements. The core acceptance criterion seems to be demonstrating comparable performance and no significant difference in key audiometric and output parameters compared to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Field Tests: 5 patients.
• Data Provenance: The document states "Field testing was conducted with five patients". Given the applicant, BHM-Tech Produktionsgesellschaft mbH, is located in Austria, and the device is manufactured there, it is highly probable the field tests were conducted in Austria or a similar European setting. The trials are implicitly prospective in nature, as they involve testing the contact forte Alpha in real-world conditions on human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not explicitly state the number or qualifications of experts used to establish the "ground truth" for the field test data beyond the general statement that "audiometric thresholds and speech perception thresholds" were assessed. For a hearing device, establishing ground truth would typically involve audiologists performing standardized audiological assessments. The document implies a direct comparison of the subject device and predicate on the same individuals, where the individuals' own established hearing thresholds serve as a baseline, and the objective measurements (audiometric thresholds, speech perception thresholds) and subjective reports are the core data points.

4. Adjudication Method for the Test Set:

The document does not describe any formal adjudication method beyond comparing the subject and predicate devices on the same patients and collecting objective measurements and subjective feedback. There is no mention of "2+1" or "3+1" methods typically used for image-based diagnostics. The comparison is direct and within-subject for the field test.

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 is not applicable to this device. The contact forte Alpha is a bone-conduction hearing aid, not an AI-assisted diagnostic tool where human readers/interpreters would "improve" with AI assistance. The performance evaluation focuses on the device's ability to amplify and transmit sound comparably to a predicate device, as perceived by patients and measured by audiometric tests.

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

This is not applicable in the traditional sense for this device. The "performance" of a hearing aid is inherently human-in-the-loop, as its function is to assist human hearing. However, the document does describe non-clinical tests such as "Magnetic Retention forces" and "Output Level Measurements" which are standalone assessments of the device's physical and acoustic properties without a human user. These non-clinical tests were performed independently of human perception.

7. The type of ground truth used:

The ground truth for the performance evaluation in the clinical field tests consisted of:

• Objective Audiometric Measurements: "Audiometric thresholds and speech perception thresholds" measured with both the predicate and subject devices. This is a form of objective functional assessment.
• Subjective User Reports: "The patients reported that they did not notice any subjective difference in hearing between the two devices." This is outcomes data based on patient perception.
• Technical Specifications/Measurements: For non-clinical tests, the "ground truth" is adherence to predefined engineering specifications and comparison against the predicate's known performance for parameters like "Magnetic Retention forces" and "Output Level Measurements."

8. The sample size for the training set:

The document does not specify a training set size. This device is a hearing aid, not an AI/machine learning model that typically requires a large training dataset for model development. The development and validation likely followed traditional engineering design and testing principles, not machine learning paradigms involving distinct training and test sets in the AI context.

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

As there's no mention of a training set in the context of an AI/ML model, this question is not applicable. The "ground truth" for the device's design and development would stem from established audiology principles, acoustic engineering standards, and the performance characteristics of the predicate device.

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miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.

Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.

The color lens may enhance or alter the apparent color of the eye.

Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.

Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.

The lenses may enhance or alter the apparent color of the eye.

Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus and Miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus

• They are daily wear soft contact lens for frequent replacement
• They are in a spherical lens design with UV blocker.
• They are available in hemispherical shell.
• The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer.
• The water content is 46%.
• A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (2.31%) in the UVB range of 280-315nm and less than 50% (12.05%) in the UVA range of 316-380nm.
• The miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus" is a light blue tinted with "reactive Blue19" for handling visibility purpose.
• The Miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus is a color lens that may enhance or alter the apparent color of the eye.
• The lens is supplied in a sterile state, packaged in a buffered saline solution.

miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus and miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus

• They are daily wear soft contact lens for daily disposable
• They are in a spherical lens desing with UV blocker.
• They are available in hemispherical shell.
• The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer.
• The water content is 48%.
• A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (2.36%) in the UVB range of 280-315nm and less than 50% (13.43%) in the UVA range of 316-380nm.
• The miacare (miafilcon B) DELiGHT 1-day Contact Lens with EautraSil Plus" is a light blue tinted with "reactive Blue19" for handling visibility purpose.
• The Miacare (miafilcon B) CONFiDENCE 1-day Color Contact Lens with EautraSil Plus is a color lens that may enhance or alter the apparent color of the eye.
• The lens is supplied in a sterile state, packaged in a buffered saline solution.

The provided FDA 510(k) clearance letter and summary describe the safety and effectiveness studies for soft contact lenses, not an AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria, ground truth, expert adjudication, MRMC studies, and standalone performance for an AI device is not applicable and not present in the document.

The document focuses on demonstrating substantial equivalence of the new contact lenses to legally marketed predicate devices through physiochemical studies, biocompatibility testing, and clinical wearer studies. The "acceptance criteria" discussed are primarily about demonstrating non-inferiority in terms of safety and effectiveness for the contact lenses when worn by human subjects, compared to existing, legally marketed lenses.

Here's an attempt to answer the questions based on the provided document, acknowledging where the requested information for AI devices is not relevant or available:

Acceptance Criteria and Study Details for BenQ Materials Corporation Contact Lenses (K242056)

This document describes the safety and effectiveness testing for soft contact lenses, which are physical medical devices, not AI software. As such, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" for an AI device (e.g., diagnostic accuracy, sensitivity, specificity, expert adjudication, MRMC studies) are not directly applicable. Instead, the studies aim to demonstrate the non-inferiority of the new contact lenses compared to predicate devices in terms of clinical safety and efficacy in human wearers.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a physical medical device (contact lens) and not an AI device, the "acceptance criteria" are generally framed as demonstrating non-inferiority to existing predicate devices in clinical performance. The document doesn't provide specific quantitative thresholds for "acceptance criteria" in a typical AI sense (e.g., target AUC, sensitivity). Instead, it states the overall finding of "no significant difference."

2. Sample Size Used for the Test Set and Data Provenance

• miacare (miafilcon A) CONFiDENCE Color Contact Lens (vs OxyPure Color Silicone Hydrogel):

  • Enrollment: 192 subjects (96 test lenses, 96 control lenses)
  • Completed: 172 subjects (85 test group, 87 control group)
  • Data Provenance: Mainland China, multi-center, open, parallel, randomized controlled comparison study, with 90 days follow-up. (Prospective clinical study)

• miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens (vs Si-Hy (olifilcon B) Color Silicone Hydrogel):

  • Enrollment: 192 subjects (96 test lenses, 96 control lenses)
  • Completed: 192 subjects (96 test group, 96 control group)
  • Data Provenance: Mainland China, multi-center, open, parallel, randomized controlled comparison study, with 90 days follow-up. (Prospective clinical study)

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the study involved clinical performance trials of physical contact lenses on human subjects, not an AI device requiring expert consensus for ground truth on imaging or diagnostic tasks. The "ground truth" here is the observed clinical outcome (e.g., adverse events, visual acuity, slit lamp findings) directly measured from the study participants by eye care professionals involved in the study. The document does not specify the number or qualifications of these eye care professionals, beyond stating the studies were conducted in "3 hospitals."

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in AI studies for resolving discrepancies in ground truth labeling by multiple experts. This concept is not applicable here. Clinical outcomes were presumably recorded by the investigators at different sites. The summary states "No statistic significant difference between test lens and control lens with respect to safety data," implying statistical comparison of observed clinical metrics between groups.

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 question is not applicable. MRMC studies are specific to evaluating human reader performance with and without AI assistance for tasks like medical image interpretation. This document describes a clinical trial evaluating the performance of contact lenses for vision correction and eye health.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. "Standalone performance" refers to the algorithm's performance without human interaction for AI devices. The devices in this submission are contact lenses, which are inherently used by humans.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in these clinical studies primarily consists of:

• Clinical Outcomes Data: Direct observations and assessments from study participants during the 90-day follow-up. This includes:
  • Adverse events reported and observed.
  • Slit lamp findings (examinations of the eye's anterior segment).
  • Symptoms/problems/complications reported by subjects.
  • Keratometry (K) readings (corneal curvature).
  • Refractive changes (absolute value).
  • Visual acuity (VA) data.
  • Average wearing time (AWT).
  • Discontinuation reasons and lens replacement data.
• Visual Acuity: The ability of the CVA (Corrected Visual Acuity) to reach "equal or higher than 1.0" (presumably 20/20 or better).
• Aesthetic Effect: The color lens's ability to "enhance or alter the apparent color of the eye."

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train an AI model. This document describes clinical trials for physical medical devices (contact lenses), not the development of an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8. There is no AI training set in this submission.

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The SPHERICAL/ASPHERE Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The TORIC Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive error in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The MULTIFOCAL Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients.

Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution with polymeric wetting agents. The color additive (Pathalocyaninto(2-))Copper, Iron Oxide and Reactive Yellow 15 are added to the lens material to create a light yellow-green edge-to-edge color to make it easier to see when handling, and additionally, reduce transmittance of short wavelength light in the range of 380nm to 460nm. In addition, lenses contain a benzotriazole monomer to filter UVA and UVB radiation. The (ocufilcon D) name has been adopted by the United States Adopted Names Council (USAN).

The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are available tinted for visibility, and tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Reactive Yellow 15, Rutile TiO2, Iron Oxide, (Pathalocyaninto(2-))Copper, Carbazole Violet, Phthalocyanine Green.

When producing the color lenses, the manufacturing process changes the specifications to the light yellow-green contact lens by pad-printing the color pigment(s)—entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.

The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses filter >95% in the UVB range (280nm - 315nm), and >80% in the UVA range (315nm - 380nm).

The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are manufactured in the sphere/asphere, toric, and multifocal design configurations.

The provided FDA 510(k) clearance letter and associated summary pertain to a contact lens device, the Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color). It's important to note that this document describes the device as a "Soft (Hydrophilic) Contact Lens," which is a device type, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study parameters related to AI/ML device performance (such as sensitivity, specificity, MRMC studies, ground truth establishment for AI/ML, etc.) are not applicable to this type of medical device submission.

The "acceptance criteria" for a contact lens device primarily revolve around its physical, chemical, and biological properties, as well as its safety and functionality for human use, established through non-clinical (laboratory) testing and comparisons to predicate devices. The study proving these criteria are met is typically a combination of non-clinical bench testing and demonstrating substantial equivalence to an already marketed predicate device.

Here's the information based on the provided document, restructured to address your points where applicable:

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

For a contact lens, explicit "acceptance criteria" are often derived from recognized standards (like ANSI Z80.20 mentioned) and the performance of predicate devices. The reported device performance is compared against these and is generally expected to be within acceptable tolerances or equivalent to the predicate.

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HPM38 (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

Disposable Wear:

Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When prescribed for Daily Disposable Wear, the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

Frequent / Planned Replacement Wear:

Eyecare practitioners may prescribe any of the above lenses for frequent / planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a spherical lens. It is fabricated from polymacon which has been adopted by the United Stated Adopted Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The lens material, polymacon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), initiated by 2, 2'-azobisisobutyronitrile (AIBN). The lens consists of 62% polymacon and 38% water by weight when immersed in standard saline solution.

HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available cosmetic tinted to enhance or alter the apparent color of the eye. It is tinted in an annular pattern, providing a clear optic zone, using a combination of one or more of the following 'listed' color additives: Reactive black 5, Titanium dioxide, Iron oxides, Solvent Yellow 18, Carbazole violet, Pigment Blue 36, Phthalocyanine green.

The proposed color lenses are manufactured by sandwiching the pattern layer containing color additives between two layers of lens materials (polymacon).

In the hydrated state, HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus, and it acts as a refracting media to focus light rays on the retina.

HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in the spherical configuration with the following features and properties: Back vertex power -10.00D to 0.00D, step: 0.25D; Base curve 8.40 mm to 8.70 mm, step: 0.10 mm; Total diameter 13.80 mm to 14.50 mm, step:0.10 mm.

The physical properties of the proposed lens are: Specific gravity 1.124; Refractive index 1.437; Light Transmission 93% ± 5%; Surface character Hydrophilic; Water content 38%; Oxygen permeability 8.99x10^-11 (cm²/s) [ml O₂/(ml·mmHg)] at 35°C.

HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is supplied sterile in the foil blister pack containing the borate buffer solution.

The provided document is a 510(k) Premarket Notification for a contact lens, the HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens. It details the device's characteristics, its comparison to a legally marketed predicate device, and the non-clinical tests performed to demonstrate its safety and effectiveness.

Based on the provided text, no information on a study proving the device meets acceptance criteria for an AI/ML powered device, specifically in the context of human-in-the-loop performance, standalone algorithm performance, or ground truth establishment by experts, is present.

The document specifically states in Section 8: "This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." This confirms that there was no clinical study, let alone one involving AI or expert human readers, to assess and prove the device meets acceptance criteria as envisioned in the prompt's requirements.

The "acceptance criteria" discussed in this document are related to the physical, chemical, optical, and biological safety and performance of the contact lens itself, not an AI/ML algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets acceptance criteria within an AI/ML context because the document is a 510(k) premarket notification for a contact lens and does not describe such a study.

However, I can extract the acceptance criteria and performance related to the contact lens itself from the document.

Acceptance Criteria and Reported Device Performance (Non-AI/ML Medical Device)

The document primarily focuses on demonstrating the substantial equivalence of the HPM38 contact lens to a predicate device (Neo Cosmo (polymacon) Soft (hydrophilic) Contact Lens, K142275) based on physical, optical, physicochemical, and biocompatibility properties. The "acceptance criteria" are implied by meeting the standards outlined in regulatory guidances and internationally recognized standards (e.g., ISO, ASTM).

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

The document presents a comparison table (Section 6) and lists performance tests (Section 7). Below is a summary of the key physical and optical properties and their reported values, which implicitly serve as the device's performance against industry and regulatory expectations for these parameters. The "acceptance criteria" are generally that these parameters fall within acceptable ranges for contact lenses and demonstrate equivalence to the predicate device.

Table: Acceptance Criteria (Implied) and Reported Device Performance for HPM38 Contact Lens

Since the document explicitly states that no clinical study was utilized and does not mention any AI/ML components, the remaining points of your request cannot be fulfilled as they pertain to such a study.

2. Sample size used for the test set and the data provenance: Not applicable. No test set for an AI/ML model or human reader study is described. The "test set" here refers to samples of contact lenses undergoing physical, chemical, and biological testing, not patient data for an AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in an AI/ML context (e.g., for image interpretation) is not established by experts in this type of submission.

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: Not applicable.

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 (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. The "ground truth" for this device's performance is established through physical measurements, chemical analyses, and biological assays (e.g., cytotoxicity tests).

8. The sample size for the training set: Not applicable. There is no mention of a training set for an AI/ML model.

9. How the ground truth for the training set was established: Not applicable.

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Infrared Thermometer is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.

The Non-contact Forehead Infrared Thermometer (Model FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) measures the body temperature based on the infrared energy emitted from the forehead. Users can get measurement results after properly scanning the forehead. The thermometer of a shell, an LCD, a measure button, a beeper, an infrared temperature sensor, and a Microprocessor.

The device is widely used for home healthcare, medical institutes and many other occasions.

The provided text describes the regulatory clearance of a Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) and details the testing done to prove its substantial equivalence to a predicate device. This is not an AI/ML device, and thus, many of the requested elements for AI/ML device studies (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable or not found in the provided document.

However, I can extract information related to the acceptance criteria and the study that proves the device meets (or is equivalent to) those criteria for a traditional medical device, specifically a thermometer.

Here's a breakdown of the requested information, adapted to the context of a thermometer and the provided document:

Acceptance Criteria and Device Performance for Non-contact Forehead Infrared Thermometer

1. Table of Acceptance Criteria and Reported Device Performance

For medical thermometers, the primary acceptance criteria revolve around measurement accuracy and clinical performance. The document refers to compliance with specific international standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: A minimum of 143 subjects were used for the clinical study. These subjects were divided into three age groups:
  • Group A1: 0 up to 3 months (Infant group)
  • Group A2: 3 months up to 1 year (Infant group)
  • Group C: Older than 1 to 5 years old (Child group)
  • Group B and C: Above 5 years old (Adult group) - Note: The document lists B Child group (Older than 1 to 5 years old) and C group older than 5 years old. This seems to be a minor typo in the extract formatting, grouping A and B as infant and child, and then C as older. The key is that multiple age groups were tested.
• Data Provenance: The document does not explicitly state the country of origin of the clinical data. It states the study was a "randomization, simple blind homologous control, pairing design of clinical investigation." It is a prospective clinical study as it involved conducting tests with human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the context of a non-contact infrared thermometer's clinical accuracy study. For such a device, a "ground truth" is typically established by comparative measurements against a highly accurate reference thermometer (e.g., a rectal thermometer) as per the ASTM E1965 standard, rather than expert consensus on images or interpretations. The expertise required would be in the conduct of the clinical study itself, ensuring proper procedure and data collection.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective assessment by multiple readers, common in diagnostic imaging. For a thermometer, the "ground truth" is a measured temperature value, not a subjective interpretation requiring adjudication among experts. The study design mentions "simple blind homologous control, pairing design."

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. The device is a Non-contact Forehead Infrared Thermometer, not an AI/ML-powered diagnostic imaging device involving human readers or AI assistance in interpretation.

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

This information is not applicable in the context of an AI algorithm. The device itself is the "standalone" product, measuring temperature. Its performance is evaluated directly through non-clinical and clinical testing, not as an algorithm interpreting data for a human.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparative temperature measurements against a reference method (likely rectal or oral temperature, as per ASTM E1965-98 standards for clinical thermometers). The study assessed the device's accuracy in relation to these established body temperature measurements. It is explicitly stated that the study followed ASTM E1965-98, which is a standard for clinical accuracy of infrared thermometers.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The document describes a traditional medical device, not an AI/ML device that requires a "training set" in the machine learning sense. The device is hardware-based, relying on infrared physics, not trained on a dataset of images or other input data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As stated above, this is not an AI/ML device with a "training set."

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The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequentl planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal. therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia. The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Polymacon) is a hydrophilic co-polymer by crosslinking 2-Hydroxyethyl methacrylate (HEMA). and Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 62.0% (Polymacon) and 38.0% water by weight of saline immersed in normal saline. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 315 to 380 nm. The lenses contain a combination of the following color additives: Phthalocyanine green, Carbazole violet, [Phthalocyaninato (2-)] copper, Titanium dioxide, Iron oxides (Red, Yellow and Black),and Mica-based pearlscent pigment (Gold, Silver and Red). All color additives used are listed in 21 CFR 73 subpart D and 74 subpart D. It is supplied in a sterile package with buffered saline solution.

This document describes the premarket notification (510(k)) clearance for the Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens. However, it does not contain information typically associated with acceptance criteria and a study that proves a device meets them in the context of an AI/ML medical device.

This type of FDA clearance (510(k)) is for a physical medical device (a contact lens) and relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than a clinical study with quantifiable performance metrics against specific acceptance criteria for an algorithm.

Therefore, many of the requested elements for an AI/ML device (like sample size for test/training sets, ground truth establishment methods, expert qualifications, MRMC studies, or standalone performance) are not applicable or not provided in this document.

Here's the breakdown of what can be extracted and what cannot:

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

The document provides a comparative table (Table 8) against predicate devices, focusing on physical and chemical characteristics. It does not present a formal "acceptance criteria" table with reported performance in the way one would for an AI/ML algorithm. Instead, it demonstrates similarity to predicate devices.

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The SLT Select Fiber Delivery Systems and Contact Tips are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems and tips achieve the precise tissue effects of incision, excision, vaporization of tissue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905connector.

·Laser must operate at a wavelength between 532 and 1064 nm.

• Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode.

• · Laser must have a numerical aperture of 0.35 or less.
  · Laser must accept universal SMA-905 connector, SLT proprietary connector, or an appropriate adapter into its fiber launch connector.

Note: These Fiber Delivery Systems are cleared for the particular indications of the laser system to which they are connected.

During use these products are exposed to biohazardous substances such as blood and other bodily fluids. They should be disposed of per your facility's procedures for biohazardous waste.

The SLT select fiber delivery system and contact tips is the transmission path for 810mm, 980mm wavelength laser generator to the surgical site, with the optical fiber as the propagation medium, by transmitting the diseased area, to achieve the treatment of the disease.

The SLT select fiber delivery system and contact tips, except for the CFE series of needle-tip one-piece flexible fibers, are fitted with a metal connector at the metal connector is threaded to connect to the contact laser tread, The FEF series models can be used as non-contact lasers without a treatment head.

The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria. The document is a 510(k) premarket notification for a non-AI medical device (SLT Select Fiber Delivery System and Contact Tips).

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details for an AI device from the provided text.

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