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Ask a specific question about this device

3nethra neo HD FA:

3nethra neo HD FA is used as a wide-field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants. The device acquires only images and does not provide any pathological analysis or diagnosis for treatment.

3nethra neo HD:

3nethra neo HD is used as a wide-field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants. The device acquires only images and does not provide any pathological analysis or diagnosis for treatment.

The 3nethra neo-HD FA is a handheld wide-angle fundus imaging system for neonatal screening. It is designed to acquire, display, store and transmit images of the posterior and anterior surfaces of human eye. The images assist clinicians in the evaluation and documentation of visual health in retinopathy of prematurity (ROP) and other problems. It operates in contact with the cornea of the eye under test. 3nethra neo HD FA uses continuous white light for operation and hence need pupil dilation. It also equipped with blue light source and green filters for fundus fluorescein angiography (FFA).

The 3nethra neo-HD is a handheld wide-angle fundus imaging system for neonatal screening. It is designed to acquire, display, store and transmit images of the posterior and anterior surfaces of human eye. The images assist clinicians in the evaluation and documentation of visual health in retinopathy of prematurity (ROP) and other problems. It operates in contact with the cornea of the eye under test. 3nethra neo HD uses continuous white light for operation and hence need pupil dilation. The 3nethra neo HD is a lower end variant of the 3nethra neo HD FA without the Fluorescein Angiography feature.

The provided 510(k) clearance letter and summary describe the acceptance criteria and a study to prove the device's performance. Here's a breakdown of the information requested:

The device in question, 3nethra neo HD FA and 3nethra neo HD, are ophthalmic cameras intended for wide-field retinal imaging and photo documentation of ocular diseases in infants. They acquire images only and do not provide pathological analysis or diagnosis.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this device, based on the provided document, is substantial equivalence to existing predicate devices, particularly in terms of image quality for the FA functionality. The study focuses on demonstrating that the fluorescent angiography (FA) images produced by the subject device are comparable in quality to those produced by a predicate device.

Study Details

The study described is a clinical observational study focused on image quality comparison.

1. Sample size used for the test set and the data provenance:

   • The document states "of all study images," implying that all images collected within the clinical observational study were used for the comparison. However, the exact numerical sample size (number of images or patients) for the test set is not explicitly stated in the provided text.
   • Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It is described as a "clinical observational study," which typically implies prospective data collection, but this is not confirmed.

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

   • The document does not explicitly state the number of experts used or their specific qualifications (e.g., number of years of experience, specific certifications). It simply refers to the primary objective being to demonstrate comparability to a cleared reference device. The process of expert evaluation for "comparable quality" is not detailed.

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

   • The document does not describe any specific adjudication method for evaluating image quality. It states that "all study images were found to be of comparable quality," but the process by which this finding was made (e.g., consensus, majority vote) is not provided.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in the provided text.
   • The device is described as an "Ophthalmic Camera" that "acquires only images and does not provide any pathological analysis or diagnosis for treatment." Therefore, there is no AI assistance component for human readers to be compared against. The study focused on assessing the image quality of the camera itself, not the impact of AI on human interpretation.

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

   • This question is not applicable as the device is an imaging camera that acquires images for human interpretation, not an algorithm providing a standalone diagnostic or analytical output. The study assessed the quality of the images produced by the device.

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

   • The ground truth for the "comparable image quality" assessment appears to be based on a clinical observational study comparing the subject device's images to those from a predicate device (RetCam 3). The implicit ground truth is the accepted, established quality of images from the predicate device.
   • The document does not mention pathology or outcomes data as a direct ground truth for image quality assessment in this context. The study aimed to show that the images themselves were of sufficient quality for their intended purpose (photo documentation) by comparing them to a cleared device.

7. The sample size for the training set:

   • The document does not mention a training set. This is because the device is an imaging camera, not a machine learning or AI algorithm that requires a training set.

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

   • This question is not applicable as there is no mention of a training set for this device.

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The intended use of the MICOR 700 System with Auto I/A is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting

Not Found

I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the MICOR 700 with Auto I/A does not contain information regarding the acceptance criteria or the study that proves the device meets those criteria. The letter primarily focuses on the regulatory aspects of the clearance, such as the substantial equivalence determination, applicable regulations, and administrative requirements.

To answer your request, I would need access to a different document, such as the 510(k) summary or the full submission, which typically contains details about performance testing, validation studies, and the established acceptance criteria.

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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 FDA 510(k) clearance letter and associated documentation for the P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) primarily focus on demonstrating substantial equivalence to a predicate device based on bench testing. This type of submission relies on comparing physical, chemical, and design characteristics, along with performance against established standards, rather than extensive clinical studies or AI algorithm performance.

Therefore, many of the typical acceptance criteria and study details relevant to AI/ML medical devices (such as MRMC studies, expert consensus for ground truth on a large test set, etc.) are not explicitly present or applicable in this regulatory context.

However, based on the provided text, I can infer and extract the acceptance criteria and the type of study conducted to prove the device meets these criteria in the context of a 510(k) for contact lenses.

Here's the breakdown:

Acceptance Criteria and Device Performance (P-CON Contact Lenses)

The acceptance criteria for this device are established by demonstrating that its physicochemical, mechanical, and biocompatibility properties are substantially equivalent to a legally marketed predicate device (K221517) and that it complies with relevant ISO standards and FDA guidance for soft contact lenses.

Table 1: Acceptance Criteria and Reported Device Performance

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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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CASIA2 is a non-contact, high-resolution tomographic and biomicroscopic device intended for the in vivo imaging and measurement of ocular structures in the anterior segment. CASIA2 measures corneal thickness, anterior chamber depth and lens thickness.

The Tomey Cornea/Anterior Segment OCT CASIA2 (CASIA2) is a non-contact, high resolution tomographic and biomicroscopic device indicated for in vivo imaging of ocular structures in the anterior segment. The Tomey Cornea/Anterior Segment OCT CASIA2 is indicated as an aid in the visualization and measurement of anterior segment findings. CASIA2 measures corneal thickness, anterior chamber depth and lens thickness.

This medical device product has functions subject to FDA premarket review (corneal thickness, curvature, anterior chamber depth and lens thickness) as well as functions that are not subject to FDA premarket review. For this application, for the (510(k) exempt functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the overall device.

CASIA2 consists of several components: the main unit, AC input power source, a touch panel LCD monitor, an external hard drive (HDD), a mouse and a keyboard.

Here’s a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for the Tomey CASIA2.

Device: Tomey Cornea/Anterior Segment OCT (CASIA2)
Measurements evaluated: Central Corneal Thickness (CCT), Anterior Chamber Depth (ACD), and Lens Thickness (LT).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined quantitative acceptance criteria (e.g., "CCT agreement must be within X µm"). Instead, it focuses on demonstrating agreement and precision compared to a legally marketed reference device (LENSTAR LS900). The "acceptance criteria" can be inferred from the study's objective to show substantial equivalence through these performance metrics. The reported device performance is presented as the actual agreement (mean difference and 95% Limits of Agreement - LOA) and precision (Repeatability and Reproducibility %CV).

Therefore, the table below reflects the demonstrated performance and implicitly what was considered acceptable for substantial equivalence.

Note on "Acceptance Criteria": The document implies that meeting or exceeding the performance of the LS900 in terms of precision, and demonstrating good agreement via Bland-Altman analysis, constituted the acceptance for substantial equivalence.

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

• Sample Size for Test Set: A total of 224 subjects were enrolled and completed the study for precision and agreement testing.
  • 55 subjects in the normal group
  • 60 subjects in the cataract group
  • 109 subjects in the special eyes group (eyes without a natural lens or eyes containing artificial materials)
    N for specific analyses (e.g., Agreement Analysis for LT) varied based on acceptable scans (e.g., N=122 for LT agreement, N=138 for CCT/ACD precision, N=76 for LT precision).
• Data Provenance: The document does not explicitly state the country of origin. It indicates "The subjects of this study had no notable or unexpected/untoward assessments..." which suggests a single clinical site. However, no specific country is mentioned.
• Retrospective or Prospective: The study was a prospective clinical study, as subjects were "enrolled," "randomized," and "assigned" to configurations and sequences, and data was collected during the study.

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

• The document implies that the LENSTAR LS900 device itself served as the reference standard for establishing "ground truth" (or more accurately, the comparator for agreement) for the measured parameters.
• It states that "The clinical site had 3 device operators trained on the devices used in the study."
• Qualifications of Experts: The specific qualifications (e.g., radiologist, ophthalmologist, optometrist expertise, years of experience) of these 3 device operators are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

• The document states, "Additional scans were taken at the operator's discretion if image quality was unacceptable based on the device DFU and the Tomey CASIA2 Reference Guide and included, missing scans, truncated scans, image defocus, floaters, presence of eye blinks, eye motion, etc. Each device operator had up to 3 attempts to obtain an acceptable scan for each of the required scans."
• This suggests an operational approach to ensure data quality rather than a formal, independent adjudication process (e.g., 2+1/3+1 consensus by experts) for the measurements themselves. The "ground truth" was derived from the in-device measurements of the LS900, not a separate expert review. Therefore, there was no expert consensus-based adjudication method for the measurements.

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

• No, a traditional MRMC comparative effectiveness study was not done.
• The study design was focused on device-to-device agreement and precision (CASIA2 vs. LENSTAR LS900) rather than evaluating how human readers' performance (e.g., diagnostic accuracy) improved with or without AI assistance.
• The CASIA2 is described as a "tomographic and biomicroscopic device intended for the in vivo imaging and measurement of ocular structures," with software providing "quantitative outputs." It does not appear to be an AI-assisted diagnostic aid for image interpretation that would typically require an MRMC study to show human reader benefit.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• The study primarily assessed the measurement performance of the CASIA2 device (algorithm/system) in generating quantitative outputs (CCT, ACD, LT) and compared these directly with a reference device. It's implied that these measurements are generated automatically by the device's software.
• The role of the human operators was to acquire an "acceptable scan" based on predefined image quality criteria, not to interpret the images or provide a human "answer" for comparison with an AI-generated reading.
• Therefore, the precision and agreement studies essentially represent the standalone performance of the CASIA2's measurement capabilities compared to the LS900.

7. Type of Ground Truth Used

• The "ground truth" (or clinical reference standard) for comparison was the measurements obtained from the legally marketed predicate/reference device, LENSTAR LS900.
• This is a device-based comparative ground truth, not expert consensus, pathology, or outcomes data. The study aimed to show that the CASIA2's measurements were interchangeable or highly agreeable with those from an established, cleared device.

8. Sample Size for the Training Set

• The document describes a clinical study for validation/testing of the updated software. It does not provide any information about a separate training set size for the development of the algorithms generating these quantitative measurements.
• It only mentions: "The device is a software upgraded version of the predicate K213265 that provides quantitative measurements. All quantitative measurements are derived from OCT images acquired with optical coherence tomography." This implies the software update incorporated algorithms to derive these measurements, but details on their development (including training data) are not provided in this 510(k) summary.

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

• As the document does not describe the training set or its development, there is no information provided on how the ground truth for any training set was established.

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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 Digital Prism Correction Feature (DPCF) is software that is intended to provide digital image adjustments in Apple Vision Pro in accordance with a user's prism prescription.

DPCF is available over-the-counter (OTC) for users with prism in their eyeglass prescription. When a prescription also includes other parts (e.g., sphere, cylinder, ADD), which can be fulfilled by optical inserts, the DPCF fulfills the prism part of the prescription while using Apple Vision Pro.

DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimension (i.e., base-up, base-down, base-in, base-out), per eye.

The Digital Prism Correction Feature (DPCF) is intended to provide a high quality visual experience in Apple Vision Pro spatial computing applications for users with a prism prescription. Specifically, the DPCF is software that is intended to provide digital image adjustments in Apple Vision Pro in accordance with a user's prism prescription, in the horizontal and/or vertical dimensions. DPCF fulfills the prism part of an eyeglass prescription. When an eyeglass prescription also includes other parts (e.g., sphere, cylinder, ADD), DPCF fulfills the prism part of the prescription, while prescription optical inserts fulfill the other parts of the prescription.

The DPCF achieves its intended use by converting a user's prism prescription into digital image adjustment parameters that are utilized by the spatial computing image system to automatically provide digital image adjustments in horizontal and/or vertical dimensions in accordance with a user's prism prescription. At this time, DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimensions (i.e, base-up, base-down, base-in, base-out), per eye.

The DPCF is available over-the-counter (OTC).

The provided FDA 510(k) clearance letter and summary for the Apple Digital Prism Correction Feature (DPCF) primarily discuss its substantial equivalence to a predicate device and its move from prescription to over-the-counter (OTC) use. It does not contain an in-depth study proving the device meets acceptance criteria in the typical sense of a clinical trial for diagnostic AI.

However, based on the information provided, we can extract details about the acceptance criteria and the type of study conducted to support the device's performance, particularly focusing on the "Summary of Non-Clinical Testing."

Here's an analysis of the requested information:

Acceptance Criteria and Reported Device Performance

Study Details

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

• Test Set Sample Size: For the human factors and usability study, the sample size was 30 subjects.
• Data Provenance: The document does not explicitly state the country of origin. The study was conducted as non-clinical testing to assess "self-selection and use-related risks associated with use of the DPCF as an OTC device." The nature of "bench validation testing" mentioned for prism tolerance requirements suggests it's a controlled engineering test rather than a patient data-driven study.

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

• The document does not specify the number or qualifications of experts involved in establishing ground truth for the human factors study. For “bench validation testing” which measured prism tolerance, the ground truth would be based on metrological standards and precision instruments, rather than expert judgment.

4. Adjudication method for the test set:

• The document does not describe any adjudication method. The human factors study assessed self-selection and use-related risks, which would typically involve observing user interactions and collecting feedback, rather than a diagnostic accuracy adjudication process. The bench testing involves direct measurement against a standard.

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, an MRMC comparative effectiveness study was not explicitly mentioned or performed. The DPCF is a "Digital Prism Correction Feature" designed to "provide digital image adjustments" based on a user's existing prism prescription. It's not a diagnostic AI device that assists human readers in interpreting medical images or data. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not directly apply to the described function of this device, which seems to be a corrective rather than diagnostic tool.

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

• Yes, in essence. The "bench validation testing that demonstrated DPCF meets prism tolerance requirements specified in ISO 8980-1:2017" represents a standalone evaluation of the algorithm's output (the digital image adjustment) against a predefined standard, independent of human interaction for interpretation. The human factors study, while involving humans, evaluates the usability and safety of the interface for an OTC product, not the diagnostic performance of an algorithm.

7. The type of ground truth used:

• For prism tolerance requirements: The ground truth is based on standardized metrological requirements as specified in ISO 8980-1:2017. This is a technical standard for ophthalmic optics.
• For human factors and usability: The "ground truth" would be the assessment of use-related risks against predefined safety and usability thresholds, determined through observation and feedback collection in a controlled user study.

8. The sample size for the training set:

• The document does not provide information regarding a training set sample size. This is consistent with the device being a "Digital Prism Correction Feature" that applies a known optical principle (prism correction) digitally, rather than a machine learning model trained on a large dataset to perform a diagnostic or predictive task. The device likely uses algorithms based on physics and geometry to implement the prism correction, rather than being a trained AI model in the typical sense.

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

• As no training set is mentioned in the context of machine learning, there is no information provided on how ground truth for a training set was established. The device functions as a digital implementation of an established optical correction principle.

Summary of Device Functionality Context: The DPCF appears to be a software feature that digitally applies prism correction within the Apple Vision Pro. Its "AI" component, if any, is not a diagnostic or predictive model in the typical sense seen in many FDA-cleared AI pathology or radiology devices. Instead, it seems to be a precise digital enactment of a known optical principle to correct for existing prism prescriptions. The studies described focus on whether this digital implementation meets optical accuracy standards and whether its use as an over-the-counter device is safe and usable.

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