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The LSH (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters.

The LSH (mangofilcon A) Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters and have near add requirements up to 3.25 Diopters.

The LSH (mangofilcon A) Toric Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or non-aphakic persons with non diseased eyes in a spherical power range of +12.00 to -20.00 Diopters and a cylinder power range of -0.50 to 2.50 Diopters.

The LSH (mangofilcon A) Toric-Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic or non-aphakic patients with non-diseased eyes in a spherical power range of +12.00 to -20.00 Diopters, a cylinder power range of -0.50 to 2.50 Diopters and an add requirement up to 3.25 Diopters.

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

The LSH (mangofilcon A) is available as a spherical, multifocal, toric, and toric-All LSH lenses are plasma treated in the dry state prior to initial multifocal lens. hydration.

The lens material, (mangofilcon A), is a non-ionic hydrophilic copolymer that consists of 51% mangofilcon A (N.N-dimethyl acrylamide (NNDMA) polymer with 3-methacryloxy propyltris(trimethylsilyl)siloxane (TRIS)), trifluoroethyl methacrylate (TFEM), 2- hydroxyethyl methacrylate (HEMA), N-vinyl-2-pyrrolidone (NVP), cross-linked with ethyleneglycol dimethacrylate (EGDMA), and 49% water by weight.

Mangofilcon A is available in clear (no tint) with or without a UV absorber to block a significant amount of the UV radiation occurring between 200 and 400 nm (UVA and UVB). The UV absorber is 2-(5-chloro-2H-benzotriazole-2-yl)-6-(1,1-dimethylethyl)-4- ethenyl phenol (UVAM).

Mangofilcon A is available in Blue or Aqua visibility tints to assist with handling, and both colors are available with or without UV absorber. The Blue lenses are tinted using 1,4-Bis[4-(2-methacryloxyethy]) phenylamino]anthraquinone (21 CFR 73.3106), and the Aqua lenses are tinted using Phthalocyanine Green (21 CFR 73.312).

The LSH (mangofilcon A) Sphere, Multifocal, Toric, and Toric-Multifocal Soft (hydrophilic) Lenses for Daily Wear are hemispheric flexible shells of the following dimensions.

Diameter(s): Sphere 10.0 mm to 16.0 mm, Multifocal 14.0 mm to 16.0 mm, Toric Not Applicable (N/A), Toric-Multifocal 14.0 mm to 16.0 mm
Center Thickness (Low Minus Lens): 0.07 mm dry
Center Thickness (Plus Lens): Up to 0.50 mm
Base Curve(s): 6.5 mm - 9.7 mm
Powers: Sphere -20.00 D to +12.00 D, Multifocal -20.00 D to +12.00 D, Toric -20.00 D to +12.00 D, Toric-Multifocal -20.00 D to +12.00 D
Cylinder Powers: Sphere N/A, Multifocal N/A, Toric -0.50 D to 2.50 D in steps of 0.25 D, Toric-Multifocal N/A
Axes: Sphere N/A, Multifocal N/A, Toric 0° to 180°, Toric-Multifocal N/A
Add Powers: Sphere N/A, Multifocal +1.00 D to +3.25 D in steps of 0.25 D, Toric N/A, Toric-Multifocal +1.00 D to +3.25 D in steps of 0.25 D

The physical/optical properties of the lenses are:
Oxygen Permeability (Dk) (35°C, Fatt Units): 49
Refractive Index: Dry - 1.470, Hydrated - 1.413
Specific Gravity: Dry - 1.112, Hydrated - 1.109
Linear Expansion Ratio: 1.26
Water Content: 49%
Visible Light Transmittance: 96%T
Plasma Treatment Required: Yes
Shore D Hardness (in blank form): ≥83

This document describes the premarket notification for the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens and its substantial equivalence to a predicate device. The information is extracted directly from the provided text.

Acceptance Criteria and Device Performance Study

The acceptance criteria for the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens are not explicitly stated as distinct numerical criteria that must be met in a table. Instead, the study aims to demonstrate that the new device is "as safe, as effective and performs as well as the predicate device" through a comparison of physical properties and clinical data. Therefore, the "acceptance criteria" are implied to be achieving comparable safety and effectiveness outcomes and similar physical properties to the predicate device.

Table of Acceptance Criteria (Implied) and Reported Device Performance

Study Details:

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

   • Test set sample size: "Seventy-five (75) patients were enrolled in the study (56 test/19 control)."
   • Data provenance: Not explicitly stated, but clinical studies for such devices are typically conducted in the country where the device is seeking regulatory clearance. Given the 510(k) summary submitted to the FDA, it's highly probable the study was conducted in the United States.
   • Retrospective or prospective: The clinical study was described as "A three month clinical study was conducted...", indicating a prospective study design.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For contact lens safety and efficacy studies, the "ground truth" is established through direct observation of physiological responses and visual acuity measurements in patients, rather than expert interpretation of images or other data. The study primarily evaluated safety and efficacy through clinical observation by eye care professionals.

3. Adjudication method for the test set: Not applicable in the context of an adjudication method typical for image-based diagnostic AI studies. Safety and efficacy were assessed through direct clinical observations and measurements over a three-month period.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This study is for a contact lens, not an AI-powered diagnostic device, so an MRMC study is not relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This study is for a physical medical device (contact lens), not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance relies on clinical outcomes data from the three-month study, including patient safety (e.g., adverse events, ocular irritation) and efficacy (e.g., satisfactory visual acuity, correction of refractive errors, comfort).

7. The sample size for the training set: Not applicable. This study is for a contact lens, which does not involve a "training set" in the context of machine learning or AI. The physical properties and design are based on manufacturing processes and material science, not trained algorithms.

8. How the ground truth for the training set was established: Not applicable, as there is no "training set" for this device.

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Menicon Progent Large Diameter Contact Lens Case is only intended for use with the Menicon Progent Protein Remover for Rigid Gas Permeable (RGP) Contact Lenses.

The Menicon Progent Large Diameter Contact Lens Case provides an alternative lens case to hold large diameter lenses (11 mm to 23 mm) during the Menicon Progent Protein Remover treatment. The case is not intended for disinfection (chemical, heat or peroxide). The case is not intended for lens storage.

The Menicon Progent Large Diameter Contact Lens Case is a non-vented barrel style contact lens case. It consists of a clear polycarbonate (PC) cylinder with acrylonitrilebutadiene-styrene (ABS) copolymer non-vented screw cap and lens holder/basket. Each lens basket is molded with a letter, "L" or "R", for ease in proper lens identification. The left lens basket is also colored grey to assist patients who are not currently wearing their contact lenses. The lens case is capable of holding the 10 mL of Menicon Progent Protein Remover A/B mixed solution for effective protein removal.

The provided text describes a 510(k) premarket notification for a medical device (Menicon Progent Large Diameter Contact Lens Case) and does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Instead, the submission details are focused on demonstrating substantial equivalence to predicate devices. This is a common pathway for Class II medical devices, where the manufacturer asserts that their new device is as safe and effective as a legally marketed device (the predicate device) that does not require premarket approval.

Here's a breakdown of why this document doesn't fit the request and what it does contain:

Why the Request Cannot Be Fulfilled from this Document:

• No Acceptance Criteria: The document does not define specific performance metrics or thresholds (e.g., accuracy, sensitivity, specificity, or physical durability standards) for the Menicon Progent Large Diameter Contact Lens Case.
• No "Study" in the sense of performance evaluation: There isn't a study described that measures the device's performance against predefined criteria. Instead, it relies on a comparison of characteristics to predicate devices.
• Focus on Substantial Equivalence: The entire submission's purpose is to show that the new device is "substantially equivalent" to existing, legally marketed devices, rather than proving it meets novel acceptance criteria through new testing.

What the Document Does Provide (Relevant to the request in a broader sense):

1. A table of characteristics (not acceptance criteria):

   Characteristic	Menicon Progent Large Diameter Contact Lens Case (New Device)	Bonasse Barrel Style Lens Case (Predicate 1)	Progent SP Vial (Predicate 2)
   Manufacturer	Menicon Pharma	Bonasse Enterprise Company, Ltd.	Bonasse Enterprise Company, Ltd.
   Device Name	Contact Lens Case	Contact Lens Case	Contact Lens Case
   Model Name	Not Applicable	BC 790	BC 760-1
   Trade Name	Menicon Progent Large Diameter Contact Lens Case	Bonasse Barrel Style Lens Case BC 760-1	Barrel Style Lens Case
   Classification	Ophthalmic (Class II, LRX, 21 CFR 886.5918)	Ophthalmic (Class II, LRX, 21 CFR 886.5918)	Ophthalmic (Class II, LRX, 21 CFR 886.5918)
   Intended Use	For Storage of RGP Contact Lenses during lens treatment (protein removal), Not for use with heat, chemical or peroxide disinfection systems.	For Storage of soft, hard and RGP contact lenses during lens treatment (chemical disinfection), Not for use with heat or peroxide disinfection systems.	For Storage of RGP contact lenses during lens treatment (protein removal), Not for use with heat, chemical or peroxide disinfection systems.
   Materials	Clear Plastic Vial (PC), White Plastic screw top lid (ABS), White and Grey plastic lens baskets/holder (ABS)	Clear Plastic Vial, White Plastic screw top lid (ABS), White plastic lens baskets/holder (ABS)	Clear Plastic Vial, Green Plastic screw top lid, Clear plastic lens holder
   Volume	10 mL	10 mL	10 mL
   Biocompatibility	Components used in this lens case have been evaluated in accordance with Part 10993 of the ISO standard for Biological Evaluation. Test results indicate the test articles meet the ISO standard.	Biocompatibility testing by a third-party laboratory demonstrated the materials are safe for use in contact lens storage and disinfection.	Biocompatibility testing by a third-party laboratory demonstrated the materials are safe for use in contact lens storage and disinfection.

2. No sample size for test set / data provenance / experts / adjudication for this comparative study. The "study" here is a comparison of characteristics to established predicate devices, not a new performance study with a test set.

3. No MRMC comparative effectiveness study. This type of study (evaluating human reader improvement with AI) is irrelevant for this device, which is a physical contact lens case and not an AI-powered diagnostic tool.

4. No standalone performance evaluation. The submission relies on the established safety and effectiveness of the predicate devices and demonstrates that the new device's characteristics are similar enough.

5. Ground Truth Type: Not applicable in the context of this 510(k) submission. The ground truth for the predicate devices' safety and effectiveness was established through their own prior clearances and clinical use. For the new device, the "ground truth" is that its materials and design are comparable to those already deemed safe and effective.

6. Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

In summary, this document demonstrates that the Menicon Progent Large Diameter Contact Lens Case is substantially equivalent to predicate devices, primarily through a comparison of physical characteristics, materials, intended use, and general safety (biocompatibility). It does not present a de novo study with acceptance criteria and performance data for the device itself.

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The TYRO™-97 (hofocon A) and ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The lenses may be disinfected only by using chemical disinfection

The TYRO™ 97 (hofocon A) Rigid Gas Permeable lens material, hofocon A, is a polymer of trifluoroethyl methacrylate and silicone methacrylate, with no methyl methacrylate. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and Cl Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, [ 2-(2'-hydroxy-5'-methacryloxyethylphenyl)-2H-benzotriazole. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.

The ONSI™-56 (onsifocon A) Rigid Gas Permeable lens material, onsifocon A,is a polymer of trifluoroethyl methacrylate polymer with tris (trimethylsiloxy) methacryloxypropylsilane 3trimethoxysilylpropylmethacrylate methacrylic acid 1,3-bis(3methacryloxypropyl)tetrakis(trimethylsiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone.

The blue tinted onsifocon A lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and Cl Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, { 2-(2'-hydroxy-5'methacryloxyethylphenyl)-2H-benzotriazole. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.

Here's a breakdown of the acceptance criteria and the study information for the TYRO™-97 and ONSI™-56 Rigid Gas Permeable Contact Lenses, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for these devices are based on demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved by comparing several key physical properties of the new contact lens materials (hofocon A and onsifocon A) to those of the predicate devices (BOSTON ES, BOSTON EO, and BOSTON XO).

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

The document describes a 510(k) Premarket Notification process, which relies on demonstrating substantial equivalence to predicate devices rather than independent clinical trials for new materials per se.

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

   • The document does not explicitly mention a "test set" in the traditional sense of a clinical trial for evaluating the performance of the new devices against specific acceptance criteria. Instead, it relies on bench testing of the material properties to justify substantial equivalence.
   • Therefore, the sample sizes for the material property tests (e.g., number of lenses tested for oxygen permeability, hardness) are not specified in the provided text.
   • The data provenance for the reported performance values (e.g., Oxygen Permeability of 97 ANSI units for hofocon A) is from laboratory testing of the new materials (hofocon A and onsifocon A). The location or context of these labs is not given, nor is it specified if this was retrospective or prospective.

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

   • This question is not applicable in this context. The "ground truth" for the material properties is established through standardized physical and chemical testing methods (e.g., Fatt Method for oxygen permeability, sessile drop method for wetting angle, Shore Hardness for hardness). These are objective measurements, not subjective expert assessments.

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

   • This is not applicable. There is no "adjudication" in the sense of resolving discrepancies between expert opinions, as the evaluation is based on objective material property measurements.

4. 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. This submission is for rigid gas permeable contact lenses, which are physical medical devices, not AI-powered diagnostic tools. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

   • This is not applicable. This refers to a medical device's algorithm performance, which is not relevant for contact lenses.

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

   • As mentioned above, the "ground truth" for the performance claims (which are material properties) is established through standardized physical and chemical laboratory testing measurements. The document explicitly lists methods like "Fatt Method" for oxygen permeability and "sessile drop method" for wetting angle.

7. The sample size for the training set:

   • This is not applicable. This submission is for physical medical devices (contact lenses), not a machine learning algorithm that requires a training set.

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

   • This is not applicable for the same reason as point 7.

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The TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyoptic and which may exhibit corneal astigmatism.

The lenses may be disinfected only by using chemical disinfection

The TYRO ™ -97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses for Daily Wear are available in spherical, aspherical and toric designs in the clear untinted or blue, green and gray tinted varieties with and without UV-blocker. Each is a shell of the following dimensions.

Spherical Contact Lens:
Horizontal Lens Size: 6.5 mm to 11.50mm
Base Curve: 6.50mm to 9.50mm
Distance Powers: +12.00D to -20.00D
Center Thickness:
for low minus 0.05mm to 0.30mm
for plus 0.10mm to 0.70mm

Aspheric Lens
Eccentricity -1.5 to 1.5 Oblate to prolate
Peripheral Curves 0.1 to 1.0mm

Toric Lens
Axis 1 to 180 degrees in 1 degree step
Cylinder power 0.50 to 4.00D

Translating Bifocal Contact Lens:
Horizontal Lens Size: 8.00mm to 10.50mm
Base Curve: 6.50mm to 8.50mm
Distance Power: +12.00D to -20.00D
Add Power 1.00D to 4.00D

The lens material, hofocon A, is a polymer of trifluoroethyl methacrylate and silicone methacrylate, with no methyl methacrylate. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and CI Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, NORBLOC 7966. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

This device is a contact lens, and as such, the "acceptance criteria" are related to the physical properties of the lens material and its safety and efficacy for daily wear. The "study" refers to the clinical trials conducted to demonstrate this.

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Sample Size: Not explicitly stated in the provided text. The document mentions "clinical trials" but does not give a specific number of participants or eyes.
   • Data Provenance: Not explicitly stated. The document refers to "clinical trials" and implies that the data was collected in accordance with a "Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses (May 1994)," which would suggest a prospective study methodology. No country of origin is mentioned.

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

   • Not applicable in the context of contact lens clinical trials for safety and efficacy. "Ground truth" for contact lenses typically refers to the objective measurements of the lens properties and the clinical outcomes (e.g., visual acuity, adverse events, comfort) observed in subjects by eye care professionals. The clinical study would have involved ophthalmologists or optometrists assessing these outcomes, but they are not establishing a "ground truth" in the same way experts would for image interpretation.

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

   • Not applicable. This type of adjudication method is used in studies involving expert interpretation of medical images. Clinical trials for contact lenses would involve clinical examinations and assessments by the study investigators.

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

   • Not applicable. This is a contact lens, not an AI-powered diagnostic device.

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

   • Not applicable. This is a contact lens. Physical and chemical properties are tested standalone, but clinical performance always involves human subjects.

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

   • For the material properties, the "ground truth" would be established by standardized laboratory testing methods (e.g., specific gravity, hardness, light transmittance).
   • For clinical efficacy and safety, the "ground truth" is based on outcomes data from the clinical trial, including measurements of visual acuity, adverse events, comfort, and signs of ocular health observed by qualified eye care professionals during the study.

7. The sample size for the training set:

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

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

   • Not applicable. (See #7)

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The ONSIJ-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism.

The lenses may be disinfected only by using chemical disinfection

The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses are available in spherical designs in the clear untinted or blue, green, gray, or blue-violet tinted varieties and blue tint with UV-blocker. Each is a shell of the following dimensions.
Spherical Contact Lens:
Horizontal Lens Size: 6.5 mm to 11.50mm
Base Curve: 6.50mm to 9.50mm
Distance Powers: +12.00D to -20.00D
Center Thickness:
for low minus 0.05mm to 0.30mm
for plus 0.10mm to 0.70mm
Aspheric Lens
Eccentricity 0 to 1.5
Peripheral Curves 0.1 to 1.0mm
Toric Lens
Axis 1 to 180 degrees in 1 degree steps
Cylinder power 0.50 to 4.00D
Translating Bifocal Contact Lens:
Horizontal Lens Size: 8.00mm to 10.50mm
Base Curve: 6.50mm to 8.50mm
Distance Power: +12.00D to -20.00D
Add Power 1.00 to 4.00D
The lens material, onsifocon A, is trifluoroethyl methacrylate polymer with tris (trimethylsiloxy)methacryloxypropylsilane 3-trimethoxysily|propylmethacrylate methacrylic acid 1,3-bis(3- methacryloxypropyl)tetrakis(trimethylsiloxy)disiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and CI Solvent Yellow 18; the blue-violet contain D&C Green No. 6 and D&C Violet No. 2; the blue-UV lenses contain D&C Green No 6 and a UV absorber, NORBLOC 7966. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.

Here's a summary of the acceptance criteria and study findings for the ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lens, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list "acceptance criteria" for the clinical study in a quantitative manner (e.g., minimum visual acuity improvement, maximum complication rate thresholds). Instead, it describes general safety and efficacy findings. The tables below summarize the product's physical properties compared to a predicate device and the clinical study findings:

Comparison to Predicate Device (Oxycon (wilofocon A))

Clinical Study Findings (Safety and Efficacy)

2. Sample Size and Data Provenance

• Test Set Sample Size: 37 subjects.
• Data Provenance: The 510(k) summary does not explicitly state the country of origin. It is a clinical trial, implying prospective data collection.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Number of Experts: Not explicitly stated, but the study involved "Three (3) investigators." These investigators would have been responsible for clinical assessments (e.g., slit lamp findings, visual acuity measurements), and thus contributed to establishing the "ground truth" through their clinical observations and measurements.
• Qualifications of Experts: Not explicitly stated, but for a contact lens clinical trial, these investigators would typically be ophthalmologists, optometrists, or other eye care professionals experienced in contact lens fitting and evaluation, often with significant clinical experience.

4. Adjudication Method (Test Set)

• The 510(k) summary does not describe any formal adjudication method (e.g., 2+1, 3+1). The findings are reported as collected by the investigators.

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

• No, an MRMC comparative effectiveness study was not done. The clinical study compared the ONSI™-56 device to "historical controls wearing wilofocon A," rather than a concurrent study with human readers comparing AI-assisted vs. non-AI-assisted performance. This is a direct device performance study.
• Effect Size: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance

• No, a standalone (algorithm only) performance study was not done. This device is a physical contact lens, not a software algorithm. Therefore, "algorithm only" performance is not applicable. The study evaluated the lens's performance in human subjects.

7. Type of Ground Truth Used

• The ground truth for the clinical study was established through expert clinical assessment and objective measurements by the investigators. This included:
  • Slit lamp findings (presence/absence and severity of conditions like edema, neovascularization, staining, hyperemia, palpebral abnormalities).
  • Visual acuity measurements.
  • Patient-reported symptoms, problems, and complaints.
  • Wear time.
  • Lens replacements.

8. Sample Size for the Training Set

• Not applicable. This study is for a physical medical device (contact lens) and not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to this device submission.

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