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The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. These devices are for use with the Whitestar Signature™ System.

The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. The vittectomy mode is used to cut and remove vitreous matter from the anterior segment of the eye during secondary intraocular lens implantation following vitreous loss associated with trauma or during primary cataract surgery. It can also be used to provide vitreous cutting in the posterior segment by enabling surgeons to remove vitreous matter for the treatment of various posterior segment conditions.

This is a 510(k) premarket notification for a medical device cleared by the FDA. As such, it does not contain a study that proves the device meets acceptance criteria in the manner requested (e.g., with detailed performance metrics, sample sizes, expert involvement, and statistical analyses typically associated with clinical trials or AI performance evaluations).

The document is a regulatory submission demonstrating substantial equivalence to a previously cleared predicate device, rather than a de novo clinical study proving novel performance criteria. Clinical studies as described in your request are not typically required for 510(k) clearances if substantial equivalence can be established through other means, such as performance testing detailed below.

Therefore, many of the requested fields cannot be directly extracted or are not applicable in their usual sense for this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device and states that "The physical and performance characteristics of the vitrectomy cutter and the irrigation sleeve are substantially equivalent to those of the predicate devices." It also states "The products will be manufactured in compliance with both FDA (QSR) and ISO standards and have demonstrated to be safe and effective for the indicated use."

Specific, quantitative acceptance criteria and their corresponding reported device performance values are not explicitly detailed in the provided text. The assessment for this type of device typically involves engineering specifications and functional performance tests (e.g., cutting rate, aspiration flow, material compatibility, sterilization efficacy, etc.) to demonstrate equivalence to the predicate device. These specific test results are usually found in the full 510(k) submission, which is more extensive than this summary.

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

• Sample Size: Not specified in the provided text. Performance testing for medical devices like this typically involves a defined number of units, but this information is not in the summary.
• Data Provenance: Not specified, but likely obtained from internal laboratory testing conducted by Advanced Medical Optics, Inc. in the USA. Given it's a 510(k) for an existing type of device, it's almost certainly retrospective in the sense that it relies on established engineering principles and performance testing benchmarks rather than prospective clinical trials to prove efficacy.

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

• Not Applicable (N/A): This type of medical device submission does not typically involve "ground truth" derived from expert consensus in a clinical diagnostic sense, as it is a surgical tool. Its performance is assessed through engineering and functional testing rather than diagnostic accuracy.

4. Adjudication method for the test set:

• Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic outcomes. For this device, performance is evaluated against engineering specifications and predicate device equivalence, not expert adjudication of clinical findings.

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: This is a surgical instrument, not a diagnostic imaging device or an AI-powered system that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant and was not conducted.

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

• No: This device is a manual surgical instrument and does not involve an algorithm or AI operating in a standalone capacity.

7. The type of ground truth used:

• Engineering Specifications / Predicate Device Performance: The "ground truth" for this submission is implicitly the established safety and performance profile of the predicate device (K950287 UnuVit and 4422CE) and adherence to recognized industry standards (FDA QSR, ISO). Performance is measured against these established benchmarks.

8. The sample size for the training set:

• Not Applicable (N/A): This device does not use machine learning or AI, so there is no "training set."

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

• Not Applicable (N/A): As there is no training set for an AI/ML algorithm, this question is not relevant.

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Used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses into the eye.

The One Series™ Ultra cartridge is used to fold and assist in the insertion of a TECNIS® 1-Piece soft acrylic intraocular lens (IOL) into the eye following cataract extraction. The cartridge, Model 1VIPR30 is a single-use component composed of polypropylene which is injection molded and coated with a lubricious coating. The cartridge is provided sterile. The IOL is loaded into the proximal portion of the cartridge using forceps. The cartridge is then placed in a reusable titanium handpiece, which advances the IOL through the tube section of the cartridge and delivers it into the eye.

The provided text is related to a 510(k) premarket notification for a medical device called the "ONE SERIES™ Ultra Cartridges" (later renamed ONE SERIESTM Ultra Cartridges). This document primarily serves as an FDA clearance letter and a 510(k) summary, establishing substantial equivalence to predicate devices rather than detailing a specific clinical study with granular acceptance criteria and performance metrics.

Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment, as typically found in detailed study reports, is not present in these documents. The document focuses on demonstrating equivalence through bench testing and biocompatibility.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or specific performance metrics in a tabular format as would be found in a detailed study report. It broadly states that the device was found equivalent to predicate devices based on "material and performance characteristics."

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

• Sample Size: Not specified. The document mentions "Bench testing and biocompatibility testing," but does not provide details on the number of cartridges or IOLs tested.
• Data Provenance: Not specified. It's likely the testing was conducted in a laboratory setting by the manufacturer (Advanced Medical Optics, Inc.) in the USA, as indicated by their address. The testing is non-clinical.

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

• This is not applicable for this type of submission. The performance testing described (folding, delivery, retention, cosmetic, dimensional, optical properties) would likely be assessed against engineering specifications and predicate device performance, not by expert human interpretation in the way an AI diagnostic device would be.

4. Adjudication Method for the Test Set

• Not applicable as the testing involves objective measurements against specifications rather than expert consensus on subjective interpretations.

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. This is not an AI-assisted diagnostic device, but rather a physical medical device (intraocular lens cartridge). Therefore, MRMC studies and AI-related effectiveness metrics are not relevant or present in this document.

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

• No. This device is an intraocular lens cartridge, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the device's performance would be engineering specifications, material standards, and benchmark performance of the predicate devices. For example, successful folding and delivery without damage to the IOL would be objectively verifiable against defined criteria. Biocompatibility would be assessed against established standards for medical devices.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The "training" for such a device involves product development, engineering, and manufacturing processes to meet design specifications, not data-driven model training.

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

• Not applicable. See point 8.

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The AMO Ophthalmic Surgical System is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The posterior segment surgery module is optional. The modular design allows the users to configure the system to meet their surgical requirements.

The AMO Ophthalmic Surgical System is a device designed for use in performing anterior segment ophthalmic surgery (cataract) and posterior segment ophthalmic surgery. The device is intended for use in performing phacoemulsification, phacofragmentation, diathermy, irrigation/aspiration, vitrectomy, extrusion and silicone oil injection and extraction.

The provided document describes the AMO Ophthalmic Surgical System, a device for anterior and posterior segment ophthalmic surgery. However, it does not include information about acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment, or any details about AI/ML algorithms or their evaluation.

This 510(k) submission is for a traditional medical device (phacofragmentation system) and focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and compliance with general safety and performance standards. It does not involve AI/ML components or associated performance studies typical for AI-powered devices.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as these elements are not present in the provided text regarding the AMO Ophthalmic Surgical System.

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Use LENS PLUS® Rewetting Drops while wearing your lenses to moisten and rehydrate them. Also, use LENS PLUS® Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.

Lens Plus® Rewetting Drops is a sterile, preservative free, buffered, isotonic, aqueous solution containing sodium chloride and boric acid. The product is packaged in a plastic sterile reclosable vial which allows remaining drops can be used throughout the day (12 hours).

The provided text describes a 510(k) summary for "Lens Plus® Rewetting Drops" and its substantial equivalence to a predicate device. This document focuses on the safety and performance of a medical device (rewetting drops) and not on the performance of an AI/ML algorithm.

Therefore, the requested information categories concerning AI/ML algorithm performance (such as sample sizes for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, and training set details) are not applicable to this document. The study described is a non-clinical bacteriostasis study.

Here's the relevant information that can be extracted from the provided text, structured to address the spirit of your request:

Acceptance Criteria and Device Performance Study for Lens Plus® Rewetting Drops (K042562)

The primary "acceptance criterion" for this device, as detailed in the 510(k) summary, revolves around demonstrating the ability of bacteria to not significantly grow and survive in the reclosable vials containing the rewetting drops over a designed period, specifically to support a 12-hour discard statement.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not explicitly stated in terms of number of vials or bacterial cultures beyond the types of bacteria tested. The study mentions testing against five specific microorganisms.
• Data Provenance: The study was conducted "in accordance with Micro Appendix C of the Premarket Notification (510(K)) Guidance Document for contact Lens Care Products." This is a non-clinical, controlled laboratory study.

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

Not applicable. This was a laboratory study evaluating bacteriostasis, not requiring human expert interpretation in the way AI/ML ground truth is established.

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

Not applicable. This was a laboratory study.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" here is the objective microbial growth/survival data obtained from the bacteriostasis study, evaluated against established microbiological standards for such products.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and no training set was used.

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

Not applicable. No training set was used.

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The SOVEREIGN® High Vacuum Pack is indicated for use with the SOVEREIGN® phacoemulsification machine. The SOVEREIGN® High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line. The SOVEREIGN® Compact High Vacuum Pack is indicated for use with the SOVEREIGN® Compact phacoemulsification machine. The SOVEREIGN® Compact High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line.

The SOVEREIGN® High Vacuum Pack and the SOVEREIGN® Compact High Vacuum Pack are accessory kits indicated for use with the SOVEREIGN® phacoemulsification machine and the SOVEREIGN® Compact phacoemulsification machine, respectively, to perform an irrigation/aspiration (I/A) procedure or a phacoemulsification procedure during cataract surgery. The tubing assembly component of the kit incorporates a flow restriction feature for preventing/neutralizing post occlusion surge following an occlusion break at the distal end of a phaco tip. The materials, basic scientific concepts, physical properties and intended use of the device kits are similar to those of the identified predicate devices.

The provided text describes a 510(k) summary for the SOVEREIGN® High Vacuum Pack and SOVEREIGN® Compact High Vacuum Pack, which are accessory kits for phacoemulsification machines used in cataract surgery. The summary focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with acceptance criteria and performance metrics in the typical sense of a diagnostic medical device.

However, based on the information provided, we can infer some "acceptance criteria" and the nature of the "study" conducted for this type of submission. The primary goal was to prove substantial equivalence to existing legally marketed devices.

Here's an interpretation of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a "sample size" in the context of clinical patient data. The evaluation was primarily bench testing. For bench testing, the sample size would refer to the number of units tested. This information is not provided in the document.
• Data Provenance: The data provenance is nonclinical bench testing. The country of origin for the testing is not explicitly stated. It is considered retrospective in the sense that it compares performance to established predicate devices.

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

• Number of Experts: Not applicable. This was bench testing, not an expert-driven clinical evaluation requiring ground truth establishment in that manner.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Bench tests typically involve direct measurement and comparison to predefined engineering specifications or predicate device performance, not expert adjudication in the clinical sense.

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

• MRMC Study: No, an MRMC study was not done. This device is a surgical accessory, not an AI-powered diagnostic tool.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This device is a physical accessory used with a phacoemulsification machine, hence inherently "human-in-the-loop" in its application during surgery. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the bench testing was derived from established performance characteristics of the predicate devices (e.g., their known flow resistance and chamber maintenance capabilities). This is a form of engineering specification/benchmark comparison, rather than expert consensus, pathology, or outcomes data in a clinical trial.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The device design and verification were based on engineering principles and comparisons to existing predicate designs.

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

• Ground Truth for Training Set Establishment: Not applicable, as there was no training set in the context of machine learning.

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COMPLETE® BLINK-N-CLEAN® Lens Drops is indicated to lubricate and rewet soft (hydrophilic) contact lenses, disposable lenses and extended wear lenses, as well as rigid gas permeable lenses before application and during wear.

COMPLETE® BLINK-N-CLEAN® Lens Drops is a sterile, isotonic, buffered, solution containing lubricants, preservatives, buffers, surfactants, ancillary ingredients, and purified water. The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.

The provided text describes a 510(k) summary for COMPLETE® BLINK-N-CLEAN® Lens Drops, which is a medical device. However, the information available in the document is primarily related to its regulatory submission and non-clinical testing for compatibility and protein removal, not advanced AI/ML device studies as implied by the detailed questions about acceptance criteria, ground truth, expert adjudication, and MRMC studies.

Therefore, many of the requested details cannot be extracted or are not applicable to the type of device and study described.

Here's an attempt to answer based on the provided text, highlighting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Compatibility Test: Thirty (30) regimen cycles of silicone acrylate and fluorosilicone acrylate rigid gas permeable (RGP) lenses.
• Data Provenance: Not specified in terms of country of origin or whether it was retrospective/prospective for the compatibility and protein removal studies. It appears to be non-clinical laboratory testing.

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

• Not applicable as the reported studies are non-clinical (compatibility and protein removal) and do not involve expert interpretation or ground truth establishment in the context of clinical expert consensus. The "ground truth" here is objective physical measurements and chemical analysis.

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

• Not applicable to the non-clinical studies described.

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

• Not applicable. This device is a lens care solution, not an AI/ML diagnostic or assistive device that would involve human readers or AI assistance.

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

• Not applicable. This device is a lens care solution, not an algorithm. The reported studies evaluate the physical and chemical performance of the solution itself.

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

• For Compatibility: Objective physical measurements (diameter, power, base curve) and visual observations (surface deposits, discoloration, deformities) of contact lenses after exposure to the product.
• For Protein Removal: Quantitative analytical methods measuring protein accumulation and removal from human-worn contact lenses in a simulated in-eye use.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

• Not applicable, as there is no training set for this type of device.

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Use blink™ CL Lubricant Eye Drops to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses; to help relieve dryness, irritation and discomfort that may be associated with lens wear; and to cushion lenses by placing a drop on the lens prior to application on the eye.

blink™ CL Lubricant Eye Drops is a sterile, isotonic, buffered solution containing a lubricant, a preservative, buffers, tonicity agents, and purified water. The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated for each non-clinical test. The clinical study was a "multi-center" and "parallel-group" evaluation, but specific patient numbers are not provided.
• Data Provenance: The document does not specify the country of origin for the data. The clinical study was conducted by AMO (Advanced Medical Optics). No information is provided on whether it was retrospective or prospective, though a "multi-center, double-masked, randomized, parallel-group, one-month evaluation" suggests a prospective design.

3. Number of Experts and Qualifications

• No information provided regarding the number or qualifications of experts used to establish ground truth for the test set in either non-clinical or clinical studies. The clinical study was "double-masked," implying that both participants and evaluators were unaware of treatment assignments, but it does not specify who established the clinical endpoints or evaluated outcomes for ground truth.

4. Adjudication Method

• No information provided on adjudication methods for establishing ground truth in either non-clinical or clinical studies.

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

• No MRMC comparative effectiveness study was done. The studies described are primarily aimed at demonstrating the equivalence of the device to predicate devices, not at evaluating the improvement of human readers with or without AI assistance. The device is a lubricant eye drop, not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only) Performance

• Not applicable. The device is a lubricant eye drop and does not involve an algorithm or AI component.

7. Type of Ground Truth Used

• Nonclinical Studies: Ground truth was established through in-vitro laboratory testing and adherence to recognized standards (e.g., ISO 14730:2000(E) for preservative efficacy, USP Sterility test requirements). The comparison was often against "control" or "predicate" devices, meaning the performance of an established, similar product served as the reference.
• Clinical Studies: Ground truth for safety and acceptability would have been based on clinical evaluations and observations, likely including patient reported outcomes and objective clinical assessments, compared against a "control" in a "double-masked" study.

8. Sample Size for the Training Set

• Not applicable. This device is a pharmaceutical product (lubricant eye drops), not an AI/ML model that requires training data.

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

• Not applicable, as there is no training set for this type of device.

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COMPLETE® brand Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:

• Chemically (NOT HEAT) Disinfect .
• Clean ●
• Rinse .
• Store
• Remove Protein .
• Condition .

COMPLETE® brand MULTI-PURPOSE Solution is a sterile, isotonic, buffered, solution containing hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, a phosphate buffer, Poloxamer 237 as a surfactant, edetate disodium as a chelating agent, sodium chloride, potassium chloride, and purified water. COMPLETE® brand MULTI-PURPOSE Solution contains no chlorhexidine or thimerosal.

The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.

The provided text is a 510(k) summary for COMPLETE® brand Multi-Purpose Solution (K030092). This document focuses on demonstrating substantial equivalence to a predicate device for a contact lens care solution, rather than providing detailed acceptance criteria and a study design for evaluating a novel medical device's performance against specific metrics. Therefore, many of the requested categories are not directly applicable or explicitly stated in the document.

However, based on the information provided, here's an attempt to address your request:

Acceptance Criteria and Device Performance for COMPLETE® brand Multi-Purpose Solution (K030092)

Note: The document describes in-vitro and clinical studies to support substantial equivalence for a contact lens solution, not a medical imaging or diagnostic device. As such, the typical metrics for device performance (e.g., sensitivity, specificity, accuracy) are not relevant here. Instead, the focus is on physical, chemical, and subjective user experience.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Clinical Studies: "Study subjects in three clinical studies" were used for subjective comfort and acceptability. An "additional clinical study" provided objective data for rub vs. no-rub regimens.
  • Sample Size: Not explicitly stated. The number of participants in each study is not provided.
  • Data Provenance: Not explicitly stated. However, given the context of a US regulatory submission (510(k)), it is highly probable the data originated from studies conducted in the United States and were prospective in nature, as they were designed to evaluate the new formulation.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable directly. This is a contact lens solution, not an interpretive device. The "ground truth" for subjective comfort comes from the study subjects themselves via questionnaires. For objective data (rub vs. no-rub), unspecified "objective data" was collected, likely related to lens cleanliness or disinfection efficacy, which would be measured by laboratory techniques rather than expert consensus on interpretation.

4. Adjudication Method for Test Set

• Not applicable. There is no "adjudication" in the sense of multiple experts independently reviewing and then resolving discrepancies for medical image interpretation. Clinical subjective data was gathered via questionnaires, and objective data via laboratory methods.

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

• No. This type of study is relevant for diagnostic imaging systems where human readers interpret cases. The provided document concerns a contact lens solution.

6. Standalone (Algorithm Only) Performance

• Not applicable. The device is a chemical solution, not an algorithm.

7. Type of Ground Truth Used

• Clinical Studies:
  • Subjective Data: User-reported comfort and acceptability via questionnaires.
  • Objective Data: Unspecified objective measures related to contact lens care performance (e.g., disinfection, cleaning, protein removal efficacy) for the rub vs. no-rub regimen comparison. This would typically be laboratory-based measurements.
• In Vitro Studies: Laboratory measurements of physical (viscosity, surface fluid retention, receding contact angle) and chemical (HPMC uptake/release) properties.

8. Sample Size for Training Set

• Not applicable. This isn't a machine learning model, so there isn't a "training set" in that sense. The studies described are for validation of the product's performance and equivalence.

9. How Ground Truth for Training Set was Established

• Not applicable. See point 8.

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