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Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens maybe prescribed in spherical powers ranging from +20.00D to -20.00D.

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters.

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for the correction of refractive ametropia) and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuty. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D with add powers ranging from +0.75D to +5.00D.

The lens is to be prescribed for single-use disposable wear and is to be discarded after each removal.

The Bausch + Lomb kalifilcon A material is made from a hvdrophilic siloxane copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline with poloxamine, poloxamer 181, qlycerin, erythritol, and polyguaternium. A UV-absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280nm to 315nm and less than 50% in the UVA range of 316nm to 380nm. This lens is tinted blue with Reactive Blue Dye 246.

The Bausch + Lomb kalifilcon A Contact Lenses are to be prescribed for single-use disposable wear.

The physical properties of the lenses are:
Refractive index: 1.4011
Light transmission: 97%
Water Content: 55%
Specific Gravity: 1.029
Oxygen Permeability: 107 x 10-11[cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C (polarographic method)

The lenses will be manufactured in spherical, toric and multifocal designs with the following parameters:
Diameter: 13.5mm to 15.0mm
Center Thickness: 0.05mm to 0.75mm
Base Curve: 7.8mm to 9.5mm
Power Range: +20.00D to -20.00D
Cylinder Power (Toric): -0.75D to -5.00D
Cylinder Axis: 0° to 180°
Add Power (Multi-Focal): +0.75D to +5.00D

The lenses are packaged in disposable blister packages containing phosphate buffered saline solution. Blister packages are labeled with lot number, expiration date and applicable lens parameters. Expiration dating is supported by product stability, package integrity, and validation of the sterilization process.

The provided text describes the acceptance criteria and a study for the Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens. It is important to note that this is a 510(k) submission, meaning the device is being cleared as "substantially equivalent" to predicate devices, rather than requiring a full demonstration of novel safety and effectiveness through extensive new clinical trials. Therefore, the "study" demonstrating it meets acceptance criteria largely relies on equivalence to previously cleared devices and specific non-clinical and limited clinical testing.

Here's the breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative table for "performance" as one might expect for a diagnostic or AI-driven device. Instead, the "acceptance criteria" for this contact lens are implicitly met through demonstrating:

• Conformance to predetermined specifications: Physical properties, dimensional parameters, materials, and manufacturing processes.
• Functional performance: The device performs as expected.
• Safety and effectiveness equivalence: To predicate devices by showing identical lens material, manufacturing process, sterilization process, packaging, and that finished lens parameters fall within previously cleared ranges.
• Biocompatibility and toxicology: Showing the device is non-cytotoxic, not an ocular irritant, and not a sensitizing agent.

Here's a table summarizing the physical properties that are part of the device's specifications and performance:

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Bausch + Lomb Preservative Free Lubricating and Rewetting Drops are indicated for use to lubricate and rewet soft (hydrophilic) contact lenses, including silicone hydrogel as well as silicone acrylate (SA) and fluorosilicone acrylate (FSA) rigid gas permeable (RGP) contact lenses during wear. The product may be used with daily or extended wear, and disposable lenses.

Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is a sterile, preservative free, buffered, isotonic, aqueous solution that contains boric acid, sodium borate, potassium chloride, erythritol, poloxamine, glycerol and hyaluronan for lubricating and rewetting soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and rigid gas permeable contact lenses during wear.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document describes the device, Bausch + Lomb Preservative Free Lubricating and Rewetting Drops, as being substantially equivalent to the predicate device, OPTI-FREE Replenish Rewetting Drops. The "acceptance criteria" are implicitly defined by demonstrating non-inferiority to the predicate device in terms of safety and effectiveness.

Here's a table summarizing the implicit acceptance criteria (non-inferiority to the predicate) and the reported device performance, as evidenced by the clinical study:

Study Details:

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

• Sample Size (Clinical Study):
  • Enrolled: 369 subjects
  • Completed: 365 subjects
  • Test Group (Bausch + Lomb Preservative Free): 188 subjects
  • Control Group (OPTI-FREE Replenish): 181 subjects
• Data Provenance: The study was a "multicenter, randomized, masked, parallel, bilateral study conducted in the USA." This indicates prospective data collection from multiple sites within the contiguous United States.

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 of experts used or their qualifications for establishing ground truth for the clinical study's endpoints. The "ground truth" for safety and effectiveness endpoints (e.g., slit lamp findings, comfort, dryness, lens deposits) would typically be assessed by the clinicians (e.g., optometrists or ophthalmologists) participating in the multicenter study.

4. Adjudication method for the test set:

The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). Since it was a "masked" study, assessors were likely blinded to the treatment assignment. The primary endpoints were compared statistically between the two groups. It's implied that the findings from the clinicians at each site contributed to the data for analysis.

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 done. This study is for contact lens rewetting drops, not an AI-powered diagnostic device. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

Not applicable. This device is a medical product (rewetting drops) and not an algorithm or AI system.

7. The type of ground truth used:

For the clinical study, the ground truth was based on clinical assessments and subjective patient reporting.

• Clinical Assessments: E.g., slit lamp findings (graded by clinicians).
• Subjective Patient Reporting: E.g., overall comfort and dryness (self-reported by subjects).
• Objective Observations: E.g., lens deposits (likely observed and graded by clinicians).

8. The sample size for the training set:

Not applicable. This is a medical product (rewetting drops), not an AI algorithm that requires a training set.

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

Not applicable. As above, there is no training set for this type of device.

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Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for the correction of refractive ametropia) and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D with add powers ranging from +0.75D to +5.00D.

The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

The Bausch + Lomb kalifilcon A material is made from a hydrophilic siloxane copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline solution with poloxamine, poloxamer 181, glycerin, and erythritol. A UV-absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280nm to 315nm and less than 50% in the UVA range of 316nm to 380nm. This lens is tinted blue with Reactive Blue Dye 246. The multifocal lenses will be manufactured with the following parameters: Diameter 13.5mm to 15.0mm, Center Thickness 0.05mm to 0.75mm, Base Curve 7.8mm to 9.5mm, Power Range +20.00D to -20.00D, Add Power (Multifocal) +0.75D to +5.00D. The lenses are packaged in disposable blister packages containing phosphate buffered saline solution.

I'm sorry, but this document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter and synopsis for a contact lens, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a specific study's methodology and results against defined acceptance criteria.

Here's what I can extract and what's missing based on your request:

What is available:

• Device Performance (from "Physical, Chemical and Spectral Properties"):
  • Refractive index: 1.4011
  • Light transmission: 97%
  • Water Content: 55%
  • Specific Gravity: 1.029
  • Oxygen Permeability: 107 x 10-11 [cm³O2(STP) x cm]/(sec x cm² x mmHg)@35°C (polarographic method)
• Non-Clinical Performance Data Overview: The document states that "Performance testing included conformance to predetermined specifications, functional test results verify that the device performs as expected and is equivalent to the predicate without creating additional risk to the user." It also lists the types of non-clinical tests conducted on the predicate device (K200528), which are deemed applicable to the subject device because it uses the identical lens material, manufacturing process, sterilization process, and packaging. These tests include:
  • Toxicology / Biocompatibility (In-Vitro Cytotoxicity, Ocular Irritation Study, Systemic Toxicity)
  • Chemistry / Leachables (Leachable Monomer and Additives)
  • Physical, Chemical and Spectral Properties (as listed above)
• Clinical Performance Data Overview: The document states, "Clinical performance data to confirm safety and effectiveness of the kalifilcon A lens material was obtained and provided in K200528. Because the subject device is of the identical lens material, kalifilcon A, the clinical study performed on the predicate device is applicable and no additional clinical study was performed."

What is missing from the provided text:

1. Detailed Acceptance Criteria Table: While mechanical and physical properties for the lens are listed, specific acceptance criteria (e.g., "oxygen permeability must be greater than X") and a direct side-by-side comparison to explicitly stated acceptance criteria are not provided. The document implies "conformance to predetermined specifications" but doesn't list them.
2. Sample Size for the Test Set: This information is not provided for either non-clinical or clinical studies.
3. Data Provenance (country of origin, retrospective/prospective): Not specified.
4. Number of Experts and Qualifications: This would typically be relevant for clinical studies involving expert assessment, which isn't detailed here.
5. Adjudication Method: Not applicable or provided in this context.
6. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is not applicable to a contact lens approval and is not mentioned.
7. Standalone Performance (algorithm only): Not applicable as this is a physical medical device, not an AI/algorithm.
8. Type of Ground Truth Used: Not explicitly stated beyond "clinical performance data to confirm safety and effectiveness" for the predicate device.
9. Sample Size for the Training Set: Not applicable as this is not an AI/machine learning device.
10. How Ground Truth for Training Set was Established: Not applicable.

To get the specific acceptance criteria and detailed study methodologies, one would typically need to refer to the full 510(k) submission (K210975) and its referenced predicate (K200528), which are usually much more extensive documents than the clearance letter and summary provided.

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Bausch + Lomb kalifilcon A Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.

Kalifilcon A Contact Lens for Astigmatism

Bausch + Lomb kalifilcon A Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters.

The kalifilcon A contact lens is to be prescribed for single-use disposable wear and is to be discarded after each removal.

The Bausch + Lomb kalifilcon A material is made from a hydrophilic siloxane copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline with 0.5% poloxamine solution. A UVabsorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280nm to 315nm and less than 50% in the UVA range of 316nm to 380nm. This lens is tinted blue with Reactive Blue Dye 246.

The Bausch + Lomb kalifilcon A Contact Lens is to be prescribed for single-use disposable wear.

The provided document is a 510(k) Premarket Notification from the FDA for Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens and for Astigmatism. The document reviews the substantial equivalence of the new device to a legally marketed predicate device.

Based on the nature of this document (a 510(k) summary for a contact lens), it does not contain the detailed information typically provided for the acceptance criteria and study proving an AI/ML-based medical device meets those criteria. The information requested in the prompt (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies, AI effect size, etc.) is specific to the validation of AI/ML algorithms.

This document describes the equivalence of a physical medical device (contact lens) and focuses on its physical properties, material composition, manufacturing, and clinical performance related to its function as a contact lens (e.g., correction of refractive error, comfort, safety like slit lamp findings).

Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI/ML device from this document. The document describes a clinical study for a standard medical device, not an AI/ML algorithm.

However, I can extract information related to the clinical study conducted for the contact lens, which might partially align with some general aspects of your request, but it won't be AI/ML-specific.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:
The document does not provide a specific table of acceptance criteria with numerical thresholds for the contact lens's performance in the way an AI model's metrics (e.g., sensitivity, specificity, AUC) would be presented. Instead, it states the achievement of primary endpoints.

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

• Sample Size: "approximately 247 patients"
• Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). It was a "controlled clinical study," implying prospective data collection for the purpose of the study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept (experts establishing ground truth) is not directly applicable in the context of a contact lens clinical trial in the same way it is for an AI algorithm interpreting images. The "ground truth" for contact lens performance is established through direct measurements, patient reported outcomes, and clinical assessments by optometrists/ophthalmologists involved in the study. The number of such clinicians and their specific qualifications are not detailed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/mentioned for a contact lens clinical trial in the context of diagnostic interpretation. Clinical trial data collection involves standardized examinations and measurements by clinicians. How disagreements among clinicians (if any) were handled is not 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 was a clinical study comparing a new contact lens to a predicate contact lens, not an AI system. No human reader improvement with AI assistance is discussed.

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

7. The type of ground truth used:
For safety, the ground truth was based on slit lamp findings assessing ocular health (e.g., signs of inflammation, corneal issues). For efficacy, the ground truth was based on visual acuity measurements with the contact lenses. These are direct clinical observations and measurements.

8. The sample size for the training set:
Not applicable. This refers to the training of an AI model, not a physical device.

9. How the ground truth for the training set was established:
Not applicable. This refers to the training of an AI model, not a physical device.

In summary, as this document pertains to a conventional medical device (contact lens) and not an AI/ML algorithm, most of the specific questions regarding AI validation criteria cannot be answered.

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The Bausch + Lomb PreVue inserter for enVista preloaded is indicated for folding and inserting of enVista IOLs (Model MX60PL) and IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.

The Bausch + Lomb PreVue inserter for enVista preloaded is a sterile, single-use device used to fold and insert an intraocular lens (MX60PL) through surgical procedure into a human eye. The Inserter provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.

The provided text is a 510(k) summary for the Bausch + Lomb PreVue Inserter for enVista Preloaded. It describes the device, its intended use, and the non-clinical testing performed to establish its substantial equivalence to predicate devices.

However, the request asks about acceptance criteria and a study that proves a device meets those criteria. The provided document concerns a medical device accessory (an inserter for intraocular lenses), not an AI/algorithm-based diagnostic device where terms like "ground truth," "expert consensus," "MRMC study," "training set," or "test set" are typically relevant. The document focuses on showing the physical device's functional performance, biocompatibility, sterilization, and packaging validation, primarily through bench tests and laboratory evaluations.

Therefore, many of the requested points in the prompt (e.g., sample size for test/training sets, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance) are not applicable to the type of device and testing described in this 510(k) summary. The "study" proving the device meets acceptance criteria refers to the non-clinical functional and safety testing performed.

Here's an analysis based on the information available in the provided text, addressing the applicable points and explaining why others are not relevant:

Device: Bausch + Lomb PreVue Inserter for enVista Preloaded
Type of Device: Intraocular Lens (IOL) Inserter (Medical Device Accessory)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "Pass" result for each test, indicating the device met the standards/requirements. Specific quantitative thresholds for "Pass" are not detailed in this summary but would be found in the full test reports.

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

• Sample Size: Not explicitly stated in the summary. For non-clinical bench testing of medical devices, sample sizes are typically determined by statistical rationale for validation, often involving multiple units per lot and multiple lots. The summary mentions "functional performance testing," but the exact number of devices or number of insertions is not provided.
• Data Provenance: The data originates from internal Bausch & Lomb laboratory and bench testing. There is no mention of specific country of origin for the data beyond the company's location in St. Louis, MO, USA. The testing is prospective as it's performed for regulatory submission of a new device.

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

• Not Applicable. This is a physical medical device accessory, not an AI or diagnostic algorithm requiring expert interpretation of images or data to establish ground truth. "Ground truth" in this context refers to meeting predefined engineering and biological safety specifications through physical and chemical testing. The "experts" involved would be engineers, chemists, and quality assurance personnel performing and verifying the tests, but their number and specific qualifications are not detailed as they would be for a clinical AI study.

4. Adjudication method for the test set:

• Not Applicable. As per point 3, this is not an AI/diagnostic algorithm study using human readers. "Adjudication" usually refers to resolving disagreements among multiple human experts. For non-clinical bench testing, results are typically objective (e.g., pass/fail based on measurements) and verified by quality control procedures.

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. MRMC studies are relevant for evaluating diagnostic accuracy or reader performance with AI assistance, which is not pertinent to an IOL inserter. No human readers or AI assistance are involved in the functional testing of this device.

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

• Not Applicable. This is a physical mechanical device, not an algorithm. Therefore, "standalone" algorithm performance is irrelevant.

7. The type of ground truth used:

• Engineering Specifications / ISO Standards: The "ground truth" for this device's performance is compliance with established engineering specifications, relevant ISO standards (e.g., ISO 11979-3 for IOLs and inserters, ISO 10993 for biocompatibility), and internal quality requirements. For example, "Fold and recovery test" and "Lens Dimensions Post Delivery" imply that the true "ground truth" is whether the IOL is inserted without damage and retains its proper form and function after insertion.

8. The sample size for the training set:

• Not Applicable. This is not an AI device that requires a "training set." The device is manufactured based on design specifications and then tested.

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

• Not Applicable. (See point 8).

Summary Rationale from the Document:
The document explicitly states: "No clinical testing was performed on the subject device." and "Bench tests, laboratory tests, and evaluations were completed on the proposed B+L Pre Vue Inserter for enVista Preloaded. No animal or clinical testing was required for this submission." This reinforces that the "study" proving the device met acceptance criteria was entirely non-clinical, focusing on functional performance, material safety, and manufacturing quality. The conclusion emphasizes that "Device functional performance testing all passed and demonstrates equivalence to predicate device." and that all results support "substantial equivalence to the predicate devices."

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Bausch + Lomb Boston Simplus Multi-Action Solution is indicated for cleaning protein, rinsing, disinfecting, conditioning, storing and cushioning fluoro silicone acrylate rigid gas permeable contact lenses.

Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses during (wetting, soaking, and disinfecting) with Boston Conditioning Solution or Boston ADVANCE Comfort Formula Conditioning Solution.

Bausch + Lomb Boston Simplus Multi-Action Solution is a sterile, aqueous, buffered solution that contains poloxamine, hydroxyalkylphosphonate, boric acid, sodium borate, sodium chloride, hydroxypropylmethyl cellulose, Glucam and preserved with chlorhexidine gluconate (0.003%), polyaminopropyl biguanide (0.0005%).

Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is a preservative free sterile, aqueous solution containing proteolytic enzyme (subtilisin) as the active ingredient, and glycerol.

This document, a 510(k) K181627 for Bausch + Lomb Boston SIMPLUS Multi-Action Solution and Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner, does not provide information about a study that proves the device meets specific acceptance criteria using a test set, expert ground truth, or MRMC studies.

The submission is for an update to labeling regarding the use of water with the products, not a re-evaluation of the product's fundamental performance against new or existing criteria. It explicitly states: "The only change proposed in this 510(k) is related to removing water from the lens case regimen, and enhancing the warnings related to the use of water. ...The modification to remove water from the lens case rinse in addition to adding warnings related to the use of water do not have an impact on the safety or efficacy of the product and the products remain substantially equivalent to the current commercialized product as there is no change in formulation or regimen."

Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory compliance with labeling guidance and demonstrating substantial equivalence based on the lack of change in formulation or primary care regimen, rather than presenting performance data from a specific study with defined acceptance criteria and test sets.

To reiterate, the provided text does not contain:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes used for a test set or data provenance.
• Information on experts used for ground truth or adjudication methods.
• Any mention of MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Details on the type of ground truth used (e.g., pathology, outcomes).
• Sample size for a training set or how its ground truth was established.

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Boston ADVANCE Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).

Boston ADVANCE Conditioning Solution is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.

Boston ADVANCE Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alkyl ether sulfate, ethoxylated alkyl phenol, tri-quaternary cocoa-based phospholipid and silica gel as cleaning agents; with titanium dioxide.

Boston ADVANCE Conditioning Solution is a sterile, aqueous, buffered, slightly hypertonic solution containing a cationic cellulose derivative polymer, a cellulosic viscosifier, polyvinyl alcohol and a derivatized polyethylene glycol as wetting and cushioning agents; preserved with chlorhexidine gluconate (0.003%), polyaminopropyl biguanide (0.0005%) and edetate disodium (0.05%).

The provided document is a 510(k) premarket notification for Bausch + Lomb Boston ADVANCE Cleaner and Conditioning Solution. It is not a document describing a medical imaging AI device or a study involving human readers and AI assistance.

Therefore, none of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance can be extracted from this document.

This document primarily focuses on demonstrating substantial equivalence of a modified contact lens care regimen (replacing water rinse with saline solution) to a previously cleared regimen, based on microbiology and lens compatibility testing, and re-using previously established biocompatibility and clinical data.

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Boston Original Cleaner is indicated for use to clean silicone acrylate and fluoro silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).

Boston Original Conditioning Solutions is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) of fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.

Boston Original Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alkyl ether sulfate and silica gel as cleaning agents, titanium dioxide and fragrance.

Boston Original Conditioning Solutions is a sterile, aqueous buffered, solution containing a cellulosic viscosifier, cationic cellulose derivative polymer and polyvinyl alcohol as wetting and cushioning agents; preserved with chlorhexidine gluconate (0.006%) and edetate disodium (EDTA) (0.05%).

The provided document is a 510(k) Premarket Notification for Bausch + Lomb Boston Original Cleaner and Boston Original Conditioning Solutions. It focuses on demonstrating the substantial equivalence of a modified regimen for using these existing contact lens care products, specifically replacing a water rinse with Bausch + Lomb Sensitive Eyes Plus Saline Solution.

Therefore, the acceptance criteria and supporting studies are related to proving the safety and effectiveness of this modified regimen, not a new device.

Here's a breakdown of the requested information based on the provided text, noting where information is not applicable or explicitly stated for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for the individual microbiological and lens compatibility test sets. It refers generally to "studies" and "results."

• Data Provenance: The studies were preclinical (laboratory testing). The specific country of origin for the lab work is not stated, but given it's a US FDA submission for a US-based company, it's likely conducted in the US or by a contracted lab. The studies are prospective for the modified regimen comparison.

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

This information is not applicable in the context of this submission. The "ground truth" for these types of tests (microbiology, lens compatibility) is established by adherence to specific, validated international standards (ISO standards) and FDA guidance documents. There isn't a need for expert consensus on individual results in the way there would be for, say, image interpretation in a diagnostic AI device.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus "ground truth." For laboratory tests like those described, the results are quantitative and objective, measured against predefined acceptance criteria from standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human readers (e.g., AI for medical imaging). The submission addresses chemical solutions and their compatibility/efficacy, which are not evaluated through MRMC studies.

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

This question is not applicable as the submission is not for an AI/algorithm-based device. The "device" here refers to contact lens cleaning and conditioning solutions.

7. The Type of Ground Truth Used

The "ground truth" for the performance of these solutions is established through:

• Adherence to International Standards (ISO): Specifically ISO 14730 (Antimicrobial preservative efficacy), ISO 14729 (Regimen testing), and ISO 11981 (Lens compatibility).
• Adherence to FDA Guidance Documents: "Pre-market Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997."
• Validated Laboratory Methods: Results are compared against specific quantitative thresholds defined by these standards and guidance.
• Historical Data: The "almost 20 years" of commercial availability of the existing products with "well demonstrated safety and efficacy" serves as substantial baseline "ground truth" for the system as a whole, negating the need for new clinical trials for a modified rinse step.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This question is not applicable as there is no "training set."

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Bausch + Lomb Boston® Scleral Lens Case is indicated for storage of gas permeable (fluoro scrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.

Bausch + Lomb Boston® Scleral Lens Case consists of a polypropylene cap and polypropylene body for storage of gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.

The provided document is a 510(k) summary for the Bausch + Lomb Boston® Scleral Lens Case, intended for storage of gas permeable contact lenses during chemical disinfection. This document describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical study establishing acceptance criteria and device performance based on a specific algorithm or AI.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and AI performance metrics are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (a contact lens case) undergoing a 510(k) clearance process based on substantial equivalence.

However, I can extract information related to the preclinical testing that was performed to demonstrate the safety and effectiveness of the device.

Here's a summary of the available information:

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

The document doesn't outline specific numerical acceptance criteria in the way one might expect for a quantitative performance study (e.g., accuracy, sensitivity, specificity thresholds). Instead, safety and effectiveness are established through biocompatibility testing against established ISO standards and comparison to a predicate device.

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

• Sample Size: Not specified in the document. Biocompatibility tests typically involve a certain number of samples, but the exact count is not given here.
• Data Provenance: The preclinical testing was "sponsored by Bausch + Lomb." The document does not specify country of origin for the data, but it's internal company testing. It is retrospective in the sense that the results were submitted after the tests were concluded.

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

• Not applicable. This is not a study requiring expert readers or ground truth establishment in the context of imaging or diagnostic accuracy. Biocompatibility testing relies on standardized laboratory protocols and analyses, not expert consensus on interpretations.

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

• Not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the case for the preclinical tests mentioned.

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/algorithm-based device and no MRMC study was conducted. The document explicitly states: "Clinical studies involving the Bausch + Lomb Boston® Scleral Lens Case were unnecessary for this application."

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

• Not applicable. This is not an algorithm or AI device.

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

• For biocompatibility: The "ground truth" is based on the results of standardized laboratory assays (e.g., cell viability in cytotoxicity tests, observation of reactions in irritation tests, systemic effects in systemic toxicity tests) as defined by the referenced ISO 10993 standards. These are objective measures rather than expert consensus on interpretations.

8. The sample size for the training set:

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

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

• Not applicable. No training set was used.

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Bausch + Lomb Sensitive Eyes Plus Salinon is a sterile, preserved solution for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before lens insertion with chemical (not heat) and hydrogen peroxide systems.

Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, isotonic, buffered solution that contains boric acid, sodium borate, potassium chloride, sodium chloride, preserved with polyaminopropyl biguanide (0.00003%) and edetate disodium (0.025%). The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.

This document describes the premarket notification (510(k)) for the Bausch + Lomb Sensitive Eyes Plus Saline Solution, which is a sterile, preserved solution for rinsing contact lenses. The study mainly focuses on demonstrating substantial equivalence to predicate devices and expanding its indications for use to include gas permeable contact lenses.

Here's an analysis of the provided text in the context of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance metrics for a diagnostic device. Instead, it refers to standards and general requirements for contact lens care products. The "acceptance criteria" are implied by adherence to these standards and the demonstration of safety and effectiveness.

Here's a summary of the performance claims based on the described studies:

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

• The document does not specify the sample sizes used for the microbiology, biocompatibility, or lens compatibility test sets.
• Data provenance: The studies were performed by or sponsored by Bausch + Lomb. The specific country of origin for the data is not mentioned but appears to be part of a submission to the U.S. FDA, indicating the data would be accepted under U.S. regulatory standards. These are preclinical (laboratory) studies, not typically categorized as retrospective or prospective in the same way clinical trials are.

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

• This information is not provided in the document. The studies are primarily laboratory-based (microbiology, lens compatibility) and a declaration of no new biocompatibility testing needed due to prior clearance. Expert consensus for "ground truth" as typically understood in diagnostic device evaluations is not applicable here.

4. Adjudication method for the test set

• This information is not provided and is not applicable for the type of laboratory and preclinical studies presented. Adjudication methods are typically used in clinical studies involving human observers or subjective assessments.

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 done. This device is a saline solution and not an AI-powered diagnostic device. Therefore, a study involving human readers and AI assistance is not relevant or described.

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

• No, a standalone algorithm performance study was not done. This device is a physical product (saline solution), not an algorithm or AI.

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

• For the microbiology studies, the "ground truth" would be defined by the established laboratory methods and criteria in ISO 14730 and the FDA Guidance document. This involves direct measurement of antimicrobial efficacy against specified microorganisms.
• For lens compatibility, the "ground truth" is defined by the objective standards and methods outlined in ISO 11981, which assess physical characteristics of lenses after exposure to the solution.
• For biocompatibility, the "ground truth" was established by previous testing and regulatory clearance of the device/components, meaning it met established safety standards.
• The absence of clinical studies for this submission means no direct "outcomes data" or "pathology" was generated for new approval, relying instead on historical data and preclinical testing.

8. The sample size for the training set

• This is not applicable as this submission is for a medical device (saline solution), not an AI/machine learning model that requires a "training set."

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

• This is not applicable for the same reason as point 8.

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