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The EyeGility Inserter for enVista preloaded is indicated for folding and inserting of enVista IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.

The EyeGility Inserter is a sterile, single-use device used to fold and insert an intraocular lens 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 describes the EyeGility™ Inserter for Preloaded enVista® IOLs and its non-clinical testing to demonstrate substantial equivalence.

Here's the information broken down as requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test. It broadly mentions "functional testing" and "nonclinical testing." The data provenance is not mentioned, but given it's a premarket notification for the US market (FDA), such tests are typically conducted by the manufacturer in a controlled laboratory setting. The study is prospective in the sense that the device was designed and then tested against established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is an inserter for Intraocular Lenses (IOLs) and the testing performed is non-clinical, focusing on the physical performance, biocompatibility, and sterility of the device against established standards (e.g., ISO standards). Ground truth, in the context of expert review, is typically relevant for interpretative devices (e.g., AI for medical imaging diagnosis), which is not the case here.

4. Adjudication Method for the Test Set
Not applicable, as this is a non-clinical device that is tested against objective, measurable performance standards rather than expert adjudication.

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. The provided text explicitly states: "No clinical testing was completed in support of the subject device." This implies no human readers or AI assistance was involved in a clinical comparative effectiveness study for this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device (an inserter) and does not involve an algorithm or AI.

7. The type of ground truth used
The "ground truth" for the non-clinical testing of this device is defined by the acceptance criteria established by international standards (e.g., ISO, ANSI/AAMI, ASTM) for medical devices and IOLs. These standards dictate acceptable performance for parameters like folding and recovery, optical quality, dimensions, biocompatibility, sterilization, and packaging integrity.

8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve machine learning or a "training set."

9. 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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The Bausch + Lomb Stellaris Elite™ vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

The Bausch + Lomb Stellaris Elite™ vision enhancement system is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. Additionally, the Stellaris Elite™ vision enhancement system may be configured with a 532 nm laser module for photocoagulation. The Stellaris Elite™ vision enhancement system was initially cleared under K 162342 which included the introduction of an Adaptive Fluidics feature as well as increase in vitrectomy cut rate. The Vitesse vitrectomy handpiece was introduced and cleared for use on the Stellaris Elite™ vision enhancement system under K170052.

A selection of disposable single-use procedure packs is available for use with this system. These packs contain the necessary tubing to facilitate delivery and removal of air and fluids to/from the patient as well as a selection of components (cannulas, cutters, probes, etc.) that facilitate the surgical procedure. The items are arranged for physician convenience and may be presented as a group intended to support all the needs of a procedure or packaged singularly to allow the physician greatest flexibility. Additional Stellaris Elite™ vision enhancement system procedure packs have been made available and these packs contain components that have been used in previously available procedure packs. Some of these Stellaris Elite™ vision enhancement system procedure packs now include the BiBlade vitrectomy cutter produced by Medical Instruments Development Lab (separately cleared via K153168).

The previously cleared Stellaris Elite™ vision enhancement system introduced new feature sets that are not available on the legacy Stellaris PC systems previously cleared under K133242/K133486 respectively. A summary of these additional feature sets for the Stellaris Elite™ vision enhancement system are listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.

The most recent clearance to the Stellaris Elite™ vision enhancement system introduced the Vitesse vitrectomy feature and was cleared via K170052 on April 19, 2017.

This traditional 510(k) incorporates updates to User Interface Computer System on Module (SOM) with an introduction of a new replacement Congatec SOM. In addition. the Stellaris Software platform is updated to Windows 10, since the current Stellaris software platform Windows XP is obsolete/incompatible with the new Congatec SOM.

The features remain the same as the previously approved Stellaris Elite™ vision enhancement system. The configuration matrix is listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.

The provided document is a 510(k) Summary for the Bausch + Lomb Stellaris Elite™ vision enhancement system. It primarily focuses on demonstrating substantial equivalence to a predicate device after software and hardware updates, rather than presenting a study proving a device meets specific acceptance criteria for performance.

Therefore, many of the requested categories cannot be fully addressed in the traditional sense of a clinical or performance study aimed at defining and meeting specific analytical or clinical performance metrics. The document describes how substantial equivalence was demonstrated, which involves various types of testing, but not a study designed to prove new performance claims against defined acceptance criteria.

Below is the information extracted and interpreted based on the context of this 510(k) submission, highlighting what is available and what is not.

Acceptance Criteria and Device Performance Study for K232084

This 510(k) submission (K232084) is for updates to the Bausch + Lomb Stellaris Elite™ vision enhancement system, not for a new device making novel performance claims. The primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device (K170052 Stellaris Elite™ vision enhancement system) after changes to the User Interface Computer System on Module (SOM) and an update to the operating system from Windows XP to Windows 10. Consequently, the "acceptance criteria" and "device performance" are framed in terms of meeting regulatory standards and maintaining performance equivalent to the predicate device, rather than achieving specific performance thresholds for a novel diagnostic or therapeutic claim.

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

Given the nature of this 510(k) for system updates, the "acceptance criteria" are regulatory compliance and maintained functionality, rather than specific numerical performance metrics for a clinical task.

2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of a dataset for AI or clinical study. Instead, it refers to "representative units" for hardware testing (electrical safety, EMC) and software verification/validation.

• Test Set Sample Size: Not applicable in the context of an AI-driven clinical test set. Testing was performed on the device itself and its software.
• Data Provenance: Not applicable as no patient data or image data was used for a test set. This submission is for hardware/software updates to an ophthalmic surgical system. The standards cited (IEC standards for electrical safety, EMC, software lifecycle) are international regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" for a test set (e.g., diagnostic labels, disease states) was established by experts in this submission, as it's not a diagnostic AI device.

4. Adjudication method for the test set
Not applicable. There was no test set requiring expert adjudication.

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-assisted diagnostic or interpretation device that would involve human readers.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a clinical performance study. For software and hardware validation, the "ground truth" would be the functional requirements and established performance specifications of the predicate device and relevant international standards.

8. The sample size for the training set
Not applicable. This device does not use a "training set" in the sense of machine learning for interpretation or diagnosis.

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

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Samfilcon B Contact Lens: Bausch + Lomb Samfilcon B Contact Lens for daily wear is indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

Samfilcon B Contact Lens for Astigmatism: Bausch + Lomb Samfilcon B Contact Lens for Astigmatism for daily wear is indicated for the correction of refractive ametropia (myopia, hyperopia and/or astigmatism) in aphakic persons with non-diseased eyes with refractive astigmatism not exceeding 10.00 diopters.

Samfilcon B Contact Lens for Presbyopia: Bausch + Lomb Samfilcon B Contact Lens for Presbyopia for daily wear is indicated for the correction of refractive ametropia (myopia or hyperopia) and presbyopia in aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

Samfilcon B Contact Lens Multifocal for Astigmatism: Bausch + Lomb Samfilcon B Contact Lens Multifocal for Astigmatism for daily wear is indicated for the correction of refractive ametropia (myopia, and/or astigmatism) and presbyopia in aphakic and not aphakic persons with non-diseased eyes with refractive astigmatism not exceeding 10.00 diopters.

When prescribed for frequent planned replacement wear, the contact lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.

The Samfilcon B Contact Lens is available for a frequent/planned replacement modality.

The Bausch + Lomb Samfilcon B Contact Lens is made from a silicone hydrogel material and is approximately 41% water by weight when immersed in a sterile phosphate buffered saline solution. This lens is tinted blue with Reactive Blue Dye 246. The color additive conforms with 21 CFR Part 73.3106.

The Bausch + Lomb Samfilcon B Contact Lens is to be prescribed for daily wear.

The custom-made lenses will be manufactured in spherical, toric, multifocal and toric multifocal designs with the following parameters:
Diameter: 10.0 mm to 16.0 mm
Base Curve: 6.5 mm to 9.7 mm
Power Range: +20.00D to -20.00D
Cylinder Power (Toric): 0D to -10.00D
Cylinder Axis: 1° to 180°
Add Power (Multifocal): +0.50D up to +4.00D

The lenses are packaged in borosilicate USP Type 1 glass vials containing phosphate buffered saline solution. A silicone vial stopper and aluminum crimp cap secure the lenses in the vial. Vials 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 510(k) premarket notification for the Samfilcon B Contact Lens. It includes information about the device's technical specifications, comparison to predicate devices, and summaries of non-clinical and clinical testing. However, it does not explicitly detail a "study that proves the device meets the acceptance criteria" in the format of specific acceptance criteria.

Instead, the document states that "The primary safety endpoint was statistical non-inferiority with respect to the proportion of eyes with slit lamp findings Grade >2 at any follow-up visit between the test and control lenses. And the primary effectiveness endpoint was statistical non-inferiority with respect to mean distance high-contrast logMAR lens visual acuity for each eye between the test and control lenses." These are the endpoints used to demonstrate substantial equivalence, rather than a direct set of acceptance criteria with reported performance against them in a table format.

Therefore, I cannot generate the requested table of acceptance criteria and reported device performance from the provided text because these specific criteria and their direct outcomes are not explicitly listed in that manner.

Below is the information that can be extracted from the provided text regarding the clinical study:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, a direct table of specific acceptance criteria and detailed reported performance is not explicitly provided in the text. However, the primary endpoints of the clinical study, which serve as the basis for proving effectiveness and safety, are stated.

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

• Sample Size for Test Set (Clinical Study):
  • Enrollment: 56 for Investigational Device (Samfilcon B Contact Lens), 28 for Control Device, Total = 84 subjects.
  • Primary Safety Endpoint Analysis: 56 for Investigational Device, 28 for Control Device, Total = 84 subjects.
  • Primary Effectiveness Endpoint Analysis: 46 for Investigational Device, 21 for Control Device, Total = 67 subjects.
• Data Provenance: The clinical study was a "multicenter, clinical study in the US." It was active-controlled, randomized, and double-masked.

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 text.

4. Adjudication method for the test set:

This information is not provided in the text. The study was double-masked, which suggests a controlled environment, but a specific adjudication method beyond that is not 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:

This was not an MRMC study, and it does not involve AI assistance. The study compared the Samfilcon B contact lens to a control lens.

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

This was not a standalone (algorithm only) study, as it involved human subjects wearing contact lenses.

7. The type of ground truth used:

For the clinical study, the "ground truth" was established through clinical observations and measurements by eye care professionals, specifically regarding:

• Slit lamp findings (for safety)
• Distance high-contrast logMAR lens visual acuity (for effectiveness)

8. The sample size for the training set:

There is no mention of a "training set" in the context of this contact lens clinical study. This term is typically used in machine learning or AI development, which is not applicable here. The study involved a test set of human subjects.

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

As there was no "training set" in the machine learning sense, this question is not applicable.

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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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The Independent Viewing Chamber (IVC-21) is a sterile container that may be used for the transportation of corneal tissue preserved in Optisol GS storage media.

The Independent Corneal Viewing Chamber (IVC) is a sterile container (consisting of a jar, lid, and o-ring) that may be used for transportation of corneal tissue preserved in Optisol GS storage media.

The provided text describes the acceptance criteria and study proving the device meets those criteria. However, it does not pertain to an AI/ML medical device, but rather a sterile container for corneal tissue. Therefore, many of the requested bullet points, such as those regarding AI model performance, training data, ground truth establishment for AI, MRMC studies, or standalone algorithm performance, are not applicable to this 510(k) submission.

Here's a breakdown of the relevant information from the provided document, addressing the applicable points:

Device: Independent Corneal Viewing Chamber (IVC-21)
Predicate Device: Independent Corneal Viewing Chamber (IVC-12)

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a single, concise table of acceptance criteria with corresponding performance data in the traditional sense for an AI/ML device. Instead, the performance data is described qualitatively or with specific pass/fail statements regarding various tests related to biocompatibility, sterility, and functional requirements for a container.

However, based on the Implicit acceptance criteria from the "Performance Data" section (VII), we can construct a table for the tests performed:

The following points are not applicable to this 510(k) submission for a physical medical device (corneal viewing chamber) as it does not involve an AI/ML component.

• 2. Sample size used for the test set and the data provenance: Not applicable for a non-AI/ML device. Tests were performed on the device itself (e.g., extracts, or the physical container). The numbers relate to test animals (e.g., 10 guinea pigs, 6 rabbits) or in vitro cell cultures, not data for an algorithm. Data provenance (country of origin, retrospective/prospective) is typically for clinical data or imaging datasets, which are not relevant here.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Relates to expert consensus for AI/ML model ground truth.
• 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. Relates to reader studies for AI/ML performance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Applies to AI/ML algorithm performance.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. Refers to ground truth for AI/ML model validation. For a physical device, performance is evaluated against defined physical, chemical, and biological standards.
• 8. The sample size for the training set: Not applicable. Relates to AI/ML model training data.
• 9. How the ground truth for the training set was established: Not applicable. Relates to AI/ML model training data.

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Bausch + Lomb ABT12 multi-purpose solution is indicated for use in the daily cleaning, conditioning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.

Bausch + Lomb ABT12 multi-purpose solution is a sterile isotonic aqueous solution [containing polyaminopropyl biguanide (0.0005%), polyquaternium (0.00015%), and alexidine (0.00025%)] for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft (hydrophilic) and silicone hydrogel contact lenses. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.

Based on the provided text, the device in question is a multi-purpose contact lens solution (ABT12 multi-purpose solution), not an AI-powered medical device for image analysis. Therefore, many of the typical acceptance criteria and study details related to AI performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of product and approval process.

The document describes the regulatory approval of a contact lens solution (Bausch + Lomb ABT12 multi-purpose solution) for which the primary claims are related to its safety and effectiveness in cleaning, disinfecting, and storing contact lenses. The "acceptance criteria" here are based on demonstrating substantial equivalence to a predicate device (COMPLETE multi-purpose solution Easy Rub Formula) through a combination of preclinical (biocompatibility, microbiology, lens compatibility, cleaning efficacy) and clinical studies.

Here's a breakdown of the requested information, adapted to the context of this non-AI medical device:

Acceptance Criteria and Study for Bausch + Lomb ABT12 Multi-Purpose Solution

As the device is a contact lens solution, not an AI-powered diagnostic tool, the typical "acceptance criteria" table for AI performance metrics (e.g., sensitivity, specificity, AUC) is not applicable. Instead, the acceptance criteria are based on demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a contact lens solution primarily revolve around meeting established safety and effectiveness standards, often demonstrated through non-inferiority to a legally marketed predicate device.

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

• Sample Size (Clinical Study - Test Set): A total of 252 subjects were enrolled. 240 subjects completed the study. These subjects were randomized into two groups:
  • ABT12 multi-purpose solution (Test): 127 subjects
  • COMPLETE multi-purpose solution (Control/Predicate): 125 subjects
• Data Provenance: The clinical study was a multicenter study conducted in the USA.
• Retrospective or Prospective: This was a prospective, randomized, masked, parallel, bilateral clinical study.

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

This question is not applicable in the context of this device. The "ground truth" for a contact lens solution's performance is established through direct clinical observations (e.g., slit lamp findings by ophthalmologists/optometrists) and patient-reported outcomes, as well as laboratory testing results, rather than expert consensus on image interpretation. The study was masked, implying that the clinicians assessing outcomes were blinded to the treatment assignment.

4. Adjudication Method for the Test Set

This concept (adjudication of interpretations) is not applicable to this type of study. Clinical outcomes were measured directly by investigators in a masked fashion and patient-reported outcomes were collected.

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

No, an MRMC study was not done. MRMC studies are typically used to evaluate the impact of a diagnostic tool (like AI) on physician performance in interpreting medical images. This study focused on the safety and effectiveness of a physical product (contact lens solution) in a clinical trial setting.

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

This question is not applicable. There is no algorithm for this device. The "standalone performance" of the contact lens solution is demonstrated through the preclinical studies (biocompatibility, microbiology, cleaning efficacy, lens compatibility) which evaluate the product's intrinsic properties irrespective of human handling errors (though proper usage instructions are provided).

7. The Type of Ground Truth Used

The ground truth was established through a combination of:

• Clinical Measurements: Objective clinical assessments by masked investigators (e.g., slit lamp findings, visual acuities).
• Patient-Reported Outcomes: Subjective data gathered directly from subjects regarding comfort, dryness, and other symptoms.
• Laboratory Testing: In-vitro and ex-vivo studies to assess intrinsic properties like microbiological efficacy, cleaning efficacy, and biocompatibility.
• Comparison to Predicate: The "truth" of effectiveness and safety was established by demonstrating non-inferiority to a known, legally marketed predicate device.

8. The Sample Size for the Training Set

This question is not applicable 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 this is not an AI/machine learning 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 Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluorosilicone 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 One Step Liquid Enzymatic Cleaner is a preservative free sterile, aqueous solution containing proteolytic enzyme (subtilisin) as the active ingredient, and glycerol.

The provided text describes a 510(k) premarket notification for a contact lens care product, the "Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner." The submission seeks to add an alternative manufacturing site and change packaging resin and raw material suppliers.

However, the document does not contain information about acceptance criteria for a device's performance based on AI/algorithm/software output, nor does it detail a study proving the device meets such criteria. The "Preclinical testing" mentioned is related to biocompatibility and confirms the safety and effectiveness of the product itself, not a software device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information (specifically points 1-9 regarding an AI/algorithm-based device and its validation) is absent from the provided text.

The text focuses on the following:

• Device Type: A contact lens care solution (not an AI/software device).
• Purpose of 510(k) Submission: To add an alternative manufacturing site and modify packaging components, not to introduce or validate a new AI/software feature or performance.
• Testing Mentioned: Biocompatibility, cytotoxicity, and ocular irritation studies related to the chemical solution and its packaging components. These are standard tests for medical devices that come into contact with human tissue, not for evaluating AI performance metrics like sensitivity, specificity, or reader improvement.

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