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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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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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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 Boston ES® (enflufocon A) and Boston EO® (enflufocon B), Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs.

The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses (Scleral) for daily wear are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:

1. cannot be adequately corrected with spectacle lenses
2. requires a rigid gas permeable contact lens surface to improve vision
3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities

Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).

The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Scleral Lens designs for daily wear are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the Boston Scleral Lenses may concurrently provide correction of refractive error.

The lenses may be disinfected using a chemical disinfection (not heat) system only.

Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from the currently marketed contact lens materials: enflufocon A, enflufocon B, and hexafocon B. Non-proprietary names were assigned by the United States Adopted Names Council (USAN). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lenses may be available with an ultraviolet absorber.

The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.

The provided document is a 510(k) Premarket Notification for Bausch & Lomb's Boston ES®, Boston EO®, Boston XO®, and Boston XO2® Rigid Gas Permeable Contact Lenses with a new Tangible™ Hydra-PEG surface coating. This document details the company's claim of substantial equivalence to previously cleared predicate devices, rather than presenting a study for a novel AI/software as a medical device (SaMD).

Therefore, the information requested for acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a device proving AI/software performance is not present in this document.

This submission focuses on demonstrating the safety and effectiveness of a modified contact lens product by comparing its technological characteristics and performance (primarily wettability and biocompatibility) to already cleared devices. The "performance data" sections refer to non-clinical (toxicology, biocompatibility, stability) and clinical (based on predicate device history) testing relevant to contact lenses, not AI model performance.

The only "acceptance criteria" explicitly mentioned and met are related to quality control for the contact lenses:

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