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BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.

BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) Contact Lenses are composed of fluoro silicone acrylate copolymers wet shipped in Boston Advance Comfort Formula Conditioning Solution and stored for up to 30 days.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BOSTON® EQUALENS® and BOSTON® EQUALENS® II RGP Contact Lenses:

The information provided is a 510(k) summary for RGP contact lenses, focusing on the stability of the lenses when wet-shipped and stored in a specific conditioning solution. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, the studies described are primarily performance and safety tests, not clinical efficacy trials in the typical sense for a new drug or high-risk device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Stability/Compatibility Test Set: The sample size is not explicitly stated. The text refers to "Silicone acrylate (SA) and fluorosilicone acrylate (FSA) tinted rigid gas permeable contact lenses" being subjected to the test.
• Microbiology Test Set: The sample size is not explicitly stated, but it refers to "a set of test lenses" and "two sets of lenses" (one control, one stored).
• Data Provenance: The studies were performed by "The applicant," Polymer Technology. The location of the testing is not specified, nor is whether the data is retrospective or prospective. Given the nature of a 510(k) submission for device approval, these would be prospective tests conducted specifically for the submission.

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

This information is not provided in the document. For these types of physical and microbiological performance tests, the "ground truth" is typically established by laboratory measurements against defined standards or protocols, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The tests described are objective laboratory measurements, not subjective evaluations requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the goal is to assess the impact of an AI algorithm on human reading performance. The described studies are physical and microbiological performance tests for contact lenses.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable in the context of this device. A standalone algorithm performance study refers to the evaluation of an AI algorithm's performance without any human intervention. The device in question is a contact lens, and the studies performed are physical and microbiological tests, not AI algorithm evaluations.

7. The Type of Ground Truth Used

• Stability/Compatibility: The ground truth for physical compatibility (diameter, base curve, power changes) was established by comparison to the DRAFT ISO/CD 8321-2: Optics and Optical Instruments – Contact Lenses - Part 1: Specifications for rigid corneal and scleral contact lenses. This is a recognized international standard for contact lens specifications.
• Microbiology (Bioburden): The ground truth for microbial contamination was established by quantitative measurement of Colony Forming Units (CFU) per lens against a defined numerical acceptance criterion.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of this device and study. Training sets are relevant for machine learning or AI models, which are not involved here.

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

This information is not applicable as there is no "training set" for this device.

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BAUSCH & LOMB® Wetting and Soaking Solution is indicated for use in disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate rigid gas permeable and hard (PMMA) contact lenses.

BAUSCH & LOMB Wetting and Soaking Solution is a sterile conditioning solution used in the care of rigid gas permeable and hard (PMMA) contact lenses and is indicated for the disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate and hard (PMMA) contact lenses. This product is contained in a plastic bottle, and consists of a sterile, buffered solution, preserved with chlorhexidine gluconate and edetate disodium.

The provided text describes the acceptance criteria and the studies conducted for the BAUSCH & LOMB® Wetting and Soaking Solution to demonstrate its safety and effectiveness.

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

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

• Toxicology (In-Vitro Cytotoxicity, Acute Ocular Irritation): The sample size for these tests is not explicitly stated, but they are described as "preclinical testing" using "laboratory animals" for the ocular irritation test, implying a controlled laboratory study. Data provenance is implied to be domestic (likely US) as it's for a US regulatory submission. The tests are retrospective in the sense that they were completed preclinical studies.
• Microbiology (Preservative Effectiveness, Disinfection Efficacy): The tests were performed on "Product stored up to 36 months at room temperature." The specific number of product samples tested is not provided, but it's a prospective stability study over 36 months. Data provenance is implied to be domestic.
• Solution Compatibility: "BOSTON IV (silicone acrylate), BOSTON ES (fluoro silicone acrylate) tinted rigid gas permeable contact lenses and BP Flex PMMA contact lenses" were subjected to a thirty-cycle study. This implies samples of these specific lens types were used. The number of individual lenses or repetitions is not specified. Data provenance is implied to be domestic.
• Wetting Angle: The study investigated "three selected RGP lens materials, BOSTON IV (silicone acrylate), BOSTON ES (fluoro silicone acrylate) tinted rigid gas permeable contact lenses and BP Flex PMMA contact lenses." The number of lenses or repetitions per material is not specified. Data provenance is implied to be domestic.

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 described are primarily analytical, microbiological, and animal-based preclinical tests, not human-reader-based evaluations that would require expert ground truth establishment in the traditional sense of medical image analysis or diagnostics.

4. Adjudication method for the test set

This information is not applicable as the studies are preclinical, analytical, and microbiological, and do not involve human interpretation or adjudication in the context of diagnostic performance.

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 type of study was not done. The submission is for a contact lens wetting and soaking solution and does not involve AI or human readers for diagnostic effectiveness.

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

This is not applicable as the device is a contact lens solution, not an algorithm, and does not have standalone or human-in-the-loop performance in the context of AI.

7. The type of ground truth used

• Toxicology: "Ground truth" for cytotoxicity and ocular irritation would be based on established biological and physiological responses in validated in-vitro assays (USP XXII Agar Diffusion Test) and animal models (Acute Ocular Irritation test), demonstrating the absence of harmful effects.
• Microbiology: "Ground truth" for preservative effectiveness and disinfection efficacy is defined by meeting "relevant preservative efficacy requirements" and "ISO Stand Alone Procedure for Disinfecting Products Primary Acceptance Criteria requirements," respectively, which are predefined quantitative targets for microbial reduction.
• Solution Compatibility: "Ground truth" is based on adherence to "ISO specifications for rigid corneal and scleral contact lenses" and subjective assessment of "cosmetic appearance" after a specified number of cleaning and soaking cycles.
• Wetting Angle: "Ground truth" is established by comparing the Dynamic Contact Angle (DCA) analysis results of the modified solution to the legally marketed predicate device, aiming for equivalence.

8. The sample size for the training set

This information is not applicable as the studies are for a medical device solution and do not involve machine learning algorithms that require training sets. There is no mention of a "training set" in the document.

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

This is not applicable as there is no training set mentioned or implied in the context of this device and its studies.

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

Boston Advance® Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alky ether sulfate, ether sulfate, ethoxylated alkyl phenol, triquaternary cocoabased phospholipid, silica gel as cleaning agents; with titanium dioxide.

This 510(k) summary describes a submission for a contact lens cleaner, Boston Advance® Cleaner. The primary goal of the submission is to demonstrate substantial equivalence to a previously marketed device. Therefore, the study focuses on showing comparable safety and efficacy rather than establishing novel performance criteria as might be expected for a new, unique device.

Here's an analysis of the provided information, structured around your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state distinct "acceptance criteria" with numerical thresholds for performance endpoints in the way you might see for an AI algorithm's accuracy or sensitivity. Instead, the "acceptance criteria" were implied by demonstrating substantial equivalence to the predicate device across various safety and efficacy parameters.

The "reported device performance" is a conclusion of "substantial equivalence" based on these tests.

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

• Clinical Study (In-vivo):

  • Total Patients: 170 patients (340 eyes)
  • Test Group (modified Boston Advance® Cleaner): 114 patients (228 eyes)
  • Control Group (marketed Boston Advance® Cleaner): 54 patients (108 eyes)
  • Completed Study: 151 patients
  • Discontinued: 17 patients (none for safety or efficacy reasons)
  • Data Provenance: The study involved 12 investigational sites. The document doesn't explicitly state the country of origin, but given the submission is to the U.S. FDA, it is highly likely that the investigational sites were in the United States. The study started in April 1997 and concluded in November 1997, making it a prospective clinical study.

• In-vitro, Toxicology, Microbiology, Shelf Life, Lens/Solution Compatibility, In-Vitro Cleaning: These studies were conducted in laboratory settings as "pre-clinical" or in-vitro tests, not on human subjects. Sample sizes and provenance vary by test (e.g., "separate samples of three lots" for Biostatic Efficacy, unspecified numbers of lenses for compatibility). The provenance would be the testing laboratories, likely within the manufacturer's or contracted facilities.

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

This type of submission (for a contact lens care product) does not typically involve "experts establishing ground truth" in the way an AI diagnostic device would.

• For the clinical study, the "ground truth" would be established through standard clinical examinations and patient reporting of symptoms by licensed eye care professionals (e.g., ophthalmologists, optometrists) at the 12 investigational sites. Their qualifications are not explicitly stated but are assumed to be appropriate for clinical trials involving contact lenses.
• For the laboratory tests (toxicology, microbiology, cleaning efficacy, etc.), ground truth is established by following validated, standardized testing protocols (e.g., USP standards) and performing objective measurements. The "experts" would be the laboratory personnel qualified to conduct and interpret these specific assays, but they wouldn't be forming consensus "diagnoses" as for medical imaging.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (like 2+1 or 3+1 consensus) for the clinical test set. In clinical trials for equivalence, outcomes (e.g., adverse events, visual acuity, comfort levels) are typically assessed individually by the investigators at each site and then aggregated for statistical comparison between the test and control groups. It's not a diagnostic scenario requiring a consensus "ground truth" in the same way.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the performance of diagnostic devices or AI algorithms where multiple human readers interpret cases, often with and without AI assistance. This submission is for a contact lens cleaning solution and does not involve such an evaluation methodology.

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

This is not applicable as the device is a contact lens cleaning solution, not an algorithm or AI product. There is no algorithm to assess in a standalone manner.

7. The Type of Ground Truth Used

• Clinical Study: The "ground truth" for the clinical study would be a combination of:
  • Clinical Assessments: Objective findings from eye examinations (e.g., corneal staining, lens deposits) performed by eye care professionals.
  • Patient-Reported Outcomes: Subjective feedback from patients regarding comfort, vision, and adverse events.
  • Comparison against the predicate device's established safety and efficacy profile. The ultimate ground truth is "substantial equivalence" to the predicate.
• Toxicology: Absence of biological reactivity (cell viability/response to extracts).
• Microbiology: Absence of microbial growth (sterility) and reduction in microbial concentration (antimicrobial efficacy) based on standardized culture methods.
• Shelf Life: Stability of the product's chemical and microbiological properties over time.
• Lens/Solution Compatibility: Physical integrity and optical properties of lenses after exposure to the solution.
• In-Vitro Cleaning: Objective measurement of surfactant properties (critical micelle concentration) and implied cleaning efficacy.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device (contact lens cleaner) and does not involve an AI algorithm that requires a "training set." The clinical study performed functions as the "test set" to demonstrate equivalence.

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

Not applicable. As there is no AI algorithm, there is no training set and hence no ground truth establishment for a training set.

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The Boston® Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses during simultaneous conditioning (wetting, soaking, and disinfecting) with Original Formula Boston® Conditioning Solution, Boston ADVANCE® Comfort Formula Conditioning Solution, or Boston SIMPLICITY® Multi-Action Solution.

The Boston® Liquid Enzymatic Cleaner is a sterile, aqueous, buffered solution containing proteolytic enzyme (subtilisin) as the cleaning agent, and glycerol. Preservative-free.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Please note: This document is from 1997 and refers to guidance documents from that era. Modern regulatory submissions often have more detailed and quantitative acceptance criteria and study reporting.

Acceptance Criteria and Device Performance Study for Boston® Liquid Enzymatic Cleaner

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, the acceptance criteria are largely implicit in the types of tests performed and the statement of "acceptable" or "substantially equivalent" results. Specific numerical performance targets are not explicitly stated in this high-level summary, which is common for 510(k) submissions of this vintage.

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

• Clinical Study Test Set:
  • Total Patients: 103 (206 eyes)
  • Boston® Liquid Enzymatic Cleaner Group: 69 patients (64 eyes)
  • Alcon OPTI-ZYME® Enzymatic Cleaner Group (Predicate): 32 patients (64 eyes)
  • Completed Study: 95 subjects
  • Discontinued: 12 subjects (none due to adverse reactions)
  • Data Provenance: Not explicitly stated, but clinical studies for FDA submissions are typically prospective and often multi-site within the US. The six investigational sites suggest a prospective, multi-center US study.

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

• The document does not specify the number or qualifications of experts for establishing ground truth in the clinical study. It is a comparative study, implying that the clinical outcomes observed by the investigators (e.g., visual acuity, irritation) would be the "ground truth" for safety and efficacy comparison, rather than an independent expert panel interpreting data.

4. Adjudication Method for the Test Set

• The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical study data or endpoints. Clinical studies for device approval rely on the observations and assessments of the participating investigators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, this was not an MRMC study. MRMC studies are typically used when multiple human readers interpret diagnostic images or data, and the device is an AI-powered diagnostic aid. This device is a contact lens cleaning solution, so an MRMC study design is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• No, this concept (standalone algorithm performance) is not applicable to this medical device. This is a physical product (liquid cleaner) that is used by patients (human-in-the-loop activity, though not AI-assisted).

7. The Type of Ground Truth Used

• For the Clinical Study: The "ground truth" was established through direct clinical observation and patient outcomes as assessed by the investigators over a three-month period. This would include parameters like visual acuity, ocular irritation, lens condition, and patient subjective experiences, compared between the investigational and predicate device groups.
• For Pre-Clinical Studies:
  • Toxicology: In vitro (cell culture reactivity) and in vivo (rabbit ocular irritation) tests with established biological reactivity and irritation scales/observations.
  • Microbiology: Direct colony counting (cfu/mL) for biostatic and disinfection efficacy against specific challenge organisms, with defined reduction criteria.
  • In-Vitro Cleaning: Protein level determination (likely quantitative protein assays on lenses) and Image Analysis to compare cleaning efficacy.
  • Sterility, Shelf Life, Compatibility: Laboratory testing with defined pass/fail criteria based on accepted standards (e.g., USP).

8. The Sample Size for the Training Set

• This is not applicable as the device is a chemical solution, not an AI/ML algorithm that requires a training set.

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

• As mentioned above, this is not applicable for this type of medical device.

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The BOSTON® MULTIVISION (enflufocon A) Contact Lens is indicated for daily wear for the correction of visual acuity in hyperopic and myopic, not-aphakic and aphakic, presbyopic patients with nondiseased eyes, who exhibit astigmatism of 2.00 diopters or less and can obtain satisfactory visual acuity. The lens provides a nominal functional add of 1.50 diopters. The lens may be disinfected using a chemical disinfecting system only

The BOSTON ES MULTIVISION (enflufocon A) is an aspheric multifocal rigid gas permeable, fluoro silicone acrylate contact lens for daily wear. The BOSTON ES MULTIVISION (enflufocon A) contact lens provides distance and near vision through the use of its back surface design. The central portion of the lens provides the distance vision; the mid-peripheral portion provides the near vision and the far peripheral portion provides the fitting performance of the lens. The aspheric design is a series of ever increasing radius curves from the center of the lens to the periphery which provides the ' add' power for central ellipse for distance vision, a hyperbolic curve in the midperiphery for the near vision, and a fillet and steeper hyperbolic design in the periphery for the fitting design.

The provided document describes a 510(k) summary for the BOSTON® ESTM MULTIVISION (enflufocon A) Contact Lens. It references a clinical study conducted for a previous 510(k) for the same material (K943177) to support the current premarket notification. Therefore, the acceptance criteria and study details are derived from this referenced study.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" with numerical thresholds. However, it implicitly uses visual acuity as a key performance indicator to demonstrate effectiveness.

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

• Sample Size: 216 patients (432 eyes)
• Data Provenance: Not explicitly stated, but implies multi-site clinical study within the United States given it's a 510(k) submission referencing US regulatory context. It is a retrospective use of data for this specific submission, but the original study was a prospective clinical study.

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

The document does not provide details on the number or qualifications of experts establishing ground truth. The "ground truth" here is the clinical endpoint of visual acuity as measured by standard optometric methods (e.g., Snellen chart readings).

4. Adjudication method for the test set

The document does not describe any specific adjudication method. Standard clinical trials for contact lenses would typically involve trained clinicians (e.g., optometrists, ophthalmologists) following a defined protocol to assess visual acuity.

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 a contact lens approval, not an AI-powered diagnostic device.

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

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

7. The type of ground truth used

The ground truth used was clinical outcomes data, specifically:

• Visual acuity measurements (e.g., Snellen chart readings).
• Patient reports of wearing time.
• Discontinuation rates and reasons (absence of adverse reactions).

8. The sample size for the training set

The concept of a "training set" is not applicable as this is not an AI/machine learning device. The 216 patients (432 eyes) represent the clinical studycohort used to evaluate the device performance.

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

Not applicable as this is not an AI/machine learning device. The clinical study established the performance data through direct patient evaluation.

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