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Found 32 results
510(k) Data Aggregation
(216 days)
MRC
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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(100 days)
MRC
The Vibrant Vue Scleral Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The VibrantVue Scleral Saline is for rinsing large diameter (scleral) rigid gas permeable (RGP) contact lenses prior to lens insertion. This solution may also be used as an insertion for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
The VibrantVue Scleral Saline is a sterile, preservative-free, unbuffered saline solution in a single dose 5 ml vial. The VibrantVue Scleral Saline is a 0.9 % saline solution that conforms to the requirements of USP saline. The rinsing solution removes loose debris and lens cleaners off rigid gas permeable (RGP) contact lenses following proper disinfection as recommended by the eye care practitioner. The sterile solution can be used to rinse contact lens cases and contact lenses as needed throughout the day.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the VibrantVue Scleral Saline:
This document describes a medical device, VibrantVue Scleral Saline, and its clearance through the FDA's 510(k) pathway. The 510(k) process is for devices found to be "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy from scratch. As such, the "acceptance criteria" discussed below relate to demonstrating substantial equivalence and meeting established standards for saline solutions and contact lens care products.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of "acceptance criteria" with numerical performance metrics in the way one might expect for a diagnostic or AI device. Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to the predicate device and meeting recognized standards for saline solutions and contact lens care products.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: The new device's intended use should be substantially equivalent to the predicate device. | The VibrantVue Scleral Saline has an identical intended use to the predicate, Menicon Saline Rinse Solution, for rinsing and insertion of large diameter RGP contact lenses, rinsing cases, and rinsing lenses throughout the day. The only difference noted is the predicate's additional indication for soft and hard contact lenses, which the new device does not claim. |
| Indications for Use Equivalence: The new device's indications for use should be substantially equivalent to the predicate device. | The indications for use are described as being substantially equivalent. |
| Actions Equivalence: The mechanism/function of the new device should be substantially equivalent to the predicate device. | The "actions" are deemed substantially equivalent. The device removes loose debris and lens cleaners. |
| Classification Equivalence: The new device should fall under the same regulatory classification as the predicate. | Both devices are classified under 21 CFR 886.5918 (Rigid Gas Permeable Contact Lens Care Products) and are Class II devices. (Predicate also had 21 CFR 886.5928; new device did not claim it). Both have product code MRC. (Predicate also had LPN; new device did not claim it). |
| Formulation Equivalence: The new device should have a substantially equivalent formulation to the predicate, particularly for key characteristics. | Both are described as sterile, preservative-free, unbuffered, single-dose, 0.9% saline solutions conforming to USP monograph. Both are supplied in 5 mL single-dose vials and plastic resin containers with twist-off caps. |
| Physical Compatibility: The device should be physically compatible with currently marketed rigid gas permeable (RGP) contact lenses. | Demonstrated through non-clinical studies. |
| Packaging Safety: The packaging should be non-toxic and non-irritating. | Demonstrated through non-clinical studies. |
| Stability and Sterility: The product inside its packaging should remain stable and sterile throughout its proposed expiration date. | Demonstrated through non-clinical studies. |
| Safety and Effectiveness: The device must be as safe and effective as the legally marketed predicate device. This is the overarching goal of the substantial equivalence determination. | Concluded based on composition and non-clinical testing results, supporting labeling directions and proposed indication. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that only non-clinical studies were conducted. There was no "test set" in the context of human patient data for the VibrantVue Scleral Saline device.
The non-clinical studies would have involved laboratory testing of the saline solution itself, its packaging, and its interaction with contact lens materials. The data provenance for these non-clinical studies is not specified (e.g., in-house lab, third-party lab), nor are specific sample sizes for these tests detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No clinical test set involving human data was used, therefore no experts were required to establish ground truth for such a set. The "ground truth" for the non-clinical tests would be defined by established scientific methods, standards (e.g., USP monograph for 0.9% saline), and regulatory requirements for sterility, compatibility, and toxicity.
4. Adjudication Method for the Test Set
Not applicable. As there was no clinical test set requiring human interpretation, no adjudication method was used. Non-clinical studies rely on standardized test protocols and objective measurements.
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 to assess human reader performance, often with and without AI assistance, for diagnostic or interpretive tasks. The VibrantVue Scleral Saline is a contact lens care solution, not a diagnostic or AI-powered device, so such a study is not relevant or required for its clearance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The VibrantVue Scleral Saline is a physical medical device (a saline solution), not an algorithm or AI system. Therefore, "standalone (algorithm only)" performance is not relevant.
7. The Type of Ground Truth Used
For the non-clinical studies, the "ground truth" was established based on:
- USP Monograph for 0.9% Saline: This defines the chemical composition and purity standards for saline.
- Industry Standards and Regulatory Requirements: For sterility, packaging safety (non-toxicity, non-irritating), and physical compatibility with RGP contact lenses. These are typically objective, measurable criteria.
8. The Sample Size for the Training Set
Not applicable. As VibrantVue Scleral Saline is a physical medical device and not an AI/ML algorithm, there was no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set.
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(268 days)
MRC
MaxiTears® CONTACTS PF eye drops have been formulated for use with both soft and rigid gas permeable (RGP) contact lenses, to rewet lenses before insertion and lubricate lenses during wear. It also relieves minor irritation, discomfort, dryness, blurring and itchiness, which may occur while wearing your lenses.
The MaxiTears CONTACTS PF are ready-to-use, isotonic, sterile eye contact lens care products (lubricants) intended to moisturize and lubricate the lens drops in eyes to reduce minor symptoms of dry eyes such as burning or itching. The intended use of these contact lens rewetting solutions is to alleviate the symptoms of dryness, discomfort, and minor irritation caused by ocular fatigue induced by the wearing of contact lenses, for example, by environmental conditions (dust, smoke, dry heat, air conditioning, wind, cold) tiredness or extended computer screen use. The MaxiTears CONTACTS PF solution can be used with all types of contact lenses, except contact lenses manufactured from Efrofilcon A, and are intended for repeated use over an extended period of time.
The MaxiTears CONTACTS PF solution it to be introduced to the US-market as an Over the Counter (OTC) medical device similar to other 510k-cleared lens drop lubricants (and identical to predicate Blink CL Lubricant Eve Drops K032030), sold as OTC medical device in retail outlets and through the internet.
OmniVision AG is offering the MaxiTears CONTACTS PF solution as Over the Counter device:
- MaxiTears' CONTACTS PF is a medium viscous preservative-free solution packaged in single-use . ampoules (single-dose units -SDU). They are supplied as single-dose unit plastic ampoules designed to administer one drop and then to be discarded. They are indicated for users with a known history of allergy to preservatives and those who wear contact lenses.
The provided text is a 510(k) summary for MaxiTears® CONTACTS PF, an over-the-counter eye drop. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.
Instead, the submission primarily focuses on demonstrating non-clinical equivalence to a predicate device (blink™ CL Lubricant Eye Drops) through various performance tests and material comparisons.
Therefore, I cannot provide the requested information for an AI/ML device, as the document explicitly states:
- "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." (Section 10. Clinical Performance Data)
- "The non-clinical testing detailed in this submission supports the substantial equivalence of the device." (Section 10. Clinical Performance Data)
This submission is for a contact lens care product (eye drops), not an AI/ML medical device. Hence, the questions related to AI/ML device validation (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to the content provided.
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(130 days)
MRC
The Nutrifill preservative free insertion solution is indicated as an insertion solution for large diameter (scleral), hybrid and rigid gas permeable (RGP) contact lenses following proper lens care disinfection as recommended by the eye care practitioner. This solution may also be used for rinsing debris and lens cleaners from rigid gas permeable, hybrid and hard contact lenses, as a rinse for contact lens cases and may be used as needed throughout the day to rinse contact lenses.
The Nutrifill preservative free insertion solution is a sterile isotonic buffered solution containing electrolytes (calcium, magnesium, phosphate, sodium) in a single dose, carry-on size 10ml vial. It rinses loose debris and cleaning solution off rigid gas permeable (RGP), hard and hybrid contact lenses prior to insertion. The sterile solution can be used to rinse contact lens cases and contact lenses as needed throughout the day.
The provided text describes a 510(k) summary for a contact lens insertion solution called Nutrifill. It outlines the device's characteristics and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of a medical imaging or AI device.
The "Performance Data" section explicitly states:
- Non-Clinical Studies: "A series of studies were completed to demonstrate the substantial equivalence of the Nutrifill preservative free insertion solution to the predicate device. Results of non-clinical testing demonstrate:
- The Nutrifill solution is non-toxic and non-irritating
- The final packaging is non-toxic and non-irritating"
- Clinical Studies: "Clinical studies involving the Nutrifill solution were unnecessary for this application. Lens care solutions used with this Nutrifill solution are already cleared for use as cleaning, rinsing, disinfection and storage solutions for contact lenses."
Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria, as this information is not present in the given document. The submission focuses on demonstrating substantial equivalence to predicate devices for a contact lens care product, rather than reporting performance against specific acceptance criteria for a diagnostic or AI-driven device.
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(51 days)
MRC
Bausch + Lomb Boston Simplus Multi-Action Solution is indicated for cleaning protein, rinsing, disinfecting, conditioning, storing and cushioning fluoro silicone acrylate rigid gas permeable contact lenses.
Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses during (wetting, soaking, and disinfecting) with Boston Conditioning Solution or Boston ADVANCE Comfort Formula Conditioning Solution.
Bausch + Lomb Boston Simplus Multi-Action Solution is a sterile, aqueous, buffered solution that contains poloxamine, hydroxyalkylphosphonate, boric acid, sodium borate, sodium chloride, hydroxypropylmethyl cellulose, Glucam and preserved with chlorhexidine gluconate (0.003%), polyaminopropyl biguanide (0.0005%).
Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is a preservative free sterile, aqueous solution containing proteolytic enzyme (subtilisin) as the active ingredient, and glycerol.
This document, a 510(k) K181627 for Bausch + Lomb Boston SIMPLUS Multi-Action Solution and Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner, does not provide information about a study that proves the device meets specific acceptance criteria using a test set, expert ground truth, or MRMC studies.
The submission is for an update to labeling regarding the use of water with the products, not a re-evaluation of the product's fundamental performance against new or existing criteria. It explicitly states: "The only change proposed in this 510(k) is related to removing water from the lens case regimen, and enhancing the warnings related to the use of water. ...The modification to remove water from the lens case rinse in addition to adding warnings related to the use of water do not have an impact on the safety or efficacy of the product and the products remain substantially equivalent to the current commercialized product as there is no change in formulation or regimen."
Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory compliance with labeling guidance and demonstrating substantial equivalence based on the lack of change in formulation or primary care regimen, rather than presenting performance data from a specific study with defined acceptance criteria and test sets.
To reiterate, the provided text does not contain:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes used for a test set or data provenance.
- Information on experts used for ground truth or adjudication methods.
- Any mention of MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Details on the type of ground truth used (e.g., pathology, outcomes).
- Sample size for a training set or how its ground truth was established.
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(50 days)
MRC
Boston ADVANCE Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).
Boston ADVANCE Conditioning Solution is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.
Boston ADVANCE Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alkyl ether sulfate, ethoxylated alkyl phenol, tri-quaternary cocoa-based phospholipid and silica gel as cleaning agents; with titanium dioxide.
Boston ADVANCE Conditioning Solution is a sterile, aqueous, buffered, slightly hypertonic solution containing a cationic cellulose derivative polymer, a cellulosic viscosifier, polyvinyl alcohol and a derivatized polyethylene glycol as wetting and cushioning agents; preserved with chlorhexidine gluconate (0.003%), polyaminopropyl biguanide (0.0005%) and edetate disodium (0.05%).
The provided document is a 510(k) premarket notification for Bausch + Lomb Boston ADVANCE Cleaner and Conditioning Solution. It is not a document describing a medical imaging AI device or a study involving human readers and AI assistance.
Therefore, none of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance can be extracted from this document.
This document primarily focuses on demonstrating substantial equivalence of a modified contact lens care regimen (replacing water rinse with saline solution) to a previously cleared regimen, based on microbiology and lens compatibility testing, and re-using previously established biocompatibility and clinical data.
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(59 days)
MRC
Boston Original Cleaner is indicated for use to clean silicone acrylate and fluoro silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).
Boston Original Conditioning Solutions is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) of fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.
Boston Original Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alkyl ether sulfate and silica gel as cleaning agents, titanium dioxide and fragrance.
Boston Original Conditioning Solutions is a sterile, aqueous buffered, solution containing a cellulosic viscosifier, cationic cellulose derivative polymer and polyvinyl alcohol as wetting and cushioning agents; preserved with chlorhexidine gluconate (0.006%) and edetate disodium (EDTA) (0.05%).
The provided document is a 510(k) Premarket Notification for Bausch + Lomb Boston Original Cleaner and Boston Original Conditioning Solutions. It focuses on demonstrating the substantial equivalence of a modified regimen for using these existing contact lens care products, specifically replacing a water rinse with Bausch + Lomb Sensitive Eyes Plus Saline Solution.
Therefore, the acceptance criteria and supporting studies are related to proving the safety and effectiveness of this modified regimen, not a new device.
Here's a breakdown of the requested information based on the provided text, noting where information is not applicable or explicitly stated for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for the modified regimen) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Microbiology - Antimicrobial Preservative Efficacy (for discard dating): Meet requirements of ISO 14730, Annex C. | Both Boston Original Cleaner and Boston Original Conditioning Solutions (test articles) met the requirements of ISO 14730, Annex C for antimicrobial preservative efficacy testing and guidance on determining discard date, initially and after simulated use for the proposed 90-day discard dates. |
| Microbiology - Regimen Evaluation: Meet FDA performance criteria for regimen evaluation as described in the May 1, 1997 Guidance for Industry, Pre-market Notification (510(k)) Guidance Document for Contact Lens Care Products, when used in a 10-second rub, 5-second rinse (per lens side) regimen. Also meet ISO Standard 14729:2001/Amd. 1:2010 (E) for regimen testing. | The modified regimen (replacing tap water with Sensitive Eyes Plus Saline Solution) met the FDA performance criteria for regimen evaluation as described in the May 1, 1997 Guidance. The products used in this regimen also met the performance criteria established in ISO Standard 14729:2001/Amd. 1:2010 (E) for regimen testing. (Note: Regimen testing was previously reviewed as part of K170483 for Sensitive Eyes Plus Saline Solution.) |
| Biocompatibility: (Implied need to ensure continued biocompatibility of the lens care system) | Biocompatibility tests were deemed "unnecessary for this application" as previous data submitted for K980133 (Boston Original Conditioning Solutions) and P820069 (Boston Original Cleaner) were still applicable. This indicates that the predicate device's biocompatibility was accepted as sufficient for the modified regimen. |
| Lens Compatibility: Ensure the modified regimen is compatible with gas permeable contact lenses. | The results of lens compatibility studies per ISO 11981 demonstrate that replacing water with Bausch + Lomb Sensitive Eyes Plus Saline Solution as part of the regimen is compatible with gas permeable contact lenses. |
| Clinical Data: (Implied need to ensure the modified regimen is safe and effective in vivo) | Clinical studies were "unnecessary for this application." The submission states, "This Cleaner - Conditioning System has been commercially available in the market for almost 20 years with well demonstrated safety and efficacy." This implies that extensive real-world usage of the existing products, coupled with the lab testing on the modified regimen, was sufficient to demonstrate substantial equivalence without new human clinical trials for this specific change. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the individual microbiological and lens compatibility test sets. It refers generally to "studies" and "results."
- Data Provenance: The studies were preclinical (laboratory testing). The specific country of origin for the lab work is not stated, but given it's a US FDA submission for a US-based company, it's likely conducted in the US or by a contracted lab. The studies are prospective for the modified regimen comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable in the context of this submission. The "ground truth" for these types of tests (microbiology, lens compatibility) is established by adherence to specific, validated international standards (ISO standards) and FDA guidance documents. There isn't a need for expert consensus on individual results in the way there would be for, say, image interpretation in a diagnostic AI device.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus "ground truth." For laboratory tests like those described, the results are quantitative and objective, measured against predefined acceptance criteria from standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human readers (e.g., AI for medical imaging). The submission addresses chemical solutions and their compatibility/efficacy, which are not evaluated through MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the submission is not for an AI/algorithm-based device. The "device" here refers to contact lens cleaning and conditioning solutions.
7. The Type of Ground Truth Used
The "ground truth" for the performance of these solutions is established through:
- Adherence to International Standards (ISO): Specifically ISO 14730 (Antimicrobial preservative efficacy), ISO 14729 (Regimen testing), and ISO 11981 (Lens compatibility).
- Adherence to FDA Guidance Documents: "Pre-market Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997."
- Validated Laboratory Methods: Results are compared against specific quantitative thresholds defined by these standards and guidance.
- Historical Data: The "almost 20 years" of commercial availability of the existing products with "well demonstrated safety and efficacy" serves as substantial baseline "ground truth" for the system as a whole, negating the need for new clinical trials for a modified rinse step.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set."
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(48 days)
MRC
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (active ingredient, sodium hypochlorite) and Progent B (active ingredient, potassium bromide). Progent A and B are mixed in a Progent Vial. Menicon Rinse solution is used once the lens soaking cycle is complete. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eye care professional's directions (to a maximum of every 5 days).
The provided text describes a 510(k) premarket notification for the "Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses." However, it explicitly states that no new clinical or non-clinical studies were performed for this particular submission (K173136).
The device's clearance is based on its prior approvals and the fact that there are no product formulation changes. Therefore, the device's acceptance criteria and the study that proves it meets those criteria are established through substantial equivalence to predicate devices (Boston Cleaner and Boston Advance Cleaner) based on historical data, not new studies presented within this document.
As such, I cannot provide a table of acceptance criteria and reported device performance from a new study conducted for this 510(k) submission, nor can I detail sample sizes, expert qualifications, or adjudication methods for studies not conducted as part of this submission. The document explicitly states:
- "Non-clinical studies were unnecessary for this application. Menicon Progent Protein Remover has been cleared in prior applications. There are no product formulation changes made in this application therefor no non-clinical studies were required." (Page 4)
- "Clinical studies were unnecessary for this application. Menicon Progent Protein Remover has been cleared in prior applications. There are no product formulation changes made in this application therefor no clinical studies were required." (Page 4)
The "Conclusion" section on page 4 further reinforces this by stating: "Based upon the product history and data presented, the Menicon Progent Protein Remover can be used as safely and as effectively as the Boston Cleaner and the Boston Advance Cleaner."
Therefore, the requested information points regarding new studies (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to the immediate content of this 510(k) summary as no such new studies were performed. The acceptance criteria essentially stem from the historical performance and regulatory compliance of the predicate devices and the Menicon Progent Protein Remover's prior clearances.
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(100 days)
MRC
Menicon Unique pH Multi-Purpose Solution is indicated for the cleaning, rinsing, disinfection and conditioning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses.
Menicon Unique pH Multi-Purpose Solution is a sterile, buffered aqueous solution. It contains hydroxypropyl guar, polyethylene glycol, poloxamine, boric acid, propylene glycol, and is preserve with polyquaternium-1 0.0011%, and edetate disodium 0.01%.
The provided text describes the 510(k) submission for the "Menicon Unique pH Multi-Purpose Solution for Rigid Gas Permeable Contact Lenses." However, it is not a study of a device that uses AI or machine learning. This submission relies on demonstrating substantial equivalence to a predicate device (Alcon RGP Multi-Purpose Solution ID 100136, K000148) by confirming that the new device has:
- The same formulation, ingredients, and intended use.
- Equivalence in chemical composition to the predicate device.
- Satisfactory biocompatibility and shelf-life stability.
Therefore, most of the requested information regarding AI/ML studies, such as sample sizes for test/training sets, expert consensus, MRMC studies, or standalone performance, are not applicable to this document. The "Performance Data" section explicitly states that "there were no additional clinical studies required to establish the safety and efficacy of the new device" due to its equivalence to the previously cleared predicate.
However, I can extract the acceptance criteria and performance data as presented for the non-clinical aspects and the general claim of equivalence.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Chemical Composition: Equivalent to predicate device. | Chemical analysis of the Japanese product confirmed equivalence to the product manufactured by Alcon (the predicate device). The composition listed for the new device is identical to the predicate device. |
| Biocompatibility: Components meet ISO 10993 standard. | "Components used in this product have been evaluated in accordance with Part 10993 of the ISO standard for Biological Evaluation. Test results indicate the test articles meet the ISO standard." (This was done for the predicate and confirmed for the new device's container). |
| Shelf-life Stability: Satisfactory. | "Shelf life stability tests" were conducted on the new device (implicitly found satisfactory, as substantial equivalence was determined). |
| Safety and Efficacy: As safe and effective as the predicate. | "Based upon the test data presented, the Menicon Unique pH Multi-Purpose Solution for Rigid Gas Permeable Contact Lenses is as safe, as effective and performs as well as the predicate device." This is based on the new device having the "same formulation, are manufactured by equivalent manufacturing processes and meet the same product release specifications" as the predicate device. |
| Intended Use: Identical to predicate device. | The "Indications for Use" for the new device are word-for-word identical to those of the predicate device. |
Explanation: The "acceptance criteria" here are that the new device must be substantially equivalent to the predicate device across key characteristics. The "reported device performance" is the evidence presented to show this equivalence.
Non-Applicable Information for this type of Submission:
The following information is not present in the provided document because the submission relies on demonstrating substantial equivalence to an existing device rather than presenting a novel AI/ML device study:
- Sample size used for the test set and the data provenance: Not applicable as no new clinical study was conducted for this device. The non-clinical testing was comparative/confirmatory.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the context of an AI/ML study. The "ground truth" for this submission is the established safety and efficacy of the predicate device.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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(156 days)
MRC
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (active ingredient, sodium hypochlorite) and Progent B (active ingredient, potassium bromide). Progent A and B are mixed in a Menicon SP Vial. Allow lenses to soak in the Progent solution mixture for 30 minutes. Soaking for longer than 30 minutes is not recommended. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eye care professional's directions (to a maximum of every 5 days).
The provided 510(k) summary for K122273 describes the Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses. This submission focuses on the equivalence of an alternative rinsing solution (sterile normal saline) to a previously cleared one (sterile purified water) and an alternative manufacturing site. Therefore, the study described is a non-clinical equivalence study rather than a study typically seen for novel diagnostic devices.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Rinsing effectiveness of sterile normal saline (based on active chlorine concentrations and pH values) is equivalent to sterile purified water. | "A comparison of the two sets of data was completed and based on active chlorine concentrations and pH values it was confirmed that the rinsing efficacy of sterile normal saline was equal to the rinsing efficacy of the sterile purified water." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size (e.g., number of lenses or test runs) used for the "Residual Progent Testing." It only mentions that the test was "repeated with sterile normal saline."
- Data Provenance: The study was conducted by Menicon Co., Ltd. (Japan) as part of their 510(k) application. It is a non-clinical, bench-top study rather than a study involving human subjects or real-world data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve human experts establishing ground truth in the traditional sense of medical image analysis or diagnostic studies. The "ground truth" here is objective chemical measurement in vitro.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical, objective measurement study, not one requiring adjudication by human observers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This was a non-clinical bench study comparing rinsing efficacy of two solutions, not a study involving human readers or comparative effectiveness in a clinical setting.
6. If a Standalone Performance Study Was Done
Yes, in a sense. The "Residual Progent Testing" was done to evaluate the performance of the rinsing solutions in a controlled environment, independently measuring residual active chlorine concentration and pH. However, it's not a "standalone algorithm performance" in the context of AI/diagnostic devices, but rather a standalone test of a specific device function. The purpose was to show equivalence to a previously cleared product, so the performance was evaluated relative to the predicate.
7. The Type of Ground Truth Used
The ground truth was established by objective chemical measurements of active chlorine concentration and pH values in the rinsing solutions. This is an in vitro measurement, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is a non-clinical, bench-top study comparing two rinsing solutions. There is no machine learning component and therefore no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied.
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