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P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) for daily wear are spherical lenses indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia ranging from -0.00 diopters to -10.00 diopters.

The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. The lenses are intended for daily wear and are to be replaced every three months (quarterly). When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

The P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in 0.9% saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).

The P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is available clear or tinted for visibility using phthalocyanine blue, tinted in unique pattern to enhance or alter the apparent color of the eye. Each unique patterns may be distributed under unique or "private label" trade names. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: C.I Reactive Black 5, Titanium Dioxide (TiO2), Carbazole Violet (i.e.,C.I Pigment Violet 23), Phthalocyanine green (i.e.,C.I PIgment Green 7), D&C Yellow No. 10, D&C Red No. 17, [Phthalocyaninato (2-)] Copper (i.e.,C.I PIgment Blue 15).

When producing the color lenses, the manufacturing process changes the specifications of the clear lens by pad-printing the color pigment(s)—entrapping the colorants in the interpenetrating network of the contact lens material—in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the clear, pre-tinted lens.

Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

The provided FDA 510(k) clearance letter and associated documentation for the P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) primarily focus on demonstrating substantial equivalence to a predicate device based on bench testing. This type of submission relies on comparing physical, chemical, and design characteristics, along with performance against established standards, rather than extensive clinical studies or AI algorithm performance.

Therefore, many of the typical acceptance criteria and study details relevant to AI/ML medical devices (such as MRMC studies, expert consensus for ground truth on a large test set, etc.) are not explicitly present or applicable in this regulatory context.

However, based on the provided text, I can infer and extract the acceptance criteria and the type of study conducted to prove the device meets these criteria in the context of a 510(k) for contact lenses.

Here's the breakdown:

Acceptance Criteria and Device Performance (P-CON Contact Lenses)

The acceptance criteria for this device are established by demonstrating that its physicochemical, mechanical, and biocompatibility properties are substantially equivalent to a legally marketed predicate device (K221517) and that it complies with relevant ISO standards and FDA guidance for soft contact lenses.

Table 1: Acceptance Criteria and Reported Device Performance

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"CAREUS Contact Lens Case" is a device intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.

"CAREUS Contact Lens Case" is a medical device for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lid. The case body is based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing. "CAREUS Contact Lens Cases" have six different models, differ in dimension, case color, and packaging. The exterior of the cases total have 9 colors: white, pink, yellow, green, light green, red, purple, blue, and transparent (no color). Contact lenses can be fully immersed into the well from both models accommodates all lenses currently being sold in the market. The bottom of each well is marked with L (left) or R (right). CAREUS Contact Lens Cases are made of polypropylene.

The provided document is a 510(k) Summary for the "CAREUS Contact Lens Case." It describes a medical device, not a device that relies on algorithms for its function. Therefore, most of the requested information regarding acceptance criteria, study details, and AI/algorithm-related aspects is not applicable to this submission.

Here is the information that can be extracted from the document:

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

The document broadly states that "All tests were verified to meet acceptance criteria" for bench testing and biocompatibility. However, it does not provide specific numerical acceptance criteria or detailed reported performance figures for the physical and chemical specifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the sample sizes for the bench testing or biocompatibility tests. It only states that testing was performed. The manufacturing country of origin for the device is China (Shanghai Care Us Medical Product Co., Ltd., Shanghai, China). The testing itself is not explicitly stated as retrospective or prospective, but bench and biocompatibility testing are generally prospective in nature for a new device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This device is a physical contact lens case and does not involve expert interpretation or ground truth establishment in the context of diagnostic accuracy, as would be relevant for an AI/algorithm-based device.

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

Not applicable. This concept applies to studies where expert interpretation is being evaluated, which is not the case for a contact lens storage device.

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 device does not involve human readers or AI assistance.

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

Not applicable. This device does not have an algorithm.

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

For the bench testing, the "ground truth" would be the predetermined physical and chemical specifications. For biocompatibility, the "ground truth" is adherence to the standards defined by ISO 10993. These do not fall into the categories of expert consensus, pathology, or outcomes data in the usual sense.

8. The sample size for the training set:

Not applicable. This device is not an algorithm and does not have a training set.

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

Not applicable. This device is not an algorithm and does not have a training set.

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Phoenix Contact Lens Case is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical disinfection.

There are three models of the Phoenix Contact Lens Case:
CL-01 "Dome Top Flat Pack" - made with LDPE and has 1.5ml wells on each side
CL-02 "Classic Flat Pack" - made with LDPE and has 1.5 ml wells on each side
CL-03 "Sunglass Shape Flat Pack" made with Polypropylene and has 2.0 ml wells on each side
All three models have hinged self sealing caps and are available in white, black, blue, orange, green, and natural.
The Phoenix contact lens cases are intended for storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. It is not to be used with heat disinfection.

The provided document is a 510(k) premarket notification for Phoenix Contact Lens Cases (CL-01, CL-02, CL-03). It outlines the device's substantial equivalence to legally marketed predicate devices.

Based on the provided text, the device in question is a contact lens case, not an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving the performance of AI/ML medical devices, is not applicable to this submission.

The document details non-clinical tests performed on the contact lens cases to demonstrate their substantial equivalence. These tests primarily focus on the biocompatibility and safety of the materials used in the contact lens cases, not on the performance of a diagnostic or therapeutic algorithm.

Here's a summary of the non-clinical tests and their conclusions, which serve as the "acceptance criteria" and "device performance" for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The following numbered points are not applicable to this device, as it is a physical contact lens case and not an AI/ML software device.

2. Sample sizes used for the test set and the data provenance: Not applicable. The tests involved in vitro cell cultures and in vivo animal models, with sample sizes determined by the respective ISO standards and USP guidelines for biocompatibility testing (e.g., specific numbers of cells, guinea pigs, rabbits, or mice as per the standard). The provenance is "laboratory testing conditions" and "experimental conditions." These are typically prospective in nature.
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 these tests is based on objective biological responses measured in a laboratory setting per standardized protocols, not human expert consensus on images or clinical data.
4. Adjudication method for the test set: Not applicable. The tests evaluate direct biological and material responses, not subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This study type is for AI/ML diagnostic performance, not for a physical medical device like a contact lens case.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI/ML algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. The "ground truth" for these biocompatibility tests is the presence or absence of a specific biological or toxicological reaction as defined by the international standards (e.g., cell viability, skin erythema/edema, systemic toxicity, fever induction, ocular irritation).
8. The sample size for the training set: Not applicable. This document describes pre-market testing for a physical device, not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established: Not applicable.

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For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered 3% hydrogen peroxide contact lens solution.

The device is a specialized lens case consisting of a transparent cup with a connected unit of screw cap, lens holders (baskets) and platinum-coated neutralization disc. The platinum catalyst coating and shape of the plastic disc are designed to effectively neutralize hydrogen peroxide in the lens care system to harmless water and oxygen gas.

The provided text describes a 510(k) premarket notification for a medical device called "Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc." This submission is for a modification to an existing device, specifically a change in the silicone material of a gasket and its coating within the lens case.

The document does not contain the kind of detailed acceptance criteria and study information typically associated with AI/ML-based medical devices or diagnostic tools. Instead, it focuses on the safety and efficacy of a contact lens care product and its components. Therefore, many of the requested fields related to AI/ML study design will not be applicable.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

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

• No negative effect on functionality characteristics of the gasket in the lens case assembly.
  (Implicitly, the criteria would be acceptable adhesion and no degradation of the gasket's designed function). | "Design functionality tests were conducted to confirm that the coating adheres reliably to the silicone material and does not affect negatively any functionality characteristics of the gasket in the lens case assembly." (Implicitly successful, as the conclusion states substantial equivalence and safety.) |
  | Overall Safety & Efficacy| The modified device must be "substantially equivalent" to predicate devices, ensuring continued safety and efficacy for its intended use (storage of soft and RGP contact lenses during disinfection with 3% hydrogen peroxide solution). The modifications should not change the indications for use or the basic technical principle of the device. | "Successful results of all nonclinical testing supported the substantial equivalence and therefore safety and efficacy of the modified AOCup Lens Case with AODisc to the existing product for its intended use." (Met) |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the tests conducted (biocompatibility, physicochemical, and design functionality). It also does not provide details on data provenance beyond indicating the submitter (Alcon Laboratories, Inc., USA, with a contact in Germany) and the FDA's review process. These types of tests are typically bench tests or laboratory assessments of materials, not clinical studies with human subjects or retrospective/prospective data collection in the sense of an AI/ML diagnostic.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to the scope of this regulatory submission. The "ground truth" here is established by adherence to recognized international standards (ISO, USP, EP) and internal engineering design specifications for material properties and device function. There were no human experts establishing a "ground truth" for a diagnostic outcome.

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

Not applicable. The tests described are laboratory and bench tests, not assessments requiring human adjudication of diagnostic outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device or a diagnostic tool involving human readers.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" or reference standards used are:

• International Standards: Subparts of ISO 10993 (for biocompatibility).
• Pharmacopeia Standards: USP (United States Pharmacopeia) and EP (European Pharmacopoeia) requirements (for extractable and leachable testing).
• Engineering Design Specifications: Related to coating adhesion and overall functionality of the gasket within the lens case.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and does not involve a "training set."

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

Not applicable. This is not an AI/ML device and does not involve a "training set."

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For storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection. Use for storage during chemical disinfection only. Do not use during heat disinfection.

The Contact Lens Case is a lens case product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic), hard and rigid gas permeable contact lenses during chemical disinfection. The Case is to be designed during chemical disinfection only. No designed for heat disinfecting system.

The Contact Lens Case includes A-1 and B-1 two models. Both have adopted the same structure design, consisting of two parts: holder and cover. The holder is based with adjoining dual wells for the containment of fluid, and two covers are designed for screwing. At the same time, the bottom of each well is marked with L (left) and R (right) letters, and the covers are also labeled with L (left) and R (right) letters.

The Contact Lens Case is simple with a well volume of 4.2mL ±0.15. This volume capacity can provide sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately over the lenses for cleaning.

The provided document describes a 510(k) premarket notification for a Contact Lens Case, Model: A-1, B-1. The primary focus of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing novel safety and effectiveness through extensive clinical trials for a new medical device. Therefore, the information regarding acceptance criteria and studies will be different from what might be found for a device requiring more comprehensive performance validation (e.g., AI algorithms or complex medical devices).

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on demonstrating equivalence in product design, material biocompatibility, and functional performance (leakage) to existing, approved predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Study Details

Given the nature of a 510(k) for a contact lens case, the "study" is primarily a set of non-clinical tests to demonstrate safety and performance equivalence.

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

• Biocompatibility Testing: The specific sample sizes for each individual biocompatibility test (cytotoxicity, sensitization, ocular irritation, systemic toxicity) are not explicitly stated in the provided text. These tests are typically performed on extracts from a representative number of device components or material samples under controlled laboratory conditions, not on a "test set" in the sense of clinical cases.
• Leakage Testing:
  • Sample Size: 120 combinations of different tops and bottoms.
  • Data Provenance: Not explicitly stated but implied to be conducted by the manufacturer or a contracted testing lab as part of the device's validation.

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

• This information is not applicable or not provided for this type of device and submission. "Ground truth" established by experts is typically relevant for diagnostic devices or AI algorithms where human interpretation is being evaluated or augmented. For a contact lens case, the "ground truth" for performance is defined by adherence to physical and biological testing standards.

3. Adjudication method for the test set:

• This information is not applicable or not provided. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations of data, usually in diagnostic imaging or clinical trials. For a non-clinical device like a contact lens case, the test results are usually measured objectively against predefined pass/fail criteria.

4. 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 type of study is relevant for AI-powered diagnostic devices involving human readers. The contact lens case is a physical medical device, not an AI diagnostic tool.

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

• No, a standalone algorithm performance study was not done. This device does not involve an algorithm.

6. The type of ground truth used:

• The "ground truth" for this device's performance is established by objective measurements against recognized international standards and specifications:
  • Biocompatibility: Adherence to ISO 10993 standards for cytotoxicity, sensitization, ocular irritation, and systemic toxicity.
  • Leakage: Absence of visible liquid escape under specified test conditions.
  • Volume/Effectiveness: Physical measurement of fluid capacity compared to the functional requirement (sufficient immersion) and predicate devices.

7. The sample size for the training set:

• Not applicable / Not provided. This device is not an AI algorithm that requires a "training set." The testing performed (biocompatibility, leakage) is for validation against established standards.

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

• Not applicable / Not provided. As there is no "training set" for an AI algorithm, this question is irrelevant to this device submission.

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

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

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

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

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

Here's a summary of the available information:

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

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

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

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

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

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

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

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI/algorithm-based device and no MRMC study was conducted. The document explicitly states: "Clinical studies involving the Bausch + Lomb Boston® Scleral Lens Case were unnecessary for this application."

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

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

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

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

8. The sample size for the training set:

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

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

• Not applicable. No training set was used.

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The Contact Lens Case is a device intended for storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.

The Contact lens case is medical device for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lids. The case body based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing. All the four variant models of this device have a capacity of 5.3 ml to allow contact lenses fully immersed into the well, and the well from these models accommodates all lenses currently being sold in the market. In addition, the contact lens case are made of polypropylene (96%) and Polyethylene (4%), which allow the same design principle with the same intended use. Speaking of the labeling, the inner lids of the case are marked with L (left) or R (right), meanwhile the bottom of each well is also labeled with L (left) or R (right) to distinguish the left and right lenses. In addition, at the bottom of the case body, two sides of which have labeled REPLACE MONTHLY respectively to remind user to replace the contact lens case at least once every month.

The provided document is a 510(k) premarket notification for a contact lens case, not an AI/ML medical device. Therefore, it does not contain the information requested regarding acceptance criteria, performance studies (like MRMC or standalone), ground truth establishment, or sample sizes related to AI/ML model development and validation.

The document focuses on demonstrating substantial equivalence to a predicate device by comparing:

• Intended Use: Both the proposed and predicate devices are for storing soft, rigid gas permeable, and/or hard contact lenses for chemical disinfection only, not heat disinfection.
• Design: Both have two adjoining wells with screw-down lids.
• Materials: While different (Polypropylene/Polyethylene vs. ABS), the proposed device's materials were tested for biocompatibility (cytotoxicity, irritation, systemic toxicity) and passed.
• Performance: Non-clinical tests were conducted for leakage and color fastness.

Since the request is specifically about AI/ML device validation, and this document is for a physical contact lens case, I cannot extract the requested information.

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The CONTACT LENS CASE ROUND GLASSES is intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.

The Contact Lens Case Round Glasses is leak-proof and made from durable plastic with secure, snap lids. Note: can be used with hard and soft contact lenses; for chemical disinfection only; rinse case thoroughly before initial use; replace contact case every 2 months. The secure snap lids are connected to the body by stainless steel hinges and securely close by use of the silicon seal within the plastic Each compartment has a capacity of 4,4ml and diameter of 26,5mm and an overall dimension of 76mm x 29mm x 17mm The Case body is in White Color and the Lids in Black Color with transparent windows. Contact lenses can be fully immersed in each compartment, and each compartment fit all standard lenses currently being sold in the market. The side of each compartment is marked with L (left) or R (right)

The document describes a contact lens case, not an AI device, so many of the requested criteria related to AI performance, such as MRMC studies, ground truth establishment, or training set size, are not applicable.

However, based on the provided text, I can extract the relevant information regarding the acceptance criteria and the study performed for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Anti-Leakage Test: 48 products (units of Contact Lens Case Round Glasses) were used. The provenance is internal testing performed by the manufacturer, FiftyTwoWavs Ltd, presumably in Hong Kong S.A.R. (based on their address). This appears to be a prospective test as it was performed on units of their product.
• Biocompatibility Tests (Cytotoxicity, Eye Irritation, Systemic Toxicity): The document states "All results show that the material is not cytotoxic, causes no eye irritation and has no systematic cytotoxic." However, it does not explicitly state the number of samples or the specific methodology/sample size used for these biocompatibility tests (ISO-10993-5, ISO 10993-10, ISO-10993-11). The results were submitted in the application.

3. Number of Experts and Qualifications

Not applicable for tests described (leakage, biocompatibility). These are laboratory/engineering tests, not expert-adjudicated clinical assessments.

4. Adjudication Method for Test Set

Not applicable. The tests performed are objective physical/chemical assessments (e.g., visual inspection for leakage, lab assays for biocompatibility).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a contact lens case, not an AI-assisted diagnostic or treatment device. No MRMC study was performed or is relevant. The submission explicitly states: "No Clinical Test Were Performed."

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical product (contact lens case), not an algorithm or software.

7. Type of Ground Truth Used

• Anti-Leakage: Empirical observation (visual inspection for liquid leakage).
• Biocompatibility: Established ISO standards (ISO-10993-5, ISO 10993-10, ISO-10993-11) for evaluating material safety. The "ground truth" is defined by the passing criteria of these standardized tests.

8. Sample Size for Training Set

Not applicable. This device is a physical product and does not involve AI/machine learning, therefore no training set is relevant.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for this device.

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For storage of soft (hydrophilic), hard and rigid gas permeable contact lenses during chemical disinfection. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT.

The Contact Lens Case is a simple device made with a polypropylene base and a polyethylene lid to store soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. This device is manufactured only for chemical disinfections with approved chemical cleaning agents to clean contact lenses.

The physical style is simple with a base volume of 4.8 milliliter and dimensions of 6.25 mm wide and 9.25 mm high. This provides sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately cover the lenses for cleaning.

The provided text is related to a 510(k) premarket notification for a Contact Lens Case. It outlines the device description, indications for use, and a summary of testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria and detailed study that proves the device meets those criteria, as typically seen for AI-based medical devices.

The information provided describes a physical medical device (contact lens case), not an AI or algorithm-based device. Therefore, the questions related to AI performance metrics (like sample sizes for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and effect size improvements) are not applicable to this document. The provided text details testing for biocompatibility and leakage, which are relevant for a physical contact lens case.

Here's an attempt to answer the questions based only on the provided text, recognizing the mismatch with typical AI/algorithmic device data:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility Testing: The text mentions "L929 mouse fibroblast cells" for cytotoxicity, "guinea pig" for skin sensitization, and "mouse" for systemic toxicity. The specific number of cells or animals used as a "sample size" is not provided.
• Leakage Testing: 240 combinations of different tops and bottoms were tested.
• Data Provenance: Not explicitly stated, but the tests were conducted according to ISO standards, implying laboratory testing. The manufacturing company is in China, so it's likely the testing was conducted there or by a certified lab. The data is prospective in the sense that the manufacturer conducted these tests specifically for this 510(k) submission.

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

• This question is not applicable. The "ground truth" for these tests (cytotoxicity, irritation, systemic toxicity, leakage) is objective biological responses or physical observation, not expert interpretation of medical images or data.

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

• This question is not applicable. Adjudication methods are typically used for subjective assessments where multiple experts might disagree (e.g., classifying medical images). The tests performed are objective laboratory and physical tests.

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 device is a physical contact lens case, not an AI or algorithmic device.

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

• Not applicable. This device is a physical contact lens case, not an AI or algorithmic device.

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

• The "ground truth" for the biocompatibility tests involved observable biological responses in cells and animals (e.g., cell viability, irritation scores, systemic effects). For leakage testing, the ground truth was the observable absence or presence of liquid leakage.

8. The sample size for the training set

• Not applicable. This device is a physical contact lens case, not an AI or algorithmic device that requires a training set.

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

• Not applicable. This device is a physical contact lens case, not an AI or algorithmic device that requires a training set.

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Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic) contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection.

Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft(hydrophilic) contact lenses while not being worn. This device is not sterile and not for heat-disinfection. Use only with chemical disinfection.

There are two main series includes the variant model DC-2001, DC-3001 and DC-6001, the other includes DC-7001 and DC-8001. All these five variant models are made of Polypropylene, which follow the same design principle with the same intended use.

All the five variant models of this device have a capacity of over 1.5 ml in each case well. And the inner height of the all wells exceeds 8.5 mm. With regard to the Center Thickness of the normal hydrophilic and hydrophobic contact lens will not outnumber 8.5 mm, the capacity is sufficient for contact lens to be fully immersed under use condition.

This document is a 510(k) premarket notification for a Contact Lens Case. It does not describe a study that uses a machine learning algorithm or AI. Therefore, I cannot provide the requested information about acceptance criteria for an AI device.

The document primarily focuses on establishing substantial equivalence to a predicate device (K071081) for a physical product (contact lens case). The "tests" mentioned are non-clinical leakage testing and biological evaluation for safety.

Here's a breakdown of why the requested information cannot be extracted:

• No AI/Machine Learning Device: The device in question is a "Contact Lens Case," a physical product for storing contact lenses. There is no mention of any AI or machine learning component.
• No Acceptance Criteria for AI Performance: Since it's a physical product, the acceptance criteria are related to its physical properties, safety, and functionality (e.g., lack of leakage, biocompatibility, sufficient capacity for lenses), not performance metrics like sensitivity, specificity, or AUC for an AI algorithm.
• No Study for AI Performance: The document explicitly states, "The subject of this premarket submission, Contact lens case did not require clinical studies to support substantial equivalence." The "Summary of Non-Clinical Leakage Testing" is a performance test for the physical case, not an AI study.
• No Ground Truth, Training Set, Experts, etc.: These concepts are relevant to AI/machine learning studies, not to the approval process for a simple medical device like a contact lens case.

Therefore, I cannot populate the table or answer the specific questions related to AI studies.

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