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

The contact lens cases in submission are intended to be used to store soft (hydrophilic) and hard contact lenses during chemical disinfection only. These are not to be used in heat disinfection.

There are 2 parts to each contact lens case, the main body/base with two wells, and two screw-on lids. In order to store contact lenses with disinfection solution, the wells for storage need to be leak-proof, which is designed so by the screw construction of the lids.

The plastic that is used in all four contact lens cases is Acrylonitrile Butadene Styrene (Product Name: Polylac ® PA-707, manufactured by Chi Mei Corporation, please refer MSDS attached: Attachment 1), which is a durable plastic that is insoluble in water and can be used for at least two months continuous use.

The cat contact lens case is black, with white printed on the lids. The color pigment used in the case is PLASBLAK® UN2014 (Supplier: Cabot Plastics, please refer MSDS attached: Attachment 2). This pigment is insoluble in water.

The sunglasses contact lens case is white, with black labels on the lids. The color pigment used in the case is DuPont™ Titanium Dioxide Pigment - Plastics Grade/Type : R-350 (Supplier: DuPont, please refer MSDS attached: Attachment 3). This pigment is insoluble in water.

The 1st contact lens case is green, with clear uncolored lids. There are 2 color pigments used in the green body (1) PV Fast Green GNX (Supplier: Clariant Chemicals (India) Limited, please refer MSDS attached: Attachment 4) and (2) MACROLEX Yellow G Granulate (Supplier: Bayer AG, please refer MSDS attached: Attachment 5). These pigments are insoluble in water.

The Geeky eyes contact lens case is red with black glasses. The color pigment used in the red case is 13575 Orange Color Powder (Supplier: Summit Color Co., Ltd., please refer MSDS attached: Attachment 6). This pigment is insoluble in water.

The individual well capacity of each contact lens are: cat contact lens case 2.8ml, sunglasses contact lens case 2.5ml, 1* contact lens case 3ml, geeky eyes contact lens case 2.8ml. The capacities aforementioned are sufficient for a contact lens to be fully soaked in the disinfection liquid.

At the base of the cat contact lens case and the sunglasses contact lens case, in each well there is L and R embossed to help users differentiate the left and right lenses. The geeky eyes contact lens case also has the L and R markings on the side of the casing outer. The 1d contact lens case does not have L and R markings on it as the two wells are situated one above and one below the disc so it is unlikely to mix up the two wells during use.

Through use, the material of the contact lens case may come into contact with the user's eyes indirectly. The user will need to put contact lenses with chemical disinfecting liquid into the contact lens case for storage. Therefore we have used a plastic material and colorants that are insoluble in water so that it will not come in contact with one's eyes.

These contact lens cases are intended for the storage of soft (hydrophilic) and hard contact lenses. The case should ensure the fluids contained do not leak. These cases are for the storage of chemical disinfecting fluids with contact lenses only, they are not to be used in heat disinfection. These are not sold sterile, so the packaging should have instructions written on them to "Rinse the case thoroughly with clean solution before use".

It is recommended to replace the contact lens case at least every 3 months.

This document describes the premarket notification (510(k)) for several contact lens cases. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and MRMC studies is not directly applicable or available in this document.

However, I can extract the relevant information and indicate where data is not provided for questions that are typically relevant to AI/diagnostic device submissions.

The Device:

Ni Hau Industrial Co., Ltd. Contact Lens Cases (Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eyes Contact Lens Case)

Acceptance Criteria and Reported Device Performance

The document doesn't define quantitative acceptance criteria in terms of metrics like sensitivity, specificity, accuracy, or other performance characteristics typically associated with AI or diagnostic devices. Instead, the acceptance criteria are based on demonstrating substantial equivalence to a legally marketed predicate device by fulfilling manufacturing, material, and functional requirements.

The "reported device performance" is implicitly that the device meets the same safety and performance characteristics as the predicate device. The comparison focuses on physical properties, intended use, and biocompatibility.

Study Information

The document describes a submission for substantial equivalence based on a comparison to a predicate device, not a de novo study demonstrating the clinical performance of a diagnostic or AI device. Therefore, many of the typical study parameters for such devices are not applicable.

1. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance or algorithm output. The "test set" would implicitly refer to the contact lens case prototypes themselves. The provenance of the materials (ABS plastic, pigments) is provided by manufacturer and product name (e.g., Chi Mei Corporation, Cabot Plastics, DuPont), and the manufacturing location is Taiwan.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic output is not established here. Compliance with international standards (e.g., ISO 10993 for biocompatibility) is used as evidence of safety, which would be evaluated by qualified testing laboratories.

3. Adjudication method for the test set: Not applicable. No diagnostic outputs to adjudicate.

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: Not applicable. This is not an AI device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is compliance with established device safety and manufacturing standards, and demonstrated equivalence to a legally marketed predicate device. This includes:

   • Material specifications (e.g., ABS composition, insolubility of pigments).
   • Physical design specifications (e.g., screw lids for leak-proofing, well capacity).
   • Biocompatibility test results (passing ISO 10993-5, 10993-10, 10993-11). These lab tests provide objective data as "ground truth" for the material's biological safety.

7. The sample size for the training set: Not applicable. This is not an AI device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered, saline, 3% hydrogen peroxide contact lens solution. Not to be used with multi-purpose (chemical) disinfection, heat disinfection or saline solutions.

The iCase is a personal contact lens case used with one step hydrogen peroxide (H2O2) lens disinfecting/cleaning solutions. The iCase monitors the initial rate of neutralization of hydrogen peroxide (H2O2) and indicates the status of the disinfection cycle using the LED display in the cap. The iCase LED display and monitoring system are disabled after 65 cycles of use to promote routine lens case replacement.

This document is a 510(k) summary for the NovaBay Pharmaceuticals, Inc. iCase Contact Lens Case. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.

Based on the provided text, the device is an iCase Contact Lens Case. The "acceptance criteria" discussed are primarily related to safety, functionality, and meeting regulatory standards for medical devices, rather than a quantifiable performance metric for an AI or imaging device.

Here's an attempt to extract and format the requested information, acknowledging that many fields will be "Not Applicable" (N/A) due to the nature of this submission (a medical device accessory designed for safety and usability, not an AI or diagnostic tool):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not explicitly stated in terms of number of devices tested for each criterion. The evaluation appears to be based on engineering tests, risk analyses, and compliance with standards rather than a statistical "test set" of consumer usage or adverse events.
• Data Provenance: The studies mentioned (Biocompatibility, Electrical Safety, Software Validation, Cycling studies, Peroxide Degradation measurements, Risk Analysis, Device Hazard Analysis, Corrosion testing) were conducted by NovaBay Pharmaceuticals, Inc. (the applicant). The country of origin of the data is not specified beyond being generated by the applicant for FDA submission. It is retrospective data collected to support the premarket notification.

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

• Number of Experts: N/A. This device is not an AI/diagnostic tool requiring expert-established ground truth for performance evaluation in a clinical sense. The "ground truth" here is adherence to engineering standards, safety requirements, and functional specifications established through recognized testing methods.
• Qualifications of Experts: N/A for the same reason. The expertise lies within the engineering, regulatory, and quality teams involved in designing, testing, and submitting the device.

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

• Adjudication Method: N/A. Not applicable to engineering and regulatory compliance testing.

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

• MRMC Study: No. This is a contact lens case, not an imaging or diagnostic device that would involve human readers or AI assistance.

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

• Standalone Performance: N/A. While the iCase has integrated electrical components and software to monitor peroxide neutralization and indicate cycle status, it's a functional device, not an "algorithm" in the sense of an AI model being evaluated for standalone performance. Its performance is intrinsically linked to the chemical process it monitors and its physical design.

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

• Type of Ground Truth: For this device, the "ground truth" is defined by:
  • Regulatory Standards: ISO biocompatibility standards, IEC electrical safety standards, FDA software validation guidance.
  • Engineering Specifications: Successful monitoring of H2O2 neutralization, accurate cycle indication via LED, proper device disablement after 65 cycles, material compatibility.
  • Predicate Device Equivalence: The performance of the legally marketed predicate device (Clear Care Contact Lens Case) forms a benchmark for "safe and effective."

8. The sample size for the training set

• Sample Size (Training Set): N/A. This is not an AI/machine learning device that uses a "training set."

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

• Ground Truth Establishment (Training Set): N/A. Not applicable.

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

Our contact lens case will consist of a lens base with dual adjoining wells for the containment of fluid. The case covers are two screw top caps. The contact lens case has a capacity of over 3.0 ml, therefore, any contact lens can be submerged into the chambers.

The provided text is a 510(k) premarket notification summary for a contact lens case. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain a study that proves the device meets explicit acceptance criteria in the way an AI/ML device submission would.

The document is a regulatory submission for a medical device (contact lens case), not an AI/ML diagnostic or prognostic device. Therefore, the detailed information requested regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies for AI/ML performance is not applicable and not present in this document.

For traditional medical devices like a contact lens case, the "acceptance criteria" are generally tied to demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device has the same intended use, technological characteristics, and raises no new issues of safety or effectiveness. The "study" in this context is the comparison against the predicate device, along with adherence to general controls and relevant regulations.

Here's how the provided information relates to your request, noting the differences for this type of device:

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

• Acceptance Criteria (Implicit for a 510(k) submission): That the device has the same intended use, similar technological characteristics, and raises no new issues of safety or effectiveness compared to the predicate device.

• Reported Device Performance: The document states that "The applicant contact lens case is similar to the predicate device in - . Intended use - . Materials - . Design" and "The applicant contact lens case introduces no new questions concerning safety and efficacy." This is the core "performance" claim for substantial equivalence. No quantitative performance metrics (like sensitivity, specificity, AUC) are reported because they are not relevant for a contact lens case's function in the way they would be for a diagnostic tool.

  Acceptance Criteria (Implied for 510(k) Equivalence)	Reported Device Performance
  Same Intended Use as Predicate	Yes (Intended use is identical; see comparison table)
  Similar Technological Characteristics as Predicate	Yes (Materials and design are similar; see comparison table)
  No New Questions of Safety or Efficacy	Yes (Explicitly stated in the conclusion)

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

• Not Applicable. This is not an AI/ML device that uses a test set of data for performance evaluation. The "test" is the comparison against the predicate device based on its design, materials, and intended use as described in the 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 is not an AI/ML device requiring expert consensus for ground truth. "Ground truth" for a contact lens case would relate to its physical properties and intended function, which are evaluated through standard engineering and manufacturing processes, and regulatory review based on established standards and the predicate device.

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

• Not Applicable. No adjudication method for a test set is mentioned or required for this type of device submission.

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 physical non-AI medical device; MRMC studies are irrelevant.

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

• Not Applicable. This is a physical device, not an algorithm.

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

• Regulatory Substantial Equivalence: The "ground truth" here is the established safety and effectiveness profile of the predicate device (Arlington Contact Lens Service, Inc. Contact Lens Case, K120969), as determined by its prior FDA clearance. The new device demonstrates "truth" by showing it aligns with this established profile. Its own physical properties and performance (e.g., fluid containment capacity) are verified through internal company testing and manufacturing controls, but not typically detailed in this type of summary.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that uses a training set.

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

• Not Applicable. This is not an AI/ML device that uses a training set.

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