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K-Y® Silicone is indicated for penile, vaginal and/or anal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

K-Y® Silicone is a non-sterile, odorless, and anhydrous personal lubricant that provides personal lubrication during intimate sexual activity and is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This product is composed of 100% Dimethicone. The product is packaged in a 50mL (1.69 FL oz.) HDPE bottle with a polypropylene pump. K-Y @ Silicone is identical in formulation and specifications to the predicate device (Durex Silicone, K143532).

The provided text describes the K-Y® Silicone personal lubricant, which claims to be substantially equivalent to the Durex Silicone (K143532) predicate device. The submission does not present a study proving the device meets acceptance criteria distinct from the predicate device; instead, it relies on the performance data of the predicate device due to their identical formulation and specifications.

Here's a breakdown of the requested information based on the provided text, recognizing that it primarily refers to the predicate device's data:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the specifications for the K-Y® Silicone, which are stated to be identical to the predicate device.

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

The document does not explicitly state the sample sizes for the testing described for the predicate device. The data provenance is described as "performance testing provided in the predicate submission for the Durex Silicone personal lubricant (K143532)." This implies the data is retrospective for the K-Y® Silicone application, as it's leveraging previously generated data. The country of origin for the data is not specified in this document.

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

Not applicable. This device is a personal lubricant, and its performance (biocompatibility, condom compatibility, sterility, shelf-life) is evaluated through laboratory and material testing, not through expert review of diagnostic images or clinical assessments requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The testing described (biocompatibility, condom compatibility, analytical chemistry, microbiology, stability) are objective laboratory tests that do not involve subjective expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This product is a physical device (personal lubricant), not an AI-powered diagnostic or assistive technology for human readers.

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

For the predicate device's testing, the ground truth was established through:

• Laboratory test results: For biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity), viscosity, color, odor, and microbiological assays (TAMC, TYMC, absence of pathogens).
• Standardized test methods: For condom compatibility (ASTM method D7661-10).
• Stability studies: For shelf-life (accelerated and real-time stability studies against device specifications).

8. The Sample Size for the Training Set

Not applicable. This is a physical product, not a machine learning model that requires a training set. The term "training set" doesn't apply in this context.

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

Not applicable, as there is no training set for a personal lubricant device.

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Intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

KY Marilyn is personal lubricant that is a non-sterile, water-based formulation that provides personal lubrication and stimulation during intimate sexual activity. It is made up of Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, PEG-40 Hydrogenated Castor Oil, Flavor, Benzoic Acid and Sodium Hydroxide. The subject device is clear in appearance. The specifications for KY Marilyn include appearance, odor, pH, viscosity, benzoic acid, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeruginosa. Staphylococcus aureus, and Candida albicans) and Antimicrobial Effectiveness.

The subject device will be packaged as follows:

• 12 mL Polyethylene terephthalate (PET) bottle
• Polypropylene (PP) pump
• Polypropylene (PP) snap-on cap
• Outer carton

The device, KY Marilyn, will be marketed as a non-prescription medical device for over-the- counter (OTC) use.

The provided document describes the K-Y® Marilyn Pleasure Gel (K151884), a personal lubricant. It presents performance data to demonstrate its substantial equivalence to predicate devices, particularly concerning biocompatibility and condom compatibility.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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Durex Silicone is indicated for perile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Durex Silicone is a Personal Lubricant Device that is a non-sterile, odorless, anhydrous, silicone formulation that provides personal lubrication during intimate sexual activity. It is made up of 100% Dimethicone. The ingredient is clear (same as water) in appearance. The Viscosity at 25°C is 80-110 cps. The device will be made available in a 1.69 FL oz. (50mL) HDPE pump sealed bottle with an outer carton. The final dimensions of the carton are 138mmx74mmx28mm.

This document is a 510(k) Premarket Notification for Durex Silicone, a personal lubricant. It does not describe a study involving an AI medical device or other complex diagnostic or therapeutic device. Therefore, many of the requested categories for acceptance criteria and study details are not applicable.

However, I can extract the relevant information regarding the performance data and the comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility (Cytotoxicity, Irritation, Systemic Toxicity, Sensitization): The document does not specify the sample sizes (e.g., number of cell cultures, animals) used for these tests. The provenance of the data is implicit as part of a regulatory submission to the FDA by the manufacturer, Reckitt Benckiser LLC. These are likely prospective laboratory and in-vivo animal studies conducted according to the cited ISO standards.
• Condom Compatibility: The testing was done using ASTM method D7661-10 with "three marketed brands of Natural Rubber Latex condoms, one brand of polyisoprene condom, and one brand of polyurethane condoms." The specific number of condoms and lubricants tested per brand is not specified.

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

• Not applicable. This device is a personal lubricant, and the 'ground truth' is established through standardized laboratory and animal testing for biocompatibility and material compatibility, not through expert clinical interpretation of medical images or patient data.

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

• Not applicable. The tests performed are laboratory-based and follow standardized protocols, not human-read expert adjudication.

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

• Not applicable. This is not an AI-enabled device.

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

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

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

• The "ground truth" used for this device's performance evaluation is based on standardized testing protocols and methodologies defined by international (ISO) and national (ASTM) standards.
  • For biocompatibility: Cellular response to extract, physiological reactions in animal models.
  • For condom compatibility: Physical and chemical interaction with condom materials as measured by ASTM D7661-10.
  • For shelf life: Stability of physical/chemical properties over time.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an AI/ML model for this type of device.

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

• Not applicable. There is no "training set" for this device.

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K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to lubricate and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms.

K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant, is a nonsterile, anhydrous, fragranced, glycol-in-silicone emulsion that provides a warming sensation upon contact with ambient moisture on the skin. It is composed of a combination of lubricants and emollients, an antioxidant, a gelling agent, a thickener, a film former, a stabilizer, a surfactant, and a fragrance. The emulsion is off-white to beige in color with a slight hint of vanilla and/or floral scent. It has a viscosity, specific gravity, and lubricity typical for emulsions of this type.

The product will be filled in printed black 3.0 ounce high density polyethylene (HDPE) heart shaped bottles, sealed with black pump closures, and packaged in printed cartons.

This document is a 510(k) Premarket Notification from the FDA regarding the K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant. It's a regulatory approval, not a scientific study describing algorithm performance. Therefore, most of the requested information about acceptance criteria, study design, and ground truth for an AI/device performance study is not applicable.

However, I can extract information regarding the device's performance in the context of its regulatory approval.

Overview of the Device and its Changes:

The device, K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant, is a personal lubricant. It is a slightly modified version of a previously cleared device (K-Y® Brand Intrigue™ 2-in-1 Massage Creme™). The primary difference is the addition of a fragrance.

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

The document does not specify quantitative acceptance criteria with numerical targets. Instead, it describes compliance with established standards and satisfactory results from specific tests to demonstrate safety and effectiveness in the context of substantial equivalence to a predicate device.

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 provide details on sample sizes for the biocompatibility, condom compatibility, or stability tests. These tests are typically conducted in a laboratory setting (prospective testing) but the document does not specify the country of origin for the data.

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 information is not applicable. The evaluations (biocompatibility, condom compatibility, stability) are technical laboratory tests, not expert-driven assessments of a "ground truth" as might be found in diagnostic AI studies.

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

This information is not applicable. Adjudication methods are typically used for expert consensus in diagnostic studies, not for laboratory performance tests of a physical product.

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

No such study was conducted. This is a physical product (personal lubricant), not an AI-powered diagnostic device.

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

This information is not applicable. This is a physical product (personal lubricant), not an algorithm.

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

The "ground truth" for the device's performance is based on established scientific and regulatory standards for safety and performance:

• Biocompatibility: Adherence to ISO 10993 series standards.
• Condom Compatibility: Adherence to ASTM D7661-10.
• Stability: Laboratory testing to demonstrate shelf-life.

8. The sample size for the training set

This information is not applicable. This is a physical product, not an AI model that requires a training set.

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

This information is not applicable. This is a physical product, not an AI model that requires a training set and ground truth establishment for it.

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Durex® RealFeel™ Pleasure Gel Personal Lubricant is intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease of comfort of intimate sexual activity and supplement the body's natural lubrication. This lubricant is compatible with polyurethane condoms. It is not compatible with natural rubber latex and polyisoprene condoms.

Durex® RealFeel™ Pleasure Gel is a non-sterile, personal silicone base lubricant. The lubricant is comprised of cyclopentasiloxane and dimethiconol. Durex® RealFeel™ Pleasure Gel contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device The specifications for Durex® RealFeel™ Gel include appearance, odor, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeroginosa, Staphylococcus aureus, and Candida albicans).

This document describes the review of Durex® RealFeel™ Pleasure Gel Personal Lubricant for 510(k) premarket notification. The review focuses on establishing substantial equivalence to a legally marketed predicate device, ONE® Silicone Lubricant (K110690).

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not specify the exact sample sizes for each of the performance tests (biocompatibility, condom compatibility, stability). However, it states that:

• Biocompatibility Studies: Four studies were conducted. The specific number of animals/samples for each endpoint (cytotoxicity, systemic toxicity in mice, maximization in guinea pigs, and vaginal irritation in rabbits) is not detailed.
• Condom Compatibility Testing: The sample size for this testing is not provided.
• Stability Studies: The sample size for the accelerated and real-time studies is not provided.

The data provenance is not explicitly stated in terms of country of origin but is implied to be from studies conducted by or for Reckitt Benckiser, LLC. These studies are retrospective to the submission date of November 18, 2014.

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

This information is not applicable as the evaluation is for a personal lubricant, not a diagnostic device requiring expert interpretation of medical images or data for ground truth establishment. The ground truth (or reference standard) for this device's performance is based on standardized testing methods and laboratory measurements, not expert consensus on medical conditions.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert consensus is needed to establish a ground truth for diagnostic accuracy, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

This information is not applicable. This is a submission for a personal lubricant and does not involve AI, human readers, or diagnostic interpretation.

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

This information is not applicable. This is not an algorithmic or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Standardized Laboratory Testing and Measurement:
  • Biocompatibility: Adherence to GLP requirements and applicable ISO 10993-1 standards for endpoints like cytotoxicity, systemic toxicity, sensitization, and irritation.
  • Condom Compatibility: Testing conducted in accordance with ASTM D7661-2010.
  • Physical and Microbiological Specifications: Internal quality control standards and established methods for appearance, odor, viscosity, specific gravity, microbial counts, and absence of specific pathogens.
  • Stability: Laboratory assessment of product specifications over time under accelerated and real-time conditions.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI device that requires a training set.

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

This information is not applicable. As this is not an AI/ML device, there is no training set or associated ground truth for a training set.

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Durex Embrace Pleasure Gels, which includes the Warming Sensation Gel and Tingling Experience Gel, are intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubricants are compatible with natural rubber latex, synthetic polyisoprene and polyurethane condoms.

Durex Embrace Pleasure Gels are clear odorless slightly viscous liquids that are packaged together and consist of two different formulation is water-based with multisensate (Tingling Experience Gel) and the female formulation (Warming Sensation Gel) is Vanillyl Butyl Ether in Glycerine base. The female lubricant (Pink Bottle) offers a warming experience, and one for the male partner (Purple bottle) offers a tingling experience. Devices are supplied in 60 ml PETG pump bottles. Both lubricant bottles are covered with a shrink sleeve including graphics that also provides tamper evident protection. Bottles are then placed in clear trays, which are then shrink-wrapped and placed in printed cartons.

The provided text describes the submission for a 510(k) premarket notification for Durex Embrace Pleasure Gels, seeking substantial equivalence to a predicate device (KY Yours + Mine). It outlines performance testing, but it is not a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.

The document is for a personal lubricant, not an AI/ML device, and therefore does not have acceptance criteria or studies related to AI/ML performance metrics (like sensitivity, specificity, F1-score, AUC, etc.).

However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its safety and performance based on the provided document.

Here's an interpretation of the request in the context of this non-AI medical device submission:

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

The document lists "Specifications" for which "acceptance specifications" have been developed, but it does not explicitly state the numerical acceptance criteria or the specific reported device performance values for each specification. It only states that "testing on samples collected up to 12 months of aging... showed that devices met their acceptance criteria" and that test results "demonstrated device materials to be biocompatible" and "non-irritating" or "did not elicit sensitization reactions."

Regarding AI/ML specific information, this document does not contain any of the following because it is not an AI/ML device:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• Multi reader multi case (MRMC) comparative effectiveness study
• Standalone (i.e. algorithm only without human-in-the-loop performance) study
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for test set
• Sample size for the training set
• How the ground truth for the training set was established

Detailed information from the document (non-AI related):

2. Sample sizes used for the test set and data provenance:

• Acute Systemic Toxicity: "test group animals" (number not specified). Data provenance: Not specified, but likely conducted in a laboratory setting as per GLP requirements.
• Vaginal Irritation Testing: Not specified, but involved "rabbits" and assessed the Warming Sensation Gel.
• Penile Irritation Study: Not specified, but involved "rabbits" and assessed the Tingling Experience Gel.
• Cytotoxicity: Not specified, but tested using "tissue culture agar diffusion test."
• Sensitization: "study animals" (number not specified). Involved "Guinea Pig Maximization test."
• Condom Compatibility: Not specified for number of condoms or samples. Testing was "conducted in accordance with ASTM D7661-10."
• Stability: "samples collected up to 12 months of aging (real-time and accelerated at 40 C-75%RH)" (number of samples not specified).
• Data Provenance: Not explicitly stated, but all studies were conducted in accordance with GLP requirements and applicable ISO 10993 standards or ASTM D7661-10, implying controlled laboratory conditions.

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

• Not applicable as this is a physical/chemical/biological performance study, not an AI/ML ground truth establishment. The "ground truth" is determined by standardized test methods and observations/measurements.

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

• Not applicable for this type of performance study. Results are based on direct observation, measurement, or established biological outcomes according to standard protocols.

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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device. The performance tests are for the product itself (lubricant).

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

• The "ground truth" for these studies is based on observable biological reactions (e.g., irritation, sensitization, systemic toxicity), physical/chemical properties (e.g., pH, viscosity), and mechanical integrity (condom compatibility), as defined by established international standards (ISO 10993, ASTM D7661).

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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SPOROX® II has the same intended use as SPOROX®. SPOROX® II is intended to be used as a ready-to-use liquid chemical sterilant for the sterilization or high level disinfection of heat sensitive medical equipment for which alternative methods of terminal reprocessing are not suitable or available.

SPOROX® II Sterilizing & Disinfecting Solution is a ready to use liquid chemical germicide. The product is a 7.5% nominal hydrogen peroxide solution buffered with phosphoric acid. The minimum effective concentration (MEC) is 6%. SPOROX II ® Sterilizing & Disinfecting Solution is intended for use in the high level disinfection of heat sensitive medical equipment using the prescribed contact conditions. Devices must be soaked for 30 minutes at 20℃ to high level disinfect. SPOROX II® may be reused for up to 21 days in conjunction with the use of an appropriate chemical indicator strip.

SPOROX® II is a nominal 7.5% hydrogen peroxide solution, buffered with phosphoric acid. Hydrogen peroxide, the active ingredient in SPOROX® II, exerts its germicide via a strong oxidation reaction with cellular components.

This document describes the premarket notification (510(k)) for SPOROX® II, a liquid chemical sterilant/high-level disinfectant. It does not contain information about an AI/ML powered medical device. Therefore, it is not possible to describe acceptance criteria, a study proving the device meets those criteria, or other details typically associated with AI/ML device evaluations.

The provided text details the substantial equivalence of SPOROX® II to a predicate device, SPOROX®, for its intended use as a liquid chemical sterilant and high-level disinfectant for heat-sensitive medical equipment. The evaluation focused on antimicrobial efficacy, stability, safety, and material compatibility.

To address your request by interpreting the closest analogous information available:

The "acceptance criteria" and "device performance" in this context relate to demonstrating substantial equivalence to the predicate device, SPOROX® (K970230).

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a submission for a chemical disinfectant, the following questions are not applicable to the provided document:

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. The "tests" here refer to chemical, biological (microbial), and material compatibility studies, not a "test set" of patient data for an AI/ML algorithm.

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. "Ground truth" in this context would implicitly be the established scientific methods and accepted standards (e.g., AOAC and EPA methodologies) for evaluating disinfectants, not expert consensus on medical images or patient outcomes.

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

• Not applicable. This refers to expert review processes for AI/ML ground truth establishment.

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 entirely irrelevant for a chemical disinfectant.

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)

• For antimicrobial efficacy: Established microbiological standards and results from AOAC and EPA methods.
• For stability: Chemical analysis over time and functional testing of reuse claims.
• For safety: Live animal testing (e.g., acute dermal/oral, irritation), in-vitro cell assays, and 28-day repeat dose oral toxicity.
• For material compatibility: Observation of materials (plastics, metals, elastomers) after prolonged exposure to the solution.

8. The sample size for the training set

• Not applicable. There is no AI/ML model to train.

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

• Not applicable. There is no AI/ML model to train or associated ground truth.

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Sporox® Sterilizing & Disinfecting Solution is a ready-to-use liquid chemical germicide. The product is a 7.5% nominal hydrogen peroxide solution buffered with phosphoric acid. The minimum effective concentration (MEC) is 6%. Sporox® Sterilizing and Disinfecting Solution is intended for use in the high level disinfection of heat sensitive medical equipment using the prescribed contact conditions. Devices must be soaked for 30 minutes at 20℃ to high level disinfect. Sporox® may be reused for up to 21 days in conjunction with the use of an appropriate chemical indicator strip.

Sporox is a nominal 7.5% hydrogen peroxide solution, buffered with phosphoric acid. Hydrogen peroxide, the active ingredient in Sporox, ® exerts i s germicide via a strong oxidation reaction of cellular components.

The provided text describes Reckitt & Colman Inc.'s Sporox, a 7.5% hydrogen peroxide solution intended as a liquid chemical sterilant and high-level disinfectant. The submission (K970230) compares Sporox to the predicate device, Cidex Formula 7.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the specific tests, particularly for the germicidal activity assays, toxicity studies, or material compatibility evaluations in terms of number of devices or organism cultures.

• Provenance: The studies were conducted by Reckitt & Colman Inc. and involved standardized in vitro (e.g., AOAC methods for germicidal activity, biocompatibility tests) and in vivo (toxicity) studies.
  • Actual Use Testing: Involves both "endoscopes after patient use" and "inoculated endoscopes." This suggests prospective or real-world application data, as well as controlled laboratory simulations.
  • Clinical Setting: Documentation of Sporox use by the Mayo Clinic in the clinical setting was submitted, which implies retrospective clinical use data.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the various tests. The nature of the device (chemical sterilant/disinfectant) means ground truth is often established by:

• Laboratory assays: Measured against established scientific standards (e.g., AOAC methods for log reduction, specified toxicity endpoints).
• Clinical outcomes: For actual use testing, the "ground truth" would be the observed efficacy (sterilization/disinfection) and safety (lack of adverse effects) in a real-world or simulated clinical setting.
• Compliance with guidance: Adherence to FDA guidance on biocompatibility and residue testing implies using established scientific protocols and benchmarks.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method like 2+1 or 3+1. These methods are typically used for interpreting subjective medical images or clinical findings. For chemical germicide testing, the results are generally objective and quantifiable (e.g., log reduction, chemical residue levels, observed toxicity endpoints), which do not typically require a panel adjudication process.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for evaluating the impact of AI-assisted diagnostic tools on human reader performance, typically in imaging. This device is a chemical disinfectant/sterilant, not a diagnostic tool requiring human interpretation of data where AI assistance would be applicable in this context.

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

Yes, the primary performance evaluation of Sporox is standalone (device-only performance). The entire suite of tests (germicidal activity, toxicity, stability, material compatibility, residue testing) evaluates the inherent properties and effectiveness of the Sporox chemical solution itself, without requiring human intervention in the performance evaluation beyond preparing the solution and conducting the tests. The "actual use testing" also assesses the device in a standalone capacity within the context of clinical reprocessing.

7. The Type of Ground Truth Used

The ground truth used is a combination of:

• Expert Consensus/Standardized Methods: For germicidal activity, "appropriate AOAC use dilution, fungicidal, tuberculocidal and sporicidal methods" establish the ground truth for microbial inactivation based on widely accepted scientific standards.
• Laboratory Benchmarks/Endpoints: For toxicity and biocompatibility studies, "FDA's guidance on biocompatibility testing" and specific endpoints (e.g., irritation, hemolysis) serve as the ground truth for safety.
• Observed Efficacy and Safety: For actual use testing, the ground truth is the observed sterility/disinfection and lack of adverse effects during reprocessing of endoscopes and in the Mayo Clinic clinical setting.
• Chemical Analysis: For residue testing, the ground truth involves quantifiable chemical levels compared against safe thresholds based on expert toxicological assessment.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. Sporox is a chemical germicide; it is not an AI/machine learning algorithm that requires training data. The data gathered from the various tests (germicidal, toxicity, stability, compatibility, residue) are for validation and characterization of the chemical product's performance against predefined criteria, not for training an algorithm.

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

As there is no training set for this type of device, this question is not applicable.

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