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Control III Elite is indicated for use in healthcare setting for environmental control of bacteria and viruses and the prevention of crosscontamination. Control III Elite is an intermediate level disinfectant. Active ingredients are a combination of quaternary ammonium chlorides requiring a 10-minute contact at 20° C. (68°F).

Control III® Elite

I am sorry, but based on the provided document, the information required to answer your request is not present. The document is a clearance letter from the FDA for a device called "Control III® Elite" and an "Indication For Use Statement." It does not contain details about acceptance criteria, specific studies, sample sizes, expert qualifications, or ground truth establishment for the device's performance evaluation.

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Pro-Portion is a general-purpose cleaner/disinfectant. Its use is restricted to a health care setting where low and intermediate level disinfection of hard, non-porous surfaces is required. It is intended to be used in a dental office as an instrument ultrasonic cleaning solution. In order to disinfect, a contact time of 10 minutes at 69°F / 20°C is required.

This product may be used to pre-clean or decontaminate of critical or noncritical medical devices prior to sterilization. Must be followed by appropriate terminal sterilization or high-level disinfection process.

Pro-Portion is a broad spectrum, multi-purpose ready to use, effective cleaner and disinfectant for use on the surfaces of inanimate objects. Pro-portion will efficiently clean and disinfect, when used as directed, such items as laminated counter tops, dental units, dental instruments, lights, and other inanimate surfaces, including those made of plastics (such as: polycarbonate, polyvinylchloride, polypropylene and polystyrene), nonporous vinyl and upholstery, stainless steel, painted surfaces, Plexiglas, glass, and other hard non-porous surfaces.

The provided text is a 510(k) summary for a phenolic cleaner/disinfectant called Pro-Portion. It outlines the product's physical characteristics, intended use, and ultimately states that the FDA found it substantially equivalent to legally marketed predicate devices.

However, the document does not contain information about acceptance criteria, a study that proves the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the performance of a device in terms of clinical or diagnostic outcomes.

This document is for a disinfectant, which is a chemical product rather than a diagnostic or therapeutic medical device that would typically involve a "study" with "acceptance criteria" for performance metrics like sensitivity or specificity. The "performance characteristics" mentioned refer to its efficacy as a cleaner and disinfectant against microorganisms, which are typically evaluated through standardized microbiological tests, not studies involving human subjects or expert consensus on interpretations.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as that information is not present in the provided text for this type of product.

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General purpose disinfectant used to disinfect hard, nonporous, inanimate environmental surfaces in dental, medical, hospital, and veterinary facilities.

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I am sorry, but the provided text does not contain the detailed information needed to construct the table and answer the questions regarding acceptance criteria, study details, and performance metrics of the device "Microstat 2™".

The document is an FDA 510(k) clearance letter from 1999, which primarily states that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (general purpose disinfectant). It confirms that the device can be marketed but does not include:

• Specific acceptance criteria (e.g., performance thresholds).
• Details of a study proving device performance (e.g., methodology, results, sample sizes, ground truth establishment, expert qualifications, adjudication methods).
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Training set details.

Therefore, I cannot fulfill your request with the given input.

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Amerse 2 is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in healthcare facilities with a 10 minute contact time at 20°C by housekeeping, nurses, and emergency medical personnel.

Amerse 2 is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces and to preclean or decontaminate critical or semi-critical medical devices prior to sterilization or high-level disinfection with a 10 minute contact time at 20°C.

Amerse 2 is a liquid chemical germicide concentrate utilizing phenolic compounds as active ingredients.

The provided text describes the 510(k) summary for "Amerse 2", a liquid chemical germicide. It details the product's description, intended use, and substantial equivalence to existing products, along with safety and effectiveness data. However, the document does not contain information about a study that would include elements like test set sample size, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML device evaluation. This document is a regulatory submission for a disinfectant, not an AI/ML medical device. Therefore, I cannot extract the requested information from the provided text.

Specifically, the document focuses on:

• Product: Amerse 2, a general purpose disinfectant.
• Intended Use: Inactivating bacteria, fungi, and viruses on hard inanimate surfaces and non-critical medical devices.
• Effectiveness Data: Passes standard tests (AOAC Germicidal Use-Dilution Test, AOAC Tuberculocidal Test, AOAC Fungicidal Test, Virucidal Qualification Test, EPA approved Dilution Method against HIV-1). These tests are laboratory-based and establish the disinfectant's ability to kill specific microorganisms under controlled conditions.

The questions you've asked are typically relevant to the evaluation of AI/ML-driven medical devices, which rely on extensive datasets, ground truth established by experts, and detailed performance metrics to assess their diagnostic or analytical capabilities. The provided text does not describe such a device or study.

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DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach is to be used as a generalpurpose intermediate level disinfectant for use as a cleaner/disinfectant of Non-Critical devices such as medical instrument and equipment surfaces, and hard surfaces such as stainless steel, porcelain, and chrome. DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach are intended for use in healthcare settings for environmental control of bacteria and viruses, and prevention of cross-contamination. DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach tuberculocidal efficacy requires two minutes contact time at room temperature (68-779F, 20-25°C).

DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach

The provided documents are a letter from the FDA regarding a 510(k) submission for a hospital cleaner disinfectant. These documents do not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for a medical device.

Instead, the documents describe the FDA's determination of substantial equivalence for a product named "DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach" and state its intended use as an intermediate level disinfectant for non-critical devices and hard surfaces in healthcare settings.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study proving a device meets these criteria based on the provided text. The documents are related to regulatory clearance (510(k)), not performance study details.

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Is a general for repose as interfact For use in health care settings for low and intermediate level disinfection of hard, non-porsus, increase in the contra suffaces of wheelchairs, medical beds, patient transfer iffs, cruiches, instrument trays, operating tables, surfaces of Pricolonalic, modical paintal chairs, medical lamps, whilipool bathing units, and other medical devices that require low or internediate level disinfection. This product may be used to preclaan or decontaminate attical or non-citical medical devices prior to sterilization or high-loved disintedion. The effectiveness of this product has been documented at a temperature of 68°F (20°C), with a ten minute contact time on the surface being treated.

Low pH Phenolic 256 is a liquid germicidal detergent formulated to clean, disinfect, and deodorize any washable, non-porous surface in one easy step. Low pH Phenolic 256 is recommended for use by hospitals, nursing homes, and other health care institutions that are dedicated to controlling cross-contamination in their establishments. Low pH Phenolic 256 is for use on any hard, inanimate surfaces such as door handles, medical bed surfaces, springs, wheelchairs, walls, floors, light switches, linen carts, stretcher wheels, toilet bowl surfaces, showers, bathtubs, bed frames, patient transfer lifts, patient scales, examination tables, dental chairs, stethoscopes, bedpans, blood donor chairs, and other hard, non-porous surfaces that need disinfection.

This document describes a 510(k) submission for a device called "Low pH Phenolic 256" (also referred to as "Cen-pHene"), which is a liquid germicidal detergent designed for intermediate-level disinfection. The submission does not describe an AI/ML powered medical device, therefore questions regarding sample size for test/training set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and data provenance are not applicable.

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

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this disinfectant are defined by its efficacy against specific microorganisms under specified conditions. The reported device performance indicates it met these criteria.

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 explicit "sample size" in terms of number of treated surfaces or biological replicates for the efficacy tests. The data provenance (country of origin, retrospective/prospective) is not mentioned.

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 as the device is a chemical disinfectant, not an AI/ML powered medical device that requires expert ground truth for interpretation. Efficacy is determined through standardized microbiological testing.

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

Not applicable. Efficacy is determined through standardized microbiological testing, not human-based 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 a chemical disinfectant, not an AI-powered diagnostic device.

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

Not applicable. This is a chemical disinfectant, not an AI algorithm.

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

The "ground truth" for this device's efficacy is the reduction or inactivation of specified microorganisms (bacteria, viruses, fungi) to acceptable levels, as determined by standardized laboratory microbiological testing methods (specifically, A.O.A.C. methods as stated).

8. The sample size for the training set

Not applicable. This is a chemical disinfectant, not an AI/ML model that requires a training set.

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

Not applicable. This is a chemical disinfectant, not an AI/ML model that requires a training set and associated ground truth establishment.

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CITREX® HOSPITAL SPRAY DISINFECTANT Is to be used as a general-purpose intermediate level disinfectant for use as a cleaner/disinfectant of Non-Critical devices such as medical instrument and equipment surfaces, and hard surfaces such as stainless steel, porcelain, and indualities and in intended for use in healthcare settings for environmental control of bacteria only of over of coss-contamination. Intermediate level disinfection using CITREX® requires one minute contact time at room temperature (68-77°F, 20-25°C).

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The provided text is a US FDA 510(k) clearance letter for a device named "CITREX® Hospital Spray Disinfectant". This document primarily deals with the regulatory approval of a disinfectant and does not contain information about the acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML performance.

The questions you've asked are typically relevant to the evaluation of AI/ML-powered medical devices, which are a different category of product from a chemical disinfectant. Therefore, most of the information requested cannot be extracted from this document because it describes a different type of product and approval process.

Here's a breakdown of what can be inferred from the document regarding its intended use:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria or provide performance metrics like sensitivity, specificity, or accuracy that are typical for AI/ML devices. Instead, the "performance" is implicitly tied to its function as an "intermediate level disinfectant" and its ability to act as a "cleaner/disinfectant of Non-Critical devices" and hard surfaces, intended for "environmental control of bacteria." The key performance characteristic mentioned is a "one minute contact time at room temperature."

2. Sample size used for the test set and the data provenance: Not applicable. This is a chemical disinfectant, not an AI/ML device relying on a test set of data.

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 an AI/ML system is irrelevant for a disinfectant. Its efficacy would typically be established through microbiology lab tests, not expert consensus on data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For a disinfectant, the "ground truth" would be established through standard microbiological assaysdemonstrating antimicrobial efficacy against specific pathogens under defined conditions. The document does not detail these studies, but FDA clearance implies such testing was performed and reviewed.

8. The sample size for the training set: Not applicable. This is a chemical product, not an AI/ML algorithm.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a regulatory approval for a chemical disinfectant, not an AI/ML medical device. Therefore, the questions posed, which are designed for evaluating AI/ML systems, are largely not applicable to this context, and the document does not contain the specific information requested.

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Kleenaseptic is a ready-to-use, spray-on general purpose disinfectant intended for use in cleaning and disinfecting equipment surfaces and non-critical devices in hospitals and other critical care areas where environmental control of cross contamination is important.

Kleenaseptic is a disinfectant when used on equipment surfaces and non-critical devices for 10 minutes at room temperature (69°F/20°C).

Kleenaseptic is a ready-to-use, spray-on isopropyl alcohol/quaternary ammonium general purpose disinfectant used for the cleaning and disinfection of equipment surfaces and non-critical devices prior to terminal sterilization/high-level disinfection in healthcare environments.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that "Kleenaseptic" meets such criteria. The document is a 510(k) summary for a general purpose disinfectant, establishing its substantial equivalence to a legally marketed predicate device based on its EPA registration.

The text does include:

• Device Name: Kleenaseptic
• Intended Use: A general purpose disinfectant for cleaning and disinfecting equipment surfaces and non-critical devices in healthcare environments, effective when used for 10 minutes at room temperature (69°F/20°C).
• Substantial Equivalence Basis: EPA registration number 46781-7 and the EPA-stamped approved label, in conformance with FDA "Guidance on the Content and Format of 510(k) Submission for General Purpose Disinfectants."

However, it does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results from a standalone algorithm-only performance study.
7. The type of ground truth used (beyond implying EPA approval implies a certain standard).
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is a regulatory submission focused on demonstrating equivalence through existing EPA registration, rather than a report detailing specific performance studies against predetermined acceptance criteria for a new medical device technology like an AI algorithm.

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T.B.Q. RTU is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces and to preciesn or decomationate cattical medical devices prior to sterilization or high-level disinfection with a 10 minute contact time at 20°C.

T.B.Q. RTU is a liquid chemical geamicide pump spray unilizing quatinary ammonium chloride compounds as active ingredients.

The provided document is a 510(k) summary for T.B.Q. RTU, a liquid chemical germicide. It describes the product, its intended use, and effectiveness data, but it does not describe an AI device or a study involving human readers. Therefore, I cannot generate the specific information requested in your prompt (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, acceptance criteria for an AI device).

However, I can extract the effectiveness data that serves as the "acceptance criteria" and "reported device performance" for this chemical germicide, as well as the types of studies performed, which are analogous to how a device's performance would be evaluated.

Here's the information based on the provided document, adapted to your requested format where possible:

Chemical Germicide Performance and Testing

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. The tests refer to standardized methods (e.g., AOAC, EPA approved methods) which would have defined sample sizes for microbial cultures, but these specifics are not provided here.
• Data Provenance: Not specified. Standardized laboratory tests are generally conducted under controlled conditions, likely in the country of the manufacturer or a certified testing lab. The document does not indicate if the testing was retrospective or prospective, but these types of germicide efficacy tests are typically prospective laboratory studies.

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 a chemical germicide efficacy study. The "ground truth" is established by the presence or absence of microbial growth based on laboratory culture methods, not by expert consensus or interpretation of images. The "experts" would be trained microbiologists performing the standardized assays. The number and qualifications are not listed.

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

• Not applicable to chemical germicide testing. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks (e.g., radiology reads), not for laboratory efficacy assays where results are typically objective (e.g., growth vs. no growth).

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 document describes a chemical germicide, not an AI device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

• Not applicable. This document describes a chemical germicide, not an algorithm or AI device. The efficacy testing is inherently "standalone" in the sense that it evaluates the chemical product's performance directly, without human intervention in the outcome determination beyond performing the assay.

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

• Ground Truth: For this chemical germicide, the "ground truth" is established by the survival or inactivation of specific microorganisms (bacteria, fungi, viruses) under controlled laboratory conditions, as determined by standardized microbiological culture and assay methods. For example, in the AOAC Use-Dilution Test, the ground truth is whether bacterial growth occurs in subculture tubes.

8. The sample size for the training set

• Not applicable. This document describes a chemical germicide, not a machine learning model, so there is no "training set."

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

• Not applicable. As there is no training set for a chemical germicide.

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Germicidal Cloth is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces.

Germicidal Cloth is a liquid chemical germicide saturated, disposable cloth utilizing quatinary ammonium chloride compounds as active ingredients.

This document describes a 510(k) submission for a germicidal cloth and does not contain detailed information about a study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement as typically found for complex medical devices with AI components. The provided text is a regulatory submission for a disinfectant product, focusing on its formulation, intended use, and comparison to substantially equivalent products, along with safety and basic effectiveness data.

Therefore, an elaborate table of acceptance criteria, device performance, and details about a "study" as requested, particularly in the context of AI/machine learning, cannot be extracted directly from the provided text. The "Effectiveness Data" section acts as the closest equivalent to performance metrics based on standard disinfectant testing.

However, I will extract relevant information that can be framed as "acceptance criteria" and "reported device performance" based on the product's regulatory approval as a germicide.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the following information is either not applicable or not available:

• 2. Sample size used for the test set and data provenance: Not mentioned. Effectiveness data refers to EPA approvals, implying testing was done, but details of sample size and data provenance (e.g., country, retrospective/prospective) are not provided in this summary.
• 3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. For germicidal efficacy, "ground truth" is established through standardized laboratory assays (e.g., AOAC methods for disinfectants) rather than expert consensus on medical images or clinical outcomes.
• 4. Adjudication method for the test set: Not applicable. Standardized lab protocols are followed, not expert adjudication methods common in diagnostic device studies.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for diagnostic devices involving human interpretation of results, not for chemical germicides.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a chemical disinfectant, not an algorithm.
• 7. The type of ground truth used: For efficacy, the "ground truth" is determined by the results of standardized microbiological assays (e.g., quantitative suspension tests, carrier tests) that measure the reduction of viable microorganisms under specified conditions. For safety, it's based on animal toxicology studies.
• 8. The sample size for the training set: Not applicable. This document describes a chemical product, not a machine learning model.
• 9. How the ground truth for the training set was established: Not applicable for this type of device.

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