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This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.

Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatius Potential and Tested for Use with Chemotherapy Drugs

This document is a 510(k) clearance letter from the FDA for Polychloroprene Powder Free Sterile Surgical Gloves and does not contain information about an AI/ML device. Therefore, it does not provide acceptance criteria or a study proving device performance as typically expected for AI/ML medical devices.

The document focuses on the regulatory clearance of a physical medical device (surgical gloves) and confirms its substantial equivalence to previously marketed devices. The "Indications for Use" section lists the device's intended purpose and data on the glove's permeation time for various chemotherapy drugs, which are essential for its specific indication as "Tested for Use with Chemotherapy Drugs."

To address your request, I will explain why your questions cannot be answered by the provided text.

Based on the provided document, the device in question is Polychloroprene Powder Free Sterile Surgical Gloves, which is a physical medical device, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, do not apply to this document.

The document focuses on the FDA's 510(k) clearance for this type of medical glove, specifically highlighting its "Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs."

Here's an analysis based on the information provided, tailored to what can be extracted for a physical device:

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

The acceptance criteria for the chemotherapy drug permeation would be that the breakthrough detection time meets or exceeds certain standards for safe handling. The reported performance is directly presented in the table within the "Indications for Use" section.

Note: The implied acceptance criterion for most drugs is ">240 min", as the glove met this for the majority. For Carmustine and Thiotepa, the values are lower, and the document explicitly cautions about these drugs having "much lower permeation times." This suggests that even these lower times were deemed acceptable within the context of their use, with the caveat for users.

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

This information is not provided in the document. For a physical device like gloves, the "test set" would refer to the number of gloves or samples tested for permeation. The document does not specify this, nor does it provide details on data provenance (e.g., retrospective or prospective) as that's more relevant to clinical studies for performance claims, rather than material properties.

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 as the ground truth for glove permeation is established through laboratory testing (e.g., using ASTM standards), not by human experts interpreting clinical data.

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

This question is not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, which are not relevant to the chemical permeation testing of the surgical gloves.

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 question is not applicable as the device is a physical surgical glove, not an AI-assisted diagnostic or predictive tool.

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

This question is not applicable as the device is a physical surgical glove, not an algorithm.

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

The ground truth for the glove's performance related to chemotherapy drug permeation would be established through laboratory testing using standardized methods, likely following ASTM guidelines (e.g., ASTM F739), which measure the breakthrough time of specific chemicals through a barrier material. This is a direct measurement, not subject to expert consensus or pathology in this context.

8. The sample size for the training set

This question is not applicable as the device is a physical product and does not involve AI/ML models that require a training set.

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

This question is not applicable for the same reason as point 8.

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This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs

This document is an FDA 510(k) clearance letter for "Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs" (K182176). It does not describe a study that uses artificial intelligence (AI) or machine learning, nor does it contain the specific types of information requested in your prompt regarding AI/ML device performance.

The document focuses on the device performance of surgical gloves in terms of their resistance to chemotherapy drug permeation. Based on the provided text, here’s an attempt to extract relevant information, but please note it does not align with the requested structure for AI/ML device studies:

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

The document presents the "Breakthrough Detection Time (Minutes)" for various chemotherapy drugs, which can be interpreted as the device's reported performance against a specified test. There isn't an explicit "acceptance criteria" listed in the way one might find for an AI algorithm's metric thresholds. However, regulatory bodies like the FDA typically have guidance or standards for what constitutes acceptable barrier protection for medical gloves against hazardous chemicals. For the purpose of this response, the reported breakthrough times are the "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)

The document does not specify the sample size for the testing, nor the data provenance in terms of country of origin or retrospective/prospective nature. This information would typically be in a detailed test report, not the summary 510(k) clearance letter.

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 is not applicable to the type of device and testing described. The "ground truth" for glove permeation testing is established through standardized laboratory methods as defined by organizations like ASTM, not by expert human interpretation in the way AI/ML ground truth is established.

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

Not applicable. This concept relates to human consensus in medical image interpretation, which is not relevant to chemical permeation testing of gloves.

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

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

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

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

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

The "ground truth" here is the measured breakthrough time of the chemotherapy drugs through the glove material, determined by quantitative laboratory testing using established standards (e.g., ASTM D6978, which is a common standard for this type of testing). This is a direct physical measurement.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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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This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.

This surgeon's glove is a device made of synthetic rubber.

The provided text is a 510(k) premarket notification for "Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs." This submission focuses on the performance of surgical gloves in resisting permeation by chemotherapy drugs.

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

The acceptance criteria are essentially the "Breakthrough Detection Time" specifications for various chemotherapy drugs. The reported device performance is the actual breakthrough time measured for each drug.

Note on Acceptance Criteria: The document directly presents the performance data rather than explicit numerical acceptance criteria for each drug from a regulatory body. However, for devices of this nature, the general "acceptance" is that the glove performs adequately for its intended use, typically implying that longer breakthrough times are better. The explicit mention of Carmustine and ThioTEPA's breakthrough times as a "Caution" implies that their performance, while reported, is at the lower end of the acceptable spectrum compared to the others that exceed 240 minutes.

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

• Test Set Sample Size: The document does not explicitly state the sample size (number of gloves or tests performed for each drug). For Carmustine and Thiotepa, three individual values are listed in parentheses (e.g., 47.8, 38.3, 37.5 for Carmustine), suggesting at least three tests were performed for these specific drugs, and an average was calculated. For other drugs, only ">240 min" is reported, so the exact number of tests is not discernible from the text.
• Data Provenance: Not specified in the document. It's likely from laboratory testing conducted by or for the manufacturer (Pt. Medisafe Technologies) to assess the glove's barrier properties against chemotherapy drugs. The country of origin of the data is not mentioned, nor whether it was retrospective or prospective.

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

This type of testing (chemotherapy drug permeation) does not typically involve human experts to establish "ground truth." The ground truth is established through standardized laboratory testing methods that measure the chemical permeation. Therefore, information about experts and their qualifications in this context is not applicable. The "ground truth" for permeation resistance is determined by the output of the testing apparatus using recognized analytical techniques.

4. Adjudication Method for the Test Set

Not applicable. As this is chemical permeation testing, there is no expert adjudication process in the traditional sense. The results are derived directly from the laboratory measurements.

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

Not applicable. This is not an imaging or diagnostic device that involves human readers interpreting cases. It's a medical device (surgical glove) whose performance is evaluated through material science and chemical permeation tests, not through human interpretation or comparative effectiveness studies with AI assistance.

6. Standalone Performance

Yes, the study describes the standalone (algorithm or device-only) performance. The reported breakthrough detection times are purely reflective of the glove's material properties and its resistance to chemical permeation, without any human-in-the-loop interaction during the performance measurement.

7. Type of Ground Truth Used

The ground truth used is laboratory measurement/chemical assay results. Specifically, it's the time until a chemotherapy drug is detected on the inner surface of the glove, as determined by appropriate analytical methods (e.g., spectroscopy, chromatography) following standardized test procedures (likely ASTM or similar international standards for chemical permeation of protective clothing).

8. Sample Size for the Training Set

Not applicable. This device is a physical product (surgical glove) whose performance is determined by its material composition and manufacturing process. There is no "training set" in the context of machine learning or AI algorithms for this type of product. The manufacturing process is validated, and the product is tested to meet specifications.

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

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

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Polychloroprene Examination Gloves - Pink with Aloe Vera and Vitamin E

This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Polychloroprene Examination Gloves - Pink with Aloe Vera and Vitamin E." It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

The letter is a regulatory approval for marketing the device based on a determination of substantial equivalence to previously marketed devices. It confirms that the device is a Class I medical device (patient examination glove), lists general controls it must adhere to, and provides contact information for further regulatory inquiries.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Powder Free Polychloroprene Light Weight Examination Gloves-Green, Blue and Pink

This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Polychloroprene Light Weight Examination Gloves - Green, Blue and Pink." It primarily focuses on the regulatory approval and substantial equivalence to legally marketed predicate devices, not on a study with acceptance criteria for a device's performance in a diagnostic or clinical setting.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study to prove a device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, and expert qualifications for ground truth.
• Adjudication methods.
• Information on MRMC comparative effectiveness studies.
• Information on standalone algorithm performance.
• Details on the type of ground truth used (beyond implying mechanical and material properties typical for examination gloves).
• Sample size for the training set.
• How ground truth for the training set was established.

This document is a regulatory approval letter based on "substantial equivalence" to existing devices, which typically relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate, or if there are differences, that those differences do not raise new questions of safety and effectiveness. The performance criteria for examination gloves would typically involve standards for tensile strength, elongation, barrier integrity (e.g., freedom from holes), and biocompatibility, which are usually tested against established industry or regulatory standards rather than through clinical studies with expert-adjudicated ground truth as might be seen for AI/ML diagnostic devices.

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This surgeon's glove is a device made of Synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Powder Free White Sterile Polyisoprene Surgical Gloves

This document is a 510(k) clearance letter from the FDA for Powder Free White Sterile Polyisoprene Surgical Gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information on acceptance criteria, a specific study proving the device meets the acceptance criteria, or any of the detailed study parameters requested in the prompt.

Instead, the letter primarily focuses on:

• Confirming the substantial equivalence of the device.
• Stating its regulatory classification (Class I, Product Code KGO).
• Outlining the general controls provisions of the Federal Food, Drug, and Cosmetic Act that the manufacturer must comply with.
• Providing contact information for various FDA offices.
• Listing the "Indication For Use" of the surgical gloves.

Therefore, I cannot provide the requested table and study details based on the provided text.

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Powder-Free Blue Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between Examiner and Patient. Tested for use with Chemotherapy Drugs as listed below.

Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs.

The provided document describes the FDA 510(k) clearance for "Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs" (K102623). It includes information about the indications for use and a table presenting the permeation times of various chemotherapy drugs through the gloves.

Based on the information provided, 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

The acceptance criteria for the gloves, specifically regarding chemotherapy drug permeation, are implicitly defined by the reported breakthrough detection times in minutes for a list of chemotherapy drugs. Although explicit "acceptance criteria" values are not stated (e.g., "must be greater than X minutes"), the table presents the performance of the device against these drugs. The key benchmark for acceptability appears to be practical protection during use.

Note regarding Carmustine: The document explicitly states, "Please note that Carmustine has an extremely low permeation time of less than 30 minutes." This acts as an important cautionary note, implying that while the glove was tested with Carmustine, its performance for this specific drug is significantly lower than for others and might not meet a reasonable expectation for prolonged protection during chemotherapy handling.

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 for Test Set: The document does not specify the sample size (i.e., how many gloves were tested for each chemotherapy drug). It only presents the breakthrough detection times.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that this is an FDA submission for a device manufactured by "PT. Medisafe Technologies JL. Batang Kuis GG. Tambak Rejo Desa Buntu Bedimbar TJ. Morawa Medan, North Sumatera Indonesia," it is highly probable that the testing was conducted either in Indonesia or at an accredited laboratory, but this is not confirmed by the document. The study would have been prospective to generate this performance 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 type of information is not applicable to this device. The "ground truth" for glove permeation is established through laboratory testing using standardized methods (e.g., ASTM F739 - Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact). It does not involve human experts or their consensus for establishing the data in the permeation table.

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

This information is not applicable to this device. Adjudication methods are typically used in studies involving subjective interpretation (e.g., radiology image reading). Glove permeation testing is an objective laboratory measurement.

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 to this device. An MRMC study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. This is a protective barrier device, and its effectiveness is measured through physical and chemical property testing, not cognitive performance improvement.

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

This information is not applicable and is framed incorrectly for this device. A "standalone" performance refers to an AI algorithm's performance without human interaction. This device is a physical barrier; its performance is inherently standalone in the sense that its protective properties are measured intrinsically without human intervention in the permeation process itself.

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

The "ground truth" for the performance data presented is derived from objective laboratory testing using standardized chemical permeation methods. This involves measuring the time it takes for specific chemotherapy drugs to permeate through the glove material under controlled conditions. This is a scientific measurement, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable to this device. "Training set" refers to data used to train machine learning models. This device is not an AI/ML device; its performance is based on intrinsic material properties.

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

This information is not applicable to this device, as there is no training set involved.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Black Nitrile Examination Gloves

This document is an FDA 510(k) clearance letter for "Powder Free Black Nitrile Examination Gloves." It does not contain any information about an AI/ML device, its acceptance criteria, or a study proving its performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study from this document. The document primarily focuses on regulatory approval for a physical medical device (gloves) based on substantial equivalence to existing products.

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The device is a disposable examination glove made of synthetic rubber intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner or when handling cytotoxic drugs listed below:

• Carmustine (BiCNU);
• Cyclophosphamide;
• Doxorubicin Hydrochloride;
• 5-Fluorouracil;
• Cisplatin;
• Etoposide;
• Paclitaxel:
• Thio-Tepa
• Dacarbazine

The device is a disposable examination glove made of synthetic rubber intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner or when handling cytotoxic drugs listed below:

• Carmustine (BiCNU);
• Cyclophosphamide;
• Doxorubicin Hydrochloride;
• 5-Fluorouracil;
• Cisplatin;
• Etoposide;
• Paclitaxel:
• Thio-Tepa
• Dacarbazine

The provided document is a 510(k) clearance letter from the FDA for "Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemo Therapy Drugs". This document does not contain any information about acceptance criteria or a study proving device performance related to an AI/ML context.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices, allowing the manufacturer to market it. The "acceptance criteria" mentioned in the request refer to performance metrics typically used for AI/ML devices (e.g., sensitivity, specificity, AUC), while this document is for a physical medical glove.

Therefore, I cannot extract the requested information from this document.

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The device is a disposable synthetic rubber examination glove intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner.

Not Found

This document is a 510(k) clearance letter for Powder Free, Sterilized, Polychloroprene Examination Gloves. It focuses on the regulatory approval of the device and does not contain information about acceptance criteria or a study proving its performance. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, which means that its performance is presumed to be similar to existing approved devices.

Therefore, I cannot provide the requested information based on this document.

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