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Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.

Latex Surgical Gloves, Powder free with Protein Content Labeling Claim (50 micrograms or less)

This FDA 510(k) clearance letter for "Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)" does not contain information about software or AI-powered medical devices. Therefore, it does not include acceptance criteria or a study proving that a device meets those criteria in the context of an AI/software device.

The document is for a physical medical device (surgical gloves) and concerns its substantial equivalence to a predicate device based on its physical properties and intended use. The content is typical for a 510(k) clearance for a Class I medical device like gloves, focusing on regulatory compliance rather than performance studies of an AI algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/software device based on the provided text. The prompt's questions (sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, ground truth, training set size) are all relevant to the evaluation of AI/software devices, but not to the "Latex Surgical Gloves" discussed in this FDA letter.

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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.

The device is a class I latex patient examination gloves 21 CFR 880.6250, Patient Examination Glove, LYY made by surface treatment on the inner and anti-tack coating on outer surface. The process modifies the surface characteristics that assist the user in donning the gloves with ease without the use of any dusting or donning powder is substantially equivalent in safety and effectiveness to the predicate device.

They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large.

The provided document is a 510(k) Premarket Notification for a Latex Examination Glove. It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This document does not describe an AI/ML-driven medical device. Therefore, it does not contain the information requested about acceptance criteria and a study proving an AI/ML device meets acceptance criteria.

The questions posed relate to the development and validation of an AI/ML device, which typically involves data sets, expert labeling, ground truth establishment, and performance metrics like sensitivity, specificity, or AUC. The provided text, however, focuses on:

• Physical properties of rubber gloves: Dimensions, tensile strength, elongation, freedom from holes, residual powder, and protein content.
• Biocompatibility testing: Skin irritation, dermal sensitization, and acute systemic toxicity.
• Comparison to a predicate device: Highlighting similarities in intended use, materials, and compliance with standards.

Since the document is for a physical medical product (gloves) and not an AI/ML device, I cannot extract the information required to answer your specific questions.

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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 Nitrile Examination Glove, Black and dual color White-Blue are Class 1 Patient Examination Gloves. The dual color White-Blue is made dual color by double dipping. They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large, Double Extra-Large and Triple Extra-Large.

This document describes the premarket notification (510(k)) for Powder Free Nitrile Examination Gloves (Black and Dual Color White-Blue) from Careplus (M) SDN BHD. This is for an examination glove, a Class I reserved device (21 CFR 880.6250) intended for medical purposes to prevent contamination between patient and examiner.

Here's an analysis of the acceptance criteria and study information provided:

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)

The document does not explicitly state the specific sample sizes used for each test. Instead, it indicates that the "performance test data from the non-clinical test met the specifications from ASTM testing methodology." ASTM standards for examination gloves (like D6319-19) typically define sampling plans for various tests (e.g., AQL for pinholes).

The data provenance is not specified beyond being generated by the device manufacturer, Careplus (M) SDN BHD, located in Seremban, Negeri Sembilan Darul Khusus, Malaysia. The studies are prospective in the sense that they were conducted to test the performance of the specific subject devices.

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 section is not applicable as the device is an examination glove, not an AI or diagnostic imaging device that requires expert interpretation to establish a "ground truth" for a test set. Its performance is evaluated against physical and chemical specifications and biocompatibility standards.

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

This section is not applicable. The performance evaluation for examination gloves typically involves objective measurements and scientific testing against established standards, not subjective adjudication by experts on a test set as would be found in AI/diagnostic studies.

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 section is not applicable. The device is an examination glove, not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant to this submission.

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

This section is not applicable. The device is a physical product (an examination glove), not an algorithm or AI system.

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

The "ground truth" for this device's performance is established by objective measurements and adherence to recognized international standards such as ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application) and ISO 10993 (Biological evaluation of medical devices for biocompatibility). For example:

• Pin-hole detection is measured against an Acceptable Quality Level (AQL).
• Physical properties like tensile strength, elongation, and dimensions are tested against minimum/maximum values specified in the ASTM standard.
• Biocompatibility is assessed through standardized tests (e.g., skin irritation, sensitization, acute systemic toxicity, in vitro cytotoxicity) as per ISO 10993, with predefined criteria for "no irritant response," "no skin sensitization effect," etc.

8. The sample size for the training set

This section is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."

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

This section is not applicable for the same reasons as point 8.

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Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:

"WARNING: Do not use with Carmustine and Thiotepa"

It is the powder-free variation of the class I sterile latex surgical gloves made on-line by surface treatment on the outside and polymer coating on inner surface.

The provided text is related to the 510(k) premarket notification for surgical gloves and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment as it pertains to an AI/ML device.

The document details the substantial equivalence of new surgical gloves to a legally marketed predicate device based on various physical, chemical, and biocompatibility tests, as well as their resistance to chemotherapy drugs. It explicitly states that "Clinical testing is not applicable to this device." This confirms that there was no study involving human readers or AI in the way your prompt describes.

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Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:

"WARNING: Do not use with Carmustine and Thiotepa"

Not Found

The provided text describes the FDA's 510(k) clearance for "ENCORE Latex Ortho" and "GAMMEX Latex Ortho" powder-free latex surgical gloves. This document is a clearance letter for a medical device (surgical gloves), not a study report for an AI/CADeX device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and studies that prove the device meets those criteria in the context of AI/CADeX devices.

The document primarily focuses on:

• Substantial equivalence to legally marketed predicate devices.
• General controls provisions for medical devices.
• Indications for Use for the surgical gloves, which includes their testing for use with chemotherapy drugs as per ASTM D6978.

However, based on the provided text, I can extract the acceptance criteria related to chemotherapy drug permeation for these gloves as a device performance specification.

Here's the closest I can get to fulfilling your request based only on the provided text, reinterpreting the "device" as the surgical gloves and the "study" as the chemotherapy drug permeation testing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" where the device is "Not for use" (e.g., Carmustine, Thiotepa) implies that the breakthrough time observed (22.0 and 24.2 minutes respectively) was not considered adequate for safe use with these specific drugs, leading to the warning statement. For other drugs, the reported performance meets or exceeds the implicit acceptance criteria (i.e., ">240" meets ">240").

Regarding the remaining points (2-9), this information is NOT available in the provided text as it pertains to AI/CADeX device studies, not the clearance of surgical gloves.

• 2. Sample size used for the test set and the data provenance: Not applicable. The text describes testing of physical gloves against chemotherapy drugs, not a data-driven AI model.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for glove permeation is established by laboratory measurement using a standard (ASTM D6978).
• 4. Adjudication method: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• 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 chemotherapy permeation, the ground truth is objective laboratory measurement according to ASTM D6978.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:

"WARNING: Do not use Carmustine and Thiotepa"

It is the powder-free variation of the class I sterile latex surgical gloves made by on-line polymer and anti-tack coating on inner and outer surface. The process modifies the surface istics and causes it to remain tack-free without the use of any dusting or donning powder. The device size comes in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577 with dimension as below:

The provided document is a 510(k) Premarket Notification for a medical device: ENCORE® Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs, Non-Pyrogenic.

This document outlines the testing performed to demonstrate substantial equivalence to a predicate device, focusing on performance characteristics and safety measures for surgical gloves, rather than an AI/ML device that requires acceptance criteria and a study to prove its performance in the context of human improvement or standalone algorithm capability.

Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device, such as those related to:

• A table of acceptance criteria and reported device performance (in the context of AI metrics like sensitivity, specificity, etc.)
• Sample sizes for test sets and data provenance (for AI model evaluation)
• Number of experts and their qualifications for ground truth establishment
• Adjudication methods
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies
• Standalone algorithm performance
• Type of ground truth (for AI diagnosis/detection)
• Training set sample size and ground truth establishment

cannot be extracted from this document because it describes a Class I medical device (surgical gloves) which undergoes physical, chemical, and biocompatibility testing, not AI/ML model validation.

However, I can extract the acceptance criteria and performance data relevant to this specific device (surgical gloves) as presented in the document:

The document focuses on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device (K983489, Encore Mark IV Powder Free Surgical Gloves). Substantial equivalence is shown through various performance tests against established ASTM and ISO standards.

Acceptance Criteria and Reported Device Performance (for Surgical Gloves):

Here's a table summarizing the acceptance criteria (standards/minimums) and the performance of the "Subject Glove" (ENCORE® Latex Textured Surgical Gloves) as reported in the "Technological Comparison Table" and "Chemotherapy Drug Permeation" section:

Additional Information from the document:

• Sample sizes used for the test set and the data provenance: The document does not specify exact sample sizes for each test (e.g., how many gloves were tested for holes, dimensions, etc.), only that tests were conducted according to specified ASTM and ISO standards. The data provenance is from non-clinical testing conducted by the manufacturer (Careplus (M) SDN BHD) in Malaysia. The tests are prospective in the sense that they are performed on the device to demonstrate compliance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical/chemical tests on a medical device, not a diagnosis or detection task requiring expert consensus on ground truth.
• Adjudication method: Not applicable for these types of tests.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is for AI/ML diagnostic devices, not surgical gloves.
• Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable. This is for AI/ML devices.
• The type of ground truth used: The ground truth for this device's performance is established by objective measurements against defined international standards (ASTM, ISO) for physical properties (e.g., dimensions, tensile strength), chemical properties (e.g., powder content, protein content, chemotherapy permeation), and biological safety (biocompatibility tests).
• The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
• How the ground truth for the training set was established: Not applicable.

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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. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest

This document is a 510(k) premarket notification acceptance letter from the FDA for Nitrilecare Nitrile Examination Gloves. It primarily deals with the substantial equivalence determination for a medical device and its general regulatory compliance.

Therefore, this document does not contain the information requested regarding:

• Acceptance criteria and reported device performance for an AI/CAD/software device, or any device requiring such a study. The table in the document relates to drug permeation times for gloves, not performance metrics of a diagnostic or therapeutic device.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document is a regulatory approval letter for examination gloves. The "study" mentioned is a chemotherapy drug permeation test for the gloves, not a clinical performance study involving AI or human reader improvement.

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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.

LATEX EXAMINATION GLOVE POWDER FREE

This document is a 510(k) premarket notification letter from the FDA regarding a Latex Examination Glove Powder Free. It does NOT contain information about acceptance criteria, device performance, a study, or any of the specific details requested in your prompt (such as sample size, data provenance, ground truth, or MRMC studies).

This document is solely an approval letter for a medical device that falls under general controls.

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A powder-free 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 NITRILE EXAMINATION GLOVE, WHITE

I am sorry, but the provided document is a letter from the FDA regarding the 510(k) clearance for a "Powder Free Nitrile Examination Glove, White". It details the regulatory classification and indications for use of the device.

This document does not contain information about:

• Acceptance criteria and reported device performance (in a table or otherwise).
• Details of a study (sample sizes, data provenance, ground truth, expert qualifications, adjudication methods).
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Training set details.

Therefore, I cannot fulfill your request for this specific document as the information you are asking for is not present within the provided text.

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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.

It is the powder-free variation of the class I latex patient examination gloves made by online polymer-coating and on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive to the powdered version of the same gloves.

The provided text describes the acceptance criteria and performance of a medical device, specifically a "Powder Free Nitrile Examination Glove, Blue (Colored)". The device is being submitted for 510(k) premarket notification to establish substantial equivalence to a legally marketed predicate device.

Here's the breakdown of the information requested:

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 used for each specific test (e.g., how many gloves were tested for water tightness, physical properties, or powder content).
• For biocompatibility tests, it mentions "No Animal Irritation" and "No Animal Sensitization," implying animal studies were conducted, but the number of animals or the specific details of the studies are not provided.
• Data Provenance: The manufacturing company is "Careplus (M) SDN BHD" located in Malaysia. The tests were presumably conducted as part of their manufacturing and quality control process. The studies appear to be prospective as they are conducted to demonstrate the performance of the device for regulatory submission.

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

• This information is not provided in the document. The "ground truth" for these types of physical and biocompatibility tests on medical gloves is typically established by laboratory testing against defined ASTM and ISO standards, rather than expert consensus on subjective data.

4. Adjudication Method for the Test Set

• This information is not applicable for the type of tests conducted. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image-based diagnostics where human readers interpret data, and discrepancies need to be resolved. The tests mentioned here are objective laboratory measurements.

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. This document describes a physical medical device (examination gloves), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance is relevant.

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

• This information is not applicable to this device, as it is not an algorithm or AI system.

7. The Type of Ground Truth Used

• The ground truth for this device's performance is established by objective measurements against established national and international standards. These include:
  • Physical Property Standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06
  • Biocompatibility Standards: ISO 10993-10, 16CFR Part 1500
• The results are compared directly to the quantitative requirements specified in these standards.

8. The Sample Size for the Training Set

• This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

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

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