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Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloyes were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The document describes the acceptance criteria and performance of a "Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim." This is a medical device, not an AI/ML device, and thus the acceptance criteria and study data provided are for a physical product, not an algorithm's performance.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and how ground truth for training set was established) are not applicable to this type of device and are not provided in the document.

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

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the performance criteria is described as follows:

• Methodology: "These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard practice outlines the procedure for testing the resistance of medical gloves to permeation by chemotherapy drugs.

Details specific to AI/ML device studies (as requested in the prompt but not applicable here):

2. Sample size used for the test set and the data provenance: Not applicable. For this physical glove, the "test set" would be the number of gloves tested and the specific conditions per the ASTM standard. This information is not provided beyond the reference to the standard.
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 a physical glove's chemical resistance is established by laboratory measurements according to a standard.
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.
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 (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance of the chemotherapy drug permeation is established through laboratory testing following the specific protocols of ASTM D6978-05 (Reapproved 2013). This involves precise measurement of breakthrough detection time.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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A powder free latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.

Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile will meet all the current specification for ASTM D3578.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Natural Rubber Latex Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each of the tests (Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Soluble Protein Level, Biocompatibility).

The data provenance is not specified beyond indicating these are "performance test data." It is highly likely these were conducted as prospective tests by the manufacturer, specifically for this submission. The country of origin of the data would be Malaysia, where WEAR SAFE (MALAYSIA) SDN. BHD. is located and conducted the testing.

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 tests performed are objective, laboratory-based physical and chemical assays, and biocompatibility tests. They rely on standardized methods rather than expert interpretation of data like in an imaging study. Therefore, the concept of "experts establishing ground truth" in the way it might apply to medical imaging or diagnostics is not directly relevant here. The ground truth for these tests is defined by the objective measurement criteria of the specified ASTM and CFR standards.

4. Adjudication method for the test set:

Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple readers might disagree on findings (e.g., radiologists interpreting images). Since these are objective physical, chemical, and biocompatibility tests, no adjudication method in this sense would have been used. The results are based on direct measurements and observations according to the test 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:

No MRMC comparative effectiveness study was done. This device is a patient examination glove, a physical product, not an AI-powered diagnostic or assistive technology. The concept of "human readers improving with AI assistance" is not applicable to this type of device.

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

No standalone algorithm performance study was done. This is a physical non-AI device.

7. The type of ground truth used:

The ground truth for these tests is based on objective measurement criteria and thresholds defined by established international standards:

• ASTM D3578-05 for Dimensions
• ASTM D 412-06ae1 for Physical Properties
• ASTM D 5151-06 for Freedom from pin-holes
• ASTM D 6124-06 for Powder Free Residue
• ASTM D 5712-05 for Soluble Protein Level
• ASTM F720-81 for Dermal Sensitization
• 16CFR Part 1500 for Primary Skin Irritation Test

These standards specify the methodology and acceptable limits for each characteristic.

8. The sample size for the training set:

Not applicable. This 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:

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

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A powder free nitrile examination glove is a disposable device made of synthetic material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants. In addition, this product is tested for use with chemotherapy drugs.

Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile (Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D6319.

Here's a breakdown of the acceptance criteria and study information for the "Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non-Sterile (Chemotherapy Drug Protection Labeling Claim)" based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

(Note: The document states "Meets" for general characteristics, implying the device performance met the specified ASTM standards. For chemotherapy drug permeation, specific breakthrough times are provided as observed performance.)

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

The document does not explicitly state the sample size used for each specific test (e.g., number of gloves tested for pin-holes, or number of samples for each chemotherapy drug).

The data provenance is from Malaysia, as the submitting company, Wear Safe (Malaysia) Sdn. Bhd., is based in Malaysia. The studies appear to be prospective performance tests conducted on the device to demonstrate compliance with standards and for chemotherapy drug permeation.

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

Not applicable. This device is a physical product (examination gloves), and its performance is assessed against established physical and chemical standards (ASTM, 16CFR). The "ground truth" is defined by the technical specifications and test methodologies outlined in these standards, not by expert consensus in a clinical diagnostic sense. Therefore, no experts in the context of clinical interpretation or diagnosis were used to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the evaluation is based on objective measurements against established standards, not on subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC comparative effectiveness study is designed for evaluating diagnostic tools where human readers interpret medical images or data, often with and without AI assistance. This is not relevant for the performance evaluation of examination gloves.

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

Yes, in essence. The performance tests conducted for the gloves are "standalone" in the sense that they assess the intrinsic physical, chemical, and barrier properties of the glove material itself, without human intervention in the interpretation of results beyond standard laboratory procedures. There is no "algorithm" involved, but the device's performance is measured directly.

7. The Type of Ground Truth Used:

The ground truth used is based on established industry standards and regulatory specifications. Specifically:

• ASTM (American Society for Testing and Materials) Standards: For dimensions, physical properties, freedom from pin-holes, and powder-free residue.
• 16CFR Part 1500: For primary skin irritation.
• ASTM F720-81: For dermal sensitization.
• Chemotherapy Drug Permeation Testing: The "ground truth" for the chemotherapy drug claim is the measured breakthrough time of each specified drug through the glove material, which is an objective measurement based on a defined test methodology (though the specific standard for this permeation testing is not explicitly cited in the provided text, it is common practice to follow recognized standards like ASTM D6978).

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as no training set was used.

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A powder free polymer coated latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.

The Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein will meet all the current specification for ASTM D3578.

This document is a 510(k) summary for a medical device: "Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein."

Here's an analysis of the provided information, structured according to your request:

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 each specific test (e.g., dimensions, physical properties). It refers to the tests as complying with specific ASTM standards. ASTM standards themselves define the sampling plans and methodologies for testing.

The data provenance is not explicitly mentioned as "country of origin" for specific test results, but the submitter is "WEAR SAFE (MALAYSIA) SDN. BHD." and the device is manufactured in Malaysia. The studies would have been conducted by or for the manufacturer. The document does not specify if the studies were retrospective or prospective, but given the nature of product testing for conformity to standards, they would generally be prospective tests on manufactured batches.

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

This information is not applicable in the context of this device. The "ground truth" for examination gloves is defined by adherence to established engineering and material science standards (ASTM, CFR). There are no "experts" in the sense of medical professionals interpreting images or clinical outcomes to establish a ground truth for these physical and chemical tests. The "ground truth" is the objective measurement against the specified standard.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where there can be disagreement among experts (e.g., image interpretation). For the objective physical and chemical tests performed on examination gloves to meet ASTM standards, such adjudication methods are not relevant. The results are based on quantitative measurements or standardized qualitative assessments (e.g., presence/absence of failure).

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

No, an MRMC comparative effectiveness study was not done. These types of studies are relevant for diagnostic devices where human readers (e.g., radiologists) interpret data, and the AI's impact on their performance is being evaluated. This document is for examination gloves, which do not involve such interpretation.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This concept is applicable to AI/ML software devices. The device in question is a physical medical device (examination gloves), and its performance is evaluated through physical and chemical testing against established standards, not through algorithms.

7. Type of Ground Truth Used

The ground truth used is established engineering standards and regulatory requirements. Specifically, ASTM standards (D3578, D412, D5151, D6124, D5712, F720) and 16 CFR Part 1500 for biocompatibility, which define the acceptable limits and methodologies for various glove characteristics.

8. Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm that requires a "training set." Its performance is based on manufacturing processes and material properties, which are then verified through adherence to established testing standards.

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

This information is not applicable, as there is no "training set" for this device.

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A powder free polymer coated latex surgical glove is a disposable device made of natural rubber material intended to be worn by operating room personnel to protect a surgical wound from contamination.

The Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein will meet all the current specification for ASTM D3577.

Here's a breakdown of the acceptance criteria and study information for the "Powder Free Polymer Coated Latex Surgical Gloves" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not provide specific details on the sample size used for the tests to demonstrate compliance with the ASTM and ISO standards. It states that "The performance test data that support a determination of substantial equivalence are described above," referring to the "Device Performance" column in the table.

Regarding data provenance, the document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer is based in Malaysia.

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

This information is not applicable to this type of device and study. The testing for surgical gloves involves physical and chemical property assessments based on established international standards (ASTM, ISO), not expert interpretation of diagnostic images or patient outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation, such as in medical imaging, to resolve discrepancies among experts establishing ground truth. The tests for surgical gloves are objective measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which is not applicable to a physical medical device like surgical gloves.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone study was done in the sense that the device's performance was evaluated independently against the specified standards without human intervention influencing the device itself. However, this is not an "algorithm-only" study as the device is a physical product, not a software algorithm. The "Device Performance" column reflects the standalone performance of the gloves.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on established objective measurements and performance specifications defined by international standards (ASTM and ISO). For example:

• Dimensions: Measured directly and compared against ASTM D3577.
• Freedom from pin-holes: Evaluated according to ASTM D5151.
• Powder Free Residue: Measured according to ASTM D6124.
• Biocompatibility (Dermal Sensitization, Primary Skin Irritation): Assessed using standardized biological tests as per ISO 10993-10, with defined criteria for "not a contact skin sensitizer" and "not a primary skin irritant."

8. The Sample Size for the Training Set:

This information is not applicable. Surgical gloves are physical devices tested against predefined standards, not machine learning models that require training sets.

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

This information is not applicable as there is no training set for this type of device.

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A powder free polymer coated latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.

The Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm- of glove or less of water soluble protein will meet all the current specification for ASTM D3578.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for Wear Safe (Malaysia) Sdn.Bhd. Powder Free Polymer Coated Latex Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

Based on the provided document, the study conducted is a non-clinical performance evaluation against established standards for patient examination gloves.

2. Sample size used for the test set and the data provenance:
   The document does not specify the exact sample size used for each test. However, it indicates that the tests were performed according to specified ASTM and ISO standards, which inherently include sampling methodologies. The provenance of the data is Malaysia, as the manufacturer is "Wear Safe (Malaysia) Sdn.Bhd." The data is retrospective in the sense that it reflects testing performed on product samples to demonstrate compliance at the time of the 510(k) 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 applicable to this type of device and study. The "ground truth" for the performance characteristics is established by adherence to the highly standardized and objective testing methods outlined in the ASTM and ISO standards. These standards themselves are developed by expert committees, but the immediate study does not involve human expert adjudication of individual test results in the way it would for, say, diagnostic image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   None in the context of human expert adjudication. The "adjudication" is met by following the prescribed methodology of the ASTM and ISO standards. For instance, pinhole testing involves visual inspection of water-filled gloves, and if a leak is observed, it's a pinhole. There isn't an "expert consensus" on whether a pinhole exists; it's a direct observation.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted, and this type of study is not relevant for examination gloves. MRMC studies are typically performed for diagnostic devices (e.g., AI for radiology) where human interpretation is a key component. This device is a barrier protection product.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" is defined by the objective measurement and observation protocols outlined in the referenced ASTM and ISO standards. For example:

   • Dimensions: Measured against specified ranges in ASTM D3578.
   • Physical Properties: Tensile strength, elongation, etc., measured using ASTM D 412.
   • Freedom from pin-holes: Evaluated according to ASTM D 5151 (e.g., water leak test).
   • Powder Free Residue: Measured using ASTM D 6124.
   • Biocompatibility: Determined through specific in vivo (e.g., animal or human patch tests, though the document doesn't specify if human or animal for this submission) tests following ISO 10993-10 guidelines, where the "ground truth" is the observed biological response (e.g., absence of sensitization or irritation).

8. The sample size for the training set:
   Not applicable. There is no "training set" as this is a physical product, not a machine learning model.

9. How the ground truth for the training set was established:
   Not applicable. There is no training set for this type of device.

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