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A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

WARNING: Do not use with Carmustine (BCNU) (3.3 mg/m1)

CAUTION: Testing showed an average breakthrough time of 40.3 minutes with Thiotepa (10 mg/ml).

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using polyisoprene and neoprene, which are synthetic rubber latex. The gloves are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.

Please find the requested information regarding the acceptance criteria and study details below.

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size for Test Set: The document does not explicitly state the sample size for each specific test (e.g., how many gloves were tested for permeation, how many samples for biocompatibility). However, it indicates compliance with standards like ASTM D3577 and ASTM D6978, which would inherently dictate minimum sample sizes for their respective tests.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The tests are reported as "conducted for determination of substantial equivalence."

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

• Not applicable. This device is a surgical glove, and the "ground truth" for its performance is established through standardized laboratory tests (e.g., chemical permeation, physical properties) as per ASTM and ISO standards, not through expert consensus on interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set:

• Not applicable. As noted above, performance is determined by objective laboratory measurements against established standards, not through adjudication of expert opinions.

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 medical device (surgical glove), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant.

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

• Not applicable. This is a physical medical device (surgical glove), not an algorithm or AI system.

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

• The "ground truth" for the device's performance is based on objective measurements and results from standardized laboratory tests according to recognized industry standards (e.g., ASTM D6978 for chemotherapy drug permeation, ASTM D3577 for physical properties, ISO 10993 for biocompatibility).

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model that requires a "training set."

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

• Not applicable. As above, no training set is relevant for this 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.

The proposed device is a disposable device intended for over the counter use. It is not made with natural rubber latex. Instead, the gloves are formulated using vinyl synthetic polymer. The glove is coated with an emollient coating. The gloves are manufactured using molds that are ambidextrous. They are offered powder-free and non-sterile.

The provided document describes the acceptance criteria and performance data for the Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu-Thera® Coating. This is a medical device application for examination gloves, and therefore the "device" in this context refers to these gloves.

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

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document does not explicitly state the sample size for each specific test mentioned (e.g., how many gloves were tested for freedom from holes or powder residual). It refers to compliance with ISO and ASTM standards, which would define appropriate sample sizes for these types of tests.

The data provenance is from non-clinical tests conducted by Cardinal Health, Inc. This is prospective testing performed on the device itself. There is no information regarding country of origin for the data beyond being submitted by a US-based company for FDA approval in the US.

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 in this context. The "ground truth" for a medical device like examination gloves is typically established through adherence to recognized international and national consensus standards (like ISO and ASTM) and regulatory requirements (like 21 CFR). These standards define objective, measurable performance criteria. Expert judgment, while informing the development of such standards, is not directly applied on a case-by-case basis to "establish ground truth" for individual glove performance during testing in the way it would be for, say, image interpretation in AI.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used when there's subjective interpretation involved, such as in clinical trials or when establishing ground truth from multiple expert readings. For objective physical and chemical tests of a medical device like gloves, the results are derived directly from the test methods and interpreted against the defined criteria in the standards.

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 is not applicable. An MRMC comparative effectiveness study is relevant for AI-powered diagnostic devices or tools that assist human interpreters (e.g., radiologists interpreting images). The device in question is an examination glove, which does not involve human "readers" or AI assistance in this manner.

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

This is not applicable. This question pertains to AI/algorithm performance. The device is a physical product (gloves) and does not involve any algorithms.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on accepted international and national consensus standards and regulatory requirements. Specifically:

• Biocompatibility: ISO 10993-10 standards.
• Physical Characteristics (Dimensions, Physical Properties, Freedom from Holes, Powder Residual): ASTM D5250, ASTM D5151, ASTM D6124, and 21 CFR 800.20.

These standards define the objective performance benchmarks that the gloves must meet.

8. The Sample Size for the Training Set

This is not applicable. This question refers to the training of an AI model. The device (examination gloves) does not utilize a training set in the context of machine learning.

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

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

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A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using polyisoprene, which is a synthetic rubber latex, and is brown in color. The glove is coated with hydrogel polymer coating.

The gloves are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.

This glove is suitable for use as a specialty surgical glove intended for orthopedic procedures or other procedures where a thicker barrier may be desired such as trauma and reconstructive surgery

The document describes the acceptance criteria and study for the Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating. This is a medical device, and the study focuses on its physical and biological performance against established standards rather than artificial intelligence or diagnostic capabilities. Therefore, some of the requested information regarding AI-specific elements (like human reader improvement with AI, ground truth for training sets, etc.) is not applicable.

Here's the information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the specific tests (e.g., number of gloves tested for freedom from holes, number of animals for biocompatibility). It refers to meeting standards like ASTM D3577 and ISO 10993-10, which would define appropriate sample sizes within their methodologies.

Data provenance is not specified as "country of origin" or "retrospective/prospective" in the context of device testing. The tests are conducted according to recognized international and national standards (ISO, ASTM, CFR).

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

This information is not applicable. The device is a surgical glove, and its performance is evaluated against established technical and biological standards, not through expert-labeled ground truth like in diagnostic AI studies.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation involves meeting predefined technical specifications and standards rather than human adjudication of results.

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

This information is not applicable. This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant.

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

This information is not applicable. This is not an algorithm or AI device. The tests described are for the physical and biological characteristics of a surgical glove.

7. The Type of Ground Truth Used

The "ground truth" used is defined by established regulatory standards and recognized consensus standards (e.g., ASTM D3577 for physical properties and freedom from holes, ISO 10993-10 for biocompatibility, and 21 CFR 800.20 for freedom from holes). For example, a glove either meets the specified AQL (Acceptable Quality Level) for freedom from holes or it does not. Similarly, it either causes irritation/sensitization or it does not, according to the test protocols.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI or machine learning device and therefore does not have a "training set."

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

This information is not applicable for the reason mentioned above.

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A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using neoprene synthetic polymer and are coated with nitrile coating and is yellow in color.

The glove are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.

The provided document describes the acceptance criteria and the study for "Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)." This is a medical device, specifically a surgical glove, and the study focuses on its physical properties, biocompatibility, and resistance to chemotherapy drug permeation. There is no AI component mentioned in this documentation, therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training) are not applicable.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against various standards, primarily ASTM D3577 for surgical gloves and ASTM D6978 for chemotherapy drug permeation.

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

The document does not explicitly state the sample sizes for the various material tests. However, the tests are laboratory-based, adhering to international and ASTM standards. The provenance of the data is from Cardinal Health's testing, conducted for the purpose of FDA submission. The studies are by nature prospective, as they are performed on the device to prove its compliance with standards.

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

Not applicable. These are physical and chemical performance tests, not clinical evaluations requiring human expert interpretation in the context of medical images or diagnoses. The "ground truth" for these tests is defined by the standards themselves (e.g., a specific breakthrough time, a dimensional tolerance, a AQL limit).

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements against predefined criteria/standards.

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 device is a surgical glove, not an AI-powered diagnostic tool. There are no human readers or AI involved in its performance evaluation as described.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for performance assessment is based on established industry standards and regulatory requirements. For example:

• Physical properties (dimensions, tensile strength) are compared against ASTM D3577.
• Freedom from holes is assessed against 21 CFR 800.20 and ASTM D3577 AQL 1.5, using ASTM D5151.
• Powder residual is assessed against ASTM D3577 (< 2mg/glove), using ASTM D6124.
• Biocompatibility is assessed against ISO 10993-10 guidance (non-irritating, non-sensitizing).
• Chemotherapy drug permeation is assessed against ASTM D6978 (minimum breakthrough detection time).

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. This is a physical device, not an AI algorithm.

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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.

The proposed device is a disposable device intended for over the counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. Gloves are not made with natural rubber latex. The glove color is cool blue.

This device submission (K122696) is for Powder-Free Nitrile Examination Gloves (Cool Blue). It is a medical device designed to prevent contamination between patients and examiners. The submission focuses on demonstrating substantial equivalence to a predicate device by meeting established performance standards for patient examination gloves.

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

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 specific sample sizes used for each individual test (e.g., number of gloves tested for freedom from holes, number of animals for biocompatibility). However, it indicates that the tests were conducted according to recognized standards like ASTM D6319, ISO 10993-10, and 21 CFR 800.20. These standards typically define appropriate sampling plans and sample sizes for their respective tests.

The data provenance is retrospective, as the tests were conducted and summarized to demonstrate that the manufactured gloves meet the pre-defined performance standards. The country of origin of the data is not specified beyond where the testing facilities are located, which is also not detailed in the provided text.

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

This submission does not involve expert-established ground truth in the traditional sense of clinical studies. The "ground truth" for this device is based on established industry standards and regulatory requirements (e.g., ASTM D6319, ISO 10993-10, 21 CFR 800.20). These standards themselves were developed through expert consensus within their respective fields, but the submission itself does not detail the specific experts involved in the testing or analysis of the results. The determination of "meets requirements" is based on objective measurements against these standards.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective measurements against pre-defined quantitative or qualitative criteria within the referenced standards. There is no subjective interpretation requiring an adjudication method like 2+1 or 3+1.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or interpretive devices where human interpretation is a critical factor, often comparing human performance with and without AI assistance. This device is a medical glove, and its effectiveness is determined by objective physical and biocompatibility properties, not interpretive performance.

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

Yes, the studies presented are essentially standalone performance studies. The "device" in this context is the physical glove, and its performance is evaluated against material and physical specifications documented in the referenced standards (ASTM D6319, ISO 10993-10, etc.). There is no "algorithm" or "human-in-the-loop" component to the glove's function that would require a separate evaluation. The tests measure the intrinsic properties of the glove itself.

7. Type of Ground Truth Used:

The ground truth used is based on established industry standards and regulatory requirements.

• Biocompatibility: Standards like ISO 10993-10 define acceptable levels of irritation and sensitization.
• Physical Characteristics: Standards like ASTM D6319 define acceptable dimensions, physical properties (e.g., tensile strength, elongation), freedom from holes (water leak test), and powder residual limits.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML-based device that requires a training set. The "device" is a physical product, and its performance is assessed through traditional engineering and material science testing methods, not through machine learning.

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

The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. The glove is made with natural rubber latex and is cream in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.

Here's a summary of the acceptance criteria and study information for the Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves (Cream), based on the provided text:

Acceptance Criteria and Device Performance

The device is a modified version of an already cleared predicate device (K120934). The primary modification is the removal of colorant from the glove formulation. The acceptance criteria and performance are based on meeting established industry standards for surgical gloves and demonstrating substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for dimensions, holes, protein content). It refers to compliance with established ASTM and ISO standards, which would typically specify sampling plans.

The data provenance is non-clinical performance testing, conducted by the manufacturer, Cardinal Health, in the context of a 510(k) submission to demonstrate substantial equivalence to a predicate device. The document does not provide details on country of origin of the data beyond "Cardinal Health" as the applicant.

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 medical glove, and the "ground truth" is established by adherence to recognized performance standards (ASTM, ISO) and laboratory testing methodologies, not by expert interpretation of images or clinical data.

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

This information is not applicable. Adjudication methods are typically relevant for studies involving subjective human interpretation (e.g., clinical trials or diagnostic accuracy studies) to resolve disagreements among observers. For physical and chemical testing of a medical device like a glove, the results are typically quantitative measurements against defined criteria.

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. An MRMC study is relevant for evaluating diagnostic imaging or AI-assisted diagnostic tools. This submission pertains to surgical gloves, which do not involve human readers interpreting cases or AI assistance.

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

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

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

The "ground truth" for the device's performance is based on objective measurements and results from standardized laboratory tests that demonstrate compliance with national and international standards (ASTM D3577, 21 CFR 800.20, ASTM D5151, ASTM D6124, ASTM D5712, ISO 10993-1, ISO 10993-10). The predicate device's prior clearance serves as the benchmark for substantial equivalence.

8. The sample size for the training set:

This information is not applicable. This is not a machine learning or AI-driven device, so there is no "training set." The device is manufactured according to specifications and tested against 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 sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. It is made with natural rubber latex and is tan in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.

The provided text describes the acceptance criteria and performance of the Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves. No study proving the device meets the acceptance criteria is detailed in the submission; rather, the document declares that the device meets existing standards and requirements.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each test (e.g., for physical properties, protein content, or biocompatibility). It states that testing was performed according to specific ASTM and ISO standards, which would imply certain sample size requirements within those standards. However, the specific numbers are not reported.

The data provenance is not explicitly stated in terms of country of origin, nor is it explicitly labeled as retrospective or prospective. It is implied to be data collected as part of the device's development and testing for this premarket notification.

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

This information is not applicable to the device described. The device is a surgical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM, ISO, CFR) rather than against expert-established ground truth in a diagnostic or interpretive sense. The "ground truth" here is the adherence to these published standards.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation or assessment is involved (e.g., medical image reading). Since this submission concerns a physical medical device (surgical gloves) and its compliance with technical standards, such adjudication methods are not relevant or described. The tests are objective measurements against defined criteria.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or interpretive devices where human readers are involved. For surgical gloves, the evaluation focuses on meeting predefined physical and biochemical standards.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical product, not an algorithm, so a standalone study in this context is irrelevant.

7. Type of Ground Truth Used

The "ground truth" used is defined by adherence to established industry and regulatory standards. Specifically:

• ASTM D3577 (for dimensions, physical properties, freedom from holes, powder residual)
• 21 CFR 800.20 (for AQL in freedom from holes)
• ASTM D6124 (for testing powder residual)
• ASTM D5712 (for protein content)
• FDA Medical Glove Guidance Manual (for protein content)
• ISO 10993-1 (for biocompatibility)
• ISO 10993-10 (for primary skin irritation and guinea pig maximization)

8. Sample Size for the Training Set

Not applicable. This device is a physical medical product, not an AI/ML algorithm that requires a training set.

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

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

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

The proposed device is a disposable device intended for over the counter use and is provided powder-free sterile. It is made with natural rubber latex. The glove is coated with nitrile coating. The glove is manufactured using exact same material used in the currently cleared device, Protegrity Blue glove (K053272). The glove is coated with emollient coating (containing Glycerol. Gluconolactone, D-Sorbitol and Provitamin-B). The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down.

The provided text describes the acceptance criteria and performance of Cardinal Health Protexis™ Latex Powder-Free Blue Surgical Gloves with Neu-Thera® Coating. It is a 510(k) submission, meaning the device is seeking substantial equivalence to a legally marketed predicate device, not necessarily proving revolutionary new efficacy.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of typical AI/software device studies. Instead, it refers to performance testing of the physical glove. The sample sizes for each specific test (e.g., biocompatibility, physical properties, freedom from holes) are not explicitly stated in this summary. It only indicates that tests were performed "in accordance with" the specified ASTM and ISO standards, which would imply a defined sample size for each test within those standards.

The data provenance is from non-clinical tests performed by Cardinal Health (the applicant). There is no mention of country of origin for the data, but the company is based in McGaw Park, IL, USA. The studies are prospective in the sense that they are conducted to demonstrate the properties of the manufactured glove for regulatory submission.

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

This information is not applicable to this type of device and study. The "ground truth" for glove performance characteristics (dimensions, hole-free, protein content, etc.) is established by adherence to standardized measurement protocols defined by ASTM and ISO, rather than expert consensus. For biocompatibility, the "ground truth" on irritation and sensitization is determined by the results of standardized animal tests as per ISO 10993-10. There are no human experts involved in establishing a "ground truth" in the way one would for a diagnostic AI study.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are typically used in clinical studies or expert-based evaluation of medical images or diagnoses, not for the physical and biological testing of a surgical glove as described here. The results are objective measurements against defined standards.

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, an MRMC comparative effectiveness study was not done. This device is a surgical glove, not an AI or diagnostic tool that assists human "readers" or practitioners in interpreting information.

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

No, a standalone performance study in the context of an algorithm or AI is not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on standardized test methods and predetermined criteria outlined in the referenced ASTM and ISO standards, and FDA regulations (21 CFR 800.20):

• Physical Characteristics: Measured values (e.g., dimensions, force at break, elongation, powder residual, protein content) are compared against the numerical thresholds and ranges specified in ASTM D3577, ASTM D6124, ASTM D5712, and 21 CFR 800.20.
• Biocompatibility: The observed biological responses (skin irritation, sensitization potential) in animal models are evaluated against the criteria for "non-irritating" and "no potential for sensitization" as established by ISO 10993-10.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical product (surgical glove) and does not involve AI or machine learning, therefore, there is no "training set." The glove's manufacturing process is established and validated, not "trained."

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

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

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This powder-free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM m and the most go res world of Medical Gloves to Permeation by Chemotherapy Drugs.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is a synthetic rubber latex. This Sterile Polyisoprene Powder-Free Surgical Glove is manufactured using exact same material used in the currently cleared device, Esteem SMT glove (K093300) that has been legally marketed by Cardinal Health. The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. It is offered powder-free and sterile.

The provided document describes the safety and effectiveness summary for "Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs." This is for a medical device and not an AI or software device, therefore, the requested information elements related to AI/algorithm performance studies like sample size for test/training sets, data provenance, number/qualification of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.

The acceptance criteria and the study proving the device meets these criteria are related to the physical, chemical, and biological properties of the surgical gloves.

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

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for holes, or how many samples for biocompatibility). However, the tests were conducted according to recognized international and national standards (e.g., ISO 10993, ASTM D3577, ASTM D6978, 21 CFR 800.20), which typically specify appropriate sample sizes and methodologies.

The "data provenance" for this type of device (surgical gloves) would relate to the manufacturing and testing environment, not patient data. The tests are non-clinical, laboratory-based studies.

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

Not applicable. For surgical glove testing, "ground truth" is established by adherence to standardized test methods and criteria defined by organizations like ASTM and ISO, not by expert human consensus on medical images or diagnoses.

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

Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or for AI output evaluation. The tests performed for these gloves (e.g., physical properties, chemical permeation) are objective laboratory measurements, not requiring 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 device is a physical medical glove, not an AI or imaging diagnostic tool.

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

Not applicable. This device is a physical medical glove, not an AI or algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective laboratory measurements and adherence to predefined specifications and test standards. For example:

• Biocompatibility: Determined by standardized in-vivo (e.g., guinea pig maximization) and in-vitro tests following ISO 10993.
• Physical Properties: Measured against specifications in ASTM D3577.
• Freedom from Holes: Determined by testing according to ASTM D5151 and meeting AQL (Acceptable Quality Level) requirements specified in 21 CFR 800.20 & ASTM D3577.
• Powder Residual: Measured using ASTM D6124 to meet ASTM D3577 limits.
• Chemotherapy Drug Permeation: Measured as breakthrough time using ASTM D6978.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. This is a physical device, not an AI model.

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A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a sterile latex powder-free surgical glove that is formulated using natural rubber latex. The glove is coated with hydrogel polymer coating. The glove is manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile.

The provided document describes a 510(k) premarket notification for "Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating." This is a medical device, and the evaluation focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or a new clinical benefit through extensive clinical studies. Therefore, many of the typical elements of AI/software device studies (like MRMC studies, training set details, or complex ground truth establishment) are not applicable here.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with ASTM standards and regulatory requirements for surgical gloves. The "reported device performance" refers to the results of tests conducted to demonstrate this compliance.

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

The document does not explicitly state the granular sample sizes (e.g., number of gloves tested) for each specific test (e.g., how many gloves for a freedom from holes test, or how many guinea pigs for sensitization). However, it indicates that the tests met the requirements of the specified ASTM standards. These standards themselves define appropriate sampling plans and methodologies.

• Sample Size: Not explicitly given numerically, but implied to be sufficient to meet the statistical requirements of the cited ASTM standards and 21 CFR 800.20.
• Data Provenance: The tests were conducted by the applicant, Cardinal Health, Inc. Implicitly, these are prospective tests performed specifically for this 510(k) submission, likely performed at their own facilities or accredited contract labs. The country of origin of the data is the USA (applicant address in McGaw Park, IL).

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

For this type of device (surgical gloves), "ground truth" is established through standardized laboratory testing and chemical analysis, not through expert clinical interpretation in the same way an AI diagnostic device would.

• Number of Experts: Not applicable in the context of clinical expert review. The "experts" are the lab technicians, chemists, and quality engineers performing and interpreting the results of the ASTM and biocompatibility tests.
• Qualifications of Experts: Not specified, but assumed to be appropriately qualified personnel trained in performing the specific ASTM and ISO (for biocompatibility) test methods.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers interpret medical images or data. This is not applicable to the performance testing of surgical gloves. The results of the tests are based on objective measures and adherence to established protocols.

• Adjudication Method: Not applicable. Performance is determined by objective laboratory measurements against acceptance criteria.

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

No. An MRMC study is used to compare the performance of human readers, often with and without AI assistance, especially in radiology and pathology. This type of study is not relevant for the regulatory clearance of surgical gloves.

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

No, this is not an AI/algorithm device. The "device" is a physical product (surgical glove). Performance is measured directly through physical, chemical, and biological testing, not through an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance claims is based on:

• Standardized Laboratory Test Results: Objective measurements obtained through recognized and validated ASTM (American Society for Testing and Materials) methods for physical properties, powder residue, and protein content.
• Biocompatibility Test Results: Objective results from tests like Primary Skin Irritation and Guinea Pig Maximization, often following ISO standards for medical device biocompatibility.
• Regulatory Standards: Compliance with specific sections of the Code of Federal Regulations (e.g., 21 CFR 800.20 for freedom from holes).

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/machine learning device, there is no "training set." The device is manufactured using a defined process, and its performance is verified through testing samples, not by training a model.

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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