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These surgical gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with chemotherapy drugs, have low dermatitis potential, and are nonpyrogenic. 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.

Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber, are white in color, and are available in sizes 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy.

This document is a 510(k) premarket notification for a medical device: "Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential" (K230079). It compares the new device to a predicate device (K190018) and provides evidence of performance through various tests.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents a comparison of the subject device (K230079) against a predicate device (K190018) and also summarizes non-clinical testing. Below is a compilation of the acceptance criteria (standards/guidance/test criteria) and the reported device performance.

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

• Chemotherapy Drug Permeation (ASTM D6978-05): The document specifies the standard used but does not provide the exact sample size for the test sets (number of gloves or replicates per drug). The data is generated from laboratory testing ("under the conditions of the study"). Data provenance is not explicitly stated but implies laboratory testing for regulatory submission.
• Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Sterility: These tests refer to ASTM and ISO standards (e.g., ASTM D3577, ASTM D5151, ASTM D6124, ISO 11137-1). These standards typically define the sampling plans (e.g., AQL 1.5 for freedom from holes), but the specific number of units tested for this submission is not directly stated. Data provenance implies manufacturer's testing for regulatory submission.
• Biocompatibility (ISO 10993 series): These are biological evaluations. The document refers to "the conditions of the study" and "animal model" for acute systemic toxicity but does not provide specific sample sizes (e.g., number of animals used). Data provenance implies laboratory testing for regulatory submission.
• Human Skin Sensitization (Modified Draize-95 Test): This test was performed on "human subject tested." The sample size (number of human subjects) is not explicitly given, it ambiguously states "the human subject tested." Data provenance is from a clinical test as per FDA guidance.
• Endotoxin Study & Material Mediated Pyrogenicity Study: The document refers to "the conditions of the study" but does not provide sample sizes. Data provenance implies laboratory testing for regulatory submission.

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

This submission is for a physical device (surgical gloves) and its material properties, not an AI/algorithm-driven device requiring expert image interpretation or similar ground truth establishment. Therefore, the concept of "experts" establishing a ground truth in that context is not applicable here. The "ground truth" for the performance tests (e.g., breakthrough time, tensile strength) is established by the validated methodologies of the referenced ASTM and ISO standards.

4. Adjudication Method for the Test Set:

Not applicable in the context of material and physical property testing of a device like surgical gloves. Test results are objective measurements based on defined standard protocols.

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

No, an MRMC comparative effectiveness study was not done. This is not an AI device or a diagnostic imaging device where human reader performance is evaluated.

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

Not applicable as this is not an AI/algorithm device. The performance tests evaluate the physical gloves without any "human-in-the-loop" interaction in the testing methodology itself beyond conducting the tests.

7. The Type of Ground Truth Used:

• Objective Measurement Standards: For most physical and chemical properties (dimensions, strength, freedom from holes, powder, sterility, chemotherapy permeation, endotoxin, pyrogenicity), the "ground truth" is defined by the objective measurement criteria and methodologies specified in the referenced ASTM and ISO standards. The results are quantitative measurements against these predefined thresholds.
• Biological Response in Models: For biocompatibility tests (cytotoxicity, skin irritation, sensitization, acute systemic toxicity), the "ground truth" is established by observing biological responses in in vitro or in vivo (animal) models as per ISO 10993 standards and the Modified Draize-95 Test for human skin sensitization.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured physical product.

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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Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are 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 D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Gammex Non Latex Pl White Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and ling chemotherapy agents

This document is a 510(k) Premarket Notification from the FDA for a medical device: Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs. The document details the substantial equivalence determination for the device.

Based on the provided text, the device in question is surgical gloves, not an AI/algorithm-based diagnostic or assistive device. Therefore, many of the requested elements of the prompt (ground truth establishment for training/test sets, expert adjudication, MRMC studies, AI effect size, etc.) are not applicable to this type of medical device submission.

The "acceptance criteria" for a physical device like a glove are typically performance specifications based on established standards (e.g., ASTM standards for dimensions, physical properties, lack of holes, chemical permeation). The "study that proves the device meets the acceptance criteria" refers to non-clinical laboratory testing.

Here's an attempt to answer the prompt using the available information, noting where AI-specific questions are not relevant:

Device: Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs

Type of Study: Non-clinical laboratory testing to assess the physical properties, chemical permeation resistance, and biocompatibility of the surgical gloves, demonstrating substantial equivalence to a predicate device.

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

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

• Sample Size for Testing: The document does not explicitly state the total number of gloves or samples tested for each criterion. It mentions "Minimum Breakthrough Detection Time (Sample 1,2,3)" in one table (page 5), implying at least 3 samples were used for chemotherapy permeation testing for each chemical. Standard testing protocols (like ASTM) would dictate specific sample sizes for each test.
• Data Provenance: The testing was "independent laboratory testing" performed by Ansell. The country of origin of the data is not specified, but the submission is to the U.S. FDA by an LLC based in Reno, Nevada, USA. The data is retrospective in the sense that it was collected prior to this submission for regulatory review.

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

• Not Applicable. For a physical device like surgical gloves, "ground truth" is established by adherence to recognized national and international testing standards (e.g., ASTM, ISO). These standards define the methodologies and acceptance limits for physical, chemical, and biological performance. Experts involved would be laboratory technicians and engineers specializing in materials testing and biocompatibility, but not in the sense of clinical "expert readers" for diagnostic images.

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing consensus "ground truth" in subjective assessments, such as radiology interpretations or clinical diagnoses. For physical device testing, results are typically quantitative measurementsagainst predefined 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:

• Not Applicable. This is a physical medical device (surgical gloves), not an AI-based diagnostic or assistive technology for human readers.

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

• Not Applicable. This is a physical device, not an algorithm. Standalone performance is assessed through the non-clinical laboratory tests showing the glove's inherent properties and resistance.

7. The type of ground truth used:

• Standard-based performance metrics and established laboratory methods. The "ground truth" for this device is based on meeting the performance requirements outlined in:
  • ASTM D3577 (Standard Specification for Rubber Surgical Gloves)
  • ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
  • ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
  • ANSI/AAMI/ISO 11137-1:2006 (Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices)
  • ISO 10993 (Biological evaluation of medical devices), specifically Parts 5 (cytotoxicity), 10 (irritation and sensitization), and 11 (systemic toxicity).
  • ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs).

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of an AI algorithm for this type of device submission. The device itself is manufactured; it does not "learn" from data.

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

• Not Applicable. See point 8.

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Gammex PI Hybrid Surgical Gloves are 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 D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Gammex Pl Hybrid Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic rubber blend of polyisoprene and polychoroprene. A polyurethane polymer coating is applied to the inner surface of the glove to make donning eay. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and effective for handling chemotherapy agents.

The provided text describes the acceptance criteria and performance of the Gammex PI Hybrid Surgical Gloves, specifically regarding their resistance to chemotherapy drug permeation.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for chemotherapy drug permeation are implicitly defined by the reported "Minimum Breakthrough Detection Time" for each drug when tested according to ASTM D6978-05. A longer breakthrough time indicates better performance. For most drugs, the performance (>240 minutes) suggests that the gloves resist permeation for at least 4 hours, which is likely the desired acceptance criterion for practical use. The specific acceptance criteria for most physical/biological aspects are meeting the referenced ASTM and ISO standards.

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

• Chemotherapy Permeation: For the permation testing, the table in section {5} (and {2}) indicates that the "Minimum Breakthrough Detection Time" is based on 3 samples (Sample 1, 2, 3), specifically shown for Carmustine and ThioTEPA. For other drugs, only the aggregate ">240" is given, implying consistent results across samples.
• Freedom from holes: For the specific ASTM D3577-09 test mentioned in section {6}, the sample size for this attribute was 100 pieces for a lot size of 35,001 to 150,000 pieces.
• Powder-Free: The average residual powder content (0.48mg per glove) was determined "during process validation," but the specific sample size for this validation is not detailed.
• Other tests (Dimensions, Physical Properties, Biocompatibility, Sterility): The sample sizes for these tests are not explicitly stated in the provided documents, but they would have been conducted according to the requirements of the respective ASTM/ISO standards.
• Data Provenance: The studies were conducted by Ansell Healthcare Products LLC, presumably at an independent laboratory, to support a labeling modification. The data is retrospective in the sense that it was performed on an already cleared device (K151694) to add a new claim (chemotherapy drug handling), rather than being part of the initial device development for the base glove. The country of origin of the data is not specified, but the applicant is based in the USA.

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

This information is not applicable as the tests performed are objective, laboratory-based chemical and physical property tests, not interpretive studies requiring human expert assessment (like image analysis or clinical diagnosis). The "ground truth" is established by direct measurement of permeation time or other physical/chemical properties according to standardized methods.

4. Adjudication Method for the Test Set

This information is not applicable. As these are laboratory measurements, there is no adjudication method in the sense of reconciling different expert opinions. The results are quantitative measurements against a predefined standard. For instance, breakthrough time is measured directly using analytical techniques.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not conducted on the subject or predicate devices." The evaluation focuses on the physical and chemical resistance properties of the gloves, not on human reader performance.

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

No, a standalone algorithm performance study was not done. This device (surgical gloves) is a physical product and does not involve any artificial intelligence algorithms or software. The evaluation is solely on the physical and chemical properties of the gloves themselves.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Direct Physical and Chemical Measurements: For chemotherapy permeation, dimensions, physical properties, freedom from holes, powder residue, and sterility.
• Standardized Biological Assay Results: For biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity).
  These are objective, quantitative results obtained through testing methods specified in internationally recognized standards (ASTM, ISO).

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (surgical gloves) and does not involve any machine learning algorithms that require a "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. No training set or associated ground truth was required for the evaluation of this physical medical device.

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