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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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Gammex PI Hybrid Surgical Glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.

The subject device is single-use disposable powder-free surgical glove that is supplied sterile and made of synthetic rubber blend of polyisoprene and neoprene.

The provided document describes a 510(k) premarket notification for a surgical glove, the Gammex PI Hybrid Surgical Glove. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a new device meets specific acceptance criteria through a clinical study.

Therefore, many of the typical acceptance criteria and study details requested in the prompt related to AI/medical imaging device performance metrics (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this document. The document focuses on showing that the new glove is as safe and effective as a previously approved glove by meeting established material and performance standards for surgical gloves.

Here's an attempt to answer the questions based on the information provided, highlighting where it is not applicable or different for a surgical glove compared to an AI diagnostic device:

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

For a surgical glove, "acceptance criteria" are typically defined by recognized standards (like ASTM or ISO) for physical characteristics, integrity, and biocompatibility. The "reported device performance" indicates whether the device met these standards.

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

This information is not applicable in the context of the provided document, as it describes a clearance for a physical medical device (surgical glove) based on conformance to established standards for manufacturing and materials, not an AI or diagnostic device that relies on a "test set" of patient data. The tests are typically performed on samples from manufacturing lots.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The ground truth for a surgical glove is derived from standardized physical, chemical, and biological tests, not expert interpretation of images or patient data.

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

This is not applicable. Adjudication methods are typically used for expert consensus on diagnostic imaging or clinical outcomes, which is not relevant here.

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

An MRMC study is not applicable. This type of study is for evaluating observer performance with AI assistance for diagnostic tasks.

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

This is not applicable. This question refers to the performance of an algorithm without human intervention, which is irrelevant for a surgical glove.

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

The "ground truth" for the surgical glove is based on objective measurements and assessments against established industry standards:

• Physical dimensions: Measured values (e.g., length, width, thickness).
• Physical properties (tensile strength, elongation): Measured values to ASTM D3577-09.
• Freedom from holes: Water leak test to ASTM D5151-06, meeting AQL 1.5.
• Powder-Free: Measurement of powder residue to ASTM D6124-06, meeting ≤ 2 mg per glove.
• Sterility: Sterilization validation to ANSI/AAMI/ISO 11137-1:2006, achieving 10-6 SAL.
• Biocompatibility: In-vivo animal studies for skin irritation and sensitization according to ISO 10993-10:2010.

8. The sample size for the training set

This is not applicable, as there is no "training set" for a surgical glove in the context of an AI/machine learning device. The manufacturing process is controlled and tested to meet specifications.

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

This is not applicable. As there is no training set. The "ground truth" for the device's characteristics is established by widely accepted and published national and international standards (ASTM and ISO).

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