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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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A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove together. Please note that the following drugs have extremely low permeation times: 3.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.

Gammex® Pl Plus Glove-in-Glove™ System tested for use with Chemotherapy Drugs is a sterile and disposable device. This glove system ismade of synthetic polyisoprene rubber. Gammex® Pl Plus Glove- in-Glove™ System Tested for Use with Chemotherapy Drugs is comprised of a single-use, sterile, white outer glove, which is a disposable, powder-free surgical glove made from synthetic polyisoprene and a single-use, sterile, green underglove which is a disposable, powder-free surgical glove made from syntheticpolyisoprene. The Gammex® Pl PlusGlove-in-Glove™ system Testedfor Use with Chemotherapy Drugs is comprised of the underglove being mechanically inserted into the outer glove prior to packing and sterilization. There is no adhesive present between the two gloves. This results in quick double gloving with only one donning event.

The provided text is a 510(k) Premarket Notification from the FDA regarding the "Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs." This document outlines the device's characteristics, its intended use, and the studies conducted to demonstrate its safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a table of non-clinical tests performed on the Gammex® PI Plus Glove-in-Glove™ System.

Chemotherapy Drug Permeation Times (Detailed)

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

The document does not specify sample sizes for individual tests like dimensions, physical properties, freedom from holes, powder-free, sterility, or biocompatibility studies. The general phrasing "Meets ASTM D..." or "Passes..." suggests that the sample sizes typically required by these standards were used.

For the Chemotherapy Drug Permeation Test (ASTM D6978-05), while the results for each drug are provided (Average Breakthrough Detection Time), the document does not specify the number of samples (e.g., gloves or glove specimens) tested for each drug.

The data provenance is prospective in the sense that these are tests conducted specifically for this 510(k) submission to demonstrate the device's performance against established standards. There is no mention of country of origin for the data; it is assumed to be from a testing facility compliant with the mentioned standards.

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

This information is not provided in the document. The "ground truth" for these tests is defined by the objective measurement methods and acceptance criteria specified in the referenced ASTM, ANSI, and ISO standards. These standards themselves are developed by expert consensus, but specific independent expert adjudication for this particular test set is not mentioned or typically required for this type of device and testing.

4. Adjudication Method for the Test Set:

An explicit adjudication method (like 2+1 or 3+1) is not applicable or mentioned for the non-clinical tests described. The tests are objective measurements against predefined criteria outlined in the consensus standards. The "Pass/Fail" results are determined directly by comparing the test outcomes to these established thresholds.

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

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not conducted on the subject device." This type of study focuses on human reader performance, often with or without AI assistance, which is not relevant to the physical and chemical resistance properties of a surgical glove.

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

No, a standalone algorithm-only performance study was not done. This device is a physical medical device (surgical glove), not an algorithm or AI software. Therefore, studies evaluating algorithm performance are not relevant.

7. The Type of Ground Truth Used:

The ground truth used for the non-clinical tests is based on consensus standards and laboratory measurements.

• For physical properties, dimensions, freedom from holes, powder residue, and sterility: The ground truth is objective measurement against the specified ASTM and ISO standards' criteria.
• For chemotherapy drug permeation: The ground truth is the measured breakthrough time determined by the ASTM D6978-05 standard.
• For biocompatibility (skin irritation, sensitization, acute systemic toxicity, cytotoxicity): The ground truth is the biological response observed in validated in vitro and in vivo models according to the ISO 10993 series of standards.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product (surgical glove) and does not involve AI or machine learning algorithms that would require 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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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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The Lifestyles Zero Lubricated Latex Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

This condom is a single use and non-sterile device intended for in home use by a consumer. The condom is made of a natural rubber latex sheath, which completely covers the penis with closely fitted membrane. The condom provides a physical barrier to fluids which helps reduce the risk of pregnancy and the transmission of sexually-transmitted infections. The device is a straight walled, cylindrical, lubricated condom with a reservoir tip. Condom dimensions are length 180+/- 10 mm, width 52±2mm, and thickness 0.045+/-0.005 mm. The condom is designed to conform to the requirements of ASTM D3492:2015 - Standard Specification for Rubber Contraceptives (Male Condoms).

Here's a breakdown of the acceptance criteria and the study information for the Lifestyles Zero Lubricated Latex Male Condom, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the Study Information:

The document describes several performance tests and validations performed to demonstrate the safety and effectiveness of the device, particularly in relation to the slightly thinner design compared to the predicate.

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

The document does not explicitly state the specific sample sizes for each test mentioned (e.g., the number of condoms tested for air burst, leakage, or dimensions). It refers to conformance with standards like ASTM D3492-15 and ISO 10993 series, which typically define appropriate sample sizes for such testing.

The data provenance is not explicitly stated as "country of origin" for the specific test data. However, the submitter is Ansell Healthcare Products LLC, located in Iselin, NJ, USA. The testing was conducted for regulatory submission in the USA. All studies appear to be prospective, laboratory-based, and animal-based (for some biocompatibility tests), rather than retrospective human studies with specific patient data.

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

This type of information is generally not applicable to the tests described in this 510(k) summary. The "ground truth" for these tests (e.g., dimensions, burst properties, leakage, lubricant quantity) is established by the specified standards (ASTM D3492-15) and internal quality control specifications, measured by calibrated equipment and trained technicians, not by expert consensus in a clinical evaluation sense.

For the biocompatibility studies, the "ground truth" is based on established biological evaluation standards (ISO 10993 series) and the scientific interpretation of the test results by trained toxicologists and histopathologists. The document does not specify the number or qualifications of these expert interpreters, but it would be implied that they are qualified professionals in a laboratory setting.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for clinical trials or studies where human readers interpret data (e.g., medical images) and their assessments are compared to reach a consensus for ground truth. This is not applicable to the physical and biological performance tests described here. The results of the mechanical tests are quantitative measurements against defined specifications. The biocompatibility tests involve laboratory observations and interpretations, which are then reported.

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 done. This type of study is relevant for AI or diagnostic imaging devices evaluating human performance, which is not the nature of this condom submission.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical product (a condom), not a software algorithm or AI-driven diagnostic tool.

7. The Type of Ground Truth Used

• For Physical Testing (Dimensions, Burst Properties, Leakage, Package Integrity, Lubricant Quantity): The "ground truth" is defined by the quantitative specifications and methodology within ASTM D3492-15 Standard Specification for Rubber Contraceptives (Male Condoms). These are objective, measurable parameters.
• For Biocompatibility (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity): The "ground truth" is established through adherence to and interpretation of results from ISO 10993-5, ISO 10993-10, and ISO 10993-11 standards, which include biological assays and animal studies. The "ground truth" here is the biological response (or lack thereof) observed in the standard test systems, interpreted by qualified personnel.

8. The Sample Size for the Training Set

This product is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data an algorithm learns from. The device itself is manufactured, and its performance is tested against established standards.

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

As there is no training set for an algorithm, this question is not applicable to this device submission.

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The Skyn Original Polyisoprene Lubricated Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

The Skyn Original Polyisoprene Lubricated Male Condom is a male contraceptive and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with fragrance oil. Fragrance oil acts as a masking agent to minimize odor originated from condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length >180mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 5-year shelf-life.

This document describes the premarket notification for a medical device, specifically, the Skyn Original Polyisoprene Lubricated Male Condom. It focuses on demonstrating substantial equivalence to a predicate device, not on AI/ML device performance. Therefore, many of the requested categories related to AI/ML device performance are not applicable to this submission.

Here's an analysis based on the provided text, flagging where information is not relevant to an AI/ML context:

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

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

• Sample Size: Not explicitly stated for each specific test (mechanical properties, shelf-life, biocompatibility). The text mentions "Performance testing conducted..." and "biocompatibility tests conducted," implying a test set was used, but the size is not quantified.
• Data Provenance: Not specified. It's likely internal testing conducted by Ansell Healthcare Products, LLC given the nature of a 510(k) submission. Retrospective/Prospective is not relevant in this context; it's product testing.

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)

• Not Applicable. This is not an AI/ML device involving human interpretation. The "ground truth" here is established by standardized testing methods outlined in ISO 23409:2011 and FDA guidance, typically executed by laboratory technicians and engineers, not "experts" in the AI/ML sense.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in AI/ML studies. For a physical device, performance is measured against established 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 is a physical medical device (condom), not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was performed.

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 (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance is based on pre-defined specifications and standardized test methods outlined in ISO 23409:2011 ("Male Condoms – Requirements and test methods for condoms made from synthetic materials") and FDA Guidance Document, "Testing guidance for Male Condoms Made from New Material (Non-Latex)." These standards dictate how mechanical properties, shelf-life, and biocompatibility are measured and what constitutes acceptable performance.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the AI/ML sense. The device is manufactured and then tested according to established standards.

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

• Not Applicable. There is no "training set" for this 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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LifeStyles® Smooth™ 2-in-1 Massage & Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

LifeStyles® Smooth™ 2-in-1 Massage & Lubricant is a non-sterile, water-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a non-staining, non-sticky, biocompatible gel-like liquid, with a strawberry aroma, that is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser

The provided text describes a 510(k) submission for a personal lubricant, not an AI-powered medical device. Therefore, the questions related to AI device performance, training sets, ground truth, expert opinions, and MRMC studies are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through various physical, chemical, and biological compatibility tests.

If this were an AI medical device submission, the following information would be required:

Acceptance Criteria and Device Performance for an AI-Powered Medical Device

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: [Number] of cases (e.g., images, patient records).
• Data Provenance:
  • Country of Origin: [List of countries where data was collected]
  • Retrospective/Prospective: [State whether the data was retrospective, prospective, or a mix of both. If mixed, specify proportions or characteristics of each.]

3. Experts for Ground Truth Establishment

• Number of Experts: [Number]
• Qualifications of Experts: [Detailed qualifications for each expert or group of experts, e.g., "Board-certified radiologists with an average of 15 years of experience in oncologic imaging, including sub-specialty training in breast MRI interpretation."]

4. Adjudication Method for Test Set Ground Truth

• Adjudication Method: [Describe the method used, e.g., "2+1 consensus (two initial reads, third expert resolves disagreement)," "3+1 (three initial reads, majority rules, fourth expert resolves persistent disagreement)," "Majority vote," "No adjudication, single expert reads."]

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

• Was an MRMC study done? [Yes/No]
• If Yes:
  • Effect Size of Human Reader Improvement (AI vs. Without AI Assistance): Human readers showed an improvement of [Quantifiable metric, e.g., "X% increase in AUC," "Y reduction in false positives per case," "Z% increase in sensitivity while maintaining specificity"] when assisted by AI compared to unassisted reads.

6. Standalone Algorithm Performance

• Was a standalone (algorithm only) performance study done? [Yes/No]
• If Yes, Report Standalone Performance: [Report relevant metrics for the algorithm alone, e.g., "Standalone sensitivity was X% and specificity was Y%," "Standalone AUC was Z."]

7. Type of Ground Truth Used

• Type of Ground Truth: [Specify the definitive source of truth for the test set, e.g., "Expert consensus," "Histopathology/Pathology results," "Longitudinal patient outcomes data," "Clinical follow-up," "Hybrid (e.g., expert consensus confirmed by pathology for a subset)."]

8. Training Set Sample Size

• Training Set Sample Size: [Number] of cases.

9. Ground Truth Establishment for Training Set

• Method for Establishing Ground Truth: [Describe how the ground truth for the training data was established. This can be similar to the test set ground truth methods but often involves more automated or scalable approaches, e.g., "Labeling by expert radiologists (same qualifications as test set experts)," "Programmatic labeling based on EMR data and pathology reports," "Crowdsourcing with expert review," "Hybrid approach combining automated extraction with targeted expert review."]

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LifeStyles® Natural Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

LifeStyles® Natural Personal Lubricant is a non-sterile, water-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a non-staining, long-lasting, biocompatible gel-like liquid that is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The provided in a plastic pump dispenser.

This document pertains to a 510(k) premarket notification for a personal lubricant, not an AI/ML medical device. Therefore, the questions regarding acceptance criteria and study design for such devices are not applicable. The information provided outlines the regulatory submission for Ansell Healthcare Products, LLC's LifeStyles® Natural Personal Lubricant.

To answer your request, I will explain why each of your specific points is not applicable to the provided document:

1. A table of acceptance criteria and the reported device performance: This type of table is used for devices that perform a measurable diagnostic or therapeutic function with specific performance metrics. Personal lubricants are assessed for their physical and chemical properties and biocompatibility, not for performance based on accuracy or efficacy in the way an AI diagnostic tool would be. The document describes "bench testing indicated that the lubricant is non-staining and that it has an appropriate viscosity, pH, specific gravity, appearance, color and odor," and "USP testing for Total Aerobic Microbial Counts, Total Yeast and Mold Counts, absence of microbial pathogens, and antimicrobial effectiveness indicated microbial quality." These are characteristics, not performance metrics against acceptance criteria in the sense of a clinical outcome or diagnostic accuracy.

2. Sample size used for the test set and the data provenance: This refers to the number of cases (e.g., medical images, patient records) used to evaluate an AI model. For a personal lubricant, the "test set" would involve samples of the product itself undergoing various laboratory and biocompatibility tests. The document mentions "Testing per ASTM D7661" and "testing for cytotoxicity, vaginal irritation, and systemic toxicity in accordance with ISO 10993." These are standard testing methodologies for medical devices to ensure safety and compatibility, not a dataset of patient information. The provenance would be the manufacturing site and the labs conducting the tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "Ground truth" typically refers to the confirmed correct diagnosis or outcome used to train and validate AI models. For a personal lubricant, ground truth isn't established by medical experts interpreting data. Its safety and effectiveness are determined through established chemical and biological testing standards conducted by qualified laboratory personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Adjudication methods are used in clinical studies to resolve discrepancies among expert readers when establishing ground truth for diagnostic AI. This is irrelevant for a personal lubricant, which does not involve subjective diagnostic interpretations.

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: MRMC studies are designed to assess the impact of AI assistance on human reader performance in diagnostic tasks. Since a personal lubricant is not a diagnostic device, such a study is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Standalone performance testing is for AI algorithms without human intervention. A personal lubricant is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As explained in point 3, the concept of "ground truth" for a personal lubricant relates to objective measurements of its physical properties, chemical composition, and biological compatibility against established scientific and regulatory standards, rather than clinical outcomes or expert diagnoses.

8. The sample size for the training set: "Training set" refers to the data used to train an AI model. A personal lubricant does not have a "training set" in this context. Its formulation is developed through research and development, and then tested for compliance with standards.

9. How the ground truth for the training set was established: Again, this concept is tied to AI model development. The "ground truth" for a personal lubricant's manufacturing process and formulation would be established by validated scientific principles, raw material specifications, and quality control tests, not by expert consensus on clinical data.

In summary, the provided document describes a regulatory submission for a Class II medical device (personal lubricant) that is evaluated based on its physical, chemical, and biological properties, and its substantial equivalence to a predicate device, rather than on AI/ML-specific performance metrics or clinical study designs involving expert interpretation of data.

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A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with chemotherapy drugs.

The Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim <50µg/dm2 per Glove of Extractable Protein, is a disposable device made of natural latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs.

The document is a 510(k) summary for the Encore® Acclaim® Sterile Powder-Free Latex Surgical Gloves. It describes the device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.

Here’s a breakdown of the information requested:

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 specify the exact sample sizes used for each test (e.g., dimensions, physical properties, freedom from holes, powder-free, protein content, biocompatibility, or chemotherapy drug permeation). It mentions that the device was "tested against the ASTM standards," which would implicitly define sample size requirements within those standards, but the specific numbers are not provided in this summary.

The data provenance is from non-clinical performance data conducted by Ansell Healthcare Products LLC. There is no information provided about the country of origin of the data or whether it was retrospective or prospective, though performance testing is typically prospective.

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

This type of information is generally not applicable to the performance testing of medical devices like surgical gloves. The "ground truth" for these tests is established by adhering to widely accepted, standardized testing protocols (e.g., ASTM standards) rather than expert consensus on individual cases. The results are objective measurements.

4. Adjudication method for the test set

Not applicable. The tests performed are objective, measurable outcomes based on ASTM standards. There is no subjective interpretation requiring an adjudication method.

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 for personal protection, not an AI-assisted diagnostic or interpretive tool. Therefore, MRMC studies and AI improvement effect sizes are not relevant.

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 or software.

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

The ground truth used for demonstrating device performance consists of established, objective measurements specified by recognized industry standards (ASTM standards). For example, the ground truth for protein content is "Maximum 50 µg/dm²" as specified in ASTM D3577-09e1 and ASTM D5712. For chemotherapy drug permeation, the ground truth is the measured breakthrough time according to ASTM D6978-05.

8. The sample size for the training set

Not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

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