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The Polyisoprene Surgical Gloves are single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. It is provided sterile.

Polyisoprene Surgical gloves

I am sorry, but the provided text from the FDA document (K240790) pertains to the clearance of "Polyisoprene Surgical gloves" and focuses entirely on regulatory information, such as:

• The FDA's decision regarding the 510(k) premarket notification.
• Classification of the device (Class I, reserved).
• Applicable regulations (e.g., 21 CFR 878.4460 for Non-Powdered Surgeon's Glove, Quality System regulation 21 CFR Part 820).
• Guidance on changes requiring new premarket notifications.
• Information on adverse event reporting and other regulatory compliance.
• The "Indications for Use" for the surgical gloves.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details related to AI/algorithm-based medical devices. It is a regulatory clearance letter for a non-software/AI medical device.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details based on the provided text.

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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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The Polyisoprene Surgical Gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.

The proposed device is Polyisoprene Surgical Gloves, sterile and disposable devices. The proposed devices are made of polyisoprene. The proposed device is white. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D3577.

The provided document is a 510(k) summary for Polyisoprene Surgical Gloves, which are a Class I medical device. The document does not describe an AI/ML-enabled device or an diagnostic device requiring an MRMC study or AI-specific acceptance criteria.

The acceptance criteria provided in the document relate to the physical and biological characteristics of the surgical gloves as per various ASTM and ISO standards, and the "study" is a series of non-clinical performance tests confirming the gloves meet these established standards.

Therefore, I cannot extract information related to AI/ML device performance, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details as these are not relevant to the product described in the input.

However, I can extract the acceptance criteria and performance data for the Polyisoprene Surgical Gloves as presented in the document.

Acceptance Criteria and Reported Device Performance (for Polyisoprene Surgical Gloves)

1. Table of Acceptance Criteria and Reported Device Performance

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A Powder Free White Sterilized Polyisoprene Surgical Gloves- Tested for Use with Chemotherapy Drugs is a disposable device intended for invasive surgery procedures that is to be worn on both the hands by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drug as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.

Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs.

This document is a 510(k) clearance letter for Powder Free White Sterilized Polyisoprene Surgical Gloves. It is for a medical device and not for an AI/ML powered device, therefore no AI-specific performance criteria or studies are present.

Here's an analysis based on the provided text, focusing on the available information regarding device performance and acceptance criteria, even though it's not an AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these surgical gloves relate to their resistance to permeation by chemotherapy drugs, as tested according to ASTM D 6978. The "acceptance criteria" here implicitly refers to showing sufficient resistance, often exceeding a certain time threshold, though the direct numerical acceptance threshold isn't explicitly stated but inferred from the predicate device comparisons and the nature of such testing. For chemotherapy gloves, a breakthrough time of >240 minutes is generally considered ideal for many drugs.

Note: The document explicitly states: "Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes." This suggests that while ideal is >240 min, the device still meets FDA requirements given its overall performance and comparison to predicate devices, and likely appropriate labeling for users about these specific drugs.

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

The document does not specify the sample size used for the permeation testing (i.e., how many gloves were tested for each drug). The data provenance refers to "as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug," indicating a standardized laboratory test method. It is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in the human data sense.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. This is a physical device subject to standardized chemical permeation testing, not a diagnostic device requiring expert opinion for ground truth. The "ground truth" is established by the chemical permeation laboratory measurement according to the ASTM D 6978 standard.

4. Adjudication Method for the Test Set

Not applicable, as the "ground truth" is based on objective chemical permeation measurements rather than subjective human assessment requiring adjudication.

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

Not applicable. This is not an AI/ML-powered diagnostic or interpretive device.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

The ground truth used is objective laboratory measurement of chemotherapy drug permeation, specifically the "Average Breakthrough Detection Time" determined according to ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."

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

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

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The Medispo Rubber/Polyisoprene surgical gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.

The proposed devices, surgical gloves, are sterile and disposable devices. There are two types of surgical gloves according to the raw materials in this submission:

• Type 1-Natural rubber surgical gloves .
• Type 2-Synthetic polyisoprene surgical gloves .
  The proposed devices are powder-free gloves with creamy white in color. There are seven sizes (6", 6.5", 7", 7.5", 8", 8.5", 9") available for the gloves whichever are smooth- or texture-surfaced, with or without a rolled rim at the cuff edge.
  The gloves are sterilized by ionizing irradiation. The shelf-life is three (3) years.

This document is a 510(k) premarket notification for Medispo Rubber Surgical Gloves and Medispo Polyisoprene Surgical Gloves. It compares the proposed devices to legally marketed predicate devices to demonstrate substantial equivalence.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria:

The document states: "The performance test of the subject devices were performed on the final finished device. The test results show the subject devices meet the requirements of ASTM D3577-19."

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

The document does not explicitly state the sample size used for each specific test or the data provenance (country of origin, retrospective/prospective). It only mentions that "performance tests...were performed on the final finished device" according to relevant ASTM and ISO standards.

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 surgical glove, and the evaluation is based on mechanical, physical, and chemical properties, as well as biocompatibility, against established standards. There is no "ground truth" requiring expert consensus in the context of medical image analysis or similar diagnostic applications.

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

This information is not applicable for the type of device and testing performed. Adjudication methods are typically relevant for subjective evaluations or interpretations, which are not present 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

This information is not applicable as the device is a surgical glove and does not involve human readers or AI assistance in its function.

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

This information is not applicable as the device is not an algorithm or AI system.

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

The "ground truth" for the performance evaluation of the surgical gloves is based on established industry and regulatory standards such as ASTM D3577-19, ASTM D3767-03(2020), ASTM D5151-19, ASTM D6124-06(2017), ASTM D412-16, relevant USP standards, and ISO 10993 series standards for biocompatibility. These standards define the acceptable physical, mechanical, and biological properties of the gloves.

8. The sample size for the training set

This information is not applicable as the device is a physical product (surgical gloves) and does not involve machine learning models that require training sets.

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

This information is not applicable as the device is a physical product and does not involve machine learning models that require training sets or their associated ground truth.

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

Powder Free White Sterile Polyisoprene Surgical Gloves

This document is a 510(k) clearance letter from the FDA for Powder Free White Sterile Polyisoprene Surgical Gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information on acceptance criteria, a specific study proving the device meets the acceptance criteria, or any of the detailed study parameters requested in the prompt.

Instead, the letter primarily focuses on:

• Confirming the substantial equivalence of the device.
• Stating its regulatory classification (Class I, Product Code KGO).
• Outlining the general controls provisions of the Federal Food, Drug, and Cosmetic Act that the manufacturer must comply with.
• Providing contact information for various FDA offices.
• Listing the "Indication For Use" of the surgical gloves.

Therefore, I cannot provide the requested table and study details based on the provided text.

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These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves meet all of the requirements of ASTM D 3577-06, Type 2.
Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves meet all of the current specifications of ASTM D 3577-06, Type 2.
Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
Characteristics: Dimensions, Physical Properties, Freedom from Holes, Powder Free
Standard: Meets ASTM D 3577, Meets ASTM D 3577, Type 2, Meets ASTM D 3577, Meets ASTM D 5151, Meets ASTM D 6124
Powder content = 2 mg per glove

This document describes the acceptance criteria and the study that proves the device meets those criteria for the Ansell Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves.

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 specify the exact sample sizes used for each test (e.g., freedom from holes, physical properties, biocompatibility). However, it indicates that the tests conform to established ASTM and ISO standards, which typically include defined sampling plans. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be laboratory testing conducted by the manufacturer or a certified lab to demonstrate compliance with the specified standards.

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. The ground truth for this device is established through adherence to physical and performance standards (ASTM, ISO, FDA hole requirements) rather than expert consensus on interpretive data (like imaging studies).

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., medical image analysis) to resolve discrepancies among experts. For this device, objective measurements against established standards determine compliance.

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 comparative effectiveness study was not applicable and not done. This device is a surgical glove, and its performance is evaluated based on physical properties, freedom from defects, and biocompatibility, not on human interpretive tasks or AI assistance.

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

A standalone (algorithm-only) performance evaluation was not applicable and not done. This device is a physical product (surgical glove), not an algorithm or AI-driven system.

7. The type of ground truth used

The ground truth used for this device is based on established standard specifications and laboratory testing outcomes. This includes:

• ASTM Standards: Defined dimensional, physical property, and hole specifications provided by ASTM D 3577 and ASTM D 5151.
• ISO Standards: Biocompatibility testing protocols from ISO.
• FDA Hole Requirements: Specific defect rate criteria mandated by the FDA.
• Industry Standards: Powder content standards as specified by ASTM D 6124.

8. The sample size for the training set

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

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

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

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BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Not Found

This document is a 510(k) clearance letter for the BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Glove, not a study report. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the way a clinical study report would.

However, based on the information provided, I can infer some aspects and highlight what is missing:

Missing Information:

• Acceptance Criteria/Reported Performance: The document provides the device name and its intended use, but it does not list specific performance metrics or acceptance criteria (e.g., tensile strength, puncture resistance, barrier integrity, biocompatibility data, etc.) that would typically be required for a surgical glove. It also does not report any device performance against such criteria.
• Study Details: There is no mention of any specific study that proves the device meets acceptance criteria. The 510(k) process relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical efficacy or performance studies in all cases. The letter indicates that the FDA "reviewed your Section 510(k) premarket notification" and deemed the device substantially equivalent. This suggests that the submission included data (likely non-clinical, mechanical, and perhaps biocompatibility testing) to support this equivalence, but those specific data points and the studies that generated them are not detailed here.

Inferences based on the document:

• Device Type: Surgical Glove (Product Code: KGO, Regulation Number: 21 CFR 878.4460)
• Intended Use: "BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination."

Summary of Missing and Inferable Information:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. Surgical gloves typically have acceptance criteria related to:

   • Barrier integrity (e.g., AQL for pinholes)
   • Physical properties (e.g., tensile strength, elongation, force at break)
   • Dimensions (e.g., length, palm width, thickness)
   • Biocompatibility (e.g., cytotoxicity, irritation, sensitization)
   • Powder content (since it's powder-free)
   • Sterility (if applicable)

   The document only states that the device was found substantially equivalent to a predicate device, implying it met certain undisclosed performance 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 provided. Any testing supporting the 510(k) submission would have involved sample sizes for specific tests (e.g., AQL testing for pinholes, mechanical property testing), but these details are absent.

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 to a submission for a surgical glove. "Ground truth" and expert reviews are typically associated with diagnostic or image-analysis AI devices, not physical medical devices like gloves. Performance data for gloves is obtained through objective laboratory testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This is not applicable for the same reasons as point 3.

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 as this is a physical medical device (surgical glove), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This is not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): This is not applicable for a surgical glove. Performance is measured against established international standards (e.g., ASTM, ISO) for glove properties.

8. The sample size for the training set: This is not applicable as there is no "training set" for a physical medical device. This term applies to machine learning/AI models.

9. How the ground truth for the training set was established: This is not applicable for the same reasons as point 8.

In summary, this document is an FDA clearance letter based on substantial equivalence, not a detailed technical report of device performance studies. The types of questions asked (e.g., ground truth, experts, training sets, MRMC studies) are characteristic of AI/diagnostic device evaluations, which do not apply to the BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Glove.

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