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Sterile Latex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and are intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Sterile Latex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and are intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

I am sorry to inform you that the provided text is a 510(k) clearance letter from the FDA for Sterile Latex Powder-Free Surgical Gloves.

This document does not contain information about a medical device that utilizes AI or algorithms, nor does it discuss acceptance criteria, study data, or ground truth establishment relevant to AI/ML device performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as the document does not contain this type of information. It is a regulatory document for a physical medical device (gloves).

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Coated Sterile Latex Powder-free Surgical gloves are formulated using natural rubber latex and are coated with a nitrile coating. These are offered powder-free and sterile.

This document describes the safety and effectiveness of "Coated Sterile Latex Powder-Free Surgical Gloves." It does not pertain to an AI device or a study involving human readers or algorithms. Therefore, much of the requested information about AI model performance, expert ground truth, adjudication methods, and sample sizes for training/test sets is not applicable.

However, I can extract information related to the acceptance criteria and the summary of testing for this medical device.

Table of Acceptance Criteria and Reported Device Performance

Information Not Applicable or Not Provided for this Device:

• Sample size used for the test set and the data provenance: Not specified, as this is a physical medical device, not an AI model.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device performance is measured through physical and chemical tests, not expert consensus on images/data.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 not an AI device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For physical medical devices, "ground truth" is established through standardized laboratory tests and regulatory requirements (e.g., ASTM standards, CFR regulations).
• The sample size for the training set: Not applicable. This is not an AI model.
• How the ground truth for the training set was established: Not applicable. This is not an AI model.

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Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. The gloves are appropriate for use during invasive and non-invasive medical procedures requiring sterility.

These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for uses during invasive as well as non-invasive surgical procedures requiring sterlity. They are intended to be worn by operating room personnel to protect a surgical wound from contamination

Ultrafree Plus Powder-Free Surgical gloves are formulated using natural rubber latex and offered sterile.

The provided text describes the safety and effectiveness of Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves. It includes a summary of testing conducted to demonstrate their performance.

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 explicitly state the sample sizes used for each specific test (Systemic Toxicity, Intracutaneous Reactivity, Guinea Pig Maximization, Ultimate Elongation & Tensile Strength, Barrier Defects, Residual Powder Level). These are standard product performance tests for medical devices. The data provenance is derived from testing conducted by the manufacturer, Allegiance Healthcare Sdn. Bhd., as part of their 510(k) submission to the FDA. The tests are retrospective in nature, performed on finished glove products.

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

Not applicable. This device is a surgical glove, and its performance is evaluated through objective physical and biological tests against established standards (e.g., ASTM, FDA regulations, ISO biocompatibility standards). Expert ground truth is not typically established for this type of device performance evaluation.

4. Adjudication method for the test set:

Not applicable. The tests involve objective measurements and established protocols, not subjective assessment requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a surgical glove and does not involve AI or human readers for its intended use or performance evaluation.

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

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

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

The "ground truth" for the performance criteria is based on:

• Established industry standards: ASTM D3577-99 for physical properties, ASTM D6124-97 for residual powder.
• FDA regulations: 21 CFR §800.20 for barrier defects (AQL).
• Biocompatibility testing guidelines: Implied for Systemic Toxicity, Intracutaneous Reactivity, and Guinea Pig Maximization, typically following ISO 10993 series or equivalent.

These standards and regulations define the acceptable performance limits for surgical gloves.

8. The sample size for the training set:

Not applicable. This device is a physical product and does not involve machine learning algorithms or training sets.

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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These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.

The Ultrafree Textured Surgical gloves are formulated using natural rubber latex and offered powder-free and sterile.

The provided document describes the Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves (K983962). Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

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Ultrafree Sterile Latex Powder-Free Surgical Gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination

The Ultrafree Surgical gloves are formulated using natural rubber latex and offered sterile.

Here's an analysis of the provided text regarding the Ultrafree Sterile Latex Powder-Free Surgical Gloves, focusing on acceptance criteria and study details. It's important to note that the document describes a 510(k) submission for a medical device (surgical gloves), which has different types of "acceptance criteria" and "studies" compared to AI/software-as-a-medical-device (SaMD) clearances. Therefore, the questions designed for SaMDs will be addressed in the context of this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for tensile strength, number of animals for biocompatibility tests). However, these types of tests are typically conducted with standardized sample sizes as dictated by the relevant ASTM standards or regulatory guidelines for biocompatibility.

• Data Provenance: The tests would have been conducted by or for Allegiance Healthcare Sdn. Bhd. (located in Penang, West Malaysia) and/or its parent company, Allegiance Healthcare Corporation (USA). The data would be prospective, as these are tests conducted specifically to support the 510(k) submission for this device.

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

This question is not applicable in the context of this device. Surgical gloves are physical products, and their performance is evaluated through standardized physical, chemical, and biological tests, not through expert consensus on interpretations like medical images. The "ground truth" is defined by the objective measurement or observation against a predefined standard (e.g., ASTM D3577-91 for tensile strength, or observed biological reactions in animal models for biocompatibility).

4. Adjudication Method for the Test Set:

Not applicable. As described above, the evaluation of surgical gloves is based on objective measurements and observations against established standards, not on subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI systems where human readers interpret medical cases. Surgical gloves do not involve human interpretation of "cases." The "comparative effectiveness" for these gloves is established by demonstrating substantial equivalence to a predicate device (Triflex® Sterile Latex Powder-Free Surgical Gloves) based on their physical and biological properties.

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

Not applicable. This device is a physical product (surgical gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used:

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

• Standardized Test Methods and Criteria: For physical properties, this includes meeting or exceeding requirements of standards like ASTM D3577-91 and 21 CFR §800.20.
• Biological Endpoints: For biocompatibility, it involves observable biological reactions (or lack thereof) in animal models or in vitro tests (e.g., no irritation, no toxicity, no lysis).
• Chemical Analysis: For powder levels, it involves quantitative chemical analysis (vacuum filtration method and negative iodine test).

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. As this is not an AI/ML device, there is no "training set" or establishment of ground truth for such a set.

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