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The Original Perry Style 42 Surgeon's Glove intended use is to be worn by operating room personnel to protect a surgical wound from contamination.

The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all of the requirements of ASTM D 3577-99, Type 1. The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-99 Rubber Surgical Gloves. The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.

The provided text describes a 510(k) summary for medical gloves and does not contain information about a device that uses AI or requires a study involving ground truth, expert consensus, or training sets as outlined in the request.

The device in question, "The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim)," is a medical glove. The acceptance criteria and "study" described are based on compliance with existing ASTM (American Society for Testing and Materials) standards for surgical gloves and FDA hole requirements.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and submission described.

Here's a breakdown of the available information based on your request, highlighting what is not applicable:

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 specified in the provided text. Compliance with ASTM standards typically involves specified sample sizes for testing, but these are not explicitly detailed here.
• Data Provenance: Not specified. The testing is described as "performance test data of the non clinical tests," implying laboratory testing rather than data from a specific country or clinical setting. It's prospective testing against a standard.

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 device is a physical product (medical glove) and its performance is evaluated against defined physical and chemical standards, not through "ground truth" established by human experts in the context of diagnostic or interpretive tasks.

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

• Not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert reviews. The testing described here is objective and based on established ASTM test methods.

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 glove, not an AI-powered diagnostic device. No human reader or AI assistance is involved in its evaluation as described.

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

• Not applicable. This is a physical product, not an algorithm.

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

• Not applicable. The "ground truth" for this device's performance is adherence to defined physical and chemical properties and biocompatibility tests as specified in ASTM standards.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm; there is no training set.

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

• Not applicable. This device is not an AI algorithm; there is no training set or associated ground truth establishment process.

In summary: The provided document describes a medical glove's compliance with established industry standards through non-clinical performance testing. It does not involve AI, human expert evaluation for "ground truth," or clinical studies of the type typically associated with AI-powered diagnostic devices.

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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.

Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim), meet all of the requirements of ASTM D 3577, Type 1. Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim) meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.

The provided document is a 510(k) premarket notification for "Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim)." The document outlines the device's characteristics and its compliance with established standards, but it does not describe a study in the traditional sense of a clinical trial or a formal performance study with a test set, ground truth experts, or multi-reader multi-case analysis.

Instead, the "study" demonstrating the device meets acceptance criteria is primarily an assertion of compliance with existing ASTM standards and FDA requirements for surgical gloves.

Here's a breakdown based on the provided input:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" for a research study. The performance is based on the inherent manufacturing and testing procedures required for compliance with ASTM standards. These standards typically involve sampling from production lots. The document implies that samples from the manufactured gloves were tested to ensure compliance.
• Data Provenance: Not explicitly stated. Likely refers to internal quality control and testing conducted by Ansell Perry during the manufacturing process. Retrospective, in that the samples were already produced, and data collected on them.

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

• Not Applicable. The "ground truth" here is the established ASTM standards and FDA regulations for surgical gloves. Compliance is determined by direct measurement and testing against these predefined criteria, not by expert consensus on individual cases.

4. Adjudication method for the test set

• Not Applicable. As there's no "test set" requiring expert interpretation or consensus, no adjudication method was used. Performance is based on objective measurements against 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 medical device (surgical gloves), not an AI-powered diagnostic or assistive tool. No MRMC study was performed, and there is no AI component.

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

• Not Applicable. This is a medical device (surgical gloves). There is no "algorithm only" performance to evaluate. The device itself is the physical product.

7. The type of ground truth used

• Established Standards and Regulations: The ground truth used is objective; it's the specific numerical and qualitative requirements outlined in:
  • ASTM D 3577 (Standard Specification for Rubber Surgical Gloves)
  • ASTM D 5151 (Standard Test Method for Detection of Holes in Medical Gloves)
  • ASTM D 6124 (Standard Test Method for Residual Powder on Medical Gloves)
  • FDA hole requirements
  • Specific thresholds for protein labeling claim (50 micrograms or less)
  • Biocompatibility testing protocols (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization).

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device. This is a manufactured product subject to quality control and compliance testing, not a machine learning model that requires training data.

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

• Not Applicable. As there is no training set, there is no ground truth established for one.

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A sterile disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.

SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves examination gloves are sterile disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

The SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves undergo a performance study to demonstrate that they meet the acceptance criteria. The study ensures that the gloves conform to the specified standards and are safe and effective for their intended medical purposes.

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 specific sample size used for each test. However, the performance is reported against ASTM standards, which would imply that testing was conducted according to the sampling plans outlined within those standards. The data provenance is not specified in terms of country of origin, but the testing is non-clinical. The studies are assumed to be prospective, specifically designed to test the glove's performance against the established 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. The device is a medical examination glove, and its performance is evaluated against established material and safety standards (ASTM standards and biocompatibility tests), not against expert clinical ground truth like in a diagnostic device. The "ground truth" here is the pass/fail criteria defined by the objective standards themselves.

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

This information is not applicable as the evaluation involves objective measurements against predefined standards rather than subjective expert interpretation 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:

This information is not applicable. The device is a medical examination glove, which is a physical barrier device, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a medical examination glove, not an algorithm.

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

The "ground truth" for the performance evaluation of these gloves is defined by:

• Established ASTM Standards: These are objective measurement criteria for physical properties (dimensions, tensile strength, elongation), freedom from holes, and powder residue.
• Biocompatibility Test Standards: These are established protocols for assessing primary skin irritation in rabbits and sensitization in guinea pigs, yielding objective pass/fail results.

8. The sample size for the training set:

This information is not applicable. The device is a physical medical glove and does not involve AI algorithms that require a "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 type of device.

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A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Nitra-Touch™ Sterile examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

This document describes the acceptance criteria and the study results for the Nitra-Touch™ Sterile Powder-Free Nitrile Medical Examination Glove by Ansell Perry.

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 individual test (e.g., for dimensions, tensile strength, freedom from holes, powder-free, or biocompatibility). However, it indicates that the tests were conducted according to established ASTM standards (D 6319, D 5151, D 6124). These standards often prescribe minimum sample sizes for testing.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are "non-clinical tests" conducted to demonstrate conformity with recognized standards like ASTM, which are generally performed in a controlled laboratory setting.

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 and not provided in the document. The "ground truth" for medical examination gloves is established by objective, quantifiable measurements against defined performance standards (ASTM standards) and biocompatibility tests, rather than expert consensus on subjective interpretations.

4. Adjudication method for the test set

This information is not applicable. The performance is measured against objective standards, not through subjective 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

This information is not applicable. This device is a medical examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effect sizes are irrelevant.

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

This information is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used for evaluating the Nitra-Touch™ gloves is defined by:

• Established Industry Standards: ASTM Standard D 6319 (Nitrile Examination Gloves for Medical Application), ASTM D 5151 (Freedom from Holes), and ASTM D 6124 (Powder Residue).
• Biocompatibility Test Pass/Fail Criteria: Standard methods for assessing Primary Skin Irritation and Guinea Pig Sensitization.
• FDA Hole Requirements: The gloves also meet FDA hole requirements.

These ground truths are objective and quantitatively measurable.

8. The sample size for the training set

This information is not applicable. There is no concept of a "training set" for a physical medical device like an examination glove. These products are manufactured and then tested for compliance with specifications.

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

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

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A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.

Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use), meet all of the requirements of ASTM D 3577, Type 2.
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.

Here's a breakdown of the acceptance criteria and study information for the Elite™ Powder Free Polyurethane Synthetic Surgical Gloves:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for the test set during the performance evaluations. It generally states that the "performance test data of the non clinical tests are the same as mentioned immediately above," referring to the ASTM standards.

The data provenance is not explicitly stated in terms of country of origin, but the testing refers to ASTM (American Society for Testing and Materials) standards, suggesting testing was conducted against these established specifications, likely in the US or by labs adhering to these standards. The testing appears to be retrospective in the sense that the results are presented as already achieved, rather than for a future study.

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 types of device performance tests (e.g., dimensions, physical properties, freedom from holes, biocompatibility) is typically established by objective measurements and standardized procedures, not by human expert consensus in the way clinical diagnostic products might be. The ASTM standards themselves define the methods and criteria.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations, often in clinical studies where multiple human readers assess cases. For objective device performance tests against ASTM standards, there isn't typically a panel of adjudicators. The tests are designed to yield objective results.

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-powered diagnostic or assistive devices where human readers (e.g., radiologists) are involved in interpreting results. The Elite™ gloves are a medical device without an AI component for interpretation.

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

No, a standalone study was not done. This question is also relevant for AI-powered diagnostic or assistive devices. The Elite™ gloves are a physical medical device, not an algorithm.

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

The ground truth used for these performance tests is based on objective measurements defined by the specific ASTM standards referenced. For example:

• Dimensions: Measured against specified tolerances in ASTM D 3577.
• Physical Properties: Determined through standardized tests (e.g., tensile strength, elongation) described in ASTM D 3577.
• Freedom from Holes: Assessed using methods outlined in ASTM D 3577 and ASTM D 5151 (e.g., water leak test).
• Powder-Free: Quantified by residue mass as per the described test in Attachment VI of K973461.
• Biocompatibility: Evaluated through standardized animal tests (rabbits for skin irritation, guinea pigs for sensitization), where "Passes" indicates compliance with established toxicity criteria.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The concept of a "training set" refers to data used to train machine learning models. The Elite™ gloves are a manufactured product, not an AI system.

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

This information is not applicable for the same reason as above.

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