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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permention by Chemotherapy Drugs.

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, blue colored, nitrile, and tested for use with chemotherapy drugs And Fentanyl Citrate. The design of the subject device is addressing the standards as ASTM D6124, ASTM D5151, ASTM D6319, ASTM D6978-05. The gloves have a minimum length of 270mm. The Subject device is nonsterile.

Below are the acceptance criteria and the study proving the device meets them, based on the provided text:

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: The document does not explicitly state the sample size used for each specific test (e.g., number of gloves tested for permeation, holes, etc.). However, it refers to standard test methods like ASTM D6319-19 which would define typical sample sizes for such evaluations.
• Data provenance: The data is generated from non-clinical (bench) testing performed by the manufacturer or a contracted lab. The country of origin of the data is not specified beyond the manufacturer's address in Hebei, P.R. China. The data is prospective in nature, as it was generated to demonstrate device performance for regulatory submission.

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 as the document describes non-clinical (bench) testing of physical properties and chemical permeation, not a study involving human expert interpretation for establishing ground truth.

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

This information is not applicable as the document describes non-clinical (bench) testing.

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 document describes non-clinical (bench) testing of a medical glove, not an AI-assisted diagnostic device.

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

This information is not applicable as the document describes non-clinical (bench) testing of a medical glove, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests is established by industry standards and defined acceptance criteria. For example:

• Physical dimensions: Measured values compared against specified ranges (e.g., length ≥270mm).
• Physical properties (tensile strength, elongation): Measured values compared against minimum performance requirements defined in ASTM standards.
• Freedom from holes: Tested according to ASTM D5151-19, with acceptance based on AQL (Acceptable Quality Limit) of 2.5.
• Residual powder: Measured amount compared against a limit of

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The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

The provided text describes the acceptance criteria and performance of a Nitrile Patient Examination Glove, not an AI-powered medical device. Therefore, the questions related to AI device performance metrics, such as ground truth, expert consensus, MRMC studies, and training/test sets, are not applicable in this context.

This document is a 510(k) Premarket Notification for a Class I medical device (nitrile examination glove), which establishes substantial equivalence to a predicate device based on physical and performance characteristics, and biocompatibility.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established ASTM and ISO standards for medical gloves. The reported device performance is compared against these standards and the predicate device.

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The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

The provided document is a 510(k) Summary for a medical device called "Nitrile Patient Examination Glove." It outlines the device's characteristics, intended use, and comparison to a predicate device, along with non-clinical performance testing.

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

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample sizes used for the test set and the data provenance:
   The document does not specify exact sample sizes for each test. However, it indicates compliance with recognized standards such as ASTM D6319-19, ASTM D5151-19, ASTM D6124-06 (Reapproved 2017), ISO 10993-10:2010, and ISO 10993-5:2009. These standards inherently define appropriate sampling plans for testing.
   The data provenance is from non-clinical tests conducted to verify design specifications. The company, Jiangxi Zhonghong Pulin Medical Products Co.,Ltd., is located in China. The nature of these tests (e.g., laboratory testing of material properties) implies prospective data collection as part of the device development and regulatory submission process.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable as the evaluation relies on established standardized test methods (e.g., ASTM, ISO standards) for material properties and biocompatibility, rather than expert interpretation of a diagnostic output. The "ground truth" is determined by the objective results of these standardized tests against their defined pass/fail criteria.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This is not applicable. The tests performed are objective, quantitative or qualitative measurements governed by international standards, not subjective interpretations requiring adjudication.

4. 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. The device is a patient examination glove, not an AI-powered diagnostic or assistive SaMD (Software as a Medical Device). Therefore, MRMC studies are not relevant.

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

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" for this device is based on objective, standardized test results against the specifications outlined in relevant ASTM and ISO standards for physical properties, barrier integrity, and biocompatibility. For example:

   • Physical properties (Tensile Strength, Elongation): Measured values compared against minimum requirements specified in ASTM D6319.
   • Freedom from Holes: Determined by testing in accordance with ASTMD5151, with an Acceptance Quality Limit (AQL) of 2.5.
   • Powder Content: Measured against requirements of ASTM D6124.
   • Biocompatibility (Irritation, Sensitization, Cytotoxicity): Determined by laboratory assays compliant with ISO 10993-10 and ISO 10993-5, where the outcome is classified as "not an irritant," "not a sensitizer," or "not cytotoxic."

7. The sample size for the training set:
   This is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.

8. How the ground truth for the training set was established:
   This is not applicable for the same reason as above.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.

NitriTec Vinyl Glove Powder Free Blue

I am sorry, but the provided text from the FDA letter (K210460) for the "NitriTec Vinyl Glove Powder Free Blue" does not contain any information about acceptance criteria or a study proving device performance for artificial intelligence (AI) or machine learning (ML) models.

This document is a 510(k) premarket notification clearance letter for a Class I medical device (Non-Powdered Patient Examination Glove). Such devices are typically cleared based on substantial equivalence to a predicate device and do not require extensive performance studies as would be necessary for a novel AI/ML diagnostic or therapeutic device.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance with the specified details (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance) using the provided text. The information simply isn't there.

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The Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTMD5151, and ASTMD5250. The proposed device is non-sterile.

This document is a 510(k) Pre-Market Notification for a Vinyl Patient Examination Glove, asserting substantial equivalence to a predicate device. It primarily focuses on demonstrating that the new device meets established standards for medical examination gloves.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by recognized industry standards, and the reported device performance is presented as compliance with these standards or specific measured values.

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

The document does not explicitly state the sample sizes for each specific test mentioned (e.g., how many gloves were tested for tensile strength, elongation, or freedom from holes). However, it refers to industry standards (ASTM D5151, ASTM D5250, ASTM D6124) which inherently define sampling plans for these tests. For instance, ASTM D5151 specifies an Acceptance Quality Limit (AQL) of 1.5, which implies a specific sampling size based on lot size for hole detection.

The data provenance is not explicitly stated in terms of country of origin for the testing itself, but given the submitter's address in China, it's reasonable to infer the testing took place there. The studies are retrospective in the sense that they are post-manufacturing tests performed on the finished product according to established 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 to this type of device and study. The "ground truth" for Vinyl Patient Examination Gloves is primarily established by objective, quantifiable physical and chemical properties and biological safety assessments derived from standardized laboratory tests. There is no subjective assessment by medical experts required to determine if a glove has a specific tensile strength or is free from holes.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., image reading) where multiple experts might disagree on an assessment. For objective laboratory tests, the results are quantitative and do not require expert adjudication in this manner.

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. This is a submission for an examination glove, which is a physical medical device, not an AI-powered diagnostic tool. Therefore, MRMC studies and assessment of AI assistance for human readers are irrelevant.

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

This is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is based on objective, quantitative laboratory measurements and biological testing results as defined by recognized consensus standards (ISO 10993-10, ISO 10993-5, ASTM D6124, ASTMD5151, ASTM D5250). For example:

• Physical Properties: Measured tensile strength and ultimate elongation against specified minimums.
• Freedom from Holes: Determined by standardized water leak tests (e.g., based on ASTM D5151).
• Powder Content: Measured gravimetrically according to ASTM D6124.
• Biocompatibility: Determined by in vitro and in vivo toxicology tests for irritation, sensitization, and cytotoxicity according to ISO 10993 standards.

8. The Sample Size for the Training Set

This is not applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning. The "training" for such devices involves adherence to manufacturing process controls and validated testing methods to ensure consistent product output.

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

This is not applicable as there is no "training set" for this type of device. The ground truth for evaluating the device's performance is established by the specified requirements in the referenced international and ASTM standards.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The subject device in this 510(k) Notification is a Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs

The subject device is a patient examination glove made from nitrile compound, blue in color, powder free and non-sterile (as per 21 CFR 880.6250, class I).

The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This document describes the acceptance criteria and performance study for the Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs (K171873).

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy Drug Permeation Performance:

Note: The document highlights that Carmustine (BCNU) and Thiotepa have "extremely low permeation times" and a warning statement is to be included in labeling for these specifically.

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

The document does not specify a distinct "test set" in terms of a dataset of items being classified or evaluated by an algorithm or human readers. Instead, it refers to bench tests conducted on the device itself.

• Sample Size: Not explicitly stated for each specific test (e.g., number of gloves tested for pinholes, physical properties, or chemotherapy permeation). The general statement is "Bench tests were conducted to verify that the proposed device met all specifications."
• Data Provenance: The tests are described as "Bench tests" which are typically laboratory-based and prospective in nature for a new device. The country of origin for the data is not specified, but the applicant company is Zhonghong Pulin Medical Products Co., Ltd. located in China.

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

This information is not applicable to this type of device submission. The "ground truth" for glove performance is established through adherence to recognized international standards (e.g., ASTM, ISO) and regulatory requirements (e.g., 21 CFR 800.20), not through expert consensus on a test set of data. The performance is objectively measured against predefined criteria in these standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, performance is measured against objective standards, not through consensus or adjudication of expert interpretations.

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

No. This type of study is not relevant for a medical device like an examination glove. MRMC studies are typically used for evaluating diagnostic imaging or AI algorithms where human interpretation plays a significant role.

6. Standalone Performance Study (Algorithm Only Without HIL)

No. This device is a physical medical glove and does not involve AI algorithms or human-in-the-loop performance evaluation in the context of an algorithm. The "device performance" refers to the physical and chemical properties of the glove itself.

7. Type of Ground Truth Used

The "ground truth" for evaluating the glove's performance is based on established industry standards and regulatory requirements. This includes:

• ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical application (Dimension, Physical Properties, Powder Residual).
• 21 CFR 800.20 & ASTM D5151-06 (2011): Freedom from pinholes.
• ASTM D6124-06 (2011): Standard Test Method for Residual Powder on Medical Gloves.
• ISO 10993-10:2010: Biocompatibility (Primary Skin Irritation, Dermal Sensitization).
• ASTM D6978-05 (Reapproved 2013): Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a training set. Its performance is evaluated through physical and chemical testing.

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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Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided document is a 510(k) summary for the Nitrile Powder Free Patient Examination Gloves, Blue Color (K152712). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a novel device meets specific acceptance criteria through a clinical study involving AI or human readers.

Therefore, many of the requested fields are not applicable to the context of this document.

Here's the information that can be extracted from the provided text, formatted to address your request:

Acceptance Criteria and Device Performance

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