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The intended use of the device is to aid in the detection of pulmonary nodules (2-30 mm in diameter) in adults (22 years of age and older) on chest radiographs. The device is intended to be used as a concurrent reader. The device is not intended to be used for diagnosis. The device is intended to be used in the radiology department.

The device is a software device that uses artificial intelligence to analyze chest radiographs. The device is intended to be used as a concurrent reader to aid in the detection of pulmonary nodules. The device is not intended to be used for diagnosis. The device is intended to be used in the radiology department.

Please provide the input text you are referring to as "{0}", "{1}", and "{2}". I need this information to describe the acceptance criteria and the study that proves the device meets them.

Once you provide the input, I will be able to construct a comprehensive response including:

1. A table comparing acceptance criteria with reported device performance.
2. Details on sample size, data provenance, and study design (retrospective/prospective).
3. Information on the number and qualifications of experts used for ground truth establishment.
4. Description of the adjudication method employed for the test set.
5. Whether an MRMC study was conducted and its findings regarding AI assistance.
6. Confirmation of standalone algorithm performance evaluation.
7. The type of ground truth utilized (e.g., expert consensus, pathology, outcomes).
8. The sample size of the training set.
9. The methodology for establishing ground truth within the training set.

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Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.

In addition, these gloves were tested for use with Chemotherapy drug and Fentanyl test claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drug and Fentanyl test claim

The subject device in this 510(k) Notification is Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim. The subject device is a patient examination glove made from nitrile compound, pink color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This document is a 510(k) premarket notification for a medical device: "Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl Test Claim." Since this is a glove, the criteria are focused on physical and chemical properties and safety, not on diagnostic accuracy of an AI model. Therefore, many of the requested categories related to AI performance, such as MRMC studies, expert adjudication, training sets, and data provenance in a diagnostic sense, are not applicable.

Below is the information derived from the provided document, tailored to the context of a medical glove.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated against ASTM standards and specific chemical resistance criteria.

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

• Sample Size for Physical/Chemical Testing:
  • For Freedom from Pin holes (AQL 2.5): ISO 2859-1/ G1 inspection level. The specific numerical sample size is not explicitly stated but is determined by the AQL and inspection level, which is a standard sampling plan for quality control in manufacturing.
  • For Dimensions (AQL 4.0): ISO 2859-1/ S2 inspection level.
  • For Physical properties (AQL 4.0): ISO 2859-1/ S2 inspection level.
  • For Powder-free residue: N=5 gloves tested.
  • For Biocompatibility: The exact number of samples (animals or cell cultures) used for biocompatibility testing is not specified in this summary but generally follows ISO 10993 guidelines.
  • For Chemotherapy Drugs and Fentanyl Permeation: The specific sample size for each drug test is not explicitly stated in this document but these tests typically involve multiple glove samples.
• Data Provenance: The tests were conducted by Riverstone Resources Sdn Bhd, a Malaysian company. The data is retrospective (i.e., tests were completed before the 510(k) submission).

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 medical glove, and "ground truth" as it relates to expert clinical assessments for diagnostic algorithms is not relevant here. The "ground truth" for the performance criteria is established by adherence to recognized international standards (ASTM, ISO) for physical, chemical, and biological properties.

4. Adjudication method for the test set

Not applicable. The testing involves standardized laboratory methods and measurements, not subjective interpretation requiring adjudication among experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. MRMC studies are used for evaluating the diagnostic performance of imaging devices or AI algorithms by comparing multiple human readers' interpretations of cases. This is a physical device (glove), not a diagnostic tool.

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

Not applicable. This is not an AI algorithm. The performance tests are for the physical and chemical properties of the glove itself.

7. The type of ground truth used

The "ground truth" is based on:

• Standardized Test Methods: Adherence to established international standards such as ASTM D6319-10 (Standard specification for Nitrile Examination Gloves), ASTM D5151-06 (Freedom from Pinholes), ASTM D6124-06 (Powder-free residue), ASTM D6978-05 (Chemotherapy drug permeation), and ISO 10993 series (Biocompatibility).
• Predicate Device Performance: For chemotherapy drug permeation, the performance of the predicate device (K192954) also serves as a benchmark for comparison.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. There is no training set for this type of device.

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The Powder Free Nitrile Examination Glove (Aqua Green) is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.

The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove (Aqua Green). The subject device is a patient examination glove made from nitrile compound, Aqua Green color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Nitrile Examination Glove (Aqua Green):

1. Table of Acceptance Criteria and Reported Device Performance

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The Nitrile Examination gloves,is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards : Practice for assessment of medical Glove to Permeation by Chemotherapy Drugs.

The subject device in this 510(k) Notification is Nitrile Examination Gloves Sterile with tested for use with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, white colour, powder free and sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-5, 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05.

This document describes the acceptance criteria and performance of the Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White device (K190725) by Riverstone Resources SDN BHD.

1. Table of Acceptance Criteria and Reported Device Performance

The device was tested against several standards, and the results are summarized below. The "Acceptance Criteria" column refers to the specified requirements in relevant ASTM and ISO standards, while "Reported Device Performance" indicates whether the device met these criteria. "N/A" indicates that specific numerical acceptance criteria were not explicitly stated in the provided text for certain categories, but compliance with the standard itself serves as the acceptance.

3. Cisplatin (1.0mg/ml): > 240 minutes
4. Doxorubicin Hydrochloride (2.0mg/ml): > 240 minutes
5. Etoposide (20mg/ml):> 240 minutes
6. Fluorouracil (50mg/ml): > 240 minutes
7. Methotrexate (25mg/ml): > 240 minutes
8. Paclitaxel (6mg/ml): > 240 minutes
9. Thiotepa (10mg/ml): 97.6 minutes

(Note: Breakthrough for Carmustine and Thiotepa listed on page 2 and 4 are the same.) |

Explanation of the Study and Device Performance:

The study conducted to prove the device meets the acceptance criteria is a series of non-clinical tests performed in accordance with recognized international and national standards. The results demonstrate that the subject device (Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White) meets all the specified performance requirements for patient examination gloves, including dimensions, physical properties, freedom from holes, residual powder, and biocompatibility.

Crucially, the gloves were specifically tested for use with chemotherapy drugs according to ASTM D6978-05: Practice for assessment of medical Glove to Permeation by Chemotherapy Drugs. The results show that for most tested chemotherapy drugs, the gloves provided a breakthrough detection time of greater than 240 minutes (4 hours), indicating good resistance. For Carmustine and Thiotepa, specific breakthrough times of 39 minutes and 97.6 minutes, respectively, were reported. These specific times serve as important cautions for users.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for dimensions, physical properties, or chemotherapy drug permeation). However, it references established standards such as ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05, as well as ISO 10993-10 and ISO 10993-11. These standards typically define appropriate sampling plans and methodologies for testing, implying that the sample sizes used conform to these guidelines.

The data provenance is from Malaysia, as Riverstone Resources SDN BHD is located in Malaysia (Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300, Bukit Beruntung Selangor, Malaysia). The studies were non-clinical, likely laboratory-based, and retrospective in the sense that the test results are reported from completed experiments to demonstrate compliance for premarket notification.

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

This information is not provided in the document. The "ground truth" for this type of device (a medical glove) is established by adherence to recognized performance standards and laboratory test methods, rather than by expert consensus in a clinical diagnostic sense. The standards themselves (e.g., ASTM, ISO) represent a consensus of expert knowledge in materials science, manufacturing, and medical device testing. The personnel conducting the tests would be qualified laboratory technicians or engineers, but their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set:

An adjudication method (like 2+1 or 3+1) is typically used in clinical studies involving interpretation of medical images or patient outcomes, especially when there's subjective assessment involved. This document describes non-clinical, laboratory-based performance testing of a physical device against objective criteria defined by standards. Therefore, an adjudication method for determining "ground truth" as described (e.g., by multiple clinical experts) is not applicable to this type of study. The "ground truth" is the objective measurement against the specified standard.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted medical imaging devices where human readers interpret cases, and the AI's impact on their performance is being evaluated. This document is for a medical glove, which is a physical protective barrier, not a diagnostic tool requiring human interpretation of clinical cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, a standalone (algorithm only) performance study was not done. This concept is applicable to AI or software medical devices. The device in question is a physical medical glove, and its performance is evaluated through laboratory tests, not an algorithm.

7. Type of Ground Truth Used:

The ground truth used for this device's evaluation is primarily based on established performance standards and objective laboratory measurements. This includes:

• Standard Specifications: Adherence to defined physical and chemical properties as outlined in standards like ASTM D6319-10 (dimensions, physical properties), ASTM D5151-06 (freedom from pinholes), ASTM D6124-06 (residual powder).
• Biocompatibility Test Results: Objective scientific assessment of biological responses in accordance with ISO 10993-10 (irritation, sensitization) and ISO 10993-11 (acute systemic toxicity).
• Permeation Resistance Measurements: Objective laboratory determination of breakthrough times for chemotherapy drugs using a standardized method (ASTM D6978-05).

8. Sample Size for the Training Set:

This information is not applicable. The device is a physical medical glove, not an artificial intelligence (AI) or machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.

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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The White Nitrile Examination Glove,Sterile, is a disposable device intended for medical purposes that is worn on the examiner Is hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards: Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs

The subject device in this 510(k) Notification is White Nitrile Examination Gloves Sterile with tested for use with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, White color, powder free and sterile (Per 21 CFR 880.6250, class I). The White Nitrile Examination Glove ,Sterile, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner (product Code LZA) and is used with chemotherapy drugs (Product code LZC).

The provided document is a 510(k) Premarket Notification for a medical device: "White Nitrile Examination Glove, Sterile Tested for use with Chemotherapy Drugs Claim." It outlines the acceptance criteria for the glove's performance, particularly its resistance to chemotherapy drugs, and summarizes the non-clinical testing performed.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the chemotherapy drug resistance claim are defined by ASTM D6978-05 standards: Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs. The device's performance is reported as the "Minimum Breakthrough detection time in minutes." The acceptance criteria are implicit in the comparison to the predicate device and the standard, aiming for breakthrough times that prevent drug permeation for a reasonable duration of use. The reported "Minimum Breakthrough detection time" for most drugs is "> 240 Minutes", indicating that no permeation was detected within the maximum test duration.

Other acceptance criteria and performance related to the general glove properties (ASTM D6319-10 Standard specification for Nitrile Examination Gloves) and Biological Evaluation on medical device:

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The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by chemotherapy Drugs.
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner .In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standards ,Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs . It is for overthe-counter use.

The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contain Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This document outlines the acceptance criteria and supporting studies for the "Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs" (K152542).

1. Table of Acceptance Criteria and Reported Device Performance

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

Orange Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, orange colour, powder free and non sterile.

This document is a 510(k) Pre-market Notification for a medical device: "RS Orange Nitrile Medical Examination Gloves (Powder Free)". This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through a full-fledged clinical study in the way a new, high-risk device might.

Therefore, the requested information about clinical study design, sample sizes for test/training sets, experts, adjudication methods, MRMC studies, and standalone algorithm performance does not directly apply to this type of submission. The "study" here refers to non-clinical performance testing and biocompatibility assessments against established standards.

Here's an interpretation of the document in the context of your request:

Acceptance Criteria and Device Performance

The device demonstrates performance against recognized standards, specifically ASTM D6319-10 for physical characteristics and FDA-recommended biocompatibility tests.

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 the physical and biocompatibility tests. These are typically standard tests performed on batches of gloves according to the relevant ASTM and ISO standards. The data provenance would be from laboratory testing of the manufactured gloves. The document originates from Malaysia (Riverstone Resources Sdn.Bhd.). The testing would be considered prospective in the sense that the tests were performed on the device being submitted.

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

This concept is not applicable here. The "ground truth" for glove performance is established by the specified standards (ASTM D 6319-10) and regulatory guidelines for biocompatibility. The results are objective measurements or categorical assessments (e.g., non-irritant, non-sensitizer) from laboratory testing, not subjective expert judgment.

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

Not applicable. Laboratory tests have defined methods for determining outcomes, rather than requiring expert 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 is for a physical medical examination glove, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is for a physical medical examination glove, not an algorithm.

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

The ground truth for this device is based on:

• Standard Specifications: Meeting the chemical and physical property requirements defined by ASTM D 6319-10.
• Biocompatibility Standards: Results from established laboratory tests (Primary Skin Irritation Test, Dermal Sensitization Assay) based on the Consumer Product Safety Commission guidelines and ISO 10993-10:2010(E).

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model.

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

Not applicable. This is a physical device, not a machine learning model.

Summary of the "Study" (Performance Testing):

The "study" for this device consists of non-clinical performance testing and biocompatibility assessments to demonstrate that the RS Orange Nitrile Medical Examination Gloves (Powder Free) meet the established requirements of ASTM D 6319-10 for physical properties (dimensions, physical properties, freedom from pinholes, powder-free status) and specific biocompatibility standards (Primary Skin Irritation Test and Dermal Sensitization Assay). The results consistently demonstrate that the device "Meets" the ASTM standard and was found to be a "non-irritant" and "non-sensitizer" in the biocompatibility tests. This data forms the basis for the conclusion that the device is substantially equivalent to the predicate devices and performs according to performance standards and FDA requirements.

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A powder-free patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.

RS BLACK Black Medical Examination Nitrile gloves (powder free) as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard Specification for Nitrile Examination Gloves. They are made from nitrile latex compound, black colour and powder free.

The document describes the acceptance criteria and performance of "RS BLACK Black Nitrile Medical Examination Gloves (Powder Free)".

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document doesn't explicitly state the sample sizes for the tests conducted to prove compliance with ASTM D 6319-10 or biocompatibility. The country of origin of the device manufacturer is Malaysia. The data appears to be prospective testing conducted for regulatory submission, as it describes the properties of the manufactured device.

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

This information is not provided in the document. The tests refer to compliance with established standards (ASTM D 6319-10, ISO 10993-10:2010(E)), which typically involve standardized testing protocols and measurements rather than expert consensus on individual cases.

4. Adjudication method for the test set:

Not applicable. The tests are against objective standards (e.g., physical properties, pinhole incidence, biocompatibility).

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 medical examination glove, not an AI-powered diagnostic or assistive tool.

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

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

7. The type of ground truth used:

The ground truth used is based on established industry standards and regulatory requirements. For physical properties (dimensions, tensile strength, freedom from pinholes, powder residue), the ground truth is defined by the specifications outlined in ASTM D 6319-10. For biocompatibility (Primary Skin Irritation Test and Dermal Sensitization), the ground truth is defined by the pass/fail criteria within ISO 10993-10:2010(E) and Consumer Product Safety Commission regulations.

8. The sample size for the training set:

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:

Not applicable. There is no training set for this device.

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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.

White Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard Specification for Nitrile Examination Gloves. They are made from nitrile latex compound, white colour, powder free and non sterile.

The provided text describes a 510(k) summary for Nitrile Examination Gloves and does not contain information about a study with acceptance criteria for a device involving AI or expert review. Instead, it details the characteristics and performance of medical gloves against established ASTM standards and biocompatibility tests.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these topics are not present in the document.

However, I can extract the acceptance criteria and reported device performance for the Nitrile Examination Gloves based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation for Missing Information:

The request implicitly assumes the device is an AI-driven medical device requiring clinical studies with human expert input. The provided text, however, relates to a Class I medical device (Nitrile Examination Gloves) where "acceptance criteria" are based on compliance with established industry standards (ASTM) and biocompatibility tests, rather than clinical efficacy studies in the context of diagnostic or therapeutic AI.

Therefore, the following points cannot be addressed from the given document:

• Sample size used for the test set and the data provenance: Not applicable, as this is a product-testing conformity document, not a clinical study on a dataset.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for glove performance is defined by the technical specifications in the ASTM standard and the results of laboratory tests.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth is defined by the objective physical and chemical properties and performance markers specified in ASTM D 6319-10 and biocompatibility testing protocols.
• The sample size for the training set: Not applicable. Manufacturing processes are typically controlled by quality assurance and quality control testing, not machine learning training sets.
• How the ground truth for the training set was established: Not applicable.

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A powder-free patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Latex Examination gloves powder free as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LYY (21CFR 880.6250). It meets all the specifications in ASTM D 3578-05, Standard Specification for Latex Examination Gloves. They are made from natural latex compound and powder free.

This document describes the regulatory submission for the "RS Care Latex Examination Gloves Powder Free." It's important to note that this is a 510(k) summary for a medical device (gloves), not an AI/ML powered device. Therefore, many of the requested categories in your prompt, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone algorithm performance," "sample size for the training set," and "adjudication method," are not applicable.

Here's the breakdown based on the provided text, focusing on the relevant acceptance criteria and study information for this type of device:

Acceptance Criteria and Device Performance Study for RS Care Latex Examination Gloves Powder Free

1. Table of Acceptance Criteria and Reported Device Performance

*Note: The "Conclusion" statement mentions the device "shall perform according to the glove performance standards," implying that studies were conducted to confirm this, as indicated by the "Meets" and "Passes" in the performance column for each characteristic.

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

The document does not specify the exact sample sizes used for each test (e.g., for dimension testing, pinhole testing, etc.). The testing aligns with established ASTM standards (ASTM D 3578-05), which typically outline sampling plans, but the specific numbers are not provided in this 510(k) summary.

Data Provenance: The device manufacturer, Riverstone Resources Sdn. Bhd., is located in Selangor, Malaysia. It is implied that the testing was conducted either internally by the manufacturer or by a contracted laboratory adhering to the specified standards. The data is retrospective in the sense that the tests were performed on finished product batches to demonstrate compliance prior to market approval.

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

Not applicable. This is not a study requiring expert interpretation of complex data (like medical images). The "ground truth" here is determined by objective measurements and standardized laboratory tests (e.g., measuring glove dimensions, counting pinholes, chemical analysis for protein content, and biological assays for biocompatibility) according to the specified ASTM and CPSC standards.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective and based on predefined measurement criteria and laboratory procedures, not subjective 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

Not applicable. This is a physical medical device (gloves), not an AI/ML powered diagnostic or assistive technology.

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

Not applicable. This is a physical medical device (gloves), not an AI/ML algorithm.

7. The Type of Ground Truth Used

The ground truth is based on objective measurements and chemical/biological assay results obtained through standardized laboratory testing procedures as defined by:

• ASTM D 3578-05 (for Dimension, Physical Properties, Freedom from pinholes, Powder-Free, and Protein Content)
• Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (for Primary Skin Irritation Test)
• ASTM-F 720-81 (Reapproved 2007) (for Dermal Sensitization Assay)

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model that requires a training set. The manufacturing process is controlled to ensure consistent product characteristics that meet the defined standards.

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

Not applicable. There is no "training set" in the context of this device's regulatory submission.

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