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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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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.

Nitrile Examination gloves powder free blue colour 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 D6319-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile latex compound, blue colour and powder free.

The provided text describes the 510(k) summary for "RS Safe Blue Nitrile Medical Examination Gloves (Powder Free)". This document is for a medical device (nitrile examination gloves), a Class I device. As such, the concept of a "study" to prove performance in the way it might apply to more complex AI/ML or diagnostic devices (e.g., MRMC, standalone algorithm performance, training/test sets, expert adjudication, effect size) is not relevant here.

The document demonstrates substantial equivalence by showing that the device meets established consensus standards for medical gloves.

Here's a breakdown of the requested information based on the provided text, focusing on how it applies to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size for each test (e.g., how many gloves were tested for pinholes, or how many subjects for biocompatibility). However, the tests are conducted in accordance with the methodologies outlined in the referenced ASTM and CPSC standards, which would define appropriate sample sizes for such physical and biocompatibility testing.
• Data Provenance: Not explicitly stated as "country of origin for data", but the testing was conducted by the manufacturer (Riverstone Resources Sdn. Bhd.) in Malaysia, as indicated by their address. The testing is assumed to be prospective, as it's part of the premarket notification process for a new device.

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 to the evaluation of medical gloves. The "ground truth" here is the pass/fail criteria defined by the internationally recognized consensus standards (ASTM, CPSC). There isn't a need for expert radiologists or similar specialists to establish ground truth for glove performance. The "experts" are the technical committees that developed the standards and the technicians who perform the tests according to those standards.

4. Adjudication method for the test set

• This concept is not applicable. Adjudication usually refers to resolving disagreements among multiple human readers. For glove testing, the results are typically objective measurements against a defined standard. There is no ambiguous 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 is not applicable. This is a physical medical device (gloves), not an AI/ML diagnostic tool. There are no "human readers" or "AI assistance" involved in its primary function or evaluation.

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

• This is not applicable. This device is a physical product, not an algorithm or software. No standalone algorithm performance was assessed.

7. The type of ground truth used

• For this device, the "ground truth" is established by consensus standards and regulatory requirements. Specifically:
  • ASTM D 6319-00a: This is the standard specification for Nitrile Examination Gloves, defining physical properties, dimensions, and freedom from pinholes.
  • Consumer Product Safety Commission (CPSC), Title 16, Chapter II, Part 1500: This covers the Primary Skin Irritation Test.
  • ASTM-F 720-81 (Reapproved 2007)El: This pertains to the Dermal Sensitization Assay.
  • These standards provide objective, measurable criteria that the device must meet.

8. The sample size for the training set

• This is not applicable. "Training set" refers to data used to train AI/ML models. This device is a physical product, not an AI/ML system.

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

• This is not applicable for the same reason as point 8.

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A medical gloves is worn on hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Nitrile Patient Examination Gloves, Trade Name: Powdered, Non-Sterile

This document is a 510(k) clearance letter from the FDA for Nitrile Patient Examination Gloves. It focuses on regulatory approval based on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed performance studies with acceptance criteria for a new AI or diagnostic device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/diagnostic device is not contained in the provided text.

The document does include:

• Device Name: Nitrile Patient Examination Gloves, Trade Name: Powdered, Non-Sterile (later specified as RS Nitrilstat Medical Examination Gloves, Powdered (Non-Sterile)).
• Applicant: Riverstone Resources Sdn. Bhd.
• Intended Use: "A medical gloves is worn on hand of health care and similar personnel to prevent contamination between health care personnel and the patient."

Without a document detailing the performance study for such a device, I cannot fulfill the request.

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A medical gloves is worn on hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

RS Nitrilstat Medical Examination Gloves, Powder Free (Non-Sterile)

This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot provide the requested information based on the given input.

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