Search Results

Non Sterile Powder Free Latex Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Non Sterile Powder Free Latex Examination Gloves

The provided document is a 510(k) clearance letter from the FDA for "Non Sterile Powder Free Latex Examination Gloves." It certifies that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any details related to AI/software performance as requested in your prompt.

The questions you've asked are typically relevant to the evaluation of AI/ML-driven medical devices (e.g., for diagnostic imaging), where performance metrics like sensitivity, specificity, or AUC are critical, and detailed study methodologies are required to demonstrate clinical validity.

This document pertains to a Class I medical device (non-powdered patient examination glove) which is a physical product, not a software or AI-based device. Therefore, the type of information you are seeking (AI performance, MRMC studies, ground truth establishment for algorithms, etc.) is not applicable and not present in this document.

Ask a specific question about this device

This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
CAUTION: Safe use of this glove by on or latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions.

Non-Sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, or ground truth for a medical device that would involve AI, human readers, or specific performance metrics like sensitivity or specificity.

The document is a 510(k) clearance letter from the FDA for Non-sterile, Powder-Free Latex Examination Gloves. This type of device does not typically involve complex performance studies with AI, human interpretation, or ground truth establishment in the way described in your request. The clearance is based on substantial equivalence to legally marketed predicate devices, and the "Indications for Use" section simply describes the intended use of the gloves for preventing contamination.

Therefore, I cannot provide the requested information as it is not present in the given text.

Ask a specific question about this device

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

This glove contains 50 micrograms or less of total water extractable protein per gram.

CAUTION: Safe use of this glove by or on latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions

Non-sterile, Powder-Free Latex Examination Glove

This document is a 510(k) premarket notification decision letter from the FDA for a Non-sterile, Powder-Free Latex Examination Glove. It is not for a medical device that utilizes AI or algorithmic performance, therefore, the requested information regarding acceptance criteria, study details, ground truth establishment, and expert involvement is not applicable to this document.

The document discusses substantial equivalence to predicate devices for a physical product (gloves) and outlines regulatory requirements for such products, not performance metrics for an AI/algorithm-based device.

Ask a specific question about this device

A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and the examiner.

The subject device of this submission is a natural rubber latex examination glove. The glove is non-sterile and meets the recommendations of ASTM D3578-05(2015). The device is natural in color.

This document describes the premarket notification for the UniTex Non-Sterile, Powder-Free, Latex Examination Glove (K161961). The study aims to demonstrate that this device is substantially equivalent to a legally marketed predicate device (K010879).

Here's the information broken down by your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting the requirements of ASTM D3578-05(2015) and specific values for various properties. The reported device performance is presented alongside the predicate device's performance for comparison.

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

The document does not explicitly state the specific sample sizes for each test performed to establish device performance. However, for inspection parameters like "Dimensions", "Physical Properties", "Water Tight Test", and "Visual Defects", AQL (Acceptance Quality Limit) levels and inspection levels (e.g., S-2, G-1) are specified. These AQLs determine the sample size and acceptance criteria for lot release, which implies that a sampling plan was followed according to the referenced standards (e.g., ISO 2859-1:1999).

The data provenance is from prospective testing conducted by UG Global Resources Sdn Bhd to demonstrate compliance with the relevant standards for their device. The manufacturing location and potentially the testing facilities are in Malaysia.

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

This submission is for a medical glove, not an AI/CAD system. Therefore, the concept of "ground truth" as established by medical experts for diagnostic purposes (e.g., radiologists interpreting images) is not applicable here. The "ground truth" for the performance of the glove is established by following standardized ASTM and ISO testing protocols, which are objective and quantitative measurements of physical and chemical properties.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. The tests are objective and based on established industry 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 not an AI/CAD device.

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

Not applicable. This is not an AI/CAD device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance consists of:

• Adherence to ASTM and ISO standards: The device is tested against established specifications outlined in standards like ASTM D3578-05(2015), ASTM D5151, ASTM D5712, ASTM D6124, and ISO 10993-10.
• Quantitative measurements: Physical properties (tensile strength, elongation, dimensions, powder content) and chemical properties (water soluble protein) are measured directly.
• Biocompatibility testing: Standardized in-vivo tests (Primary Irritation Test, Dermal Sensitization Assay) are conducted to determine irritation and sensitization potential.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/CAD device that requires a training set. The performance is assessed through physical and chemical testing.

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

Not applicable. This is not an AI/CAD device.

Ask a specific question about this device

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.

Non-Sterile, powder-free latex examination gloves with protein claim (50 micrograms or less).

This looks like a 510(k) premarket notification for non-sterile, powder-free latex examination gloves, which typically doesn't involve complex algorithms or AI. The acceptance criteria and "study" described here refer to conformance with established performance standards for medical gloves, rather than a clinical trial or AI model validation.

Therefore, many of the typical AI/ML study components (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.

Here's a breakdown of the available information relating to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of a numerical count of individual gloves tested. The submission refers to meeting standards like "AQL 2.5" for pinholes, which implies a sampling plan defined by ASTM D3578. However, the specific number of gloves sampled for each test is not provided in this summary.
• Data Provenance: The testing was performed by "Siam Sempermed Laboratories in Thailand" for physical properties and "Consumer Product Testing" in Fairfield, New Jersey, USA for biocompatibility. This suggests a combination of in-house (Thailand) and third-party (USA) testing. The data is prospective in the sense that the manufacturer tested their actual product to demonstrate compliance.

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

• This is not applicable. The "ground truth" for glove performance is defined by the objective, quantifiable metrics within the referenced ASTM and ISO consensus standards (e.g., specific dimensions, tensile strength, protein limits, pinhole AQL). There are no "experts" establishing ground truth in the way a clinical study would for medical imaging.

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

• Not applicable. Adjudication methods are relevant for subjective interpretations, whereas these tests involve objective measurements against predefined thresholds in 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 device is a physical medical glove, not an AI or imaging device that uses "human readers" or "AI assistance."

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

• Not applicable. This is not an algorithmic or AI device. The performance tests are for the physical properties of the glove itself.

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

• The "ground truth" is established by consensus standards (ASTM D3578-05, ISO 10993-10/2002) which specify measurable physical, chemical, and biological properties that the gloves must meet for their intended use. These standards are developed through a consensus process involving experts in the field.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable.

Ask a specific question about this device

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.

Non-Sterile, powder-free latex examination gloves and protein claim (50 micrograms or less).

Acceptance Criteria and Device Performance Study for Non-Sterile, Powder-Free Latex Examination Gloves

This document outlines the acceptance criteria and the study conducted to demonstrate that the device, Non-Sterile, Powder-Free Latex Examination Glove with Protein Claim (50 micrograms or less), meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against established industry standards and specific tests for biocompatibility. The table below summarizes these criteria and the reported performance.

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

The provided document does not explicitly state the sample sizes used for each specific test within the ASTM D 3578-05-e1 standard or for the biocompatibility studies. However, the standard itself dictates sampling plans for various tests (e.g., AQL for pinholes).

Data Provenance: The studies were conducted by Siam Sempermed Corp., Ltd., an organization based in Thailand. The nature of the tests (physical properties, chemical analysis, and animal biocompatibility studies) indicates that the data is retrospective relative to the date of the 510(k) submission, meaning the tests were performed prior to the submission to demonstrate compliance. The country of origin for the data is Thailand, where the manufacturer is located.

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

For this type of device (medical gloves), the "ground truth" is not typically established by human experts in the same way as, for example, medical imaging diagnostics. Instead, the ground truth is defined by objective, measurable parameters outlined in the referenced standards (ASTM D 3578-05-e1) and established protocols for biocompatibility testing.

• ASTM D 3578-05-e1: Compliance with this standard is determined through prescribed laboratory testing methods, not by expert consensus. Therefore, no number of human experts with specific qualifications like "radiologist with 10 years of experience" would be involved in establishing this ground truth. The "experts" would be qualified laboratory technicians performing the tests according to the standard.
• Biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization): These are standardized animal tests with defined pass/fail criteria. The interpretation of results would typically be done by qualified toxicologists or veterinarians specializing in animal studies, following established protocols. The number of such individual experts is not specified but is implicit in the execution of these regulatory-driven tests.

4. Adjudication Method (for the test set)

As described above, the "ground truth" for this device's performance is determined by adherence to established, quantitative standards and prescribed test protocols. Therefore, a human "adjudication method" like 2+1 or 3+1 (common in studies involving subjective interpretation, e.g., clinical diagnosis) is not applicable here. The results of the tests are objective and directly compared against the acceptance criteria outlined in the standards.

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

An MRMC comparative effectiveness study is not applicable and therefore was not done for this device. MRMC studies are used to evaluate the performance of human readers (e.g., radiologists) with and without the assistance of AI in interpreting medical images or data. This device is a physical product (examination glove), not an AI diagnostic tool, so such a study would be irrelevant.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study is not applicable for this device. This device is a physical product, not an algorithm or AI model. Therefore, there is no "algorithm-only" performance to evaluate. The studies performed are to demonstrate the physical and chemical properties of the glove itself.

7. Type of Ground Truth Used

The type of ground truth used is predominantly objective, quantitative measurements against established industry standards and regulatory biological safety protocols.

• ASTM D 3578-05-e1: Ground truth is defined by the specific values, ranges, and methodologies prescribed by this standard for dimensions, tensile strength, elongation, freedom from holes (AQL), and powder-free residue.
• Protein Level: The ground truth is the quantitative measurement of protein, with an acceptance criterion of "50 micrograms or less."
• Biocompatibility: Ground truth is established by the outcomes of validated animal tests (Primary Skin Irritation in Rabbits and Guinea Pig Sensitization) against predefined "pass" criteria for these biological responses.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable for this device. Training sets are used in machine learning and AI development to teach an algorithm to recognize patterns. Since this device is a manufactured physical product, its characteristics are determined by the manufacturing process and material properties, not by an algorithm trained on data. There is no software or AI component that requires a training set.

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

As stated above, a "training set" is not applicable for this device. Therefore, the question of how its ground truth was established is moot.

Ask a specific question about this device

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.

Non-Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less)

The provided text describes a 510(k) submission for non-sterile, powder-free latex examination gloves. The study described focuses on non-clinical performance data to demonstrate substantial equivalence to a predicate device, rather than a clinical study involving human patients or complex algorithms.

Here's an analysis of the provided information, addressing each point as applicable to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

This table indicates that the device's performance was evaluated against established ASTM (American Society for Testing and Materials) standards and biocompatibility tests.

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

The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for dimensions, pinholes, etc., or number of animals for biocompatibility). The data provenance is not detailed in terms of country of origin but implies laboratory testing. The study is non-clinical and focuses on physical and chemical properties of the device itself.

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

This type of device submission (examination gloves) does not typically involve "experts" establishing a "ground truth" for a test set in the way an AI/ML medical device would. The standards (ASTM D 3578-05) themselves define the acceptable parameters, and laboratory technicians or engineers perform the measurements and assessments against these objective criteria. No information on the number or qualifications of experts for ground truth is provided, as it's not applicable in the context of this submission.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where human interpretation of data (e.g., radiology images) is involved and discrepancies need resolution. For physical and chemical testing of gloves against objective standards, an adjudication method is not relevant. The results are quantitative measurements or qualitative observations that either meet or do not meet the predefined standard.

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

No. An MRMC comparative effectiveness study is designed to assess the performance of human readers, sometimes with and without AI assistance, on a set of cases. This is a non-clinical submission for examination gloves, which does not involve human readers interpreting cases or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This submission is for a physical medical device (examination gloves), not an algorithm or AI model. Therefore, the concept of a "standalone" algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The ground truth for this device is based on established objective standards. Specifically:

• ASTM D 3578-05: This standard dictates the acceptable dimensions, physical properties, freedom from pinholes, powder-free residue, and protein levels for medical examination gloves.
• Biocompatibility tests: These tests (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization) determine the biological safety of the materials in contact with skin, with "passing" results indicating acceptable biocompatibility.

8. The Sample Size for the Training Set

This concept is not applicable. "Training set" refers to data used to train an artificial intelligence or machine learning model. This submission is for a physical medical device and does not involve AI/ML.

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

Not applicable, as there is no training set for an AI/ML model in this submission.

Ask a specific question about this device

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA Water leak test.

Here's a breakdown of the acceptance criteria and study information for the Green Prospect Sdn Bhd Non-Sterile Powder Free, Latex Examination 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 explicitly state the specific sample sizes used for each test. However, it references ASTM D3578-01, which is a standard specification for rubber examination gloves. This standard outlines procedures for sampling and testing. For example, for watertightness, it specifies an Acceptance Quality Limit (AQL) of 2.5, which implies a sampling plan where a certain number of gloves are tested from a lot, and the number of failures must not exceed a specified threshold for the lot to be accepted.

The data provenance is from Green Prospect Sdn Bhd, Malaysia. The studies appear to be retrospective in the sense that the data presented are the results of tests already conducted to demonstrate compliance with existing standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable in this context. The "ground truth" for medical gloves is established by predefined ANSI/ASTM and FDA standards and requirements, not through expert consensus on qualitative assessments. The tests are objective measurements against these established quantitative limits.

4. Adjudication Method for the Test Set

This is not applicable. The tests performed on medical gloves are objective and quantitative measurements (e.g., length, thickness, tensile strength, protein content). The results are compared directly to the numerical acceptance criteria defined in the relevant standards (ASTM D3578-01 and FDA requirements). There is no subjective interpretation requiring an adjudication process.

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

This is not applicable. MRMC studies are used to evaluate the diagnostic accuracy of imaging or other interpretive devices, often with and without AI assistance, comparing human reader performance. This device is a medical glove, and its performance is assessed through physical and chemical property testing, not through human interpretation of cases.

6. Standalone (Algorithm Only) Performance

This is not applicable. This device is a physical product (medical glove), not an algorithm or software. Its performance is inherent in its physical and chemical properties, measured directly through laboratory testing.

7. Type of Ground Truth Used

The ground truth used for evaluating the device is based on pre-established industry standards and regulatory requirements:

• ASTM D3578-01 Standard Specification for Rubber Examination Gloves
• FDA Pinhole Requirements
• FDA Minimum Powder Residual Content
• Label Claim of maximum 50 micrograms per gram of glove or less for water extractable protein.
• Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test).

8. Sample Size for the Training Set

This is not applicable. This device is a manufactured product (medical glove), not an AI/ML model or a diagnostic algorithm that requires a "training set" in the context of machine learning. The testing described is for product quality control and regulatory compliance.

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

This is not applicable for the same reasons mentioned in point 8.

Ask a specific question about this device

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.

Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E, and protein claim (50 micrograms or less).

The provided 510(k) summary for the "Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E and protein claim (50 micrograms or less)" does not contain a study to prove the device meets specific acceptance criteria in the manner of a typical clinical performance study for an AI/ML device or diagnostic tool. Instead, this submission is an Abbreviated 510(k) based on substantial equivalence to a predicate device (Siam Sempermed Latex Patient Examination Glove, Powder free, 510(k) #K970794).

The acceptance criteria here are primarily regulatory and performance characteristics being compared to the predicate device, demonstrating that the new device is as safe and effective as the previously cleared one.

However, I can extract the information requested based on the context of a 510(k) submission for a medical glove.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating "substantial equivalence" to a predicate device. This involves comparing technological characteristics and showing that the new device is as safe and effective. The reported device performance is implicitly that it meets or is comparable to the predicate device across various parameters.

Study Details (as applicable for a 510(k) of a medical glove)

Given that this is a 510(k) for a medical glove based on substantial equivalence, the "study" referred to generally involves a comparison of technical characteristics and performance testing rather than a clinical trial with experts establishing ground truth in the way of an AI/ML diagnostic.

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

   • The provided summary does not detail specific sample sizes for performance tests (e.g., tensile strength, puncture resistance, protein content). Such data would typically be found in the "additional technical comparative table" mentioned but not included in this extract.
   • Provenance: Not explicitly stated, but typically these tests are conducted internally by the manufacturer (Siam Sempermed Corp., Ltd.) during product development and quality control.

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

   • Not applicable in the sense of clinical ground truth. For a medical glove, "ground truth" relates to objective physical, chemical, and biological properties (e.g., dimensions, barrier integrity, protein content, biocompatibility). These are established through standardized testing procedures, not by human expert interpretation.
   • The experts involved would be quality engineers, chemists, and microbiologists conducting the tests, often overseen by qualified staff (e.g., Dr. Poonsuk Cherdkiatgumchai, Chief Quality Officer).

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in interpreting complex clinical data (e.g., radiology reads). For a physical device like a glove, test results are typically objective measurements against engineering specifications or established standards (e.g., ASTM).

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:

   • Not applicable. This device is a medical glove, not an AI/ML diagnostic tool. There are no "human readers" to assist in interpretation.

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

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

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

   • The "ground truth" for a medical glove refers to its objective, measurable physical, chemical, and biological properties as defined by relevant standards (e.g., ASTM D3577 for examination gloves, ISO 10993 for biocompatibility) and regulatory requirements (e.g., protein content limits).

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI/ML model that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. No training set is used for this type of device.

Ask a specific question about this device

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.

Non-sterile, powder-free latex examination gloves with polymer coating, vitamin E, and protein claim (50 micrograms or less).

The provided document is a 510(k) summary for non-sterile, powder-free latex examination gloves. It does not describe an AI/ML powered medical device, nor does it contain information about a study with acceptance criteria, sample sizes, expert ground truth, or adjudication methods for an AI/ML device.

Instead, this document is concerned with demonstrating substantial equivalence to a predicate device (Siam Sempermed Latex Patient Examination Glove, Powder free, 510(k) #K970794) for regulatory purposes. The comparison table confirms that the new device has "Identical" or "Similar" characteristics to the predicate device across various technological aspects.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them, as this document is not about such a device.

Ask a specific question about this device