Search Results

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

Non-sterile, Powder-free Nitrile Examination Glove with Polymer coating, Aloe and Vitamin E. Blue.

The provided text describes a 510(k) summary for a Nitrile Examination Glove, not a medical imaging AI device. Therefore, it does not contain information related to acceptance criteria, study methodologies (like sample size, ground truth establishment, expert adjudication, MRMC studies, or standalone performance) typically associated with the development and validation of AI models for medical imaging.

The document focuses on demonstrating substantial equivalence of a new glove product to existing predicate devices based on material, intended use, physical properties, and biocompatibility.

Therefore, I cannot extract the requested information as it is not present in the provided text.

If you have a document describing an AI device for medical imaging, please provide that, and I will be happy to extract the relevant details.

Ask a specific question about this device

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.

Non sterile, Powder free Nitrile Examination Glove, Blue.

The provided text describes a 510(k) summary for a Non-sterile, Powder-free Nitrile Examination Glove, Blue. This is a medical device, and the information presented is for its regulatory clearance, not a study evaluating an AI device or a diagnostic tool. Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of device and its regulatory submission.

The document focuses on demonstrating that the new glove is "substantially equivalent" to an already legally marketed predicate device by meeting established performance standards.

Here's an analysis of the provided information, addressing the applicable categories:

1. Table of Acceptance Criteria and Reported Device Performance

Note: "ASTM D 6319-10" refers to "Standard Specification for Nitrile Examination Gloves for Medical Application," which outlines the specific acceptance criteria (e.g., minimum tensile strength, maximum pinhole AQL, etc.) for each characteristic. The document states the device "Meets" or "Passes" these standards.

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

• Sample Size: Not specified in the provided text. The testing for glove performance standards like ASTM D 6319-10 typically involves taking samples from production lots. The specific number of gloves tested for each characteristic (e.g., dimensions, tensile strength, freedom from holes) is defined by the ASTM standard itself and quality control procedures, but this detail is not present in the 510(k) summary.
• Data Provenance: The manufacturer is Siam Sempermed Corp., Ltd, located in Songkhla, Thailand. Therefore, the data would have originated from their testing facilities in Thailand. The data is based on non-clinical performance testing of the device's physical and biocompatibility characteristics, conducted to demonstrate compliance with the ASTM standard. This is prospective data generated for the purpose of 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. For this type of device (medical glove), "ground truth" is established by adherence to established, objective, and quantitative physical and chemical standards (e.g., ASTM D 6319-10, biocompatibility testing protocols). There are no human "experts" interpreting results like in an image analysis or diagnostic study to establish a ground truth in the typical sense. Laboratory technicians and quality control personnel perform the tests according to standardized protocols.

4. Adjudication method for the test set

• Not Applicable. Adjudication is typically used in studies where there is subjective interpretation or disagreement among observers (e.g., radiologists). For objective glove performance testing, the results are quantitative measurements compared directly against a standard. If a test fails, it fails; there is no 'adjudication' process.

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

• Not Applicable. MRMC studies are used to evaluate diagnostic performance with human readers. This document describes a physical medical device (a glove), not a diagnostic or AI-driven system.

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

• Not Applicable. This device is a physical product and does not involve algorithms or AI.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by objective physical and chemical measurements compared against the acceptance criteria defined by recognized consensus standards, specifically ASTM D 6319-10 for physical properties, and standard biocompatibility testing protocols (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). These are quantitative, laboratory-based measurements.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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

Based upon 21 CFR Part 880.6250; "Patient examination glove" . A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner

Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coated, Tested for use with chemotherapy drugs.

The provided text describes Siam Sempermed Corp., Ltd.'s "Non-sterile, Powder-free Nitrile Examination Glove, Blue with Polymer coating Tested for use with chemotherapy drugs." The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission presents a table comparing the device's characteristics against recognized standards.

Note: The document states that the device was "Tested for use with chemotherapy drugs," but specific acceptance criteria and performance data for chemotherapy drug permeation are not included in this table or description. This is a crucial omission for a device marketed with this claim.

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

The document does not specify the sample sizes used for the tests to evaluate dimensions, physical properties, freedom from pinholes, or powder-free residue. It also does not provide details on the sample size for the biocompatibility tests (number of rabbits or guinea pigs).

The data provenance is from Thailand, where Siam Sempermed Corp., Ltd. is located. The tests were presumably conducted as part of the device's development and regulatory submission. The document does not explicitly state whether the data is retrospective or prospective, but given it's for a 510(k) submission, it would generally be considered pre-market testing data generated specifically for this purpose.

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

The document does not mention the involvement of experts in establishing ground truth for the test set. The acceptance criteria are based on established ASTM (American Society for Testing and Materials) standards. Compliance with these standards is typically assessed through laboratory testing protocols, not through expert consensus on individual cases.

For biocompatibility, the assessment of "Primary Skin Irritation" and "Guinea Pig Sensitization" would be conducted by trained toxicologists or scientists. However, the exact number and qualifications of these experts are not provided.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned or relevant here. The evaluation against ASTM standards and biocompatibility tests typically involves objective measurements and adherence to specified protocols, rather than expert adjudication of conflicting interpretations.

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

No MRMC comparative effectiveness study was done. This type of study is not relevant for evaluating the performance of a medical glove against technical standards. MRMC studies are typically used to assess the effectiveness of diagnostic or screening devices where human interpretation plays a significant role, often comparing AI-assisted performance against human-alone performance.

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

A standalone study was done in the sense that the device was tested independently against objective standards. The "performance" of the glove is its ability to meet the physical and biological requirements outlined in the ASTM standards. There is no "algorithm" involved in the glove's function, so the concept of an "algorithm only" performance doesn't apply here.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is defined by the established ASTM standards (e.g., ASTM D 6319-00a-05 for dimensions, physical properties, and freedom from pinholes; ASTM D 6124-06 for powder-free residue) and biocompatibility test protocols (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). These standards and protocols represent a consensus on acceptable performance thresholds.

8. Sample Size for the Training Set

There is no "training set" in the context of this device. Medical gloves are manufactured products, and their performance is evaluated through physical and biological testing against established standards, not through training a machine learning model.

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

As there is no training set for this type of device, this question is 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.

The tested chemotherapy drugs are as follows: Amethopterin Hydrate (Methotrexate), Cisplatin, Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), 5-Fluorouracil, Paclitaxel (Taxol), and Vincristine Sulfate.

Non sterile, Powder free Nitrile Examination Glove, Lavender Blue with Polymer coated, Tested for use with chemotherapy drugs.

The provided text describes the acceptance criteria and performance of a Non-sterile, Powder-free Nitrile Examination Glove, Lavender Blue with Polymer coated, Tested for use with chemotherapy drugs. This document is a 510(k) Summary.

Here's an analysis of the provided information, addressing your specific points:

1. A table of acceptance criteria and the reported device performance

Comment: The document outlines the specific ASTM standards used for various physical and chemical properties and indicates that the device met these standards or "passed" the tests.

Regarding the study that proves the device meets the acceptance criteria, and further points:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data. It does not describe a clinical study in the typical sense (e.g., involving human subjects, patient data, or a complex AI model evaluation). Instead, it presents laboratory test results against established standards.

Therefore, many of your requested points regarding clinical study design (sample size for test set, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set) are not applicable to this type of device submission and the information provided.

Let's address the relevant points based on the document's content:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact number of gloves or samples tested for each characteristic (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). The ASTM standards themselves would specify the minimum sample sizes for their respective tests, but this detail is not present in the 510(k) summary.
• Data Provenance: The testing was non-clinical (laboratory and animal studies). The document does not explicitly state the country where the tests were conducted, but the submitter is "Siam Sempermed Corp., Ltd" from Thailand, and the official correspondent is Sempermed USA Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This device evaluation relies on objective measurements against engineering and biocompatibility standards, not on expert interpretation of medical images or clinical outcomes. The "ground truth" is defined by the technical specifications and test methods outlined in the ASTM standards.

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

• Not Applicable. This concept is relevant for studies involving human interpretation or subjective assessments, often in clinical imaging. The testing here is based on objective laboratory measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a medical device, but not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant here.

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

• Not Applicable. This is not an algorithmic device. The device itself is the glove, and its performance is measured against physical and chemical standards.

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

• The "ground truth" for this device's performance is established by validated technical standards and test methods (e.g., ASTM D 6319-00a-05 for physical properties, ASTM D6978-05 for chemotherapy drug permeation, and established animal testing protocols for biocompatibility). The acceptance criteria are specified within these standards.

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" as it is not a machine learning or AI-based device.

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

• Not Applicable. As there is no training set, this question is not relevant.

In summary, the provided 510(k) document details how the glove device meets established industry standards for physical properties, biocompatibility, and resistance to chemotherapy drug permeation through laboratory and animal testing. It's a non-clinical submission demonstrating substantial equivalence to a predicate device, and thus, many of the questions related to clinical trials, human expert evaluation, and AI/ML algorithms are not applicable.

Ask a specific question about this device

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

Non sterile, Powdered Nitrile Examination Glove, Blue

The provided document is a 510(k) summary for a Non-Sterile, Powdered Nitrile Examination Glove, Blue. It describes the device's characteristics and its substantial equivalence to a predicate device, rather than a study with acceptance criteria and device performance in the context of an AI or diagnostic medical device.

Therefore, many of the requested elements are not applicable to this type of submission. However, I can extract the information that is present and clearly state where the requested information is not available due to the nature of the document.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the typical sense of a diagnostic or AI device (e.g., sensitivity, specificity thresholds). Instead, it refers to industry standards that the device "meets" or "passes."

(Note: The term "acceptance criteria" here refers to the standards against which the glove's performance was measured.)

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

The document does not specify the sample sizes used for testing each characteristic (Dimensions, Physical Properties, Biocompatibility, etc.). It only states that the device "Meets" or "Passes" the listed standards.

Regarding data provenance, no information is provided about the country of origin of data or whether it was retrospective or prospective.

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

This information is not applicable to a glove's performance testing for physical and biocompatibility characteristics. The "ground truth" for these measurements would be defined by the ASTM standards and expert interpretation of the test results according to those standards, not by clinical expert consensus in the way it applies to diagnostic image analysis.

4. Adjudication Method for the Test Set

This information is not applicable as it relates to expert consensus or interpretation for data labeling, which is not relevant for the type of testing described for this device.

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

No MRMC study was conducted or is mentioned, as this device is a patient examination glove and not an AI or diagnostic imaging device that would typically involve human readers interpreting cases.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a physical product (glove) and does not involve an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on the objective measurements and established protocols defined within the ASTM D 6319-00a-05 standard for physical properties and freedom from pinholes, and standardized laboratory animal testing protocols for biocompatibility (Primary Skin Irritation in Rabbits and Guinea Pig Sensitization). It's not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning model, so there is no "training set."

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

Not applicable, as there is no training set 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 or finger to prevent contamination between patient and examiner.

Non-Sterile, powdered latex examination gloves.

The acceptance criteria for the "Non-sterile, powdered latex examination gloves" and the study proving adherence to these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test (e.g., freedom from pinholes, physical properties, etc.). It refers to "The performance test data of the non-clinical tests that support a determination of substantial equivalence" suggesting that tests were conducted.

The data provenance is not explicitly mentioned as country of origin but implies the tests were conducted by the manufacturer, Siam Sempermed Corp., Ltd, based in Thailand. The nature of the tests (e.g., ASTM standards for physical properties, animal studies for biocompatibility) indicates that these were likely prospective laboratory tests conducted to meet established standards for medical devices.

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 "ground truth" for these tests is implicitly defined by the ASTM standards and the biological test methodologies. For example, "Passes" for Biocompatibility (Primary Skin Irritation in Rabbits) signifies that the results fell within the acceptable parameters defined by the test method, rather than being determined by expert consensus on specific device defects.

4. Adjudication method for the test set

Not applicable. The tests mentioned (e.g., ASTM D 3578-05, Primary Skin Irritation in Rabbits) are objective laboratory or animal studies with clear pass/fail criteria based on predefined specifications or biological responses. They do not involve human interpretation or adjudication in the sense of consensus building among experts.

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 device (examination gloves), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant to its evaluation.

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

Not applicable. As this is a physical medical device, there is no algorithm or AI component to evaluate in a standalone capacity.

7. The type of ground truth used

The ground truth used for evaluating the device's performance is based on:

• Established Industry Standards: ASTM D 3578-05 for various physical characteristics (dimensions, physical properties, freedom from pinholes, powdered residue, protein level).
• Standardized Biological Test Methods: "Primary Skin Irritation in Rabbits" and "Guinea Pig Sensitization" for biocompatibility.

These methods define the objective criteria that the device must meet to be considered acceptable.

8. The sample size for the training set

Not applicable. This device is a physical medical product, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development.

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

Not applicable, as there is no training set 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 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

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 betweeen patient and examiner.

Non sterile, Powder free Nitrile Examination Glove, Blue ,Polymer coating with Chemotherapy claim .

{
  "acceptance_criteria_and_performance_table": {
    "title": "Acceptance Criteria and Device Performance for Non-Sterile, Power-Free Nitrile Examination Glove",
    "headers": ["CHARACTERISTICS", "STANDARDS", "DEVICE PERFORMANCE"],
    "data": [
      ["Dimensions", "ASTM D 6319-00a (Re-approved 2005)", "Meets"],
      ["Physical Properties", "ASTM D 6319-00a (Re-approved 2005)", "Meets"],
      ["Freedom from pinholes", "ASTM D 6319-00a (Re-approved 2005)", "Meets"],
      ["Powder Free Residue", "ASTM D 6124-2006", "≤ 2 mg/glove"],
      ["Biocompatibility (Primary Skin Irritation in Rabbits)", null, "Passes"],
      ["Biocompatibility (Guinea Pig Sensitization)", null, "Passes"]
    ]
  },
  "sample_size_test_set": "Not specified; the document refers to performance data but does not detail the sample sizes for the specific tests.",
  "data_provenance": "Not specified explicitly in the provided text. The submitter is Siam Sempermed Corp., Ltd from Thailand, suggesting testing could have occurred there or in the US.",
  "number_of_experts_ground_truth_test_set": "Not applicable. The tests performed are objective, laboratory-based physical and chemical property assessments according to ASTM standards, and biocompatibility tests. Expert consensus is not required for establishing ground truth for these types of measurements.",
  "qualifications_of_experts": "Not applicable.",
  "adjudication_method": "Not applicable. The tests involve quantifiable measurements against established standards, not subjective assessments requiring adjudication.",
  "mrmc_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data.",
  "effect_size_of_human_readers_with_ai_vs_without_ai_assistance": "Not applicable, as no MRMC study was performed and this device type does not involve AI assistance for human reader interpretation.",
  "standalone_performance_study": "Yes, a standalone (algorithm only without human-in-the-loop performance) was effectively done. The device's performance was evaluated against established ASTM and biocompatibility standards independently, without human interaction with an AI component.",
  "type_of_ground_truth_used": "Objective measurements from laboratory tests according to established international standards (ASTM) and biological response tests (biocompatibility).",
  "sample_size_training_set": "Not applicable. This device is a medical glove, not an AI/ML-based device that requires a training set.",
  "how_ground_truth_for_training_set_was_established": "Not applicable, as there is no training set for this device type."
}

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 betweeen patient and examiner.

Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating

This document describes the premarket notification (510(k)) for the "Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating" by Siam Sempermed Corp., Ltd. The study aims to demonstrate substantial equivalence to a predicate device.

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 sample sizes used for the specific tests (Dimensions, Physical Properties, Freedom from pinholes, Powder Free Residue, Biocompatibility). The tests reference ASTM standards (ASTM D 6319-00-ae³ and ASTM D 6124-2006), which would specify sampling methods and sizes.

The data provenance is from non-clinical performance testing conducted by Siam Sempermed Corp., Ltd., in Thailand (based on the submitter's address). The data is prospective in the sense that it was generated for the purpose of this 510(k) submission to demonstrate the device's adherence to standards.

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

Not applicable. This is a medical device performance study, not a study involving human expert interpretation of data like imaging. The "ground truth" for the device's performance is established by standardized testing methods and their inherent pass/fail criteria or quantitative limits, as defined by ASTM standards and biological testing protocols.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret complex data and their interpretations need to be reconciled (e.g., in radiological studies). For material property testing and biocompatibility assessments, the results are derived directly from the test procedures, eliminating the need for adjudication of human interpretations.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. This submission is for an examination glove, which does not involve human interpretation in the same way.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This device is not an algorithm, but a physical product (a medical glove).

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Adherence to recognized industry standards: ASTM D 6319-00-ae³ for dimensions, physical properties, and freedom from pinholes.
• Quantitative measurement against a specified limit: ASTM D 6124-2006 for powder-free residue (≤ 2 mg/glove).
• Biological testing outcomes: "Passed" for Primary Skin Irritation in Rabbits and Guinea Pig Sensitization, indicating non-toxicity/non-sensitization according to established biological evaluation protocols.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI algorithm that requires a training set. The performance data is based on samples of the manufactured gloves being tested against established standards.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device