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THIS DEVICE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PROPOSE THAI IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl
Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl

The provided document is a 510(k) clearance letter from the FDA for medical gloves, specifically "Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl" and "Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl".

This document does not contain any information about an AI/ML medical device, its acceptance criteria, or the study that proves it meets those criteria. It is entirely focused on the regulatory clearance of examination gloves, outlining their indications for use, the chemotherapy drugs they were tested against, and fentanyl permeation times. There is no mention of algorithms, machine learning, human readers, or any other aspects related to AI/ML device evaluation.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device based on this document.

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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.

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

Non sterile, Powder free Nitrile Examination Glove, Blue.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the provided text. The document states "The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above," referring to the table of characteristics, but does not detail the sample sizes used for each test.
• Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin for the data collection itself. However, the tests cited are ASTM standards, which are internationally recognized. The manufacturer is Siam Sempermed Corp., Ltd from Thailand.

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

• Not Applicable. This device is a nitrile examination glove. The "ground truth" for its performance is established through standardized physical and biocompatibility testing (e.g., tensile strength, freedom from holes, skin irritation), not through expert interpretation of medical images or clinical outcomes that would require adjudicators.

4. Adjudication method for the test set:

• Not Applicable. As mentioned above, the evaluation of this device relies on standardized physical and chemical tests against ASTM standards, not on subjective assessment or consensus 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 patient examination glove and does not involve AI or human "readers" in its intended use or evaluation.

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

• Not Applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" is based on objective measurements and observations according to established industry standards (ASTM D 6319-10) for physical properties (dimensions, tensile strength, elongation, freedom from holes, powder residue) and standardized biological assays for biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization).

8. The sample size for the training set:

• Not Applicable. This device concerns a physical product tested against standards, not a machine learning model requiring a training set.

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

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

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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.

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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 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

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 is a 510(k) summary for a non-sterile, powder-free nitrile examination glove. It outlines the device's characteristics, intended use, and a comparison to established standards and a predicate device.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for testing each characteristic. It only states that the performance tests were conducted. The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission. The country of origin of the data is not explicitly stated for the testing itself, but the manufacturer is based in Thailand. The study is retrospective in the sense that the testing was conducted prior to the submission for regulatory approval.

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

Not applicable to this type of device. The "ground truth" for the performance characteristics of an examination glove is defined by the technical specifications and testing methods described in the referenced ASTM standards (e.g., ASTM D 6319-00-ae3, ASTM D 6124-2001) and biocompatibility test protocols. These standards dictate objective measurements rather than subjective expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable. The performance testing of examination gloves involves laboratory measurements against established standards, not a process requiring adjudication among human reviewers.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or other tools where human interpretation plays a significant role and can be enhanced by AI assistance. This device is a disposable medical glove, and its performance is assessed through physical and chemical testing, not through human reader interpretation.

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

Not applicable. This device is a physical product (a glove), not an algorithm or AI system. Its performance is inherent to the product itself, not a function of an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on established industry standards and scientifically recognized test methods. Specifically:

• ASTM D 6319-00-ae3: Specifies ground truth for dimensions, physical properties (e.g., tensile strength, elongation), and freedom from pinholes for nitrile examination gloves. These are objective, measurable criteria.
• ASTM D 6124-2001: Specifies the ground truth for powder-free residue, which is a quantitative measurement.
• Biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization): These involve standardized animal testing protocols where "passes" indicates the absence of a defined level of adverse reaction, serving as the ground truth for biological safety.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for manufacturing such a device would involve process control and quality assurance, not a data-driven training set in the AI sense.

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

Not applicable, as there is no training set in the context of this 510(k) submission for a physical medical device like an examination glove.

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