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A Powder Free Nitrile Patient Examination Glove is a dispoable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves are worn to protect against exposure to some chemotherapy drugs.

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D 6319-00a83

The Perusahaan Getah Asas Sdn. Bhd. Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) demonstrates compliance with established acceptance criteria through a series of tests as detailed in the provided 510(k) submission.

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 for each individual test conducted to demonstrate device performance. However, the data provenance is implied to be from testing conducted by or for Perusahaan Getah Asas Sdn. Bhd., a company located in Malaysia. The studies are all retrospective in the sense that the data is presented post-hoc to demonstrate compliance with pre-defined standards. The data itself would have been generated through prospective experimental testing in a laboratory or clinical setting (e.g., the Modified Draize Test would involve human subjects in a prospective manner).

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

For the most part, the "ground truth" for the performance tests (e.g., dimensions, physical properties, freedom from pin-holes, powder-free residue, chemotherapy drug permeation) is established by standardized laboratory methods and instrumentation, not by human expert consensus in the way a medical image interpretation might be. These are objective measurements against established ASTM and ISO standards.

For Biocompatibility tests (Dermal Sensitization, Primary Skin Irritation, Cytotoxicity, and the Modified Draize Test for Low Dermatitis Potential), experts would have been involved in the design, execution, and interpretation of these studies. However, the exact number and qualifications of these experts (e.g., toxicologists, dermatologists, clinical researchers) are not specified in the provided document. The Modified Draize test, by its nature, would typically involve at least one qualified dermatologist or clinician to assess skin reactions.

4. Adjudication Method for the Test Set:

For the physical and chemical property tests, adjudication is not typically applicable in the same way as for medical image interpretation or clinical trials involving subjective assessment. The results are generally objective measurements against established thresholds according to the given standards.

For the biocompatibility and low dermatitis potential tests, if multiple assessors were involved in evaluating skin reactions in the Modified Draize Test, their findings would likely be subject to an adjudication process to reach a consensus, but the document does not specify any adjudication method. It only states the conclusive finding ("Did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.").

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 typically relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a patient examination glove, and its performance is evaluated through physical, mechanical, and biological properties, not through human interpretation of cases.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a physical product (a glove), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only) performance" does not apply. The device's performance is inherently "standalone" in the sense that it is measured directly without human-in-the-loop interpretation.

7. Type of Ground Truth Used:

The ground truth for most of the performance criteria (dimensions, physical properties, pin-holes, powder residue) is based on objective measurements against publicly recognized and established industry standards (ASTM, ISO, CFR).

For biocompatibility and low dermatitis potential, the ground truth is established through experimental results from standardized in-vitro and in-vivo tests designed to assess biological responses, with clinical observations (for the Modified Draize Test) serving as the ultimate verification of safety for skin contact.

8. Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development. The manufacturing process and quality control would involve ongoing testing, but this is not analogous to an AI 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.

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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. Tested for use with Chemotherapy Drugs.

Powder-free Nitrile Patient Chemotherapy Examination Glove, Blue or Green or Violet or White (Non-colored) Colored

The provided text describes a 510(k) premarket notification for a "Powder-Free Nitrile Patient Chemotherapy Examination Glove." This is a regulatory approval document for a medical device that does not involve software or an AI algorithm, but rather a physical glove.

Therefore, we cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, or ground truth for an AI/software device because the document describes a purely physical medical device (examination gloves).

The information in the document pertains to the regulatory approval process for the glove, its classification, and general controls under the Federal Food, Drug, and Cosmetic Act. It does not contain any details relevant to the performance evaluation of an AI or software component.

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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.

Barrier-Pro™ Co-polymer Patient Examination Glove, Powdered, White (non-colored) or Green colored. Note: (a) Glove made from Synthetic Butadiene Methylmetacrylate Methacrylic Acid Co-polymer Rubber (b)Barrier-Pro™ is a registered trade mark of Dow Reichhold Specialty Latex LLC

The provided text is a 510(k) premarket notification letter from the FDA regarding "Barrier-Pro™ Co-Polymer Patient Examination Gloves." This document does not contain information about the acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets those criteria.

Instead, this document is a regulatory approval for a physical medical device (patient examination gloves) based on substantial equivalence to a legally marketed predicate device.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, training set details) from this document as it pertains to a different type of medical device and regulatory review process.

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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.

Powder-free Barrier-Pro™ Co-polymer Patient Examination Clove, White (non-colored) or Green colored. Note: (a) Glove made from Synthetic Butadiene Methylmetacrylate Mcthacrylic Acid Co-polymer Rubber (h)Barrier-ProTM is a registered trade mark of Dow Reichhold Specialty Latex LLC

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a "Powder-free Barrier-Pro™ Co-Polymer Examination Glove." This document is a regulatory approval for a medical device and does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/software-as-a-medical-device (SaMD) products.

The 510(k) process for this type of device (a Class I patient examination glove) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, primarily through adherence to general controls (e.g., manufacturing practices, labeling) rather than specific performance metrics derived from clinical studies in the way an AI algorithm would be evaluated.

Therefore, I cannot extract the requested information points because they are not present in this type of regulatory document for this type of medical device.

To directly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states a "substantial equivalence determination" was made, but no specific performance criteria or results are listed.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method: Not provided.
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 and not provided. This is a physical medical device (glove), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable and not provided. This is a physical medical device.
7. The type of ground truth used: Not applicable and not provided.
8. The sample size for the training set: Not applicable and not provided.
9. How the ground truth for the training set was established: Not applicable and not provided.

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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.

Powder-free Nitrile Patient Examination Glove, White (non-colored), Blue and Green Colored

The provided text is a 510(k) premarket notification letter from the FDA regarding a Powder-Free Nitrile Patient Examination Glove. This document confirms that the device is substantially equivalent to a predicate device already on the market and does not require an approval for a premarket approval application (PMA).

The document does not detail any studies, acceptance criteria, or performance metrics for the device. It is a regulatory letter of approval based on the substantial equivalence principle, rather than a report on device performance testing. As such, I cannot provide the requested information from the given text.

The information I can extract directly from the provided text is:

• Device Name: Powder-Free Nitrile Patient Examination Glove, White (non-colored), Blue and Green Colored
• Intended Use: A disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
• Regulatory Class: I
• Product Code: LZA
• Regulation Number: 880.6250 (Patient Examination Gloves)

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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.

Powder-free Latex Patient Examination Glove, White (non-colored) or Blue Colored, with extractable protein content labelling claim (50 microgram per gram of glove or less)

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the "Powder-Free Latex Patient Examination Glove."

The document is a 510(k) premarket notification letter from the FDA, indicating that the device is substantially equivalent to legally marketed predicate devices. It covers regulatory aspects, labeling requirements, and contact information but does not contain data from performance studies.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, ground truth, or expert qualifications.

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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.

Polymer-Coated, Powder-free, Latcx Patient Examination Glove with Protein Labelling Claim (contain 50 microgram or less of total water extractable protein per gram)

There is no information about the acceptance criteria or a study proving device performance in the provided text. The document is an FDA 510(k) clearance letter for "Polymer Coated, Powder-Free Latex Examination Gloves."

This letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory requirements and classification but does not contain details about specific performance metrics, clinical studies, or an AI device.

Therefore, I cannot provide answers to the requested points, as they are not present in the given document.

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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.

Latex Patient Examination Glove, Powdcred Type II, Low Modulus, with extractable protein content labelling claim (200 microgram per gram of glove or less)

This document is a 510(k) clearance letter for "Latex Examination Gloves, Powdered Type II, Low Modulus with Extractable Protein Content Labeling Claim (200 Micrograms or Less)". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about acceptance criteria, device performance studies, or ground truth establishment typically found in detailed device validation reports.

The provided text focuses on the regulatory clearance process rather than technical performance data. Therefore, I cannot extract the requested information.

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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.

On-line Powder-free Latex Patient Examination Gloves, Type II, Low Modulus with Extractable Protein Content Labeling Claim (50 Micrograms per gram or less)

The provided text is a 510(k) premarket notification approval letter for a medical device: "On-line Powder-free Latex Patient Examination Gloves, Type II, Low Modulus with Extractable Protein Content Labeling Claim (50 Micrograms per gram or less)".

This document is a regulatory approval and does not describe a study to prove the device meets acceptance criteria in the way envisioned by the request. The request asks for details about a study to evaluate "device performance" in terms of metrics like accuracy, effect size with AI assistance, and ground truth establishment, which are typical for diagnostic or AI-powered devices.

For a patient examination glove, the "acceptance criteria" and "study" would refer to manufacturing standards, chemical composition, biocompatibility, physical properties (e.g., tensile strength, elongation), and extractable protein content. The approval letter confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it meets the same safety and effectiveness standards.

Therefore, I cannot fulfill the request as formatted because the provided document does not contain the information required to populate the requested table and answer the study-specific questions. There is no information on:

1. A table of acceptance criteria and reported device performance in the context of an accuracy study.
2. Sample sizes for test sets, data provenance, or retrospective/prospective nature.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone performance of an algorithm.
7. Type of ground truth used (e.g., pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory confirmation of substantial equivalence for a physical medical product, not a clinical or performance study report for a diagnostic or AI device.

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