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A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.

Powdered Latex Examination Gloves (Protein Label Claim) (50 microgram or less)

The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powdered Latex Examination Gloves." This letter grants market clearance based on a determination of substantial equivalence to a predicate device.

It does not contain information about acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, expert qualifications, or details of a study that proves the device meets acceptance criteria.

The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This is a regulatory clearance based on substantial equivalence, not a detailed description of an efficacy or performance study. Therefore, I cannot generate the requested information based on the provided text.

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A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.

Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim) 50 MICROGRAMS OR LESS

The provided text is a 510(k) clearance letter from the FDA for "Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim of 50 micrograms or less)." This type of document does not typically contain acceptance criteria or study details in the way a clinical study report or a technical design document for a complex medical device (like an AI algorithm) would.

A 510(k) clearance is based on demonstrating "substantial equivalence" to a predicate device already on the market. This often involves showing that the new device meets recognized standards, performs similarly in basic tests, and has the same intended use and technological characteristics as the predicate. The focus is usually on manufacturing, material conformity, and basic performance parameters relevant to the device's function (e.g., barrier integrity for gloves), rather than complex diagnostic accuracy studies.

Therefore, many of the requested categories for acceptance criteria and study information will not be directly available or applicable from this specific document.

However, I can extract what is implied or stated (even if it's minimal) and indicate where information is missing or not relevant for this type of device and document.

Implied Acceptance Criteria and Performance (Based on Device Type and Clearance Letter):

The core "acceptance criterion" for this 510(k) clearance is substantial equivalence to existing legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • Not specified in this document. For gloves, testing would typically involve batches of manufactured gloves to assess properties like tensile strength, elongation, barrier integrity (e.g., freedom from pinholes), and protein levels. This would likely be internal testing by the manufacturer.
   • Provenance: This would be generated by the manufacturer, likely from their production batches. Country of origin for testing is not stated, but the manufacturer is based in Malaysia.

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

   • Not applicable/specified for this type of device. "Ground truth" in the context of examination gloves isn't established by expert consensus on diagnoses. It's established by laboratory testing against recognized standards (e.g., ASTM standards for medical gloves) for physical properties and chemical composition. The "experts" would be laboratory technicians or engineers qualified to perform such tests.

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

   • Not applicable. This refers to methods for resolving discrepancies in expert opinions, which is not relevant for objective laboratory testing of glove properties.

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 glove, not an AI-powered diagnostic device.

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

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

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

   • The "ground truth" for this device would be established by objective laboratory measurements of physical properties (e.g., barrier integrity, tensile strength, elongation) and chemical analysis (e.g., protein content) in accordance with relevant national or international standards (e.g., FDA guidance documents, ASTM standards).

8. The sample size for the training set:

   • Not applicable. This is not a machine learning/AI device. There is no concept of a "training set" in this context.

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

   • Not applicable. As above, no training set.

In summary, the provided document is an FDA clearance letter for a low-risk medical device (examination gloves), which is fundamentally different from devices that would require complex clinical trials, AI algorithm validation, or expert consensus "ground truth" studies. The "study" for this device would involve internal validation testing by the manufacturer to ensure the gloves meet specifications and recognized standards, which FDA reviews for substantial equivalence to a predicate device.

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A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.

Powdered Latex Examination Gloves (Protein Label Claim) (150 MICROGRAMS OR LESS)

This document is a 510(k) clearance letter from the FDA for Powdered Latex Examination Gloves. It primarily addresses the device's substantial equivalence to a predicate device and outlines general regulatory compliance.

Therefore, the document does not contain any information regarding:

• Acceptance criteria and reported device performance (in a table or otherwise)
• Sample sizes (test, training)
• Data provenance
• Number or qualifications of experts
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance studies
• Type of ground truth used or how it was established

The letter confirms the device's classification as Class I, reiterates the general controls provisions of the Medical Device Amendments, and permits the marketing of the device. The "Indications For Use" section simply defines what a patient examination glove is and its function, which is standard for such a device.

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

Powderfree Latex Examination Gloves (Protein Label Claim) 50 MICROGRAMS OR LESS

I'm sorry, but without further context, I cannot extract the specific acceptance criteria and detailed study information you're looking for. The provided text is a 510(k) clearance letter from the FDA, which confirms the substantial equivalence of Powderfree Latex Examination Gloves to a predicate device.

This document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on ground truth establishment, expert qualifications, or adjudication methods.
• Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The letter focuses on the regulatory clearance process for a medical device (gloves), not on a study proving a device meets specific technical performance criteria in the way you've outlined.

To provide the information you requested, I would need a different document, such as a clinical study report, a performance evaluation report, or a detailed technical specification document for a device that uses algorithms or requires complex performance analysis.

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

Nitrile Powder-Free Examination Gloves

Based on the provided text, this document is a 510(k) clearance letter for "Nitrile Powder-Free Examination Gloves." This type of document does not contain information about acceptance criteria or a study proving that an AI/device meets acceptance criteria in the way you've described for medical AI.

This 510(k) clearance signifies that the device is substantially equivalent to a predicate device, meaning it has similar indications for use, technological characteristics, and safety and effectiveness. The FDA's review for such a device typically focuses on performance data (e.g., strength, durability, biocompatibility for gloves) in comparison to a predicate, rather than the complex clinical study designs often associated with AI software.

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

However, if this were a document about a medical AI device, here's what each section of your request generally refers to:

1. A table of acceptance criteria and the reported device performance: This would typically list metrics like sensitivity, specificity, AUC, F1-score, accuracy, or other relevant performance indicators, alongside the predefined thresholds the device needed to meet.
2. Sample size used for the test set and the data provenance: This would specify the number of cases/patients in the independent test set, and details about where the data originated (e.g., anonymized patient data from multiple hospitals in the US, Europe), and whether it was collected historically (retrospective) or specifically for the study (prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would detail how many highly qualified specialists (e.g., board-certified radiologists, pathologists) independently reviewed the test cases to determine the true diagnosis or finding.
4. Adjudication method for the test set: This explains how discrepancies among expert opinions for ground truth were resolved (e.g., 2+1 means two experts agree, or a third experienced expert acts as tie-breaker).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This would assess if human clinical performance improved when using the AI device as an aid compared to reading without it. An effect size (e.g., increase in AUC, sensitivity) would be reported.
6. If a standalone performance study was done: This measures the algorithm's performance without any human intervention.
7. The type of ground truth used: This specifies the gold standard against which the device's performance was measured (e.g., confirmed by pathology, long-term clinical outcome follow-up, consensus of multiple experts).
8. The sample size for the training set: The number of cases/patients used to train the AI model.
9. How the ground truth for the training set was established: Similar to the test set, but specifically for the data used to teach the AI.

Again, this type of information is not present in the provided 510(k) clearance letter for examination gloves.

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

Powdered Nitrile Examination Gloves

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for "Powdered Nitrile Examination Gloves." This document is a regulatory communication, not a scientific study report describing device performance or acceptance criteria in the typical sense of a clinical or performance study of an AI/software device.

Therefore, the specific information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) cannot be extracted from the provided text.

The document states that the device is "substantially equivalent" to predicate devices, meaning it has sufficiently similar characteristics and indications for use as a device already legally marketed. For examination gloves, the "performance" typically refers to physical properties like tensile strength, elongation, and barrier integrity (e.g., freedom from holes), which are usually tested against established international standards (like ASTM or ISO standards for medical gloves). The 510(k) process involves demonstrating compliance with these standards, but the detailed results of those tests are not typically included in the final clearance letter itself.

The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or human-AI improvement.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is concerned with the regulatory clearance of a physical medical device (examination gloves), not a software or AI-driven diagnostic or therapeutic device that would undergo the types of studies described in your prompt.

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

Powdered Green Latex Examination Gloves (Polymer Coated)

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for "Powdered Green Latex Examination Gloves (Polymer Coated)."

It states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. However, it does not include details about specific performance acceptance criteria or a study that rigorously demonstrates the device meets those criteria. The letter primarily focuses on regulatory approval based on substantial equivalence, rather than providing a detailed technical study report.

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

Powder-Free Nitrile Examination Gloves (Polymer Coated)

This document is a 510(k) clearance letter from the FDA for "Powder-Free Nitrile Examination Gloves (Polymer Coated)". It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device

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

Powdered Green Latex Examination Gloves

The provided document is an FDA 510(k) clearance letter for "Powdered Green Latex Examination Gloves." This document does not contain any information regarding acceptance criteria, device performance studies, or details about AI-based device evaluations.

The letter is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses general controls, regulations, and contact information for the manufacturer.

Therefore, I cannot answer your request based on the provided text. There is no information in the document about:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, or adjudication methods for a test set.
3. Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
4. Type of ground truth or training set details.

Ask a specific question about this device

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

Powderfree Green Latex Examination Gloves

The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder-Free Green Latex Examination Gloves." This document does not contain any information about acceptance criteria for a device, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information. The document is solely an FDA clearance letter for a medical device that determines substantial equivalence to a predicate device.

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