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A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.

The provided text describes a 510(k) premarket notification for "Syntex Healthcare Products Co., Ltd Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)". This is a medical device approval application, not a study of an AI/ML device. Therefore, the specific questions related to AI/ML device performance, such as sample sizes for test sets, expert ground truth, MRMC studies, and standalone algorithm performance, are not applicable.

However, I can extract the acceptance criteria and performance data for this device as it relates to the non-clinical tests conducted.

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

The acceptance criteria are generally established by recognized standards like ASTM D 6319-00a (2005)e1, ASTM D6124-06, ISO 10993 Part 10, and 16CFR 1500.41/1500.3. The "Performance Results" column indicates if the device meets these standards.

Breakthrough Detection Times (BDT) for Chemotherapy Drugs (Resistance to Permeation):

Important Note: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes." This implies that while the device was tested against these drugs, their low BDTs are a critical factor for users to consider, and the labeling states "Do not use with Carmustine and Thiotepa."

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

The document does not explicitly state the sample sizes for each non-clinical test (e.g., how many gloves were tested for dimensions, physical properties, or permeation). It mentions the tests were performed by Syntex Healthcare Products Co., Ltd in China (the submitter's location), so the data likely originates from China. The tests are non-clinical and would be considered prospective 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 (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

These questions are designed for AI/ML device evaluations. The presented document describes a traditional medical device (examination gloves) and its non-clinical testing. Therefore, these questions are not applicable to this submission. The "ground truth" for this device is determined by physical and chemical testing against established standards (e.g., ASTM standards for glove properties and permeation resistance). No AI/ML components are mentioned or evaluated in this 510(k) summary.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Nitrile Patient Examination Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00€3

This document describes the validation of a medical device, specifically a "Powder Free Nitrile Blue Textured Examination Glove." However, it focuses on the physical and biological characteristics of the glove and its substantial equivalence to a predicate device, rather than the performance of an AI or software-based medical device.

Therefore, many of the requested categories (e.g., sample size for test set, ground truth experts, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device submission.

Here's the information that can be extracted and presented, with clarifications for the questions that don't apply:

Acceptance Criteria and Reported Device Performance

Study Details (as applicable for a physical medical glove)

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

   • Sample Size: Not explicitly stated as a single "test set" for performance evaluation in the way a software algorithm would be. Instead, testing was conducted on samples from manufacturing lots based on AQLs (Acceptable Quality Levels).
     • Physical and Dimensions Testing: Inspection level S-2, AQL 4.0.
     • Water Fill Test: AQL 2.5, inspection level G-1.
   • Data Provenance: Not specified, but generally, such testing would be conducted by the manufacturer (Syntex Healthcare Products Co., Ltd.) in China, where the device is manufactured. The testing is likely retrospective in the sense that it's performed on finished products, but it represents ongoing quality control.

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

   • Not Applicable. The "ground truth" for a physical glove is determined by established physical and chemical test methods against defined standards (ASTM, FDA). It does not involve expert consensus in the way an AI diagnostic tool would for clinical images.

3. Adjudication method for the test set:

   • Not Applicable. Pertains to expert review for ambiguous cases in diagnostic studies, not physical product testing.

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

   • Not Applicable. This is a physical, disposable medical device, not an AI software.

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

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

6. The type of ground truth used:

   • Established Standards and Test Methods: The ground truth for this device's performance is based on recognized consensus standards (ASTM D-6319-00€3, ASTM D-6124-01) and regulatory test methods (FDA 1000 ml. Water Fill Test), as well as biocompatibility testing for skin irritation and sensitization.

7. The sample size for the training set:

   • Not Applicable. This refers to machine learning algorithms, which are not involved here.

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

   • Not Applicable. As above, no training set for an AI algorithm.

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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.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.

The provided text is a 510(k) summary for a medical device: "Syntex Powder-Free Nitrile Examination Glove, Tested for Chemotherapy." Based on the provided document, the device is a Class I patient examination glove. The document describes non-clinical tests to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (This refers to a sampling plan for quality control rather than a specific sample size for a "test set" in an AI/Software context).
• FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level G-1. (Again, a sampling plan for quality control).
• Biocompatibility (Skin Irritation/Sensitization), Residual Powder Test: No specific sample sizes are mentioned for these tests, only that testing was "conducted."
• Data Provenance: Not applicable in the context of this device (a physical glove). The tests are performed on manufactured gloves.

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

This information is not applicable to this type of device (a physical examination glove). Ground truth in this context is established by physical measurements and laboratory analyses against defined standards, not by expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device. Adjudication methods are typically used in studies involving human interpretation or subjective assessment.

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

This information is not applicable to this type of device. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use the AI for assistance. This device is a physical glove.

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

This information is not applicable to this type of device. "Standalone performance" refers to the performance of an algorithm without human intervention, which is not relevant for a physical glove.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on defined physical and chemical standards as outlined in relevant ASTM standards and FDA requirements. This includes:

• Physical dimensions and tensile strength (ASTM-D-6319-00aE3)
• Barrier integrity (FDA 1000 ml. Water Fill Test for pinholes)
• Biocompatibility (Primary Skin irritation and Skin Sensitization testing via laboratory methods)
• Powder content (ASTM D6124-01)
• (Implied: Chemotherapy permeation data based on the device name, but methods/results are not detailed in this summary).

8. The Sample Size for the Training Set

This information is not applicable to this type of device. Training sets are relevant for machine learning algorithms, not for physical products like gloves.

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

This information is not applicable to this type of device, as it does not involve a training set for an algorithm.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

Ultrasense AF Blue Power-free Nitrile Examination Gloves

This document pertains to the clearance of "Ultrasense AF Blue Power-Free Nitrile Examination Gloves" (K033777). As such, it is a device submission for a physical product (gloves), not a diagnostic AI/ML algorithm or software as a medical device (SaMD).

Therefore, the requested information regarding acceptance criteria, study design, ground truth, expert involvement, and sample sizes for an AI/ML device is not applicable to this document.

The document discusses the substantial equivalence determination for examination gloves based on regulatory requirements for a physical medical device, not a software-based diagnostic tool.

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A powder-free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Syntex Powder-Free Latex Examination Gloves - Blue Color. A powder-free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder.

The provided text is a scanned FDA 510(k) clearance letter for "Syntex Powder-Free Latex Examination Gloves". This document pertains to the regulatory clearance of a medical device based on substantial equivalence to a predicate device, rather than a study proving performance against specific acceptance criteria.

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

Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or information about training sets for an AI/algorithm-based device.

The questions are designed for a scenario where an AI or algorithm-based device undergoes performance evaluation and validation, which is not the subject of this 510(k) clearance for a physical medical product like 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 finger to prevent contamination between patient and examiner.

Powder-Free Nitrile Examination Glove -- Purple Color

The provided document is a 510(k) clearance letter from the FDA for a device called "Syntex Powder-Free Nitrile Examination Glove, Purple Color." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any details related to AI or comparative effectiveness studies.

The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined the new device is as safe and effective as a device already on the market, based on its indications for use, technological characteristics, and performance data. However, the performance data itself, including specific acceptance criteria and study results, is typically found in the 510(k) submission summary, which is not part of this letter.

Therefore, I cannot provide the requested information from this document.

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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.

Syntex Pre-Powdered Latex Examination Glove

The provided text is a FDA 510(k) clearance letter for a medical device: "Syntex Pre-Powdered Latex Examination Glove."

This type of document does not contain the detailed technical information requested about acceptance criteria and study designs that prove device performance.

FDA 510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on new, extensive clinical studies proving efficacy or specific performance metrics in the way a PMA (Premarket Approval) would.

Therefore, I cannot provide the requested information from the given input. The letter essentially states that the device is "substantially equivalent" for its indicated use based on the information provided in the 510(k) submission, and it lists various regulatory requirements for the manufacturer.

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A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Syntex Powder-Free Latex Examination Glove

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The document is a 510(k) premarket notification letter from the FDA to Syntex Healthcare Product Company Limited regarding their "Syntex Powder-Free Latex Examination Glove".

This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device and can be marketed. However, it does not include details about:

1. Acceptance criteria: There is no table of specific performance metrics or a detailed description of what constitutes "acceptance."
2. Reported device performance: The letter does not contain any test results, data, or performance statistics for the Syntex glove.
3. Study details: There is no mention of a specific study, its design, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for either training or test sets.

The letter primarily focuses on the regulatory decision of substantial equivalence and general compliance requirements. To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSD), a clinical study report, or a more detailed 510(k) submission document that typically includes performance data.

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A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Pre-Powdered Nitirile Examination Glove

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The text provided is an FDA clearance letter for a medical device (Syntex Pre-Powdered Nitrile Examination Glove), outlining its substantial equivalence to a predicate device and regulatory compliance. It does not contain details about specific performance metrics or studies.

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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 Polymer-Coated Latex Examination Glove

This document is a 510(k) premarket notification letter for a Syntex Powder-Free Polymer-Coated Latex Examination Glove. It is from the FDA to Syntex Healthcare Products Co Ltd. and states that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence, not a performance study report.

Therefore, I cannot provide the requested table or answer any of the questions about a performance study, sample sizes, ground truth, or expert qualifications based on the provided text.

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