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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Disposable Powder Free Vinyl Exam Gloves, With Aloe Vera, Green Color

This document is a 510(k) clearance letter for "Disposable Powder Free Vinyl Exam Gloves, With Aloe Vera Green Color." It does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The letter is a regulatory approval for a medical device (gloves), not an AI/ML product.

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

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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.

The provided text describes a 510(k) summary for Rich Mountain Medical Products Inc.'s Disposable Powder Free Vinyl Synthetic Exam Gloves With Aloe Vera, Green Color. This document is a premarket notification for a medical device and therefore focuses on demonstrating "substantial equivalence" to a predicate device rather than providing detailed acceptance criteria and a comprehensive study that proves the device meets those criteria in the way a more advanced AI/ML device would.

However, I can extract the relevant information from the document to construct the closest possible answer based on the provided text, interpreting the "device performance" in terms of compliance with relevant standards and tests for gloves.

1. Table of acceptance criteria and the reported device performance

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

• ASTM D5250-06 (Physical and Dimensions Testing): Inspection level S-2, AQL 4.0. (Specific sample size not provided, but implies standard sampling per ASTM).
• FDA 1000 ml Watertight Test based on ASTM D-5151-06 (Pinhole integrity): AQL 2.5, Inspection level I. (Specific sample size not provided, but implies standard sampling per ASTM).
• Biocompatibility (Primary Skin Irritation and Skin Sensitization): Not specified.
• Data Provenance: Not explicitly stated, but assumed to be from tests conducted by the manufacturer, Rich Mountain Medical Products Inc. No mention of country of origin for the testing data itself, but the manufacturer is in China. Retrospective/Prospective is not applicable in this context as these are manufacturing quality control tests.

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

Not applicable. For a medical glove, "ground truth" is established by adherence to predefined engineering and biological standards (e.g., ASTM standards for physical properties, ISO standards for biocompatibility). The "truth" is whether the glove meets the defined pass/fail criteria of these standardized tests, not an expert's interpretive assessment.

4. Adjudication method for the test set

Not applicable. The tests involve objective measurements against established criteria, not subjective expert judgment that would require adjudication.

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 disposable medical glove, not an AI/ML-driven diagnostic or interpretative system.

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

Not applicable. This is not an algorithm or AI. It is a physical device.

7. The type of ground truth used

The ground truth used is based on:

• Engineering standards (e.g., ASTM for physical dimensions, tensile strength, elongation).
• Performance standards (e.g., ASTM for watertightness/pinhole integrity).
• Biocompatibility standards (e.g., for skin irritation and sensitization).
• Chemical residue standards (e.g., for powder content).

8. The sample size for the training set

Not applicable. This device does not involve a training set in the context of AI/ML. Manufacturing processes are optimized over time, but this doesn't constitute a "training set" in the sense of AI.

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

Not applicable. As above, there is no "training set" in the AI/ML sense for this device. The ground truth for the device's performance is established by the specified ASTM and FDA testing standards.

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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.

This is a 510(k) summary for a medical device that is a disposable powder-free vinyl synthetic examination glove. The document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device. It is not a study of an AI-powered diagnostic device, thus many of the requested categories are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Sizes:
  • Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact number of units sampled is not explicitly stated but is determined by the AQL and inspection level.
  • Watertight Test: Samplings of AQL 2.5, Inspection level I. The exact number of units sampled is not explicitly stated.
  • Primary Skin Irritation and Skin Sensitization: The document does not specify the number of subjects or samples used for these biological tests.
  • Residual Powder Test: Conducted at "finished inspection," but the sample size is not specified by AQL or number of units.
• Data Provenance: The report describes non-clinical laboratory testing performed by the manufacturer. The location of the manufacturer is Xuzhou, Jiangsu Province, China. The data would therefore be considered prospective testing conducted by the manufacturer for regulatory submission.

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

This document describes the testing of a physical medical device (gloves), not an AI diagnostic algorithm. Therefore, the concept of "ground truth" established by experts in the context of diagnostic accuracy is not applicable here. The "ground truth" for these tests are the objective measurements against established ASTM standards and FDA requirements.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of medical images or data requiring adjudication. The tests performed are objective, quantitative measurements against predefined standards.

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 document pertains to physical product testing of medical gloves, 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 not an AI-powered device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on established industry standards (ASTM) and FDA regulatory requirements. These are objective measurements and biological test results, not expert consensus, pathology, or outcomes data in the diagnostic sense. For example, a glove either passes the watertight test according to the AQL, or it doesn't.

8. The Sample Size for the Training Set

Not applicable. This is not an AI-powered device requiring a training set.

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

Not applicable. This is not an AI-powered 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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR

I am sorry, but the provided text is a 510(k) clearance letter for "Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color." This document does not contain information about the acceptance criteria and study proving a device meets these criteria in the context of an AI/ML medical device.

The letter discusses the substantial equivalence of the gloves to a legally marketed predicate device and the general regulatory requirements for such a device. There is no mention of an algorithm, AI, machine learning, or any performance study related to such a system.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications from this document.

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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR

This document is a 510(k) premarket notification for "Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color." It is a regulatory clearance letter from the FDA, and as such, it does not contain information about specific acceptance criteria or a study proving device performance in the way requested.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined it is as safe and effective as a device that was on the market before May 28, 1976, or has been reclassified. This determination is based on the information provided in the 510(k) submission, which typically includes comparisons to a predicate device regarding materials, design, and performance characteristics, but not necessarily a new clinical study with the detailed elements you've requested.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document doesn't detail specific performance metrics or acceptance criteria for the gloves beyond their intended use.
2. Sample size used for the test set and the data provenance: Not applicable, as a new performance study is not detailed.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a medical device (gloves), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on the regulatory aspects of device clearance based on substantial equivalence, rather than detailed performance study results.

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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR

This document is a letter from the FDA regarding the approval of "Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color." It grants premarket notification to Canopus Medical Supply Company Limited.

The document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence to legally marketed predicate devices, not an evaluation of performance against specific acceptance criteria for this new device.

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

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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR

This FDA 510(k) clearance letter pertains to Disposable Powder Free Vinyl Synthetic Examination Gloves With Aloe Vera, Green Color. As such, the "device" is essentially a commodity, and the provided document is a regulatory approval, not a scientific study report. Therefore, most of the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment is not present or applicable in this context.

However, I can extract information related to the device description and the regulatory context.

• Device Name: Disposable Powder Free Vinyl Synthetic Examination Gloves With Aloe Vera, Green Color
• Regulation Number: 880.6250
• Regulation Name: Patient Examination Gloves
• Regulatory Class: I
• Product Code: LYZ

Since this is a clearance for examination gloves, the "acceptance criteria" generally refer to meeting established performance standards for medical gloves, which are typically defined by organizations like ASTM International. The study to prove these criteria would involve standardized physical and chemical testing. The document does not detail these specific tests or their results.

Here's how I can address the prompts based on the available information, with explanations for what cannot be found:

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

Explanation: The letter does not describe specific acceptance criteria or performance data. For examination gloves, these criteria would typically include tests for tensile strength, elongation, barrier integrity (e.g., freedom from holes), biocompatibility (e.g., skin irritation, sensitization), and powder content as per relevant ASTM standards (e.g., ASTM D5250 for vinyl examination gloves). The "reported device performance" would be the results of these tests, which are not detailed in this regulatory letter.

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

Information Not Present: The document does not specify sample sizes for testing or data provenance.
Likely Context: For medical gloves, sample sizes for performance tests are generally determined by international standards (e.g., ISO 2859-1 for sampling procedures) or specific test methods. The data would originate from laboratory testing of glove batches, likely conducted by the manufacturer (Shanghai PM Plastics Enterprise Company Limited) in China, as that is the company's location. These would be prospective tests on manufactured samples.

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)

Information Not Applicable/Present: For a commodity device like examination gloves, "ground truth" as typically understood in AI/imaging studies (e.g., expert consensus on a diagnosis) is not applicable. The "ground truth" for glove performance is established by standardized, objective laboratory tests. The "experts" involved would be technicians performing these tests and engineers/quality control personnel interpreting the results against established standards. Their qualifications would be in laboratory testing, material science, or quality assurance, not clinical diagnosis.

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

Information Not Applicable/Present: Adjudication methods like 2+1 or 3+1 are typically used in clinical or imaging studies where subjective interpretation is involved. For standardized physical testing of examination gloves, adjudication in this sense is not employed. Test results are objective measurements (e.g., force to break, number of pinholes) and are compared directly to numerical specifications. Quality control processes would involve reviewing test reports and ensuring compliance with specifications.

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

Information Not Applicable: This is an approval for a physical medical device (examination gloves), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is entirely irrelevant to this device.

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

Information Not Applicable: As noted above, this is not an AI-powered device. Therefore, no standalone algorithm performance study was conducted.

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

Type of Ground Truth: The "ground truth" for examination gloves is based on objective, standardized laboratory measurements of physical properties (e.g., tensile strength, elongation, barrier integrity) and chemical characteristics (e.g., powder content, biocompatibility) as defined by applicable consensus standards (e.g., ASTM standards for medical gloves). It is not expert consensus on an image, pathology, or outcomes data.

8. The sample size for the training set

Information Not Applicable/Present: For a physical medical device like examination gloves, there isn't a "training set" in the context of machine learning. The manufacturing process is controlled by Good Manufacturing Practices (GMPs) and quality systems, where process parameter adjustments are made based on ongoing quality control feedback and engineering principles, not a distinct "training set" of data for an algorithm.

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

Information Not Applicable: As there is no "training set" in the machine learning sense, the concept of establishing ground truth for it is not applicable. The "ground truth" for the performance of examination gloves is established by adherence to specified performance dimensions in recognized standards, which are met through controlled manufacturing and quality assurance testing.

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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR

The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color." This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter primarily:

• Confirms the FDA has reviewed the 510(k) submission (K022087).
• Determines the device is substantially equivalent to legally marketed predicate devices.
• Explains the regulatory classification and general controls provisions of the Federal Food, Drug, and Cosmetic Act.
• Grants permission to market the device.
• Provides contact information for further questions.

The "Indications For Use" statement describes the intended purpose of the gloves, but it does not specify performance acceptance criteria or details of a study.

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

Ask a specific question about this device