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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.

The provided text describes a 510(k) premarket notification for disposable powder-free vinyl synthetic exam gloves. This is a medical device and the submission focuses on demonstrating substantial equivalence to a predicate device, not on proving effectiveness through clinical studies with specific acceptance criteria in the way a diagnostic or therapeutic AI device would.

Therefore, many of the requested points are not applicable to this type of device and submission. I will address the applicable points and note where information is not relevant to this submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0." The exact sample size is not explicitly stated, but these are standard sampling plans (e.g., in accordance with ISO 2859-1 or similar). The data provenance is not specified beyond being generated by the device manufacturer, Rich Mountain Medical Products Inc.
• Watertight Test: "samplings of AQL 2.5, Inspection level 1." The exact sample size is not explicitly stated, but these are standard sampling plans. The data provenance is not specified.
• Primary Skin Irritation and Skin Sensitization: Sample size not specified.
• Residual Powder Test: Sample size not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This submission is for physical examination gloves, not an AI/ML device that requires expert-established ground truth for a test set. The tests performed are laboratory-based and involve physical properties and biocompatibility.

4. Adjudication Method for the Test Set

• Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is not an AI/ML device, and no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This is not an AI/ML algorithm; it is a physical medical device.

7. Type of Ground Truth Used

• Physical and Biocompatibility Test Results: The "ground truth" for this device comes from adherence to established engineering standards (ASTM D5250-06, ASTM D-5151-06, ASTM D6124-06) and biocompatibility testing results (primary skin irritation and sensitization). These are objective measurements and assessments against predefined criteria.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device, and therefore does not have a "training set" in the context of machine learning. The manufacturing process is implicitly "trained" through quality control and adherence to standards, but not in the machine learning sense.

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

• Not applicable. See point 8.

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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 GINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN (YELLOW GOLD)

This document is a 510(k) clearance letter from the FDA for a medical device: "Opus-E Disposable Powder Free Vinyl Synthetic Exam Gloves With Vitamin Complex, Nopal and Lanolin (Yellow Gold)".

The letter states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls provisions. It does not contain information about:

1. Acceptance criteria and reported device performance: This document is a regulatory approval, not a performance study report.
2. Sample size and data provenance: No study data is presented.
3. Number and qualifications of experts for ground truth: No ground truth establishment is discussed for a study.
4. Adjudication method: Not applicable as no study is detailed.
5. MRMC comparative effectiveness study: No such study is mentioned.
6. Standalone performance study: No such study is mentioned.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

The document is a clearance letter, indicating regulatory approval based on substantial equivalence, not a detailed report of a performance study with acceptance criteria.

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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.

ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN, YELLOW GOLD COLOR

This document is a 510(k) clearance letter from the FDA for a medical device: "Ennoble Disposable Powder Free Vinyl Synthetic Exam Gloves With Vitamin Complex, Nopal and Lanolin, Yellow Gold Color."

This type of document (510(k) clearance) does not contain the detailed information required to answer your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device specifications, materials, and performance standards to the predicate. The FDA letter confirms this substantial equivalence has been met, but it does not delve into the specific studies and data you're requesting that would typically be found in a clinical study report or a more detailed technical submission.

Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical study demonstrating device performance against specific acceptance criteria.

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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.

OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES & Nopal + Vitamin C

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Opus-E Disposable powder Free Vinyl synthetic Exam Gloves with Nopal & Vitamin E". This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, or clinical trial details.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory declaration, not a detailed performance study summary.

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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.

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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

The provided text is a 510(k) premarket notification approval letter for "Disposable Powder Free Vinyl Synthetic Exam Gloves." This type of document from the FDA relates to the regulatory clearance of a medical device based on substantial equivalence to a predicate device, rather than a study proving the device meets specific performance acceptance criteria in the way an AI/ML algorithm would.

Therefore, the information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, MRMC study, etc.) is not applicable to this document.

Here's why and what information can be extracted:

• Acceptance Criteria & Device Performance: The approval is based on "substantial equivalence" to a legally marketed predicate device. This means the FDA determined the new device is as safe and effective as a previously cleared device. There aren't explicit performance metrics or acceptance criteria stated in a quantitative table for this type of device in this document. Instead, the device is expected to meet general controls and standards applicable to patient examination gloves.
• Study Details (Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone): These concepts are relevant to the validation of AI/ML algorithms, clinical trials, or performance studies that assess diagnostic accuracy, sensitivity, specificity, etc. A premarket notification for disposable exam gloves does not typically involve such studies described in the context you've provided. The "study" for this device would have involved demonstrating compliance with relevant standards (e.g., for barrier integrity, biocompatibility, dimensions, strength), commonly through laboratory testing, not clinical trials with human readers or AI.
• Training Set & Ground Truth for Training: Again, not applicable. This device is a physical product (gloves), not an AI algorithm requiring a training set.

In summary, the provided document does not contain the information needed to answer your questions because it concerns the regulatory clearance of a physical medical device (gloves) under the 510(k) pathway, which is distinct from the validation process of an AI/ML diagnostic or assistive 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

Based on the provided text, the device in question is "Disposable Powder Free Vinyl Synthetic Exam Gloves." The document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence to a predicate device, rather than outlining a detailed study with specific acceptance criteria and performance metrics typically found for more complex medical devices like AI algorithms.

Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria cannot be directly extracted from this document, as it doesn't pertain to an AI/software device. However, I can infer some "acceptance criteria" from the nature of the device and the FDA's declaration of substantial equivalence.

Here's an attempt to answer the questions based on the available information and general understanding of medical device regulation for such products:

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

Since this is a Class I device (Patient Examination Glove), the "acceptance criteria" are implied by the regulatory framework for patient examination gloves and the predicate device. These typically relate to physical properties and barrier integrity. The document does not provide specific numerical performance metrics from a study.

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

This document does not specify a sample size for a test set or data provenance for a study. For a glove, testing typically involves batches of gloves to ensure quality and compliance with standards. It would be prospective testing on manufactured products.

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)

This is not applicable to this type of device. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic devices interpreting medical images or data. For a patient examination glove, "ground truth" relates to physical and material property measurements.

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

Not applicable. This concept is for diagnostic interpretation, not for evaluating the physical properties of a glove.

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 concept is for diagnostic AI devices, not for patient examination gloves.

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

Not applicable. This concept is for AI algorithms, not for patient examination gloves.

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

For patient examination gloves, the "ground truth" for performance would be based on objective physical and chemical tests conducted in laboratories (e.g., tensile testing machines, water leak test for pinholes, chemical analysis for leachables).

8. The sample size for the training set

Not applicable to this type of device and submission. This is relevant for machine learning models.

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

Not applicable, as there is no "training set" in the context of an AI model for this device. The manufacturing process and quality control would be based on established material science and engineering principles for glove production.

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