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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 Glove, Blue Color

The provided documents are an FDA 510(k) clearance letter for a Disposable Powder Free Vinyl Exam Glove. This type of document does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML or medical imaging diagnostics.

The FDA 510(k) clearance process for a patient examination glove primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, assessing characteristics like material safety, freedom from pinholes, and tensile strength, rather than diagnostic accuracy or AI performance.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from these documents as they are irrelevant to such a request.

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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, Powdered Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06

The document provided describes the acceptance criteria and study for the Rich Mountain Medical Products Inc. Disposable Vinyl Synthetic Examination Gloves, Powdered Yellow Color.

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. The exact number of samples is not explicitly stated, but these AQL (Acceptable Quality Limit) parameters refer to sampling plans as defined in statistical quality control standards.
• Watertightness Test (based on ASTM D-5151-06): Samplings of AQL 2.5, Inspection level I. The exact number of samples is not explicitly stated, but these AQL parameters refer to sampling plans.
• Primary Skin irritation and Skin Sensitization: The document does not specify the sample size for this testing.
• Data Provenance: The document does not specify the country of origin of the data for the testing conducted. It is implied that the testing was performed in the context of Rich Mountain Medical Products Inc., which is based in China. The data would be considered retrospective in the context of this 510(k) submission, as the tests were performed prior to the submission.

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 as the evaluation of medical devices like gloves primarily relies on adherence to established physical, chemical, and biological performance standards (e.g., ASTM standards, FDA watertightness tests). It does not involve human expert interpretation for establishing a "ground truth" in the same way clinical imaging or diagnostic devices would.

4. Adjudication method for the test set:

This is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., clinical trials, AI performance evaluation) to resolve discrepancies among experts. The testing here is objective measurement against 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:

This is not applicable. This submission is for a disposable medical glove, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study involving human readers or AI assistance was performed.

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

This is not applicable. The device is a physical product (gloves), not an algorithm or AI system.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by objective measurements and adherence to recognized industry standards and regulatory requirements. Specifically:

• ASTM Standard D5250-06 for physical and dimension properties.
• FDA 1000 ml Watertight Test based on ASTM D-5151-06 for barrier integrity.
• Biocompatibility testing against established criteria for primary skin irritation and sensitization.
• Conformity to 21 CFR references and "pinhole FDA requirements."

8. The sample size for the training set:

This is not applicable. This device is a physical product, not a machine learning model, so there is no "training set" in the context of artificial intelligence.

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

This is not applicable for the reasons stated in item 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 document describes the premarket notification (510(k)) for the Rich Mountain Medical Products Inc. Disposable Vinyl Examination Glove, Powder Free. The focus of the provided text is to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study as would be typical for more complex medical devices.

Therefore, many of the requested elements pertaining to clinical studies and associated metrics (like sample sizes for test sets, expert consensus, MRMC studies, training set details) are not applicable to this type of device and submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on meeting established industry standards and regulatory requirements for patient examination gloves.

Study Details for Demonstrating Acceptance Criteria (Non-Clinical Tests)

The "study" described here is a series of non-clinical, laboratory-based tests.

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

   • ASTM D5250-06 (Physical and Dimensions): "Inspection level S-2, AQL 4.0." (Specific sample size not explicitly stated, but statistical sampling plan indicated).
   • ASTM D-5151-06 (Watertightness): "samplings of AQL 2.5, Inspection level I" (Specific sample size not explicitly stated, but statistical sampling plan indicated).
   • Biocompatibility (Skin irritation/sensitization): Sample size for this biological testing is not provided.
   • ASTM D6124-06 (Residual Powder): Sample size for this testing is not provided.
   • Data Provenance: The tests were performed by Rich Mountain Medical Products Inc. (manufacturer), presumably in China (country of origin for the submitter). These are retrospective tests conducted on samples of manufactured gloves.

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 these tests is defined by the objective pass/fail criteria of the ASTM standards and FDA requirements, which do not typically involve human expert adjudication in the same way as, for example, image interpretation.

3. Adjudication method for the test set: Not applicable. Results are based on objective measurements and comparison to defined thresholds within the standards.

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 not an AI-assisted diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.

6. The type of ground truth used: The ground truth is defined by the objective, quantitative measurements against established thresholds and specifications outlined in the referenced ASTM standards (D5250-06, D5151-06, D6124-06) and FDA requirements (e.g., biocompatibility criteria, pinhole limits, powder limits).

7. The sample size for the training set: Not applicable. This device does not use an algorithm that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

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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

Here's a breakdown of the acceptance criteria and study information for the Rich Mountain Medical Products Inc. Disposable Vinyl Examination Glove, Powdered, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set:
  • For Physical and Dimensions Testing (ASTM D5250-06): Inspection level S-2, AQL 4.0. (The exact numerical sample size is not explicitly stated, but these AQL and inspection levels define the sampling plan.)
  • For FDA 1000 ml Watertight Test (ASTM D-5151-06): AQL 2.5, Inspection level I. (Again, the exact numerical sample size is not explicitly stated, but these AQL and inspection levels define the sampling plan.)
  • For Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but these are typically tested on a defined number of subjects or animal models according to biocompatibility guidelines.
• Data Provenance: The document does not explicitly state the country of origin of the data for the testing. It is implied that the testing was conducted by or for Rich Mountain Medical Products Inc. which is based in China. The studies are prospective as they were conducted specifically for the purpose of demonstrating substantial equivalence.

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 submission. The device is a medical glove, and the evaluation relies on adherence to established ASTM standards and FDA guidelines for physical properties, barrier integrity, and biocompatibility, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set:

• This information is not applicable. The testing involves objective measurements against predefined standards and biological responses rather than subjective expert evaluations requiring 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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CAD devices that assist human readers in interpreting medical data. The device here is a physical product (a glove) and does not involve AI or human readers for diagnostic purposes.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No, a standalone study was not done. This concept applies to AI algorithms. The device is a physical product.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is established by objective measurements and standardized test methods as defined by ASTM D5250-06 and ASTM D-5151-06, along with established protocols for biocompatibility testing. There is no expert consensus, pathology, or outcomes data used in the typical sense for diagnostic devices.

8. The Sample Size for the Training Set:

• This information is not applicable. The device is a physical product, not an AI model, therefore, there is no "training set."

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

• This information is not applicable as there is no training set for a physical product like a medical glove.

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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.

Here's a breakdown of the acceptance criteria and study information for the Rich Mountain Medical Products Ltd. Disposable Vinyl Synthetic Examination Gloves, Powder Free, 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

• Sample Size:

  • For Physical and Dimensions Testing (ASTM D5250-06): Inspection level S-2, AQL 4.0 (The exact numerical sample size is not explicitly stated but is defined by the AQL and inspection level, which are standard sampling methods).
  • For FDA 1000 ml Watertight Test (ASTM D-5151-06): AQL 2.5, Inspection level I (Again, the exact numerical sample size is not explicitly stated but is defined by these parameters).
  • For Primary Skin Irritation and Skin Sensitization: Not specified beyond "testing was conducted."
  • For Residual Powder Test: Not specified beyond "samplings."

• Data Provenance: The manufacturing company is Rich Mountain Medical Products Ltd., located in China (Jiangsu Province). The testing appears to have been conducted by or for the manufacturer. The data is retrospective relative to the submission date, as it reflects tests performed on manufactured batches of gloves.

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

This type of information is not applicable to this device. This is a Class I medical device (patient examination glove), and the testing involves objective measurement against performance standards (e.g., physical properties, watertight integrity, chemical residue, biocompatibility), not subjective assessments requiring expert consensus on a "ground truth" for diagnostic or interpretative accuracy.

4. Adjudication Method for the Test Set

This information is not applicable. The tests are objective measurements against established standards, not subjective assessments requiring 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices. The device in question is a physical barrier (examination glove), and its effectiveness is measured by its physical properties and barrier integrity, not by human reader performance or AI assistance.

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

No, a standalone algorithm performance study was not done. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by:

• Established ASTM Standards: D5250-06 (Physical and Dimensions), D-5151-06 (Watertight), D6124-06 (Residual Powder).
• Biocompatibility Testing: Results showing "no primary skin irritant or sensitization reactions."
• Regulatory Requirements: FDA's 1000 ml Watertight Test and good manufacturing practices.

These standards and direct measurements form the objective "ground truth" against which the glove's performance is evaluated.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the conventional sense. The "training" for the manufacturing process would be quality control and adherence to manufacturing specifications.

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

Not applicable. As there is no AI/ML component, there is no "training set" or "ground truth" for such a set. The manufacturing process's "ground truth" is adherence to quality control parameters and the specifications outlined in the ASTM 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) 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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