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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.

Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 Classified by I DA's General Hospital and Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

The provided text describes a 510(k) submission for "Hong Di Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, Yellow" and focuses on demonstrating substantial equivalence to a predicate device. This type of submission relies on non-clinical tests to prove safety and efficacy, rather than clinical trials with human subjects or a focus on AI algorithm performance.

Therefore, many of the requested categories are either "Not Applicable" or cannot be extracted from the provided document.

Here's the breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: For the ASTM-related tests, the document mentions "Inspection level S-2, AQL 4.0" for physical/dimensional testing and "AQL 2.5, inspection level 1" for the water fill test. These are sampling plans, not explicit sample sizes. AQL (Acceptable Quality Level) and inspection levels refer to statistical sampling methods, but the exact number of gloves tested is not specified.
• Data Provenance: Not specified, but generally, such testing is conducted by the manufacturer or accredited labs on their product batches. The document does not specify country of origin for the data (beyond the manufacturer's country of origin being China) or if it's retrospective or prospective (implied prospective testing for lot release).

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

• Not Applicable. This device is a medical glove, and its performance is assessed through standardized physical and chemical tests, not clinical evaluation requiring expert ground truth in the context of disease diagnosis or intervention.

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

• Not Applicable. See point 3. Testing involves objective 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 is not an AI-enabled device, nor does it involve human readers interpreting medical cases.

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

• Not Applicable. This is not an AI algorithm.

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

• Standardized Test Methods and Specifications: The "ground truth" for this device's performance is established by adhering to the specifications and pass/fail criteria defined in industry standards like ASTM D-5250-06e1, ASTM D-6124-06, and FDA-specific test methods (e.g., 1000 ml. Water Fill Test), as well as biological safety testing (skin irritation/sensitization).

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

• Not Applicable. See point 8.

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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.

Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

The provided text describes the 510(k) summary for the "Hong Di Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves." This submission is for a Class I medical device (patient examination glove), which is a low-risk device. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and adherence to recognized standards, rather than complex clinical studies involving human readers or extensive ground truth establishment typical of AI/CADe devices.

Here's an analysis of the provided text against your requested criteria:

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

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

• Sample Size for Test Set:
  • For ASTM D-5250-06e1 (Physical and dimensions testing): Inspection level S-2, AQL 4.0. (Specific sample number not given, but refers to a standard sampling plan).
  • For FDA 1000 ml. Water Fill Test: AQL 2.5, inspection level I. (Specific sample number not given, but refers to a standard sampling plan).
  • For Primary Skin Irritation and Skin Sensitization: Not specified.
  • For Residual Powder Test: Not specified (but based on ASTM D-6124-06).
• Data Provenance: Not explicitly stated, but the tests were performed by the manufacturer, Hong Di Plastic Products Co., Ltd., which is located in China. The data would be prospective as it's part of the device's validation.

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)

Not applicable. This device is a patient examination glove, and its performance evaluation relies on objective, standardized physical and chemical tests, not on expert interpretation of medical images or clinical outcomes.

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

Not applicable. The tests are objective and quantitative (e.g., measuring dimensions, water fill, powder count, skin reaction), not subject to expert 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 glove and does not involve AI or human readers for its intended use.

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

Not applicable. This is not an algorithmic or AI-based device.

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

The "ground truth" for this device's performance is established by objective measurements and adherence to recognized industry standards (ASTM) and regulatory requirements (FDA). For example:

• Physical properties (tensile strength, elongation, dimensions) are measured against ASTM D-5250-06e1 specifications.
• Pinhole integrity is assessed by the FDA 1000 ml Water Fill Test.
• Biocompatibility is assessed through in-vitro/in-vivo tests for irritation and sensitization.
• Powder content is measured against ASTM D-6124-06.

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 that context. The manufacturing process is controlled to meet the specifications.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Ask a specific question about this device

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 Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-06.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Vinyl Patient Examination Glove, Yellow:

This document is a 510(k) summary for a medical device (patient examination glove) and focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel efficacy through detailed clinical studies. Therefore, many of the requested points related to advanced AI/ML studies (like MRMC, effect size, training sets, and detailed ground truth establishment for a complex algorithm) are not applicable in this context. The "acceptance criteria" here mainly refer to meeting established physical, chemical, and biocompatibility standards for gloves.

Acceptance Criteria and Reported Device Performance

Study Details (as applicable for this type of device submission)

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

   • Test Set Sample Size:
     • For Physical/Dimensions Testing: Inspection level S-2, AQL 4.0 (specific sample size from a lot is not explicitly stated but is derivable from the AQL tables).
     • For Pinhole (Water Fill) Test: AQL 2.5, inspection level I (specific sample size from a lot is not explicitly stated but is derivable from the AQL tables).
     • For Biocompatibility Testing: Not specified, but standard animal or human patch test panels are typically used for irritation/sensitization.
     • For Residual Powder Test: Not specified, but samples from batches would be tested.
   • Data Provenance: The tests were conducted by the manufacturer, Hong Di Plastic Products Co., Ltd., in China. The data would be prospective from their manufacturing and quality control processes.

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

   • Not Applicable. For this type of device, "ground truth" is established by adherence to recognized industrial standards (ASTM) and FDA test methods. There are no "experts" in the sense of clinical reviewers establishing a diagnostic "ground truth" for the device's performance, but rather qualified lab personnel performing standardized tests.

3. Adjudication method for the test set:

   • Not Applicable. The "adjudication" is essentially the pass/fail criteria defined by the ASTM standards and FDA test methods (e.g., AQL levels for defects, negative results for irritation/sensitization). There's no consensus-based adjudication as would be seen in reading medical images.

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 device is a patient examination glove, not an AI-powered diagnostic or assistive tool.

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

   • Not Applicable. This is a physical medical device (glove), not an algorithm.

6. The type of ground truth used:

   • Standardized Test Results & Compliance to Specifications: The "ground truth" for this device is its performance against established, quantitative specifications outlined in ASTM standards (D-5250-06, D-6124-06) and FDA-mandated tests (1000 mL Water Fill, biocompatibility assays).

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set. The "training" for manufacturing involves process control and adherence to quality systems for all produced gloves.

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

   • Not Applicable. As above, no training set in the AI/ML sense. "Ground truth" for manufacturing process quality is established through ongoing quality control and adherence to Good Manufacturing Practices (GMPs) and the specified ASTM standards throughout the production lifecycle.

Ask a specific question about this device

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 Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-06.

The provided text describes the regulatory submission for Powder Free Vinyl Patient Examination Gloves. It details the product's characteristics, intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

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

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

• ASTM D-5250-06: Inspection level S-2, AQL 4.0. The specific sample size is not explicitly stated but is implicitly defined by the AQL (Acceptable Quality Limit) standard.
• FDA 1000 ml Water Fill Test: Inspection level I, AQL 2.5. The specific sample size is not explicitly stated but is implicitly defined by the AQL standard.
• Primary Skin Irritation and Skin Sensitization: The sample size for these biocompatibility tests is not mentioned.
• Residual Powder Test (ASTM D-6124-06): The sample size for this test is not mentioned.
• Data Provenance: The data appears to be from non-clinical laboratory testing performed by or for the manufacturer, Hong Di Plastic Products Co., Ltd., which is based in Hebei, China. The text does not specify retrospective or prospective data collection but implies these were conducted specifically for this submission.

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

Not applicable. The tests performed are non-clinical and rely on established ASTM standards and FDA test methods, not on expert human interpretation for "ground truth" in the way, for example, a diagnostic imaging study would.

4. Adjudication method for the test set

Not applicable. The tests performed are objective, quantitative, or standard qualitative assessments (e.g., pass/fail for irritation), not subjective assessments requiring adjudication by multiple experts.

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 patient examination glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

Not applicable. This device is a physical product (a glove), not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance claims is based on established industry standards (ASTM) and regulatory test methods (FDA 1000 ml Water Fill Test, biocompatibility testing guidelines). For instance, the "ground truth" for pinhole detection is defined by the FDA 1000 ml Water Fill Test's criteria, and for mechanical properties, it's defined by ASTM D-5250-06. For biocompatibility, it's defined by the absence of specific adverse reactions.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this type of device.

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