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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand or finger to prevent contamination between patient and examiner.

Powder Free Latex Examination Glove

This appears to be an FDA 510(k) clearance letter for a Class I medical device, specifically "Powder Free Latex Examination Gloves." This type of clearance focuses on demonstrating substantial equivalence to a predicate device, primarily through established performance standards and manufacturing controls, rather than extensive clinical study data.

Therefore, the document does not contain the information requested regarding acceptance criteria and studies proving the device meets those criteria, as typically seen for higher-risk devices or AI/software-as-a-medical-device (SaMD) products.

Here's why and what kind of information would typically be needed for the questions you've asked, if this were a different type of device:

• For a Class I device like examination gloves: The "acceptance criteria" primarily relate to national/international standards for glove performance (e.g., ASTM standards for barrier integrity, dimensions, tensile strength, protein content for latex gloves). The "study" proving this would involve laboratory testing against these standards, typically performed by the manufacturer and submitted to the FDA as part of their 510(k) application to demonstrate conformance. The provided document is the outcome of that review, not the detailed submission itself.

If this were a more complex device (e.g., an AI/SaMD product), the requested information would look like this:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: Would typically define specific thresholds for performance metrics (e.g., sensitivity ≥ 90%, specificity ≥ 85%, AUC ≥ 0.90, average reading time reduction ≥ X seconds). These would often be based on clinical need, predicate device performance, or stakeholder input.
   • Reported Device Performance: Would present the actual values achieved by the device in predefined test sets for those metrics, along with confidence intervals.

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

   • Sample Size: A specific number of cases/patients (e.g., 500 cases).
   • Data Provenance: Details like "retrospective, multi-center data from 3 hospitals in the USA and 2 in Europe" or "prospectively collected data from a single academic institution in Japan."

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

   • Number of Experts: E.g., "3 experts."
   • Qualifications: "Board-certified radiologists, each with over 10 years of experience in chest imaging, including sub-specialization in oncology."

4. Adjudication method for the test set:

   • Method: E.g., "2+1 consensus (if two experts agreed, that was the ground truth; if they disagreed, a third expert resolved the discrepancy)" or "majority vote among 3 readers."

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

   • Yes/No: Explicitly state if one was done.
   • Effect Size: "Readers improved their AUC by an average of 0.05 (from 0.85 to 0.90) with AI assistance, a statistically significant improvement (p < 0.001)." Or "AI assistance reduced average reading time per case by 15% (from 60 seconds to 51 seconds) while maintaining diagnostic accuracy."

6. Standalone performance study:

   • Yes/No: Explicitly state if one was done. This measures the algorithm's performance without integration into human workflow.

7. Type of ground truth used:

   • Type: E.g., "Expert consensus," "Histopathology confirmation (biopsy results)," "Longitudinal follow-up data (e.g., 6-month clinical outcomes and subsequent imaging)," "Disease-specific gold standard (e.g., culture for infection)."

8. Sample size for the training set:

   • Sample Size: A specific number of cases/patients (e.g., 10,000 cases).

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

   • Method: E.g., "Ground truth was established by a single experienced physician's review of clinical reports," "Automated extraction from electronic health records using natural language processing and validated by a physician review of a subset," or "Same method as the test set: 2+1 expert consensus."

In summary, the provided FDA clearance letter for examination gloves does not contain the detailed performance study information typically requested for AI/SaMD or more complex medical devices.

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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.

POWDER FREE LATEX EXMAINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 µg/dm² OR LESS

This document is a letter from the FDA regarding a 510(k) premarket notification for "Powder-Free Latex Examination Gloves with Protein Content Labeling Claim of 50 ug/dm2 or Less." It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on confirming the substantial equivalence of the device to legally marketed predicate devices and outlines the regulatory obligations of the manufacturer. There is no performance data, study design, or expert review mentioned within this text.

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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue).

This document is a 510(k) premarket notification approval letter for "Powder Free Latex Examination Gloves, Tested For Use with Chemotherapy Drugs (Blue)". It is not a study that proves the device meets acceptance criteria in the sense of a clinical trial or AI algorithm validation. Instead, it demonstrates substantial equivalence to a predicate device, which includes fulfilling certain performance standards for medical gloves.

Here's an analysis based on the provided document, addressing the requested points where information is available:

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

The document focuses on the chemotherapy drug permeation aspect of the gloves. While it doesn't explicitly state "acceptance criteria" in a separate column, the values presented are the "Average Breakthrough Detection Time in Minutes" for various chemotherapy drugs, which would be compared against a standard or established threshold for acceptable performance. The implicit acceptance criterion is that the breakthrough time should be as long as possible, ideally exceeding the duration of typical exposure.

Note: The document explicitly states: "Please note that Thiotepa has an extremely low permeation time of less than 30 minutes." This indicates that for Thiotepa, the performance is below a generally accepted threshold for robust protection and needs careful consideration.

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

This information is not provided in the document. The document is an FDA approval letter, not a detailed study report. The results presented in the table are likely summarized from testing conducted by the manufacturer, but the specifics of the sample size (n for each test) and provenance are not included.

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 and not provided. This document pertains to the physical performance of a medical device (gloves) against chemical permeation, not a diagnostic or AI-driven system requiring expert interpretation or ground truth establishment in the traditional sense. The "ground truth" here is the objective measurement of chemical breakthrough.

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

This is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for chemical permeation testing of gloves.

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 document is for a medical glove, not an AI-assisted diagnostic tool.

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

This is not applicable. This document is for a medical glove, not an algorithm.

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

The "ground truth" for the chemotherapy drug permeation data would be the objective measurement of the breakthrough time of the specific chemotherapy drugs through the glove material. This is determined by standardized chemical testing protocols (e.g., ASTM D6978 for medical gloves). It does not involve expert consensus, pathology, or outcomes data in this context.

8. The sample size for the training set

This is not applicable and not provided. This is not an AI/machine learning device that requires a training set. The "training" for such a device would be the manufacturing process itself, aiming to meet established performance standards.

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

This is not applicable and not provided. As explained above, this is not an AI/machine learning device.

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A powder free latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.

Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile will meet all the current specification for ASTM D3578.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Natural Rubber Latex Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each of the tests (Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Soluble Protein Level, Biocompatibility).

The data provenance is not specified beyond indicating these are "performance test data." It is highly likely these were conducted as prospective tests by the manufacturer, specifically for this submission. The country of origin of the data would be Malaysia, where WEAR SAFE (MALAYSIA) SDN. BHD. is located and conducted the testing.

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

This information is not provided in the document. The tests performed are objective, laboratory-based physical and chemical assays, and biocompatibility tests. They rely on standardized methods rather than expert interpretation of data like in an imaging study. Therefore, the concept of "experts establishing ground truth" in the way it might apply to medical imaging or diagnostics is not directly relevant here. The ground truth for these tests is defined by the objective measurement criteria of the specified ASTM and CFR standards.

4. Adjudication method for the test set:

Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple readers might disagree on findings (e.g., radiologists interpreting images). Since these are objective physical, chemical, and biocompatibility tests, no adjudication method in this sense would have been used. The results are based on direct measurements and observations according to the test protocols.

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 MRMC comparative effectiveness study was done. This device is a patient examination glove, a physical product, not an AI-powered diagnostic or assistive technology. The concept of "human readers improving with AI assistance" is not applicable to this type of device.

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

No standalone algorithm performance study was done. This is a physical non-AI device.

7. The type of ground truth used:

The ground truth for these tests is based on objective measurement criteria and thresholds defined by established international standards:

• ASTM D3578-05 for Dimensions
• ASTM D 412-06ae1 for Physical Properties
• ASTM D 5151-06 for Freedom from pin-holes
• ASTM D 6124-06 for Powder Free Residue
• ASTM D 5712-05 for Soluble Protein Level
• ASTM F720-81 for Dermal Sensitization
• 16CFR Part 1500 for Primary Skin Irritation Test

These standards specify the methodology and acceptable limits for each characteristic.

8. The sample size for the training set:

Not applicable. This device is a physical product, not a machine learning model, so there is no "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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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This glove is tested for use with Dacarbazine (DTIC), Cyclophosphamide (Cytoxan), Doxorubicin Hydrochloride, 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol)

Warning: Not Recommended For Use With Carmustine and Thio-Tepa

Powder Free Latex Examination Gloves, Blue Tested For Use With Chemotherapy Drugs

This document is a 510(k) clearance letter from the FDA for a medical device: "Powder Free Latex Examination Gloves, Blue Tested for Use With Chemotherapy Drugs".

The document does not contain any information regarding acceptance criteria for a study, reported device performance, sample sizes for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Instead, this letter is an administrative notification that indicates the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It lists the regulation number, regulation name, product code, and the indications for use. It also outlines the manufacturer's responsibilities under the Act.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

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A powder-free 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.

A powder-free 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.

Here's a breakdown of the acceptance criteria and study information for the "Powderfree Latex Examination Gloves" described in the provided documents:

The documents provided are a 510(k) Summary and an FDA substantially equivalent letter for "Powderfree Latex Examination Gloves" manufactured by PT. Maja Agung Latexindo. This type of regulatory filing demonstrates substantial equivalence to a predicate device, rather than proving performance against novel acceptance criteria through a full-fledged clinical study.

Therefore, the study design and "acceptance criteria" here refer to meeting established industry standards for similar devices and demonstrating equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided documents. For physical property testing of gloves adhering to ASTM standards, specific sample sizes are typically defined within the ASTM standard (e.g., ASTM D3578-05ae2 for latex examination gloves specifies sampling plans for various tests like dimensions, physical properties, and watertightness).
• Data Provenance: The manufacturing location is "Jln. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA". The testing data would originate from the manufacturer's quality control or third-party testing facilities related to their manufacturing process. The data is retrospective, as it refers to tests conducted on manufactured batches to ensure compliance with the standard.

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

• This question is not applicable in the context of this 510(k) submission. The "ground truth" for the performance specifications of these gloves is defined by the ASTM D 3578-05ae2 Standard and FDA's pinhole requirements. These are engineering and performance specifications, not subjective expert interpretations of medical images or outcomes. The "experts" involved would be the engineers and quality control personnel who conducted the tests and verified compliance with the standard.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation). The tests conducted for glove performance (tensile strength, elongation, dimensions, pinhole) are objective measurements against a defined standard.

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 a study involving human readers or AI assistance. It is a device 510(k) submission for examination gloves, which are physical medical devices, not diagnostic software.

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

• Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

• The ground truth used is established industry standards and regulatory requirements, specifically:
  • ASTM D 3578-05ae2 Standard for Powder-Free Latex Examination Gloves
  • FDA pinhole requirement for examination gloves.
  • The specifications defined in the 510(k) summary for dimensions and physical properties, which are derived from or meet these standards.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this device manufacturing and regulatory submission. The gloves are manufactured and tested against predefined specifications.

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

• Not applicable, as there is no training set for this type of device. The specifications for performance (ground truth) were established over time through industry consensus and regulatory guidance, leading to standards like ASTM D 3578-05ae2.

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A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material 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.

POWDER FREE LATEX EXMAINATION GLOVES

This document, K071322, is a 510(k) premarket notification for Powder Free Latex Examination Gloves. It is a regulatory clearance letter from the FDA, and as such, it does not contain the detailed technical study information typically found in a scientific publication or clinical trial report that describes acceptance criteria and device performance in the way requested.

Therefore, I cannot provide a direct answer to your request regarding acceptance criteria and a study proving the device meets them from the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for this class of device based on comparisons to existing products, rather than presenting a novel study designed to establish new performance criteria.

Here's why each of your requested points cannot be extracted from this specific document:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., tensile strength, viral barrier effectiveness) or present results from tests against such criteria. It's a regulatory clearance letter, not a performance report.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or mentioned.
4. Adjudication method: Not applicable or mentioned.
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 physical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic "ground truth." For gloves, "ground truth" might refer to established physical properties and barrier effectiveness, but this document does not detail the testing.
8. The sample size for the training set: Not applicable. Examination gloves do not typically involve "training sets" in the machine learning sense.
9. How the ground truth for the training set was established: Not applicable.

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A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Powder free Latex Examination Gloves, BLACK

The document provided describes a 510(k) premarket notification for "Powder Free Latex Examination Gloves, Black" and outlines the technological characteristics and performance data used to demonstrate substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Performance data is the same as mentioned immediately above," implying the reported device performance met or exceeded the specified criteria in ASTM D 3578-05ae2.

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

The document does not explicitly state the specific sample sizes used for testing each characteristic. However, it references compliance with ASTM D 3578-05ae2 Standard, which would dictate the appropriate sampling plans for each test.

The data provenance is from PT. Maja Agung Latexindo, an Indonesian manufacturer. The study appears to be retrospective in the sense that the results are presented as having already been achieved and verified against established standards.

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

The document does not provide information about the number or qualifications of experts used to establish a "ground truth" for the test set. For medical devices like examination gloves, compliance with established industry standards (like ASTM D 3578-05ae2) and regulatory requirements (like FDA pinhole requirements) serves as the primary benchmark. These standards are developed by expert consensus within their respective fields, but individual expert adjudication of specific test results for this 510(k) submission is not described.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1, none) for the test set is mentioned. Compliance is demonstrated by meeting the quantitative specifications of the ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was done. This type of study is typically associated with diagnostic imaging or interpretative tasks where human readers' performance is augmented by AI. For examination gloves, the performance is mechanically and physically evaluated against defined specifications, not through human interpretation.

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

This is not applicable as the device is a physical medical glove, not an algorithm or an AI-powered system. The "performance" refers to the physical and mechanical properties of the glove itself.

7. The Type of Ground Truth Used

The ground truth used is primarily compliance with established industry standards and regulatory requirements, specifically:

• ASTM D 3578-05ae2 Standard: This standard defines the physical and performance requirements for medical examination gloves.
• FDA pin hole requirement: A specific regulatory requirement for glove integrity.
• Labeling claim: Verification that the product's actual performance aligns with its stated labeling.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (latex examination gloves), not an AI algorithm that requires a "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 device like a glove.

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A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Powder free Latex Examination Gloves

The provided document describes the acceptance criteria and performance data for "Powder Free Latex Examination Gloves" manufactured by PT. Haloni Jane.

Here's an analysis of the requested information 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:

• The document does not explicitly state the sample size used for the tests.
• The data provenance is prospective, as it describes the results of tests performed on the manufactured gloves. The country of origin of the manufacturer is Indonesia.

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 and testing. The acceptance criteria are based on established industry standards (ASTM D 3578-05ae2) rather than expert interpretation of a ground truth in a clinical context.

4. Adjudication method for the test set:

• This information is not applicable. Adjudication methods are typically used in studies where there is subjective interpretation involved, such as reading medical images. For physical property testing of gloves, objective measurements against a standard are performed.

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. This device is not an AI-assisted diagnostic tool; it is a physical medical device (examination gloves).

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

• This information is not applicable. This device is not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the performance of these gloves is defined by objective physical property measurements and adherence to regulatory standards (ASTM D 3578-05ae2 and FDA pin hole requirements). There is no expert consensus, pathology, or outcomes data used as ground truth for this type of product.

8. The sample size for the training set:

• This information is not applicable. As this is not a machine learning or AI device, there is no concept of a "training set."

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

• This information is not applicable.

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The Powder Free Latex 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 hands or finger(s) for medical purposes to provide a barrier.against potentially infectious materials and other contaminants.

The Powder Free Latex Examination Gloves. Natural or Blue Colour and with Protein Content Labeling Claim is equivalent to the exiting model, i.e. Latex Patient Examination Gloves. Powder Free which had submitted and cleared under 510(k) number K924356.

The differences in this submission are:

• With or without colour additive upon customers` preference or request. a)
• With protein content labeling claim, i.e. "This latex glove contains 50 micrograms or b) less of total water extractable protein per gram``.

The provided document is a 510(k) summary for a medical device: "Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 Micrograms or Less)". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, many of the typical clinical study criteria (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone AI performance, and training set information) are not applicable or not detailed in this type of regulatory filing.

The acceptance criteria are primarily based on established ASTM standards and FDA regulations for patient examination gloves. The "study" proving the device meets these criteria is a series of tests against these standards.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Pinhole Freedom: 125 gloves were tested.
• Sample Size for Visual Inspection: 125 gloves for both major and minor defects.
• Sample Size for Powder Residual: Not explicitly stated, but an average value (Avg. 0.96 mg/glove) is given, implying multiple samples were measured.
• Sample Size for Protein Content: Not explicitly stated, but a range (17 - 29 µg/g) is given, implying multiple samples were measured.
• Sample Size for Physical Properties (e.g., dimensions, tensile strength): Not explicitly stated, but averages or ranges are provided, indicative of testing on multiple units.
• Data Provenance: The document implies testing was conducted by the manufacturer, Medipure Corporation (M) Sdn Bhd, located in Malaysia. The testing is laboratory-based performance testing, not human clinical trial data. It is inherently retrospective in the sense that these are tests performed on manufactured product batches.

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

• This information is not applicable as the device is a physical product (examination gloves) tested against predefined technical standards and physical properties, not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable. The assessment involves objective physical and chemical tests against quantitative standards (e.g., palm width in mm, tensile strength in MPa, protein content in µg/g). There is no "adjudication" in the sense of reconciling differing expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices where multiple human readers' performance with and without AI assistance is evaluated. This device is a medical glove, and such a study is irrelevant to its function or regulatory clearance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Not applicable. This 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, standardized laboratory measurements and tests. These tests align with the specifications outlined in:
  • ASTM D 3578 (Standard Specification for Latex Examination Gloves)
  • ASTM D 6124 (Standard Test Method for Residual Powder on Medical Gloves)
  • ASTM D 5712 (Standard Test Method for Analysis of Aqueous Extractable Protein in Latex and Natural Rubber)
  • FDA 21 CFR 800.20 (Medical devices; effectiveness in preventing pinholes in rubber prophylactics and gloves)
  • 16 CFR Part 1500 (Federal Hazardous Substances Act regulations, regarding primary skin irritation)
  • Buehler Method (for dermal sensitization)
  • In-House Specifications (for visual inspection of major and minor defects).

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product, not an AI or machine learning model that requires a "training set."

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

• Not applicable. As stated above, this device does not utilize a training set. The "ground truth" for the device's manufacturing and quality control is established by adherence to the standardized tests mentioned in point 7.

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