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The surgeon's glove is a device made of synthetic copolymer intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Class I synthetic surgeon's glove, 79 KGO, powdered. It is a styrene-butadiene block copolymer glove.

The provided text describes the acceptance criteria and performance of "PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)" based on a 510(k) submission (K982600) to the FDA. The study aims to demonstrate substantial equivalence to a predicate device by meeting ASTM D3577-91 Type 2 and FDA 1000 ml watertight test requirements.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

1. Single Sampling Plan, S-4, AQL 1.5
2. Multiple Sampling Plan, GII, AQL 2.5 |
   | 2. Length (mm) | | |
   | Size 6½ | min 265 | 301 |
   | Size 7 | min 265 | 299 |
   | Size 7½ | min 265 | 298 |
   | Size 8 | min 265 | 301 |
   | Size 8½ | min 265 | 303 |
   | 3. Palm Width (mm) | | |
   | Size 6½ | 83 ± 6 | 85 |
   | Size 7 | 89 ± 6 | 92 |
   | Size 7½ | 95 ± 6 | 96 |
   | Size 8 | 102 ± 6 | 104 |
   | Size 8½ | 108 ± 6 | 110 |
   | 4. Single Wall Thickness (mm) | | |
   | Finger | min 0.10 | 0.27 |
   | Palm | min 0.10 | 0.25 |
   | Cuff | min 0.10 | 0.20 |
   | 5. Physical Properties (Type 2) | | |
   | Before Aging: | | |
   | Tensile Strength (MPa) | min 17 | 19.62 |
   | Ultimate Elongation (%) | min 650 | 1108 |
   | Stress at 500% Elongation (MPa) | max 7.0 | 1.92 |
   | After Aging: | | |
   | Tensile Strength (MPa) | min 12 | 16.35 |
   | Ultimate Elongation (%) | min 490 | 1101 |

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

• Sample Size: The document does not explicitly state the exact numerical sample size for each test. However, for the watertight test, it refers to "Single Sampling Plan, S-4, AQL 1.5" and "Multiple Sampling Plan, GII, AQL 2.5." These are statistical sampling plans defined by ISO standards (or equivalent for medical devices) that dictate sample size based on lot size and acceptable quality limits (AQL). Without the lot size, the exact sample numbers cannot be determined from this text alone. For other physical property tests, specific sample sizes are not mentioned.
• Data Provenance: The data originates from "WEMBLEY RUBBER PRODUCTS (M) SDN BHD" located in Sepang, Selangor Darul Ehsan, Malaysia. The data appears to be retrospective as it's presented in a regulatory submission to demonstrate compliance of an already manufactured device.

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

This type of study (device performance against a standard) does not typically involve human experts establishing a "ground truth" in the same way an AI diagnostic study would. The acceptance criteria themselves (ASTM D3577-91 Type 2 and FDA 1000ml watertight test) serve as the objective 'ground truth' against which the device performance is measured. The tests are typically conducted by trained technicians in a laboratory setting according to the standard's procedures. The document does not mention any experts in this context.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is a performance test against objective standards, not a diagnostic task requiring expert adjudication of results. The "adjudication" is whether the measured values meet the specified limits of the ASTM standard and FDA watertight test.

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 a study evaluating the physical performance specifications of a medical device (surgical gloves), not a comparative effectiveness study involving human readers or AI assistance.

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

Not applicable. This is not an AI algorithm study. It's a physical device performance study.

7. The Type of Ground Truth Used

The ground truth used is objective performance standards defined by:

• ASTM D3577-91 Type 2 (Standard Specification for Rubber Surgical Gloves)
• FDA 1000 ml watertight test requirements

These standards specify the acceptable ranges for various physical and performance characteristics of surgical gloves.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI study, 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. The "ground truth" for evaluating the glove's performance against regulatory requirements is established by the specifications within the ASTM D3577-91 Type 2 standard and the FDA's watertight test criteria.

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1. The chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.

Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.

Here's a breakdown of the acceptance criteria and study information 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:

The document does not explicitly state the sample sizes used for each test. However, it references ASTM D 3578-91 and FDA 1000 ml watertight test, which are standard specifications for latex examination gloves and often include sampling plans (e.g., AQL for watertightness). For the watertight test, an "AQL of 1.5" is mentioned, implying a sampling plan was followed.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the study was conducted by WEMBLEY RUBBER PRODUCTS (M) SDN BHD in Malaysia, suggesting the data was generated in Malaysia. Given that these are performance tests of a manufactured product, they are typically prospective in nature, performed on a batch of gloves.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or diagnostic studies. The "ground truth" here is objective physical and chemical measurements (e.g., length, thickness, tensile strength, protein content) as defined by established standards like ASTM D 3578-91 and the FDA watertight test. These standards themselves are developed by expert consensus in their respective fields.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study that involves human interpretation or diagnosis requiring adjudication. The tests involve objective measurements against predefined criteria.

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

No, an MRMC comparative effectiveness study was not done. This document describes the performance testing of a medical device (examination gloves) against established physical and chemical standards, not a diagnostic or interpretative AI system.

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

No, this is not an algorithm, but a physical product. The tests conducted are standalone in the sense that they evaluate the glove's intrinsic properties without human interaction beyond the testing procedure itself.

7. The Type of Ground Truth Used:

The ground truth used is based on:

• Standardized Specifications: Specifically, the requirements outlined in ASTM D 3578-91 for latex examination gloves.
• Regulatory Requirements: The FDA 1000 ml watertight test requirement.
• Manufacturer's Claims: For powder, moisture, and protein content, the manufacturer established target levels (e.g., "below 2 mg / glove" for powder content). These claims are validated by testing.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI study that involves a "training set." The tests are evaluating the physical properties of a manufactured product.

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

Not applicable, as there is no training set in this context.

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1. The chemotherapy examination glove is a specialty medical glove which is a The onemedial device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.

Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The document describes the performance of "CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)" against established standards for patient examination gloves.

1. A table of acceptance criteria and the 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 individual test (e.g., how many gloves were tested for watertightness, length, etc.). It generally refers to "performance test data."

The data provenance is from WEMBLEY RUBBER PRODUCTS (M) SDN BHD in Malaysia. The study is a non-clinical performance test of the manufactured device. It is a retrospective evaluation of the product's characteristics against a standard, not a prospective clinical trial.

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 "ground truth" (acceptance criteria) for most tests is the ASTM D 3578-91 standard itself. For the "Watertight (1000 ml)" test, the acceptance criteria is "S-4, AQL 4.0," which is a widely accepted standard in glove manufacturing. The protein content claim is a specific assertion about the glove's composition. These are objective measures against established technical standards, not subjective expert assessments.

4. Adjudication method for the test set

This information is not applicable as the tests are objective measurements against published standards (ASTM D 3578-91 and FDA 1000 ml watertight test). There is no reference to human experts adjudicating results.

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 describes the performance characteristics of medical examination gloves, not an AI or imaging device that would involve human readers or cases.

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

This is not applicable. This document describes the physical and chemical performance of medical examination gloves, not an algorithm.

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

The ground truth used primarily consists of established technical standards and specifications:

• ASTM D 3578-91: This is a comprehensive standard for rubber examination gloves.
• FDA 1000 ml watertight test: Another specific test for glove integrity.
• Protein content labeling claim: A manufacturer-defined specification for the protein level, which is then verified using a standard method (ASTM D5712).

These are objective, quantifiable criteria.

8. The sample size for the training set

This is not applicable. This is not a machine learning model, so there is no training set. The data presented is for the performance evaluation of a manufactured product.

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

This is not applicable as there is no training set for a machine learning model. The "ground truth" for the device's performance evaluation is established by the aforementioned ASTM and FDA specifications.

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The surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Class I natural rubber latex surgeon glove, 79 KGO, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3577-91.

The provided document describes the acceptance criteria and performance data for "PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)".

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The study concludes that the PROFEEL Powder Free Surgical Gloves exceed the ASTM D 3577-91 requirements, meet FDA pinhole requirements, and meet the protein content labeling claim.

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

The document does not explicitly state the sample size used for the test set for each individual test. It refers to "Performance data of gloves to ASTM D 3577-91 and FDA 1000 ml watertight test," which are established standards that would define sample sizes for testing. For example, "S-4, AQL 1.5" for the watertight test refers to a sampling plan from an acceptance sampling standard (often MIL-STD-105E or equivalent) which would specify sample sizes based on lot size and AQL.

The data provenance is from Malaysia, as the manufacturer, Wembley Rubber Products (M) Sdn. Bhd., is located in Sepang, Selangor Darul Ehean, Malaysia. The data is non-clinical performance data, likely generated through laboratory testing of the gloves, not from human subject studies. Therefore, it is retrospective in the sense that the tests were performed on manufactured products, rather than prospectively collected clinical outcomes.

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

This information is not applicable to this type of device and study. The "ground truth" for the performance of surgical gloves is established by objective measurements against industry standards (ASTM D 3577-91 and FDA watertight test for pinholes), not by expert consensus or interpretation of subjective data. The tests are designed to quantitatively measure physical properties.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective, quantitative measurements against predefined standards, not on subjective interpretations 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

This is not applicable. This document describes the performance of a physical medical device (surgical gloves), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

This is not applicable. There is no algorithm or AI component to this medical device.

7. The Type of Ground Truth Used

The ground truth used is objective quantitative measurements against established industry standards (ASTM D 3577-91 for physical properties, and FDA 1000 ml watertight test for freedom from pinholes). For powder and protein content, specific laboratory tests (e.g., ASTM D5712 for protein content) are used to provide quantitative "ground truth" values.

8. The Sample Size for the Training Set

This is not applicable. This refers to a manufactured physical product. There is no machine learning model involved that would require a training set.

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

This is not applicable for the same reason as above; there is no training set for a physical product like surgical gloves.

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The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, protein labeling content, that meets all of the requirements of ASTM standard D3578-91.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • Watertight test: "S-4, AQL 4.0" and "AQL of 2.5" relate to sampling plans (e.g., ISO 2859-1 or MIL-STD-105E). While the exact sample size isn't explicitly stated, these AQL levels imply a statistically determined sample size for lot release testing based on batch quantity.
   • Clinical data (Modified Draize test): 200 human subjects.
   • Data Provence: Not explicitly stated, but the manufacturer is Wembley Rubber Products (M) Sdn Bhd in Selangor, Malaysia, suggesting the testing was likely conducted in Malaysia or a related region, or according to international standards. The data is retrospective for the purpose of this 510(k) submission.

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

   • For the physical and chemical property tests (watertight, length, width, thickness, tensile strength, elongation, powder, and protein content), the "ground truth" is established by the specifications defined in ASTM D 3578-91 and FDA 1000 ml watertight test. These are standardized tests with objective measurements, not typically requiring individual expert consensus for ground truth but rather adherence to validated testing methodologies by qualified technicians.
   • For the Modified Draize test, the "ground truth" regarding dermal irritation or sensitization is established by the clinical assessment of the 200 human subjects by qualified personnel (e.g., dermatologists or clinical researchers experienced in dermatological assessments). The number and specific qualifications of these experts are not detailed in the provided text.

4. Adjudication method for the test set:

   • For the physical and chemical tests, adjudication is not typically used as the tests yield objective, quantitative results against defined criteria. A "pass" or "fail" is determined directly by measurement against the standard.
   • For the Modified Draize test, the determination of "no potential for eliciting either dermal irritation or sensitization" would be based on the assessment of the clinical researchers overseeing the study. The specific adjudication method (e.g., blind assessment, multiple reader agreement) is not specified.

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, this document pertains to the performance testing of a physical medical device (examination gloves), not an AI-powered diagnostic or interpretive system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

   • Not applicable. This is for a physical medical device.

7. The type of ground truth used:

   • For physical and chemical properties: Objective criteria defined by recognized standards (ASTM D 3578-91) and regulatory requirements (FDA 1000 ml watertight test).
   • For hypoallergenic claim: Clinical outcomes data from a Modified Draize test on 200 human subjects (dermal irritation and sensitization results).

8. The sample size for the training set:

   • Not applicable. This document describes performance testing of a manufactured product against standards, not the development or training of an algorithm.

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

   • Not applicable.

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The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, low protein, that meets all of the requirements of ASTM standard D3578-91.

The document describes the acceptance criteria and performance of "COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)".

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Non-Clinical Performance Data: The sample sizes for the physical and watertight tests (length, palm width, thickness, tensile strength, elongation, powder content) are not explicitly stated, but the performance is presented as single values for each metric for each size. The "Watertight (1000 ml)" test results are reported against an AQL (Acceptable Quality Limit) of 2.5, indicating a sampling plan was used according to the ASTM and FDA standards. The provenance of this data is not specified beyond being generated by the device manufacturer.
• Clinical Performance Data (Hypoallergenic Claim):
  • Sample Size: 200 human subjects.
  • Data Provenance: Not explicitly stated, but implies a prospective clinical study conducted to assess the hypoallergenic claim.

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

• Non-Clinical Performance Data: The document does not specify the number or qualifications of experts for establishing ground truth for the physical and chemical properties tests (e.g., tensile strength, protein content). These are standard laboratory tests typically performed by trained technicians according to established protocols (ASTM D 3578-91 and ASTM D5712 for protein content).
• Clinical Performance Data (Hypoallergenic Claim): The "Modified Draize test" is mentioned, which is a standardized patch test for skin irritation and sensitization. This test involves clinical assessment by trained personnel, typically dermatologists or clinical researchers. However, the document does not specify the number or specific qualifications of the experts (e.g., dermatologists with X years of experience) involved in assessing the 200 human subjects.

4. Adjudication Method for the Test Set

• Non-Clinical Performance Data: Not explicitly mentioned. Standardized tests (ASTM) usually have clear pass/fail criteria.
• Clinical Performance Data (Hypoallergenic Claim): Not explicitly mentioned. The Modified Draize test results would likely involve trained evaluators assessing skin reactions, but an explicit adjudication method (e.g., independent review by multiple experts) is not described.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This document pertains to the performance of examination gloves, not an AI-assisted diagnostic device.

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

This question is not applicable as the device is a medical glove, not an algorithm or AI system. The performance evaluated is "standalone" in the sense that it's the raw physical and chemical properties of the glove.

7. The Type of Ground Truth Used

• Non-Clinical Performance Data:
  • Expert Consensus: Not explicitly stated. The "ground truth" for these measurements (e.g., length, tensile strength) is defined by the objective measurement obtained through validated laboratory testing methods (e.g., ASTM D 3578-91, ASTM D5712).
  • Pathology/Outcomes Data: Not directly applicable. The data is based on physical and chemical measurements.
• Clinical Performance Data (Hypoallergenic Claim):
  • Clinical Assessment/Outcomes Data: The ground truth for the hypoallergenic claim was established through clinical observation and assessment of the human subjects for dermal irritation or sensitization using the Modified Draize test. The outcome (presence or absence of reaction) serves as the ground truth.

8. The Sample Size for the Training Set

This question is not applicable as the device is an examination glove, not a machine learning model that requires a training set. The manufacturing process and quality control would be "trained" through process optimization and adherence to standards, but not in the sense of a data-driven training set for an algorithm.

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

This question is not applicable for the reasons mentioned in point 8.

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The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, low protein, that meets all of the requirements of ASTM standard D3578-91.

Here's an analysis of the provided text, focusing on the acceptance criteria and the studies mentioned for the "COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)":

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Chemical Properties: The document refers to "Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test" but does not explicitly state a sample size for these tests. The AQL (Acceptance Quality Level) of 2.5 for watertight is mentioned, which implies a sampling plan was followed, but the specific number of gloves tested for each characteristic is not provided. The data provenance is not stated, but given the manufacturer is Malaysian, it's likely the testing occurred in Malaysia or a closely affiliated region.
• Hypoallergenic Claim: 200 Human subjects were used for the Modified Draize test. This was a prospective study as it involved testing on human subjects to assess the device's performance regarding the hypoallergenic claim. The country of origin for this specific trial is not stated.

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

• For Physical and Chemical Properties: The "ground truth" is established by the ASTM D 3578-91 standard and the FDA 1000 ml watertight test. These standards themselves are products of expert consensus and rigorous scientific methods, but individual experts are not explicitly named as providing ground truth for this specific device's test set. The tests are objective measurements against established criteria.
• For Hypoallergenic Claim: A "Modified Draize test" was performed. This type of test typically involves trained professionals (e.g., dermatologists, toxicologists, or technicians under their supervision) to observe and record skin reactions. However, the number and specific qualifications of the experts (e.g., dermatologists with X years of experience) who assessed the reactions in the 200 human subjects are not mentioned in the document.

4. Adjudication Method for the Test Set

• For Physical and Chemical Properties: Adjudication is not applicable in the sense of expert consensus for primary endpoints. The results are objective measurements against predefined thresholds in the ASTM standard. AQL (Acceptance Quality Level) indicates a statistical sampling plan for quality control rather than expert adjudication.
• For Hypoallergenic Claim: The document does not specify an adjudication method like 2+1 or 3+1. The Modified Draize test protocol itself would define how reactions are observed and interpreted. It's likely observations were made by trained personnel, but details on how conflicting interpretations (if any) were resolved are not provided.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where multiple human readers assess cases with and without AI assistance. The device in question is an examination glove, and the studies described are related to its physical properties, chemical composition, and biocompatibility/allergenicity, not diagnostic interpretation.

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

This question is not applicable to the device described. The "device" is a physical examination glove, not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The type of ground truth used

• For Physical and Chemical Properties: The ground truth is based on objective measurements compared against pre-defined standards (ASTM D 3578-91 and FDA requirements).
• For Hypoallergenic Claim: The ground truth is established through clinical observation of human subjects in a controlled test (Modified Draize test) for the presence or absence of dermal irritation or sensitization.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical product (examination gloves), not an AI algorithm, so there is no concept of a "training set" in this context.

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

This question is not applicable, as there is no training set for this physical device.

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The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel to provent containmation between environment environment.

Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, protein labeling content, that meets all of the requirements of ASTM standard D3578-91.

The provided document describes the acceptance criteria and performance data for "COMFIT POWDER FREE LATEX EXAMINATION GLOVES (HYPOALLERGENIC, UNBEADED, PROTEIN LABELING CONTENT)".

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical Performance Data (ASTM D 3578-91 and FDA 1000 ml watertight test): The sample sizes for each specific test (e.g., watertight, length, width, thickness, physical properties) are not explicitly stated in the provided document. The document only states "Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test."
• Clinical Performance Data (Hypoallergenic): 200 Human subjects were used for the Modified Draize test.
• Data Provenance: The document is a K953590 summary, indicating it's a regulatory submission. The company is Wembley Rubber Products, located in Malaysia. It does not explicitly state if the studies were retrospective or prospective, but clinical trials are typically prospective.

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

• For Physical Performance Tests: The ground truth is established by the specified ASTM and FDA standards. These are standardized tests and do not typically involve experts establishing "ground truth" in the same way as an image interpretation study. The results are quantitative measurements against defined criteria.
• For Clinical Performance Data (Hypoallergenic): The Modified Draize test protocol, a standard for assessing skin irritation and sensitization, is the basis. It typically involves a trained clinical professional to conduct and assess the results. The document does not specify the number or qualifications of experts directly involved in establishing the ground truth for the 200 human subjects.

4. Adjudication method for the test set

• For Physical and Clinical Performance Tests: Adjudication methods like 2+1 or 3+1 are typically used in subjective assessments, such as radiology interpretations, where multiple readers might disagree. For objective physical and chemical tests, the results are quantitative and directly measured against a standard, so such adjudication is generally not applicable. For the Modified Draize test, the assessment of dermal irritation/sensitization follows a standardized scoring system. The document does not mention any adjudication method for these tests.

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. This type of study (MRMC for AI assistance) is not applicable to an examination glove, which is a physical medical device, not an AI diagnostic tool.

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

• No. This question is also not applicable as the device is a physical examination glove, not an algorithm or AI system.

7. The type of ground truth used

• For Physical Performance: The ground truth is established by the requirements of reference standards, specifically ASTM D 3578-91 and FDA 1000 ml watertight test (which implies physical measurement and adherence to regulatory limits).
• For Chemical Content (Powder and Protein): Quantitative laboratory measurements (e.g., below 2 mg/glove for powder, below 50 microgram/gram for protein using ASTM D5712).
• For Clinical Performance (Hypoallergenic): The ground truth is established by the results of a Modified Draize Test on human subjects, which assesses dermal irritation and sensitization potential based on standardized observations.

8. The sample size for the training set

• Not applicable. This device is a physical medical device. There is no "training set" in the context of an AI algorithm learning from data. The manufacturing process is subject to quality control and testing against standards.

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

• Not applicable. As there is no training set, this question is not relevant.

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The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Class I natural rubber latex surgeon glove, 79 KGO, powdered with absorbable dusting powder, hypoallergenic, that meets all of the requirements of ASTM standard D3577-91.

Here's the analysis of the acceptance criteria and the supporting study for the Comfit Brown Beaded Surgeon's Gloves, 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

For the physical and watertight tests (ASTM D 3577-91 and FDA 1000 ml watertight test), the sample size is not explicitly stated in the provided text. However, the Watertight test mentions an "AQL of 1.0" which implies a sampling plan was used according to the ASTM standard.

For the "hypoallergenic" claim:

• Sample size: 200 human subjects.
• Data provenance: Not explicitly stated, but it refers to a "Clinical data of 200 Human Modified Draize test," suggesting a prospective clinical study involving human volunteers. The country of origin is not specified.

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

• For physical and watertight tests: No "experts" in the sense of medical professionals are mentioned for establishing ground truth for these objective performance metrics. The ground truth is established by the specifications defined in ASTM D 3577-91 and the FDA 1000 ml watertight test, which are industry standards. Testing would be performed by lab personnel following these standard procedures.
• For the hypoallergenic claim: The "Modified Draize test" is a recognized method for assessing skin irritation and sensitization. The results would be interpreted by qualified personnel (e.g., dermatologists or toxicologists) according to standard protocols for assessing reactions. However, the specific number and qualifications of experts are not provided in this document.

4. Adjudication Method for the Test Set

• For physical and watertight tests: Adjudication is not applicable in the conventional sense. Performance is measured against fixed, objective criteria defined by the ASTM standard and FDA test. It's a pass/fail determination based on quantitative results.
• For the hypoallergenic claim: The "Modified Draize test" involves observations of skin reactions. While the text doesn't explicitly state an adjudication method (e.g., blinded readings, consensus panels), standard practice for such tests would involve trained observers assessing the dermal responses based on a predefined scoring system.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not reported. This device is a medical glove, and the performance criteria are physical and biological (hypoallergenic), not related to image interpretation or diagnostic tasks where AI assistance for human readers would be relevant.

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

This question is not applicable to a medical device like a surgeon's glove. The device itself is the "product" being tested, not an algorithm. The performance data presented pertains to the physical and biological properties of the glove itself.

7. The Type of Ground Truth Used

• For physical and watertight tests: The ground truth is established by objective engineering and material science standards (ASTM D 3577-91) and a regulatory agency defined test (FDA 1000 ml watertight test).
• For the hypoallergenic claim: The ground truth for hypoallergenic potential is established through a clinical test on human subjects (Modified Draize test) designed to assess dermal irritation and sensitization.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the document describes the testing of a physical medical device (a glove), not a machine learning algorithm.

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

This question is not applicable due to the reasons stated above (no algorithm, no training set).

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The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Class I natural rubber latex surgeon glove, 79 KGO, powdered with absorbable dusting powder, hypoallergenic, that meets all of the requirements of ASTM standard D3577-91.

COMFIT ORTHOPAEDIC brown surgical gloves are 0.30 mm (minimum) thick single wall at finger and palm areas to reduce damage from contacting bone, screws, wires or instruments.

Here's a breakdown of the acceptance criteria and study 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:

• Non-Clinical Performance Data (Physical/Mechanical Tests): The document doesn't explicitly state the sample size for each specific test (e.g., how many gloves were tested for length or tensile strength). However, it refers to passing based on an AQL (Acceptable Quality Level) of 1.0 for the watertight test, which implies a sampling plan was followed. The data provenance is not explicitly stated as country of origin, but the manufacturer is based in Selangor, Malaysia. The data is retrospective, as it's a summary of performance.
• Clinical Performance Data (Hypoallergenic Claim): The test set for the "hypoallergenic" claim used 200 Human Subjects in a Modified Draize test. The provenance or specific location of these human subjects is not mentioned. This data is also retrospective.

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

• Non-Clinical Performance Data: Not applicable. The ground truth for these tests (e.g., length, tensile strength) is objectively measured against specified ASTM standards, not established by human experts.
• Clinical Performance Data (Hypoallergenic Claim): The document does not specify the number or qualifications of experts involved in establishing the ground truth for the Modified Draize test. The "Modified Draize test" itself is a standardized method for assessing skin irritation and sensitization, and its interpretation would typically be done by qualified personnel (e.g., dermatologists, toxicologists), but their role in this specific submission is not detailed.

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

• Non-Clinical Performance Data: Not applicable for objective measurements against a standard.
• Clinical Performance Data (Hypoallergenic Claim): The document does not describe any specific adjudication method for the Modified Draize test results beyond conducting the test itself.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical glove, not an imaging or diagnostic AI-assisted device, so such a study would not be applicable.

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

• Not applicable. This is a physical medical device (surgical glove), not an algorithm or AI system.

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

• Non-Clinical Performance Data: The ground truth is established by objective measurements against predefined scientific and engineering standards (ASTM D 3577-91).
• Clinical Performance Data (Hypoallergenic Claim): The ground truth for the "hypoallergenic" claim is established through the outcomes data of a Modified Draize test on human subjects, demonstrating no potential for dermal irritation or sensitization.

8. The sample size for the training set:

• Not applicable. This is a physical medical device. There is no concept of a "training set" in the context of validating its physical properties or hypoallergenic claim.

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

• Not applicable. As there is no training set for this type of device, no ground truth needed to be established for it.

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