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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 inches to 17 inches (22 cm - 42 cm). The device detects the appearance of irreqular heartbeats during measurement and gives a warning signal with readings. This blood pressure monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension quideline of 135/85 mmHq. The Omron 780N3 model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Automatic Blood Pressure Monitor Model: HEM 780N3

This document is a 510(k) clearance letter for the OMRON Automatic Blood Pressure Monitor Model: HEM-780N3. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain the acceptance criteria, study details, or performance data that would typically be found in a clinical study report or a more detailed submission document.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or stated based on the provided text, and what information is missing:

1. Table of acceptance criteria and reported device performance:

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

• Sample size: Not provided.
• Data provenance: Not provided (e.g., country of origin, retrospective/prospective). This document only covers the FDA's decision on substantial equivalence, not the details of the studies conducted by the manufacturer.

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

• Number of experts: Not provided.
• Qualifications of experts: Not provided.

4. Adjudication method for the test set:

• Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" interpreting output. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant for this type of device.

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

• Yes, implicitly. As an automatic blood pressure monitor, its core function is to produce a blood pressure reading without human interpretation of raw data. The performance study (which is not detailed here) would have assessed the device's accuracy in a standalone capacity.

7. The type of ground truth used:

• Not explicitly stated, but highly likely to be a reference standard blood pressure measurement. For blood pressure monitors, the ground truth is typically established by simultaneous measurement using a highly accurate, often invasive or a standardized auscultatory method (e.g., Korotkoff sounds by trained observers with a mercury sphygmomanometer), following protocols like ISO 81060-2 or AAMI standards.

8. The sample size for the training set:

• Not applicable/Not provided. As an automatic blood pressure monitor, the term "training set" is usually associated with machine learning devices. While there is likely calibration data used during development, it is not referred to as a "training set" in the context of traditional medical device validation. If the device uses any form of adaptive algorithm, details of its development data would be in a separate study report.

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

• Not applicable/Not provided. (See point 8).

Summary of what the document does provide:

• Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR MODEL: HEM-780N3
• Intended Use: Measuring blood pressure and pulse rate in adult patients with arm circumference 9-17 inches (22-42 cm).
• Additional features: Detects irregular heartbeats and provides a warning signal. Compares average readings to AHA hypertension guidelines (135/85 mmHg).
• Limitation: Not intended to be a diagnostic device.
• Regulatory Class: Class II (two)
• Product Code: DXN
• Predicate Device: Substantially equivalent to devices marketed prior to May 28, 1976.

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The 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.

Class I nitrile latex patient examination's glove, 80 LZA, powder free. It meets ASTM Standard D 3578-99 for all properties with the exception of ultimate elongation before the aging test.

The provided document is a 510(k) summary for the WRP COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE. It details the product's specifications and its compliance with relevant standards. Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the device "meets ASTM Standard D 3578-99 for all properties with the exception of ultimate elongation before the aging test." However, the conclusion later states that the nitrile gloves "meet the requirement of FDA's 1000 ml Watertight Test and ASTM D 3578-99 Standard Specification for tensile strength." It also mentions that "Our in-house specifications for tensile strength is minimum 15.5 MPa and test results exceed the in-house specifications and ASTM D 3578-99 requirement fro tensile strength."

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

• Sample Size: The document does not explicitly state the sample size for each specific test (e.g., how many gloves were tested for length, thickness, or watertightness). It refers generally to "Performance data of gloves to ASTM D 3578-99 standard and FDA 1000 ml watertight test." and "refer to Attachment 8 of Device Test Report of Compliance" for detailed results.
• Data Provenance: The tests were conducted internally by WRP Asia Pacific Sdn Bhd (Malaysia). The tests were performed to comply with ASTIM D 3578-99 and FDA 1000 ml watertight test. The data is retrospective in the sense that it was collected and analyzed as part of the 510(k) submission process, but the tests themselves would have been prospective evaluations of manufactured gloves.

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

• This information is not applicable. The "ground truth" for glove performance characteristics is established by objective measurements against predefined international standards (ASTM D 3578-99) and regulatory tests (FDA 1000 ml watertight test), not by expert consensus or interpretation.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where there might be disagreement among reviewers (e.g., in image interpretation studies). For objective physical and performance tests of medical gloves, measurements are taken, and the results are compared directly to the specified criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with vs. without AI Assistance

• This information is not applicable. The device described is a medical glove, not an AI-powered diagnostic tool or system 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 information is not applicable. The device is a physical medical glove, not an algorithm.

7. The Type of Ground Truth Used

• The ground truth is based on established international standards and regulatory performance requirements. Specifically:
  • ASTM D 3578-99 Standard Specification for Rubber Examination Gloves: This standard defines the acceptable physical dimensions, and mechanical properties (tensile strength, ultimate elongation) before and after aging for examination gloves.
  • FDA 1000 ml Watertight Test: This is a specific regulatory test to assess the barrier integrity of examination gloves.

8. The Sample Size for the Training Set

• This information is not applicable. The device is a manufactured product (medical glove) undergoing performance testing, not a machine learning model that requires a training set. The manufacturing process itself (Good Manufacturing Practices) ensures consistent quality.

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

• This information 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 and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

The 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.

COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE

Class I nitrile latex patient examination's glove, 80 LZA, powder free. It meets ASTM Standard D 3578-99 for all properties with the exception of ultimate elongation before the aging test.

The provided text describes the acceptance criteria and performance of the COMFIT Powder Free Nitrile Examination Glove, Sterile, against ASTM D 3578-99 standard and FDA 1000 ml watertight test.

Here’s a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

1. Single Sampling Plan, G-I, AQL 2.5
2. Multiple Sampling Plan, G-II, AQL 4.0 |
   | 2. Length (mm) | | |
   | XS | min 220 | - |
   | S | min 220 | 248 |
   | M | min 230 | 250 |
   | L | min 230 | 260 |
   | XL | - | - |
   | 3. Palm Width (mm) | | |
   | XS | $70 \pm 10$ | - |
   | S | $80 \pm 10$ | 84 |
   | M | $95 \pm 10$ | 95 |
   | L | $111 \pm 10$ | 104 |
   | XL | - | - |
   | 4. Single Wall Thickness (mm) | | |
   | Finger | min 0.08 | 0.21 |
   | Palm | min 0.08 | 0.14 |
   | 5. Physical Properties | | |
   | Before Aging : | | |
   | Tensile Strength (MPa) | min 14.0 | 23.88 |
   | Ultimate Elongation (%) | min 700 | 669 |
   | After Aging : | | |
   | Tensile Strength (MPa) | min 14.0 | 20.48 |
   | Ultimate Elongation (%) | min 500 | 668 |
   | 6. Residual Powder | Less than 4mg/glove | Less than 2mg/glove |

Note: The device did not meet the ultimate elongation before aging criteria (669% vs min 700%). The document later states, "The performance test data of device as shown above indicate that these nitrile gloves meet requirements of ASTM D 3578-99 Standard Specification for Rubber Examination Gloves with the exception of ultimate elongation before the aging test." However, the conclusion states, "Based on the test results, these nitrile gloves meet the requirement of FDA's 1000 ml Watertight Test and ASTM D 3578-99 Standard Specification for tensile strength. Our in-house specifications for tensile strength is minimum 15.5 MPa and test results exceed the in-house specifications and ASTM D 3578-99 requirement for tensile strength." This implies the tensile strength was the critical parameter for equivalence despite the elongation discrepancy.

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: The document does not explicitly state the specific number of gloves tested for each individual parameter (Length, Palm Width, Thickness, Tensile Strength, Elongation, Residual Powder). For the watertight test, it mentions "Single Sampling Plan, G-I, AQL 2.5" and "Multiple Sampling Plan, G-II, AQL 4.0," which are statistical sampling plans, but the exact sample size chosen based on these plans is not specified.
• Data Provenance: The tests were conducted by WRP Asia Pacific Sdn Bhd, located in Sepang, Selangor Darul Ehsan, Malaysia. The data is retrospective in the sense that the tests were performed on finished products to demonstrate compliance with existing standards.

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

• This type of device (examination gloves) does not typically involve "experts" in the sense of medical professionals establishing a ground truth for a test set. The ground truth is objective, measurable physical properties defined by the ASTM D 3578-99 standard and the FDA 1000 ml watertight test. The "experts" would be the personnel performing the standardized laboratory tests according to established protocols, likely with relevant certifications or training in materials science or quality control. The document does not specify the number or qualifications of these individuals.

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

• Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, typically in medical imaging or clinical trials where expert consensus is needed to resolve discrepancies. For objective physical testing of gloves against a standard, such adjudication is not applicable. The results are typically quantitative measurements and pass/fail criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. This type of study relates to diagnostic accuracy and reader performance in interpreting medical data, often with AI assistance. It is not relevant to the physical performance testing of medical gloves.

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

• No, a standalone algorithm performance study was not done. This concept applies to AI/software as a medical device, which is not applicable to a physical medical device like an examination glove. The performance described is of the glove itself.

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

• The ground truth used is primarily standardized test criteria and specifications defined by:
  • ASTM D 3578-99 Standard Specification for Rubber Examination Gloves
  • FDA 1000 ml watertight test
• These standards specify the acceptable ranges for physical properties (length, width, thickness, tensile strength, elongation, residual powder) and performance criteria (watertightness).

8. The sample size for the training set:

• This concept is relevant for machine learning models. For a physical medical device like an examination glove, there is no "training set" in the computational sense. The manufacturing process is designed for consistency, and quality control samples are taken from production lots.

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

• As there is no "training set" in this context, the question is not applicable. The "ground truth" for the device's design and manufacturing is adherence to the established ASTM and FDA standards.

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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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