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Powder-Free Vinyl Exam Gloves, clear is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The subject device is a powder free vinyl patient examination glove, provided as non-sterile and disposable device. It is provided with clear color. Available in four sizes small, medium, large, and extra - large users can choose the most suitable option.

The provided FDA 510(k) clearance letter and summary describe the regulatory approval process for "Powder-Free Vinyl Exam Gloves, clear." This is a Class I medical device, and the clearance is based on demonstrating substantial equivalence to a predicate device, K220469, "Disposable Vinyl Examination Glove."

The study described is not a clinical study involving human patients or complex AI algorithms necessitating multi-reader, multi-case (MRMC) studies or expert adjudication of medical images. Instead, it's a non-clinical performance study focused on the physical, chemical, and biological properties of the gloves.

Therefore, many of the requested points related to AI performance, human reader improvement, and complex ground truth establishment for medical diagnosis are not applicable to this type of device and study.

Here's the breakdown of the information that is applicable:

Acceptance Criteria and Device Performance for Powder-Free Vinyl Exam Gloves, Clear

The acceptance criteria and device performance are primarily based on non-clinical testing according to recognized industry standards (ASTM and ISO). The goal is to demonstrate that the subject device meets the same performance specifications as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a precise numerical sample size (e.g., number of gloves) for each non-clinical test. However, it indicates that testing was performed according to the specified ASTM and ISO standards, which inherently define the necessary sample sizes and methodologies for ensuring statistical validity within their respective contexts (e.g., AQL for the water leak test).
• Data Provenance: The document does not explicitly state the country of origin for the data. Given the "Basic Medical Technology Inc." is located in Ontario, CA (presumably California, USA) and the predicate device manufacturer is a Chinese company (CHIFENG HUAWEI MEDICAL SCIENCE TECHNOLOGY CO., LTD.), the testing could have been performed either in the US, China, or accredited labs elsewhere.
• Retrospective or Prospective: This testing is inherently prospective as it involves the manufacturing and testing of new device samples to demonstrate compliance with standards.

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

• Not Applicable: For this type of non-clinical device (medical gloves), "ground truth" is not established by medical experts interpreting images or clinical data. Instead, it's established by the physical and chemical properties of the material as measured by standardized laboratory methods. The "experts" would be the accredited laboratory personnel performing the tests according to the ASTM and ISO standards, not medical professionals like radiologists.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations of complex data (like medical images). This is a physical product testing scenario where results are quantitative measurements against objective criteria, so no adjudication by multiple human observers is required.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable: An MRMC study is relevant for evaluating the impact of AI algorithms on human reader performance in tasks like diagnostic imaging. This device is a pair of medical gloves; there is no AI component or human reader interpretation task involved.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not Applicable: This pertains to AI algorithm performance evaluation. There is no AI algorithm in "Powder-Free Vinyl Exam Gloves, clear." The "standalone" performance here refers to the device's physical and biological properties.

7. Type of Ground Truth Used

• The "ground truth" for this device is based on objective, standardized measurements of its physical properties (e.g., dimensions, tensile strength, elongation, hole detection) and biological compatibility (e.g., cytotoxicity, irritation, sensitization), as defined by internationally recognized ASTM and ISO standards. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

• Not Applicable: This is not an AI/machine learning device. Therefore, there is no "training set" in the context of an algorithm. The manufacturing process of the gloves would have its own quality control and process validation, which might involve data collection analogous to a training set for process refinement, but this is distinct from AI model training.

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

• Not Applicable: As there is no AI training set, this question is irrelevant.

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

Gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric acid and Xylazine in Fentanyl Citrate in accordance with ASTM D6978-05 Standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are pink color, non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, and single use only, and come in different sizes- XS, S, M, L, XL and XXL.

The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been been tested for biocompatibility and permeability to chemotherapy drugs, Fentanyl Citrate, Gastric Acid and Xylazine in Fentanyl Citrate.

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device submitted for FDA 510(k) clearance.

The device in question is Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate.

Acceptance Criteria and Device Performance Study

The acceptance criteria for this device are primarily based on established industry standards for medical examination gloves and specific permeation resistance tests for various chemical substances. The study conducted to prove the device meets these criteria is a series of non-clinical performance tests.

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 specific sample sizes (number of gloves) used for each individual test. However, it indicates that the tests were conducted according to established ASTM and ISO standards, which typically specify appropriate sample sizes for such tests to ensure statistical validity.

The data provenance is through non-clinical testing performed in accordance with recognized international and national standards (ASTM, ISO). This implies the data were prospectively generated for the purpose of this submission. The country of origin of the data is not specified, but the use of international standards suggests a globally accepted testing methodology.

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

This information is not applicable (N/A) as the device is a physical product (medical glove) and the performance is evaluated through objective, standardized laboratory tests (e.g., measuring permeation time, tensile strength, dimensions) rather than expert interpretation of images or clinical data. There is no "ground truth" established by human experts in the context of diagnostic accuracy for this type of device.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reason as above. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. The tests performed for this device are objective measurements.

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 (N/A). This document pertains to the clearance of a physical medical device (gloves), not an AI algorithm or a diagnostic imaging device that would involve human readers.

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

This information is not applicable (N/A). As mentioned, this is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective, quantitative measurements obtained through standardized laboratory testing methodologies (ASTM and ISO standards). For example:

• Permeation: Measured breakthrough time of specific chemicals through the glove material.
• Physical Properties: Measured tensile strength, elongation, length, width, and thickness.
• Biocompatibility: Observed biological responses (e.g., irritation, sensitization, systemic toxicity) in controlled in-vitro or in-vivo (animal) tests as per ISO standards.
  This is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on direct physical and chemical testing.

8. The Sample Size for the Training Set

This information is not applicable (N/A). This device is a manufactured product that undergoes performance and biocompatibility testing. There is no "training set" in the context of machine learning. The manufacturing process is designed and validated to consistently produce gloves meeting the specified criteria.

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

This information is not applicable (N/A) as there is no training set for this device. The "ground truth" for the device's design and manufacturing is derived from the established standards (ASTM, ISO) that define the performance characteristics expected of such gloves. Quality control during manufacturing ensures conformity to these standards.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, fentanyl citrate, xylazine, gastric acid, fentanyl in gastric acid and xylazine in gastric acid in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.

Warning: do not use with Carmustine and Thiotepa.

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:

• Carmustine (BCNU) 3.3 mg/ml 21.5 minutes
• Thiotepa 10.0 mg/ml 13.6 minutes

"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.

The provided document is an FDA 510(k) clearance letter for a medical device: "Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid."

This is a physical medical device (a glove), not a software device or an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML model validation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of FDA submission.

The document assesses the device's physical properties and its resistance to permeation by various hazardous substances. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to bench testing against established ASTM and CFR standards for medical gloves.

Here's the breakdown of the relevant information from the document, tailored to the nature of this device:

Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

The device (Disposable Powder Free Nitrile Examination Glove, Blue Color) was tested against several physical and chemical permeation standards. The acceptance criteria and results are outlined in the "Assessment of Non-Clinical Performance Data" section (Page 17-19) and the "Indications for Use" section (Page 4-5) and summarized within the "510(k) Summary" (Page 7-11).

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

• Sample Size: The document does not explicitly state numerical sample sizes for each specific test (e.g., how many gloves were tested for a burst, tensile, or permeation). However, it implies that testing was conducted according to the specified ASTM and FDA methodologies, which inherently define minimum sample sizes for material testing (e.g., AQL levels for freedom from holes).
• Data Provenance: The tests are "bench testing" conducted on physical glove samples. The manufacturer is "Ever Global (Vietnam) Enterprise Corporation" from Vietnam, so the testing was likely conducted in accordance with international standards at a facility associated with the manufacturer or a certified testing lab. The data is non-clinical performance data from laboratory experiments, not patient data.

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

• Not Applicable. As this is a physical device subject to material property and permeation testing, "ground truth" is established by adherence to physical measurement standards and chemical analysis protocols (e.g., ASTM D6319-19 for physical properties, ASTM D6978-05 for permeation). No human expert interpretation or consensus is required to establish the "truth" of a chemical breakthrough time or tensile strength value.

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

• Not Applicable. Adjudication methods are relevant in subjective human interpretation tasks (e.g., radiology image reading). For objective bench testing of physical properties, results are determined by instrumentation and adherence to standardized protocols, not human adjudication.

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

• Not Applicable. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in medical imaging. This 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 is a physical device, not an algorithm.

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

• The "ground truth" is established through objective, standardized laboratory measurement methods as defined by the referenced ASTM (American Society for Testing and Materials) and CFR (Code of Federal Regulations) standards.
  • For physical properties (Dimensions, Tensile Strength, Elongation, Powder Residual, Freedom from Holes), the ground truth is the measured physical values against the defined thresholds in ASTM D6319-19 and 21 CFR 800.20 & ASTM D5151-19.
  • For chemical permeation (Resistance to Hazardous Drugs), the ground truth is the measured breakthrough time determined by chemical analysis according to ASTM D6978-05.
  • For Biocompatibility, the ground truth is the biological response (cytotoxicity, dermal reactions) as measured per AAMI/ANSI/ISO 10993-5 and 10993-10 standards.

8. The sample size for the training set:

• Not Applicable. This is a physical product, not a machine learning model; therefore, there is no "training set." The product's design and manufacturing process are developed through engineering and material science, not data training.

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

• Not Applicable. As there is no training set for this physical device.

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Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

• Arsenic Trioxide (1 mg/ml)
• Bendamustine, (5 mg/ml)
• Blenoxane (15 mg/ml)
• Bleomycin (15 mg/ml)
• Bortezomib (1 mg/ml)
• Busulfan (6 mg/ml)
• Carboplatln (10 mg/ml)
• Carfilzomib (2 mg/ml)
• Cetuximab (2 mg/ml)
• Cisplatin (1 mg/ml)
• Cyclophosphamide (Cytoxan) (20 mg/ml)
• Cytarabine (100 mg/ml)
• Dacarbazine (DTIC) {10 mg/ml)
• Daunorubicin {5 mg/ml)
• Decitabine (5 mg/ml)
• Docetaxel (10 mg/ml)
• Doxorubicin HCL (2 mg/ml)
• Ellence (2 mg/ml)
• Erbitux (2 mg/ml)
• Eribilin Mesylate (0.5 mg/ml)
• Etoposide (Toposar) (20 mg/ml)
• Fludarabine (25 mg/ml)
• Fulvestrant (50 mg/ml)
• Gemcitabine (Gemzar) (38 mg/ml)
• Idarubicin (1 mg/ml)
• Ifosfamide (IFEX) (50 mg/ml)
• Irinotecan (20 mg/ml)
• Mechlorethamine HCL (1 mg/ml)
• Melphalan (5 mg/ml)
• Methotrexate (25 mg/ml)
• Mitomycin C (0.5 mg/ml)
• Mitoxantrone (2 mg/ml)
• Oxaliplatin (2 mg/ml)
• Paclitaxel (Taxol) (6 mg/ml)
• Paraplatin (10 mg/ml)
• Pemetrexed Disodium (25 mg/ml)
• Pertuzumab (30 mg/ml)
• Raltitrexed (0.5 mg/ml)
• Rituximab (Rituxan) (10 mg/ml)
• Temsirolimus (25 mg/ml)
• Thiotepa (10 mg/ml)
• Topotecan HCL (1 mg/ml)
• Trastuzumab (21 mg/ml)
• Trisenox (1 mg/ml)
• Velcade (1 mg/ml)
• Vinblastine (1 mg/ml)
• Vinorelbine (10 mg/ml)

Carmustine (3.3 mg/ml) permeation occurred at 60.0 minutes.

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

• Fentanyl Citrate Injection (100 mcg/2 ml)
• Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)

Caution: Testing showed a minimum breakthrough time of 60.0 minutes with Carmustine.

The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:

• Cytovene (10 mg/ml)
• Retrovir (10 mg/ml)
• Triclosan (2 mg/ml)
• Zoledronic Acid (0.8 mg/ml)

Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable, 12"purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, nonsterile patient examination gloves.

The provided text is an FDA 510(k) clearance letter and summary for a medical glove, not an AI-powered medical device. Therefore, many of the requested fields related to AI study design (like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "number of experts," etc.) are not applicable and cannot be found in the document.

However, I can extract the acceptance criteria and performance data for the glove based on the provided information, focusing on the non-clinical and clinical tests described.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Chemotherapy and Hazardous Drug Permeation (ASTM D6978-05): The document does not specify the exact sample size (number of gloves/runs per drug) for the permeation tests. The data provenance is not specified, but it would have been generated from laboratory testing of the manufactured gloves.
• Biocompatibility (ISO 10993 parts 10, 11, 23): "No animals" for systemic toxicity implies a small animal study; the exact number is not stated. For irritation, an animal study is also implied. For skin sensitization, the "Grade < 1.0" implies a quantitative assessment from an animal study. Data provenance is laboratory testing.
• Physical Properties (ASTM D6319, D5151, D6124): These standards typically involve statistical sampling plans for testing batches of gloves (e.g., AQL levels). The exact number of gloves tested is not explicitly stated in the summary but assumes testing according to the standards. Data provenance is laboratory testing.
• Modified DRAIZE-95 Test (Low Dermatitis Potential):
  • Sample Size: 204 human subjects.
  • Data Provenance: Prospective human clinical study. The country of origin is not specified, but these types of studies for FDA clearance are generally conducted under U.S. or international clinical study guidelines.

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

Not applicable. This device is a physical medical glove undergoing non-clinical and a small clinical study, not an AI/software device requiring expert interpretation for ground truth. The "ground truth" here is objective laboratory measurements (e.g., breakthrough time, physical dimensions, chemical residues) and clinical observations of skin reactions.

4. Adjudication method for the test set

Not applicable. For laboratory tests, results are typically determined by instrumental readings and standard protocols. For the human clinical study, it would involve direct observation and assessment by trained clinical personnel (e.g., dermatologists or nurses) of skin reactions, but an explicit adjudication method (like 2+1) usually associated with image interpretation is not 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 is not an AI device.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

• Chemotherapy and Hazardous Drug Permeation: Objective measurement of chemical permeation/breakthrough time using analytical techniques (e.g., gas chromatography).
• Biocompatibility: Objective biological responses in animal models (e.g., presence/absence of toxicity, irritation, sensitization).
• Physical Properties: Objective measurements (e.g., length, width, thickness, tensile strength, elongation, powder amount) and qualitative assessment for pinholes (e.g., water leak test).
• Modified DRAIZE-95 Test: Clinical observations by dermatological or trained personnel of skin irritation and allergic reactions in human subjects.

8. The sample size for the training set

Not applicable. The glove's performance is not determined by a "training set" in the context of machine learning. The manufacturing process is refined based on quality control and adherence to standards, but there isn't a "training set" like in AI.

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

Not applicable. As above, there is no "training set" for this type of medical device clearance.

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Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff, is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff, are disposable, single-use, sterile, blue-colored, and powder-free examination gloves made from nitrile latex.

The provided FDA 510(k) clearance letter pertains to medical examination gloves, not an AI-powered medical device. Therefore, the document does not contain information about the acceptance criteria and study proving an AI device meets those criteria.

The information typically found in such a submission would include:

• Device performance: This document explicitly states the "Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)" has been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
• Acceptance Criteria/Performance Data: The acceptance criteria for the gloves are based on relevant ASTM standards for physical properties, barrier integrity, and biocompatibility. The chemotherapy drug resistance is presented as "Minimum Breakthrough Detection Time in Minutes."
• Study Design (Non-Clinical): The studies are non-clinical, primarily laboratory-based physical and chemical tests compliant with recognized international and national standards (e.g., ASTM, ISO).
• Ground Truth: For these types of devices, the "ground truth" is typically defined by quantifiable physical and chemical properties measured against established standard methods (e.g., measuring milligrams of residual powder, breakthrough time of chemicals). There are no human experts, adjudication, or training/test sets in the context of AI for this type of device.

Given this, I cannot extract the information required for an AI-powered device from this document. The sections you asked for (sample size for test/training, expert qualifications, MRMC studies, standalone performance, etc.) are specific to AI/software as a medical device (SaMD) assessments and are not present in a submission for examination gloves.

However, I can summarize the acceptance criteria and reported performance for the examination gloves as provided in the document:

Acceptance Criteria and Reported Device Performance (for Examination Gloves)

This table summarizes the non-clinical acceptance criteria and the "result" or reported performance for the Sterile Nitrile Powder Free Examination Gloves.

Chemotherapy Drug and Fentanyl Citrate Permeation Results

Device Performance (Minimum Breakthrough Detection Time in Minutes)

Since the provided document is not for an AI device, the following points cannot be addressed:

• Sample sized used for the test set and the data provenance: Not applicable to a physical glove.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves is based on physical/chemical measurements by laboratory technicians following standard protocols.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For gloves, it's objective physical/chemical measurements according to ASTM/ISO standards.
• The sample size for the training set: Not applicable (no AI training involved).
• How the ground truth for the training set was established: Not applicable.

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The glove is disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)

The provided document is a 510(k) premarket notification approval letter for Nitrile Powder-Free Exam Gloves. It details the device's substantial equivalence to existing predicate devices and lists the results of permeation tests for various chemotherapy drugs, opioid fentanyl citrate, and simulated gastric acid.

However, the document does not describe a study involving an AI/software medical device requiring ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies. The "acceptance criteria" discussed in this document relate to the gloves' resistance to permeation by specific chemicals, measured in "Minimum Breakthrough Detection Time."

Therefore, based solely on the provided text, it is not possible to answer the questions related to AI/software device performance, expert ground truth, adjudication methods, or MRMC studies.

Here's an attempt to answer the questions based on the information available in the document, acknowledging that most questions are not applicable to this type of device:

Acceptance Criteria and Device Performance for Nitrile Powder-Free Exam Gloves

The study presented here is a series of permeation tests conducted to determine the resistance of Nitrile Powder-Free Exam Gloves to various hazardous substances, specifically chemotherapy drugs, opioid fentanyl citrate, and simulated gastric acid. The acceptance criteria are implicit in the detailed breakthrough detection times, aiming to demonstrate the gloves' barrier properties against these substances. The tests were performed in accordance with ASTM D6978-05 standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document directly states the "Minimum Breakthrough Detection Time" for each substance for both the Light Blue and Dark Blue gloves. The implicit acceptance criterion would be that the gloves demonstrate a sufficiently long breakthrough time (ideally >240 minutes) for safe handling, or to clearly identify substances for which the gloves are not suitable. The reported performance is the actual measured breakthrough time.

Light Blue Glove Performance:

Note: Warnings are explicitly provided for Carmustine and ThioTEPA due to extremely low permeation times.

Dark Blue Glove Performance:

Note: Warnings are explicitly provided for Carmustine and ThioTEPA due to extremely low permeation times.

2. Sample Size and Data Provenance for the Test Set:
The document does not explicitly state the sample size (number of gloves tested for each substance) used for these permeation tests. It only lists the test results. The data provenance is stated as being tested "in accordance with ASTM D6978-05 standards," which implies a standardized laboratory testing setting. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable to this type of device and study. The "ground truth" here is the physical measurement of chemical permeation, which is determined by laboratory instrumentation and protocols defined by the ASTM standard, not by human expert interpretation or consensus.

4. Adjudication Method for the Test Set:
This section is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human readers/experts evaluating data (e.g., medical images) to establish a consensus ground truth. In this study, the "ground truth" is a direct physical measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This section is not applicable. MRMC studies are performed for AI/software devices where human readers interpret medical data, often comparing human performance with and without AI assistance. This document describes chemical permeation tests of gloves, not a diagnostic or prognostic medical device involving human interpretation.

6. Standalone (Algorithm Only) Performance:
This section is not applicable. This refers to the performance of an AI algorithm without human intervention. The device in question is a physical glove, not an algorithm.

7. Type of Ground Truth Used:
The "ground truth" for this study is a physical measurement of chemical permeation through the glove material, determined by laboratory testing protocols as defined by the ASTM D6978-05 standards. It is not derived from expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:
This section is not applicable. This study does not involve a training set as it's not an AI/machine learning model development context.

9. How the Ground Truth for the Training Set was Established:
This section is not applicable for the reasons stated above.

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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on examiner's hand to prevent contamination between patient and examiner. In addition, the glove was evaluated using ASTM D6978 for permeation of chemotherapy drugs and fentanyl citrate. The glove is single use and non-sterile.

The following chemotherapy drugs have been tested on the glove:

*Please note that the following drugs have low permeation time.

1. Carmustine
2. ThioTepa

Warning: Do not use with Carmustine & ThioTepa

The proposed Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl is a disposable device intended for over-the-counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Polychloroprene. The gloves are not made with natural rubber latex. General specifications of the glove are as below:

1. Overall Length: 240 mm minimum
2. Width: 95 ± 5 mm minimum (for medium glove)
3. Palm Thickness: 0.05 mm minimum
4. Finger Thickness: 0.05 mm minimum
5. Cuff Thickness: 0.05 mm minimum
6. Tensile Strength
   • a. Before Aging: 14 MPa minimum
   • b. After Aging: 14 MPa minimum
7. Ultimate Elongation
   • a. Before Aging: 500 % minimum
   • b. After Aging: 400 % minimum
8. Pinhole AQL: 2.5

The provided FDA 510(k) clearance letter and associated documentation pertain to a Powder-Free Polychloroprene Examination Glove. This is a physical medical device, not an AI/software device. Therefore, the questions related to AI/software performance criteria (such as multi-reader multi-case studies, human-in-the-loop performance, training/test set ground truth, and expert adjudication) are not applicable to this documentation.

The acceptance criteria and performance data provided in the document relate to the physical and chemical properties of the gloves, and their resistance to permeation by chemotherapy drugs and fentanyl.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text, focusing on the relevant physical device aspects:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance

*Note: The document explicitly warns that Carmustine and ThioTepa have low permeation times and should not be used with the glove. This is a crucial labeling instruction based on the test results.

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

• The document does not explicitly state the specific sample sizes used for each physical, chemical, and permeation test. However, tests are typically performed on a statistically relevant number of samples to ensure representativeness and robust results according to the specified ASTM and ISO standards.
• Data Provenance: The tests appear to have been conducted by Encompass Industries Sdn. Bhd. or a contracted lab on their behalf. The company is located in Kertih Bio-Polymer Park, Kemaman, Terengganu, Malaysia. The data is prospective in the sense that the tests were specifically performed on the proposed device 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

• This question is not applicable as the document describes a physical medical device (examination glove) and its material/permeation performance, not a software/AI device that requires expert human interpretation of data for ground truth establishment. The "ground truth" for these tests is based on objective, standardized laboratory measurements (e.g., precise measurements of length, thickness, tensile strength; chemical analysis for powder residue; standardized biological assays for biocompatibility; and analytical chemistry for drug permeation breakthrough times).

4. Adjudication Method for the Test Set

• This question is not applicable for the same reason as point 3. Testing of physical device characteristics and chemical permeation is typically performed according to established laboratory protocols with quantitative, measurable endpoints, not through a process of expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This question is not applicable as the document describes a physical medical device (examination glove), not an AI-assisted diagnostic or therapeutic tool.

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

• This question is not applicable as the document describes a physical medical device (examination glove), not an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the performance of the examination gloves is based on objective, standardized laboratory measurements and adherence to established international and national standards (e.g., ASTM D6977-19, ASTM D6319-19, ASTM D5151-19, ASTM D412-16, ASTM D573, ASTM D6124-06, ASTM D6978-05, ISO 10993-10, ISO 10993-11, 21 CFR 800.20).
  • Examples include:
    • Physical measurements: Direct measurement of glove dimensions (length, width, thickness).
    • Mechanical properties: Tensile strength and elongation determined by standard material testing methods.
    • Integrity: Freedom from holes determined by water leak testing (ASTM D5151-19).
    • Chemical analysis: Measurement of residual powder.
    • Biocompatibility: In-vivo (skin irritation, sensitization, acute systemic toxicity) tests using animal models, following ISO standards.
    • Permeation: Breakthrough detection time of specific chemotherapy drugs and fentanyl using analytical methods (ASTM D6978-05).

8. The Sample Size for the Training Set

• This question is not applicable as the document describes a physical medical device, which does not involve a "training set" in the context of machine learning or AI.

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

• This question is not applicable for the same reason as point 8.

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The Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) is a disposable device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Not Found

This document is a 510(k) clearance letter from the FDA for Powder Free Polyurethane Examination Gloves. It is not a document describing an AI/ML-driven medical device or software. Therefore, the information requested in your prompt (acceptance criteria, study details for AI/ML performance, ground truth establishment, etc.) cannot be extracted from this letter.

This letter confirms that the gloves are "substantially equivalent" to legally marketed predicate devices, meaning they meet the safety and effectiveness standards for their intended use as barrier protection. The "study" here refers to the documentation and evidence the manufacturer provided to demonstrate this substantial equivalence based on established performance characteristics for medical gloves (e.g., barrier integrity, tensile strength, biocompatibility), not an AI/ML efficacy study.

To answer your prompt, I would need a document related to the clearance of an AI/ML medical device, which typically includes detailed performance studies and acceptance criteria related to its algorithmic accuracy and clinical utility.

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The Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

• Azacitidine (25 mg/ml)
• Bendamustine HCl (5 mg/ml)
• Bleomycin Sulfate (15 mg/ml)
• Bortezomib (1 mg/ml)
• Busulfan (6 mg/ml)
• Capecitabine (26 mg/ml)
• Carboplatin (10 mg/ml)
• Carfilzomib (2 mg/ml)
• Cetuximab (2 mg/ml)
• Cisplatin (1 mg/ml)
• Cladribine (1 mg/ml)
• Cyclophosphamide (20 mg/ml)
• Cytarabine HCl (100 mg/ml)
• Dacarbazine (10 mg/ml)
• Dactinomycin (0.5 mg/ml)
• Daunorubicin HCl (5 mg/ml)
• Decitabine (5 mg/ml)
• Docetaxel (10 mg/ml)
• Doxorubicin HCl (2 mg/ml)
• Epirubicin HCl (2 mg/ml)
• Etoposide (20 mg/ml)
• Fludarabine Phosphate (25 mg/ml)
• Fluorouracil (50 mg/ml)
• Fulvestrant (50 mg/ml)
• Gemcitabine HCl (38 mg/ml)
• Idarubicin HCl (1 mg/ml)
• Ifosfamide (50 mg/ml)
• Irinotecan HCl (20 mg/ml)
• Leuprolide Acetate (5 mg/ml)
• Mechlorethamine HCl (1 mg/ml)
• Melphalan HCl (5 mg/ml)
• Methotrexate (25 mg/ml)
• Mitomycin C (0.5 mg/ml)
• Mitoxantrone HCl (2 mg/ml)
• Oxaliplatin (5 mg/ml)
• Paclitaxel (6 mg/ml)
• Pemetrexed (25 mg/ml)
• Raltitrexed (0.5 mg/ml)
• Rituximab (10 mg/ml)
• Temsirolimus (25 mg/ml)
• Topotecan HCl (1 mg/ml)
• Trisenox (Arsenic Trioxide) (1 mg/ml)
• Vinblastine Sulfate (1 mg/ml)
• Vincristine (1 mg/ml)
• Vinorelbine Tartrate (10 mg/ml)

The following chemotherapy drugs and concentration showed breakthrough detected in less than 100 minutes:

• Carmustine (3.3 mg/ml) No breakthrough up to 44.5 minutes.
• Thiotepa (10 mg/ml) No breakthrough up to 99.1 minutes.
• Warning- Not for use with Carmustine and ThioTEPA

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

• Fentanyl Citrate Injection (100 mcg/2 ml)
• Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:

• Chloroquine (50 mg/ml)
• Cyclosporin A (100 mg/ml)
• Cytovene (10 mg/ml)
• Retrovir (10 mg/ml)
• Triclosan (2 mg/ml)
• Zoledronic Acid (0.8 mg/ml)

The Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable, 9.5" purple‐colored, chlorinated, nitrile, powder‐free, textured fingertip, ambidextrous, sterile patient examination gloves.

The provided text is a 510(k) clearance letter and summary for medical examination gloves, not an AI/ML device. Therefore, it does not contain information related to AI/ML specific acceptance criteria or study details such as:

• Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document focuses on the physical and chemical properties of the gloves and their resistance to various chemicals, using established ASTM and ISO standards for medical gloves.

However, I can extract the acceptance criteria and reported device performance for these medical gloves based on the provided document.

Analysis of Acceptance Criteria and Device Performance for Medical Gloves

The document details the non-clinical testing performed on the Halyard Purple Nitrile* Powder-Free Exam Gloves to demonstrate their safety and effectiveness. The acceptance criteria and the results of these tests are clearly outlined.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates that testing was performed according to specific ASTM and ISO standards (e.g., ASTM D6978-05, ASTM D5151, ASTM D6124, ASTM D6319, ISO 10993 Parts 10, 11, 23, ANSI/AAMI/ISO 11137). These standards inherently define the sample sizes and methodologies for testing. For instance, AQL (Acceptable Quality Level) values like 2.5% and 4.0% are mentioned for pinholes and physical properties, which dictates sampling plans for quality control.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" in the context of an AI/ML study. It is implied to be laboratory testing data generated prospectively for the purpose of this 510(k) submission, confirming product specifications.

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

This is not applicable to the evaluation of medical gloves. The "ground truth" for glove performance is established by adherence to recognized international standards (ASTM, ISO, ANSI/AAMI) for physical, chemical permeation, and biocompatibility testing, rather than expert human interpretation of medical images or data. The testing is objective and quantitative.

4. Adjudication method for the test set

Not applicable. Testing involves standardized objective measurements, not subjective human evaluations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

Not applicable. MRMC studies are relevant for imaging diagnostics or other AI/ML applications where human interpretation is a key component. This document describes the testing of a physical medical device.

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

Not applicable. This is not an algorithm, but a physical product.

7. The type of ground truth used

The "ground truth" used is defined by the objective measurement criteria and methodologies specified in the cited international standards (ASTM D6978-05, ASTM D5151, ASTM D6319, ASTM D6124, ISO 10993, ANSI/AAMI/ISO 11137). For example, for chemical permeation, the ground truth is the chemical breakthrough time measured according to ASTM D6978-05. For biocompatibility, it's the observed biological reactions in animal models or in vitro tests compared to established toxicity/irritation/sensitization thresholds.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable. As above, this document describes a physical medical device, not an AI/ML system.

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

These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as per ASTM D6978-05 (2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

The following drugs and concentration had NO breakthrough detected up to 240 minutes:

• Bendamustine HCl (5 mg/mL)
• Bleomycin Sulfate (15 mg/mL)
• Busulfan (6 mg/mL)
• Carboplatin (10 mg/mL)
• Carfilzomib (2 mg/mL)
• Cetuximab (Erbitux) (2 mg/mL)
• Chloroquine (50 mg/mL)
• Cisplatin (1 mg/mL)
• Cladribine (1 mg/mL)
• Cyclophosphamide (20 mg/mL)
• Cyclosporin A (100 mg/mL)
• Cytarabine HCl (100 mg/mL)
• Cytovene (10 mg/mL)
• Dacarbazine (10 mg/mL)
• Daunorubicin HCl (5 mg/mL)
• Decitabine (5 mg/mL)
• Docetaxel (10 mg/mL)
• Doxorubicin HCl (2 mg/mL)
• Epirubicin HCl (2 mg/mL)
• Etoposide (20 mg/mL)
• Fludarabine Phosphate (25 mg/mL)
• Fluorouracil (50 mg/mL)
• Fulvestrant (50 mg/mL)
• Gemcitabine HCl (38 mg/mL)
• Idarubicin HCl (1 mg/mL)
• Ifosfamide (50 mg/mL)
• Irinotecan HCl (20 mg/mL)
• Mechlorethamine HCl (1 mg/mL)
• Melphalan HCl (5 mg/mL)
• MESNA (100 mg/mL)
• Methotrexate (25 mg/mL)
• Mitomycin C (0.5 mg/mL)
• Mitoxantrone HCl (2 mg/mL)
• Oxaliplatin (2 mg/mL)
• Paclitaxel (6 mg/mL)
• Pemetrexed (25 mg/mL)
• Propofol (10 mg/mL)
• Raltitrexed (0.5 mg/mL)
• Retrovir (10 mg/mL)
• Rituximab (10 mg/mL)
• Temsirolimus (25 mg/mL)
• Topotecan HCl (1 mg/mL)
• Triclosan (1 mg/mL)
• Trisenox (Arsenic Trioxide) (1 mg/mL)
• Velcade (Bortezomib) (1 mg/mL)
• Vidaza (Azacitidine) (25 mg/mL)
• Vinblastine Sulfate (1 mg/mL)
• Vincristine Sulfate (1 mg/mL)
• Vinorelbine Tartrate (10 mg/mL)
• Zoledronic Acid (0.8 mg/mL)

The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes:

• Carmustine (3.3 mg/mL), breakthrough detected at 55.5 minutes
• Thiotepa (10 mg/mL), breakthrough detected at 50.8 minutes

Warning: Not recommended for use with Carmustine and Thiotepa

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

• Fentanyl Citrate Injection (100mcg/2mL)
• Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

The subject device, Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid is a single use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This product demonstrated reduced potential for sensitizing users to chemical additives, supported by a negative skin sensitization test (Modified Draize-95 Test) and tested for use with chemotherapy drugs, fentanyl citrate and gastric acid.

The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state.

The provided FDA 510(k) clearance letter and summary concern a medical device, "Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid." This document details the product's attributes, testing, and comparison to a predicate device for regulatory clearance.

However, the questions you've asked (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, and training set details) are highly specific to the performance of an AI/ML medical device rather than a physical product like examination gloves. The provided document describes the physical and chemical performance of the gloves (e.g., resistance to permeation by chemotherapy drugs, physical properties, biocompatibility, and skin sensitization), not the performance of an artificial intelligence or machine learning algorithm.

Therefore, many of your questions are not applicable to the information contained within this 510(k) clearance for medical gloves. I will answer the applicable questions based on the provided text, and explicitly state when a question is not relevant to this type of device.

Acceptance Criteria and Device Performance for Nitrile Examination Gloves

The "acceptance criteria" for these gloves are primarily physical, chemical, and biological performance standards, as demonstrated through various ASTM and ISO tests. The "reported device performance" indicates whether the gloves met these pre-defined standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Chemotherapy Drugs Permeation Test (ASTM D6978-05): The document does not explicitly state the sample size (number of gloves tested) for the permeation tests, but ASTM standards typically specify these per test. The data provenance is implied to be from laboratory testing as per the ASTM standard. The document does not specify country of origin for the data (beyond the applicant being from Malaysia). This would be a prospective experimental study in a lab setting, not a retrospective or prospective clinical data collection.
• Clinical Sensitization Test (Modified Draize-95 Test):
  • Sample Size: 209 non-sensitized human subjects (inner surface) and 200 non-sensitized human subjects (outer surface).
  • Data Provenance: This was a prospective clinical test on human subjects. The document does not explicitly state the country of origin for these subjects.

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

This question is not applicable to this type of device. "Ground truth" established by human experts (e.g., radiologists, pathologists) is relevant for AI/ML device studies where an algorithm is interpreting complex, subjective data (like medical images). For medical gloves, the "ground truth" is established by adherence to physical, chemical, and biological performance standards measured using established laboratory protocols (e.g., ASTM, ISO). There are no "experts" creating a subjective ground truth for a test set in the way there would be for an AI diagnostic device. The results are objective measurements.

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

Not applicable. Adjudication methods are used in AI/ML studies to resolve discrepancies among expert readers establishing ground truth. For the physical and chemical tests of medical gloves, the results are objective measurements, not 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

Not applicable. An MRMC study is relevant for AI/ML devices where the AI is intended to assist human readers (e.g., radiologists interpreting images). This device is a physical product (gloves) and does not involve human readers or AI assistance.

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

Not applicable. "Standalone performance" refers to the algorithm's performance without human intervention. This device is a physical product.

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

The "ground truth" for this device's performance is tied to objective measurements against established industry standards and validated laboratory test methods. This includes:

• Physical properties (e.g., tensile strength, elongation, dimensions) measured according to ASTM D6319-19.
• Barrier integrity (freedom from holes) measured according to ASTM D5151-19.
• Chemical permeation resistance measured according to ASTM D6978-05.
• Biocompatibility assessments (skin sensitization, systemic toxicity, irritation) performed according to ISO 10993 series.
• Clinical skin sensitization test (Modified Draize-95 Test) observing actual human subject responses.

Therefore, the "ground truth" is based on controlled experimental and clinical testing data demonstrating adherence to pre-defined performance specifications derived from recognized standards.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device. "Training set" refers to data used to train an AI algorithm. The manufacturing process for gloves is not "trained" using a data set in this manner.

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

Not applicable, as this is not an AI/ML device.

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