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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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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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Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate 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, Gastric acid and Xylazine in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and 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 non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, blue colored nitrile gloves featuring an inner coating of hyaluronic acid and single use only. There are six different sizes- XS, S, M, L, XL and XXL. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs, opioid Fentanyl Citrate, simulated Gastric Acid and Xylazine per ASTM D6978-05.

The provided document is a 510(k) clearance letter from the FDA for Nitrile Powder-Free Exam Gloves. It details the device's characteristics, indications for use, and a comparison with predicate and reference devices, as well as a summary of non-clinical testing.

However, the nature of this medical device (examination gloves) means that the provided information does not include the typical "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device for diagnostic or prognostic purposes, which is what your questions #2 through #9 are geared towards.

For examination gloves, the "acceptance criteria" are based on physical properties, biocompatibility, and permeation resistance to certain chemicals, assessed through laboratory testing, not clinical studies involving patient data or expert interpretation.

Therefore, I will answer the questions that are applicable to the provided document and explicitly state when a question is not applicable.

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

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

Chemotherapy and Other Drug Permeation Minimum Breakthrough Detection Times:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (e.g., number of gloves tested for each physical or chemical property) for the non-clinical tests. It only states that testing was conducted. Data provenance (e.g., country of origin, retrospective/prospective) is not provided as these are laboratory tests of a manufactured product, not data collected from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for glove performance tests (physical properties, biocompatibility, chemical permeation) is established by adherence to standardized testing methodologies (e.g., ASTM, ISO standards) and measurable outcomes, not by expert consensus or interpretation in the way it is for diagnostic AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies or similar diagnostic contexts where expert consensus is required for labeling data. This does not apply to the laboratory testing of gloves.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This type of study is relevant for AI-powered diagnostic or screening tools that assist human interpreters. The device in question is examination gloves, which do not involve human readers interpreting cases or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical product (gloves), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on direct measurements and observations derived from standardized laboratory tests (e.g., tensile strength, elongation, hole detection, chemical permeation) defined by recognized industry standards (ASTM, ISO).

8. The sample size for the training set
Not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable. The device is not an AI/ML algorithm.

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Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black/White) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with Chemotherapy drugs and Fentanyl using ASTM D6978-05.

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black, White) is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are 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 tested for biocompatibility and permeability to chemotherapy drugs and Fentanyl Citrate.

The provided document pertains to the 510(k) premarket notification for Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black, White).

This submission is for a Class I medical device (gloves), which typically does not involve complex AI algorithms or diagnostic imaging. Therefore, many of the requested criteria related to AI/MRMC studies, expert consensus for ground truth, and training set information are not applicable to this type of device and submission.

The "acceptance criteria" here refer to the performance standards and safety requirements for medical gloves, particularly their resistance to permeation by chemotherapy drugs and fentanyl, and their physical and biological properties.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents acceptance criteria and reported performance in the "Summary of Non-Clinical Performance Data" and the "Chemotherapy Drugs Comparison Claim" tables.

Table 1: General Performance Acceptance Criteria and Reported Results (from page 10)

Table 2: Permeation by Chemotherapy Drugs and Fentanyl Citrate Acceptance Criteria and Reported Results (from page 9)

Note: The warning regarding Carmustine and Thiotepa for both black and white gloves is highlighted due to their low permeation times, similar to the predicate device, which also shows a low time for Carmustine and a higher time for Thiotepa. The critical aspect for these drugs is to provide clear warning on the labeling.

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

The document specifies that the tests were non-clinical, adhering to various ASTM and ISO standards. These standards prescribe the sample sizes and testing methodologies. For example:

• Freedom from Holes (ASTM D6319-19, ASTM D5151-19): References "inspection level G-I, AQL 2.5 (ISO2859-1)," which indicates specific sampling plans and acceptance quality limits for batch inspection, not individual sample sizes like in a typical clinical study.
• Permeation by Chemotherapy Drugs (ASTM D6978-05): This standard outlines the test method, including the number of specimens (typically 3 specimens per drug per material), continuous monitoring of breakthrough, and reporting of average breakthrough times.
• Biocompatibility (ISO 10993 series): These standards specify the number of animals or in-vitro tests required, but precise numbers are not explicitly stated in this summary.

Data Provenance: The data comes from non-clinical laboratory testing conducted by the manufacturer (Basic Medical Technology Inc.) to demonstrate compliance with recognized industry standards (ASTM, ISO). The document does not specify the country of origin of the raw test data but implies it was generated to support a US FDA submission. The tests are prospective in the sense that they were conducted for this specific submission to demonstrate the device's performance.

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

Not Applicable. This is a physical device (medical gloves) and not an AI/diagnostic software. "Ground truth" in this context is established by standardized, objective laboratory test methods (e.g., measuring dimensions, tensile strength, breakthrough time using analytical instruments), not by expert consensus on clinical images or data.

4. Adjudication method for the test set

Not Applicable. As per point 3, ground truth is established by objective laboratory measurements and adherence to standardized testing protocols, not by expert review or adjudication.

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

Not Applicable. This is a Class I physical medical device (gloves), not an AI algorithm or diagnostic tool involving human readers.

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" for this device is based on objective measurements performed according to recognized international and national standards (ASTM, ISO). This includes:

• Physical properties (e.g., dimensions, tensile strength, elongation).
• Chemical resistance (breakthrough time for chemotherapy drugs and fentanyl).
• Biological safety (irritation, sensitization, systemic toxicity).

8. The sample size for the training set

Not Applicable. This is a physical device. There is no AI model or "training set" in the context of this submission. The "training" for the device would be the manufacturing process and quality control, which are governed by Quality System (QS) regulations.

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

Not Applicable. As explained in point 8, there is no training set as per AI/ML terminology. The manufacturing process and material specifications are developed and validated based on established engineering principles and industry standards to ensure the gloves meet their intended performance characteristics.

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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 Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are 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 provided [K243441](https://510k.innolitics.com/search/K243441) document is a 510(k) premarket notification for Nitrile Powder-Free Exam Gloves. This type of device is a Class I medical device and does not involve AI or complex algorithms requiring human-in-the-loop studies or ground truth established by experts.

Therefore, most of the requested information regarding AI/algorithm performance, human reader studies, and expert-established ground truth is not applicable to this document. The "device" in this context is a physical examination glove, not an AI-powered diagnostic tool.

The acceptance criteria and performance are related to the physical properties and barrier efficacy of the gloves, not to analytical or diagnostic performance of an algorithm.

However, I can extract the relevant acceptance criteria and reported performance for the physical glove testing:

Acceptance Criteria and Reported Device Performance

As the device is a physical medical glove and not an AI/software device, the acceptance criteria and performance relate to its physical and chemical barrier properties.

Table of Acceptance Criteria and Reported Device Performance:

Detailed Permeation Performance (Minimum Breakthrough Detection Time in minutes):

(Light Blue Glove)

Warning: Do not use Light Blue glove with Carmustine (16.6 minutes) and ThioTEPA (44.9 minutes).

(Dark Blue Glove)

Warning: Do not use Dark Blue glove with Carmustine (21.5 minutes) and ThioTEPA (17.9 minutes).

Regarding the other requested information (which is not applicable to this physical device):

• 2. Sample size(s) used for the test set and the data provenance: Not explicitly stated as "sample size" in a statistical sense for AI. Testing involves physical samples of gloves manufactured for the purpose of meeting ASTM standards. Data provenance is implied to be from laboratory testing according to the listed ASTM and ISO standards.
• 3. Number of experts used to establish the ground truth...: Not applicable. Ground truth for physical properties and chemical permeation is established by standardized laboratory testing procedures (e.g., measuring dimensions, tensile strength, or breakthrough time), not by expert consensus on images or medical data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is not relevant for objective laboratory measurements.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable. This is a physical product, not an AI or imaging device that would involve human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device is based on objective measurements and established physical/chemical standards (e.g., ASTM, ISO), not expert medical interpretation or clinical outcomes data in the context of an AI device.
• 8. The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable. There is no training set.

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