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Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim of 50 Micrograms per dm2 or Less Protein are single use. Non sterile, natural rubber latex powder-free examination gloves. They are available in one color (blue) and come in five sizes: Small, Medium, Large, Extra Large, and Extra Extra Large. The subject gloves meet all the requirements of ASTM D3578-19 Standard Specification for Rubber Examination Gloves.

This document is a 510(k) clearance letter for medical examination gloves. It is not a document describing a study for a medical device that uses AI or requires expert ground truth. Therefore, I cannot provide the requested information.

The prompt specifically asks for details related to:

• A table of acceptance criteria and device performance for an AI/ML device.
• Sample sizes for test and training sets (relevant to AI/ML).
• Number and qualifications of experts for ground truth (relevant to AI/ML).
• Adjudication methods (relevant to AI/ML).
• MRMC studies (relevant to AI/ML).
• Standalone algorithm performance (relevant to AI/ML).
• Type of ground truth used (relevant to AI/ML).
• How ground truth was established for training (relevant to AI/ML).

The provided text discusses the non-clinical performance testing of rubber examination gloves. The "acceptance criteria" and "results" tables in the document pertain to physical and chemical properties of gloves (e.g., length, width, thickness, tensile strength, protein content, biocompatibility) tested against established ASTM and ISO standards for medical gloves.

There is no mention of an algorithm, AI, machine learning, human-in-the-loop performance, or expert review for diagnostic purposes. The "ground truth" in this context refers to the measured physical and chemical properties of the gloves conforming to established industry standards, not expert interpretations of medical images or data.

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

The tested chemotherapy drugs and permeation times are as follows:

Bleomycin Sulfate 15 mg/mL, >240 minutes
Busulfan 6 mg/mL, >240 minutes
Carboplatin (Paraplatin) 10 mg/mL, >240 minutes
Carmustine (BCNU) 3.3 mg/mL, 1.9 minutes
Cisplatin 1.0 mg/mL, >240 minutes
Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes
Cytarabine HC1 100 mg/mL, >240 minutes
Dacarbazine (DTIC) 10 mg/mL, >240 minutes
Daunorubicin HC1 5 mg/mL, >240 minutes
Docetaxel 20 mg/mL, >240 minutes
Doxorubicin Hydrochloride 2 mg/mL, >240 minutes
Epirubicin HC1 (Ellence) 2 mg/mL, >240 minutes
Etoposide (Toposar) 20 mg/mL, >240 minutes
Fludarabine 25 mg/mL, >240 minutes
Fluorouracil 50 mg/mL, >240 minutes
Gemcitabine 38 mg/mL, >240 minutes
Idarubicin HCl 1 mg/mL, >240 minutes
lfosfamide 50 mg/mL, >240 minutes
Irinotecan 20 mg/mL, >240 minutes
Mechlorethamine HC1 1 mg/mL, >240 minutes
Melphalan 5 mg/mL, >240 minutes
Methotrexate 25 mg/mL, >240 minutes
Mitomycin C 0.5 mg/mL, >240 minutes
Mitoxantrone 2 mg/mL, >240 minutes
Paclitaxel (Taxol) 6 mg/mL, >240 minutes
Rituximab 10 mg/mL, >240 minutes
Thiotepa 10 mg/mL, 3.7 minutes
Trisenox 1 mg/mL . >240 minutes
Vincristine Sulfate 1 mg/mL, >240 minutes

Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes

WARNING: Not for use with Carmustine or Thiotepa.

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

I cannot fulfill this request. The provided text is an FDA 510(k) clearance letter for examination gloves. It does not contain any information about acceptance criteria or a study proving a device meets acceptance criteria related to a medical imaging AI device or similar complex medical technology.

The text exclusively details the clearance of Latex Examination Gloves Powder Free (Ocean Blue and Natural White), citing regulation numbers, product codes, and the review process for market clearance. It mentions general controls, quality system regulations, UDI rules, and reporting of adverse events, all pertaining to the manufacturing and marketing of physical medical devices (gloves in this case), not performance studies of an AI algorithm or diagnostic device.

Therefore, I cannot extract the information required to answer your specific questions about acceptance criteria, study design, ground truth, or expert involvement, as this information is not present in the provided document.

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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.

Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)

I am sorry, but this document is an FDA clearance letter for a medical device (Powder Free Latex Patient Examination Glove), not a study report for a device that utilizes Artificial Intelligence or Machine Learning. Therefore, it does not contain the information required to answer your request regarding acceptance criteria and performance studies for an AI/ML device.

The document discusses regulatory information, indications for use for a glove, and administrative details, but there is no mention of an algorithm, AI, or any associated performance metrics typically found in studies for such devices.

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The Sterile Latex Examination Gloves Powder Free is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.

The Sterile Latex Examination Gloves Powder Free are natural color, single use only, disposable examination gloves intended for medical purposes to be worn by examination between the patient and the examiner. The device is ambidextrous and can be worn on either the left or right hand. The gloves are offered in sizes small, medium, large and extra-large, and sterilized by Gamma radiation. The gloves are designed and manufactured in accordance with the ASTM D3578-19 standard.

The provided text describes the 510(k) summary for "Sterile Latex Examination Gloves Powder Free". This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance and biocompatibility testing, rather than an AI-driven medical device requiring extensive clinical validation of diagnostic accuracy. As such, many of the requested elements for AI/ML device studies (like sample sizes for test sets, expert ground truth adjudication, MRMC studies, training set details) are not applicable to the information provided.

However, I can extract the acceptance criteria and performance results for the non-clinical tests conducted for these gloves:

1. Table of Acceptance Criteria and Reported Device Performance

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

The proposed device is Powder-Free Latex Examination Gloves. The gloves are single use and are provided non-sterile. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The proposed device is provided with natural color. The device is available in two lengths, each with six sizes, extra-small (XS), small (S), medium (M), large (L) and extra-large (XL), and extra extra-large (XXL). The device is non-sterile.

The provided document is a 510(k) premarket notification for Powder-Free Latex Examination Gloves. This type of device is classified as a Class I medical device (21 CFR 880.6250 - Non-Powdered Patient Examination Glove).

The information requested regarding acceptance criteria and a study proving the device meets those criteria typically applies to more complex devices, especially those involving AI/ML components or requiring clinical performance studies to establish safety and effectiveness.

For this specific device (examination gloves), the "study" that proves it meets acceptance criteria is primarily non-clinical testing against established ASTM and ISO standards for physical properties, integrity, and biocompatibility. Clinical studies are explicitly stated as not included in this submission.

Therefore, many of the requested points are not applicable in the context of this 510(k) submission for examination gloves. I will address the applicable points and explicitly state where information is not present or not relevant to this type of device.

Acceptance Criteria and Device Performance for Powder-Free Latex Examination Gloves (K222612)

For this device, the "acceptance criteria" are defined by compliance with recognized consensus standards (ASTM and ISO). The "study" proving acceptance is the non-clinical testing performed against these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not explicitly state the sample sizes (e.g., number of gloves) used for each specific non-clinical test. These sample sizes would be specified within the methodologies of the referenced ASTM and ISO standards.
• Data Provenance: The testing was conducted by or on behalf of Guangdong Kingfa Sci.&Tech. Co., Ltd., based in China. The data is from non-clinical laboratory testing, not human subjects, and is inherently retrospective as it was conducted prior to this submission.

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. For this type of device, "ground truth" is established by the physical and chemical properties measured against the objective metrics defined in the ASTM and ISO standards, using calibrated equipment and standard laboratory procedures. It does not involve human expert interpretation or consensus comparable to image-based medical device studies.

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

• Not applicable. Adjudication methods are relevant for human-interpretable data where multiple readers might have differing opinions (e.g., medical image interpretation). This submission relies on objective laboratory test results.

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

• Not applicable. MRMC studies are used for evaluating human performance, typically involving AI assistance in diagnostic tasks. This device is an examination glove, not an AI-enabled diagnostic tool. No clinical study was performed.

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

• Not applicable. This device does not have an "algorithm" or standalone AI component. Its performance is measured directly through physical and chemical testing.

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

• The "ground truth" for this device is based on objective measurements against established engineering and biocompatibility standards. For example, tensile strength measured in MPa, hole detection based on water leak AQL, residual powder in mg/glove, protein content in µg/dm², and ISO 10993 series for biological responses (irritation, sensitization, systemic toxicity) are the "ground truth" metrics.

8. The sample size for the training set:

• Not applicable. This is a physical product, not a machine learning model, so there is no "training set."

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

• Not applicable due to the absence of a training set.

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Non Sterile Powder Free Latex Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Non Sterile Powder Free Latex Examination Gloves

The provided document is a 510(k) clearance letter from the FDA for "Non Sterile Powder Free Latex Examination Gloves." It certifies that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any details related to AI/software performance as requested in your prompt.

The questions you've asked are typically relevant to the evaluation of AI/ML-driven medical devices (e.g., for diagnostic imaging), where performance metrics like sensitivity, specificity, or AUC are critical, and detailed study methodologies are required to demonstrate clinical validity.

This document pertains to a Class I medical device (non-powdered patient examination glove) which is a physical product, not a software or AI-based device. Therefore, the type of information you are seeking (AI performance, MRMC studies, ground truth establishment for algorithms, etc.) is not applicable and not present in this document.

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Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free and Non-Sterile.

The provided document describes the FDA 510(k) premarket notification for "Latex Examination Powder Free Gloves." This is a Class I medical device, which typically does not require a complex AI/algorithm-based study with human readers, ground truth establishment by experts, or MRMC studies. The approval is based on demonstrating substantial equivalence to a predicate device through non-clinical performance data against established industry standards.

Therefore, many of the requested elements for describing AI acceptance criteria and study methodology (like sample sizes for test/training sets, expert ground truth, adjudication, MRMC studies, standalone algorithm performance, etc.) are not applicable to this type of device and submission.

The document explicitly states "H. SUMMARY OF CLINICAL TESTING: Not applicable." This reinforces that the submission did not rely on clinical performance data involving human readers or sophisticated AI algorithms.

However, I can extract the acceptance criteria and performance data as presented for these gloves.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Latex Examination Powder Free Gloves" are based on established ASTM (American Society for Testing and Materials) standards for rubber examination gloves. The table below summarizes these criteria and the reported performance of the device (K222348) compared to the predicate device (K192329).

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (Applicable to this Device Type)

Given this is a 510(k) for examination gloves, the "study" is a series of non-clinical, laboratory tests performed according to specific ASTM and ISO standards, rather than a clinical trial or an AI algorithm performance study.

2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for length, width, or tensile strength). However, it implies that standard testing methodologies as defined by ASTM and ISO were followed. These standards usually specify the number of samples required for each test. The data provenance is from JR Engineering & Medical Technologies (M) SDN.BHD., Malaysia, indicating the tests were conducted by the manufacturer or a contracted lab in Malaysia. The data is non-clinical performance data, reported as part of a premarket notification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" for this device is physical and chemical adherence to specific measurable standards (e.g., a glove is X mm long, has Y tensile strength), not a diagnostic interpretation requiring expert medical opinion. The standards themselves, like ASTM D3578-2019, serve as the "ground truth" for performance.

4. Adjudication Method for the Test Set:
Not applicable. This is not a human-interpreted diagnostic task requiring adjudication. The tests are objective measurements against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, this was not done. MRMC studies are typically for diagnostic imaging devices or algorithms where the performance of human readers (with and without AI assistance) on clinical cases is evaluated. This device is an examination glove.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is not an AI algorithm. Its performance is measured through physical and chemical properties.

7. The Type of Ground Truth Used:
The ground truth used is objective engineering and material science standards (e.g., ASTM D3578-2019, ASTM D5151-2019, ASTM D6124-06, ASTM D5712-95, ISO 10993 series). These are internationally recognized standards for manufacturing and safety.

8. The Sample Size for the Training Set:
Not applicable. This is not an AI device trained on a dataset. The "training" for such a device would be the manufacturing process development and quality control to ensure consistency.

9. How the Ground Truth for the Training Set was Established:
Not applicable, as it's not an AI training set. The "ground truth" for manufacturing would be the specifications and quality control procedures adherence to ensure gloves meet the physical and chemical standards.

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Disposable Medical Rubber Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

The Disposable Medical Rubber Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (no color is added) and are powder free. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

The provided text describes the acceptance criteria and the study results for the "Disposable Medical Rubber Examination Gloves" (K221374) device.

Here's the breakdown of the requested information:

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

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 for Physical Dimension, Physical Property, Freedom From Holes, Powdered Glove, and Extractable Protein Tests: The sample sizes are specified by the ASTM standards and AQL levels. For example:
  • Physical Dimensions: Inspection Level S-2, AQL 4.0 (This implies a sampling plan defined by ASTM D3578-19, which would dictate the sample size based on lot size).
  • Physical Property Characteristics: AQL 4.0 (similar to above).
  • Freedom From Holes: Inspection Level I, AQL 2.5 (implies a sampling plan as per ASTM D5151-06).
  • Powdered Glove Test: N=5 (5 gloves were tested for residual powder).
  • Extractable Protein Test: N=3 (3 samples were tested for extractable protein).
• Sample Size for Biocompatibility Tests:
  • Acute Systemic Toxicity: ICR mice (number not specified, but typically a standard number per group as per ISO 10993-11).
  • Skin Irritation: Rabbits (number not specified, but typically a standard number as per ISO 10993-23).
  • Skin Sensitization: Guinea pigs (number not specified, but typically a standard number as per ISO 10993-10, using the Guinea Pig Maximization method).
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond indicating they are "bench tests" and "nonclinical tests" conducted for the subject device manufactured by Hebei Titans Hongsen Medical Technology Co., Ltd. in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes performance testing of a physical medical device (examination gloves) against established engineering and biocompatibility standards, not an AI/imaging device requiring expert interpretation for ground truth.

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

This information is not applicable for the same reason as point 3. The device under review is an examination glove, and its performance is determined by objective physical and chemical tests, not by human interpretation 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

This information is not applicable. This document describes an examination glove, not an AI-assisted diagnostic device.

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

This information is not applicable. This document describes an examination glove, not an AI-assisted diagnostic device.

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

The "ground truth" for the performance of the Disposable Medical Rubber Examination Gloves is established by:

• International Standards: Primarily ASTM D3578-19 (Standard Specification for Rubber Examination Gloves) for physical properties and dimensions, and various ISO 10993 series standards for biocompatibility (ISO 10993-11 for systemic toxicity, ISO 10993-23 for irritation, ISO 10993-10 for sensitization).
• Objective Test Methods: Laboratory tests as described (e.g., steel ruler and thickness measurement apparatus for dimensions, dumbbell/straight section specimens for physical properties, water leakage for holes, gravimetric methods for residual powder, modified Lowry Method for protein content).
• Animal Models: For biocompatibility tests (ICR mice for acute systemic toxicity, rabbits for skin irritation, guinea pigs for skin sensitization).

8. The sample size for the training set

This information is not applicable. The device is a physical product (examination gloves), not a software algorithm that requires a training set. The performance is based on manufacturing and testing against established standards.

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

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

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The Single-use medical latex examination gloves 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.

The Single-use medical latex examination qloves 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. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is provided non-sterile, in sizes XS, S, M, L and XL, natural white color, powder free, and the shelf life is 3 years.

The provided text describes the 510(k) premarket notification for a medical device: "Single-use medical latex examination gloves (LG100)". This document is not for an AI/ML-based medical device. Therefore, the questions related to AI/ML device testing (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (K214017) through non-clinical performance testing against established ASTM and ISO standards for examination gloves.

Here's the relevant information based on the provided text, primarily focusing on the acceptance criteria and performance of the glove:

Acceptance Criteria and Device Performance for Single-use Medical Latex Examination Gloves (LG100)

This device is not an AI/ML system, but rather a physical medical device (examination gloves). Therefore, the acceptance criteria and study data relate to physical, chemical, and biological properties of the gloves, not algorithmic performance.

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

• Width ± 10mm
• Length: XS-S 220 min, M-XL 230 min
• Thickness (finger and Palm): 0.08 min | Meet the requirement |
  | ASTM D3578-19 | Determination of Physical Properties | Before and after accelerated aging, the gloves shall conform to the physical requirements in Table 3 of ASTM D3578-19.
  Before Aging:
• Tensile Strength: 18 MPa min
• Stress Elongation: 5.5 MPa max
• Ultimate Elongation: 650% min
  After Accelerated Aging:
• Tensile Strength: 14 MPa min
• Ultimate Elongation: 500% min | Meet the requirement |
  | ASTM D5151-19 | Water Leak Test for Detection of Holes | The gloves shall be free from holes when tested in accordance with the method given in ASTM D5151. AQL=2.5 | Meet the requirement |
  | ASTM D6124-06 (Reapp. 2017) | Residual Powder Content Test | The powder residue content shall be not more than 2mg per glove. | Meet the requirement |
  | ASTM D3578-19 | Protein Content | ≤ 200 ug/dm² | Meet the requirement |
  | ISO 10993-5:2009 | In vitro Cytotoxicity | Non-cytotoxicity | Failed (Potential toxicity Grade 3 or 4) Self-contradictory with the conclusion of "as safe" |
  | ISO 10993-10:2010 | Skin Sensitization | Non-sensitizing | Meet the requirement |
  | ISO 10993-10:2010 | Skin Irritation | Non-irritating | Meet the requirement |
  | ISO 10993-11:2017 | Systemic Toxicity | Non-systemic toxicity | Meet the requirement |

Note: The results for "In vitro Cytotoxicity" indicate "Failed (Potential toxicity Grade 3 or 4)", which seems to contradict the overall conclusion of the device being "as safe, as effective, and performs as well as or better than the legally marketed predicate device". This would warrant further investigation if this were a complete regulatory review. However, the provided text is the basis for this answer.

The following questions are not applicable to this 510(k) submission as it pertains to a physical medical device (examination gloves) and not an AI/ML-based device:

2. Sample sizes used for the test set and the data provenance: Not applicable. Tests are conducted according to published standards (e.g., AQL for water leak tests), not on subjective data sets. The testing is non-clinical, done by the manufacturer (Fitone Latex Products Co., Ltd. Guangdong, China).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is established by objective physical and chemical testing standards, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on established international standards (ASTM, ISO) for physical, chemical, and biological properties of medical gloves (e.g., tensile strength, freedom from holes, protein content, cytotoxicity tests).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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This non-powdered 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.

The subject device in this 510(k) Notification is Iconic Latex Glove - Powder Free Latex Examination Glove. The subject device is a patient examination glove made from Latex compound, Natural White color, powder free and non-sterile (Per 21 CFR 880.6250 - class I). The device meets the specifications in ASTM D3578-19 Standard specification for Rubber Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Larqe.

The information provided describes the acceptance criteria and the study conducted for the Iconic Latex Glove, a non-powdered patient examination glove.

Here's a breakdown of the requested information:

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

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