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The Disposable Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is in blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for Disposable Nitrile Examination Gloves. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study findings based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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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 in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue/black/purple colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in six sizes: S, M, L, XL. The subject device is non-sterile.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Cytotoxicity: The table on page 11 explicitly states "Under conditions of the study, device extract is cytotoxic." for ISO 10993-5. This appears to contradict the general conclusion that the device is "as safe, as effective." However, the predicate comparison table on page 8 indicates that the predicate device also stated "ISO 10993-5 Under conditions of the study, device extract is cytotoxic," and the subject device has a "/" for this criterion without a definitive pass/fail statement in that specific comparison table. In the non-clinical testing summary, it lists ISO 10993-5 as one of the standards conducted. If the device genuinely exhibited cytotoxicity, it would typically be a concern. Given the overall clearance, there might be further explanation or context not fully detailed in this summary (e.g., the level of cytotoxicity was deemed acceptable, or the "is cytotoxic" statement might be an error in the summary table on page 11, or the nature of the cytotoxicity and its relevance to direct patient contact for a glove was evaluated and deemed non-critical).

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

• Physical Dimensions (ASTM D6319): Not explicitly stated, but the results show ranges across sizes (S, M, L, XL).
• Watertightness Test (ASTM D5151): The results specify "0/125/Pass," indicating a sample size of 125 items (gloves) were tested, all passing (0 failures).
• Powder Content (ASTM D6124): Not explicitly stated.
• Physical Properties (ASTM D412): Not explicitly stated.
• Biocompatibility (ISO 10993-5, -10, -11): Not explicitly stated.
• Chemotherapy Drug Permeation (ASTM D6978-05): Not explicitly stated, however, the standard ASTM D6978 mandates three specimens be tested for each drug exposure for each material tested (so, 3 specimens per drug per color of glove). There are 12 drugs tested for 3 colors, so at least 3 x 12 x 3 = 108 specimens would have been tested as a minimum requirement for this standard.

The data provenance is from non-clinical bench testing conducted to relevant ASTM and ISO standards, indicating laboratory testing. The country of origin of the test data is not explicitly stated, but given the manufacturer is Jiangsu Bytech Medical Supplies Co.,Ltd. in China, it is likely the testing was performed either in China or by a certified lab contracted by the manufacturer. The data is reported retrospectively as part of the 510(k) submission.

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

This device is a physical product (gloves) and the tests conducted are bench-top performance tests and biocompatibility tests. Therefore, human experts are typically not used to establish a "ground truth" in the way they would for an AI diagnostic device (e.g., radiologists reviewing images). The ground truth is established by the methods and specifications defined in the referenced industry standards (ASTM, ISO). Laboratory technicians and chemists, qualified to perform these specific tests, would have conducted the studies.

4. Adjudication method for the test set:

Not applicable, as this involves objective laboratory measurements against established standards, not human interpretation 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. This device is a medical glove, not an AI diagnostic or assistance tool. The evaluation focuses on its physical and chemical properties.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

The ground truth is based on:

• Standardized Test Methods: Specifications and methodologies outlined in ASTM (e.g., D6319, D5151, D6124, D412, D6978) and ISO standards (e.g., 10993-5, 10993-10, 10993-11).
• Objective Measurements: These standards define how properties like dimensions, watertightness, powder content, tensile strength, elongation, and drug permeation breakthrough times are measured objectively.
• Pre-defined Acceptance Criteria: The pass/fail criteria for these measurements are often specified within the standards or derived from regulatory guidance for the device type.

8. The sample size for the training set:

Not applicable. This is a physical device, not a machine learning model, so there is no training set in this context.

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

Not applicable. There is no training set.

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The Disposable Nitrile Examination Gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

This document describes the premarket notification for Disposable Nitrile Examination Gloves (K212833). Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Device Performance

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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 in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large. The subject device is non-sterile.

Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves

This document outlines the acceptance criteria and details the studies conducted to demonstrate that the "Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)" meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For Carmustine (BCNU) and ThioTepa, the device performance did not meet the implicitly accepted longer breakthrough times of the predicate device for safe use, and as such, a warning was issued for non-use with these specific drugs. For other drugs, the device demonstrated comparable or superior performance to the predicate.

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for each test. However, for the Watertightness Test (ASTM D5151), the result "0/125/Pass" indicates a sample size of 125 gloves were tested, and none failed.

The data provenance is implied to be prospective bench testing conducted specifically for the submission of this device, presumably within China, given the manufacturer's and correspondent's addresses. There is no information provided regarding country of origin of data beyond the manufacturer's location.

3. Number of Experts and Qualifications for Ground Truth

This section is not applicable as the studies are primarily bench testing of physical and chemical properties of a medical device (gloves). The "ground truth" for these tests is established by published ASTM and ISO standards and their specified methodologies, not by expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable as the studies involve objective physical and chemical testing against established standards, not interpretation of data requiring adjudication.

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

This is not applicable. The device is a medical glove, and the evaluation does not involve diagnostic imaging or human-in-the-loop performance with AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a medical glove, not an algorithm, and its performance is assessed directly through physical and chemical testing.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

• Established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards: These standards define the test methodologies, performance criteria (e.g., minimum tensile strength, maximum powder content, minimum breakthrough times for chemotherapy drugs, irritation/sensitization levels), and acceptable limits.
• Objective laboratory measurements: Physical dimensions, tensile strength, elongation, watertightness, powder content, and chemical permeation breakthrough times were measured directly according to the specified standard test methods.

8. Sample Size for the Training Set

This is not applicable. The device is a physical product (medical gloves), not an AI algorithm that requires a training set. The performance is based on direct testing of the product itself.

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

This is not applicable as there is no training set for this type of device. The "ground truth" for the performance evaluation is established by the relevant ASTM and ISO standards as mentioned in point 7.

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Disposable Latex Powder Free Patient Examination Gloves (Non-sterile) Are intended for use in the medical field and worn on the examiner's hands to protect patient and user from cross contamination.
Disposable Nitrile Powder Free Patient Examination Gloves (Non-sterile) Are intended for use in the medical field and worn on the examiner's hands to protect patient and user from cross contamination.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Latex Examination Gloves (Non-Sterile)" and "Disposable Nitrile Examination Gloves (Non-Sterile)."

This document does not contain information about a medical device that uses AI or machine learning, nor does it discuss acceptance criteria and study results for such a device. Instead, it is a regulatory document for standard patient examination gloves.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the given text.

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The Disposable Nitrile Examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Disposable Nitrile Examination gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

The document describes the acceptance criteria and the results of the non-clinical performance testing for the "Disposable Nitrile Examination gloves."

1. Table of Acceptance Criteria and Reported Device Performance:

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The DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device, DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.

The proposed device is not provided as sterilized The proposed device is made of Nitrile.

This document is a 510(k) Summary for a medical device called "DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue)". It is an FDA submission to demonstrate substantial equivalence to a legally marketed predicate device.

The section providing acceptance criteria and performance data is "Table 5 Performance Test Results Summary" on pages 8-10.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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Disposable Nitrile Examination Gloves is a non-sterile 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 Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.

The provided text describes the non-clinical testing performed for a Class I medical device, "Disposable Nitrile Examination Gloves" (K211073). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the efficacy of an AI/ML algorithm. Therefore, many of the requested bullet points, particularly those related to AI algorithm performance, human-in-the-loop studies, and ground truth establishment for training sets, are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and study results for this specific device.

Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves (K211073)

The provided document details non-clinical tests conducted to verify the safety and performance of the "Disposable Nitrile Examination Gloves" (K211073) against established standards and to demonstrate substantial equivalence to a predicate device (K181106).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Cytotoxicity, Skin Sensitization, Skin Irritation, Acute Systemic Toxicity: Sample sizes are not explicitly stated as numerical values for these biological tests but refer to "test article" which implies sufficient samples as per the respective ISO standards. The data provenance is not specified beyond being part of the submission for a Chinese manufacturer; presumably, the tests were conducted under controlled laboratory conditions, not on human patients or retrospectively/prospectively collected clinical data.
• Watertightness Test:
  • Sample Demand: 125 gloves
  • Batch size: 35,000 gloves (for lot-by-lot inspection, implies the sample is drawn from a manufacturing lot)
  • Provenance: Not specified, but generally implies in-house or contracted lab testing for manufacturing batches.
• Physical Dimensions Test:
  • Sample Demand: 13 gloves
  • Batch size: 35,000 gloves
  • Provenance: Not specified.
• Determination of Physical Properties:
  • Sample Demand: 13 gloves
  • Batch size: 35,000 gloves
  • Provenance: Not specified.
• Surface Powder Test:
  • Sample size: 5 sub-samples (N=5) as per Table 1 (page 5), although another section mentions "3 sets of 2 gloves/batch". The results section states "Mean: 0.18mg/glove" for a test on 5pcs sub-samples (N=5).
  • Provenance: Not specified.

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

• Not Applicable. This document describes non-clinical, laboratory-based physical and biological performance tests, not AI algorithm validation requiring expert human ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. This is not a human interpretation study. Acceptance is determined by meeting predefined numerical or qualitative criteria specified in the relevant ASTM/ISO standards.

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 document pertains to the regulatory clearance of a physical medical device (examination gloves), not an AI/ML diagnostic tool. There is no AI component.

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

• Not Applicable. No AI algorithm is involved.

7. The Type of Ground Truth Used

• Objective Measurement and Standard Compliance: The "ground truth" for these tests is based on objective laboratory measurements (e.g., water leakage, dimensions, tensile strength, residual powder) and predefined biological responses in accordance with internationally recognized standards (ASTM, ISO). For biocompatibility, it's about whether the material elicits a specific biological reaction (e.g., cytotoxicity, irritation, sensitization).

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" and therefore no ground truth establishment for it in this context.

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The Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device, Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Purple-Blue. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for Disposable Nitrile Examination Gloves.

Important Note: This document pertains to the clearance of a medical device – specifically disposable nitrile examination gloves. The concepts of "AI models," "human readers," "effect size," "multi-reader multi-case (MRMC) comparative effectiveness studies," "standalone algorithms," and "ground truth establishment for training sets" as typically applied to AI/ML medical devices do not apply to this product. This submission focuses on the physical and performance characteristics of the gloves themselves compared to a predicate device.

Therefore, the answers to several of your requested points will be "Not Applicable" or refer to standard laboratory testing rather than AI/ML model validation.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue)

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

The proposed Disposable Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, and is made of nitrile (Acrylonitrile-butadiene copolymer) and chemical additives. It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile.

The provided text describes the acceptance criteria and performance of "Disposable Nitrile Examination Gloves" (K210897) in comparison to a predicate device (K192333), as part of an FDA 510(k) summary.

Here's a breakdown of the requested information:

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

| Characteristics | Acceptance Criteria | Proposed Device Performance (Disposable Nitrile Examination Gloves - K210897) | Predicate Device Performance (Blue Nitrile Examination Gloves Powder Free - K192333) |
|---------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| Comparison |
| General Comparison | | | | |
| 510K Number | / | K210897 | K192333 | - |
| Product Code | LZA | LZA | LZA | Same |
| Classification | Class I (21 CFR 880.6250) | Class I (21 CFR 880.6250) | Class I (21 CFR 880.6250) | Same |
| Intended Use | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The device is for over-the-counter use. | A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use. | A powder free patient 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. | Same |
| Material Use | Nitrile | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Blue | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Performance Testing | | | | |
| Dimensions (ASTM D6319-19) | Overall Length (mm): 220 mm = (sizes XS-S), 230 mm = (sizes M-XL); Width (± 10 mm): Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm; Thickness at Finger (mm): All Sizes = 0.05mm; Thickness at Palm (mm): All Sizes = 0.05mm | Length (mm): 220 mm = (sizes XS-S), 230 mm = (sizes M-XL); Width (± 10 mm): Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm; Thickness-Finger (mm): All Sizes ≥ 0.05mm; Thickness-Palm (mm): All Sizes ≥ 0.05mm | Size: M, Length Min: 230mm, Palm Width Min: 95+/-10mm, Finger Thickness min: 0.05 mm, Palm Thickness min: 0.05 mm | Same |
| Tensile Strength (Before Aging ASTM D6319-19) | $\ge$ 14 MPa | > 14 min MPa | > 14 min MPa | Same |
| Ultimate Elongation (Before Aging) | $\ge$ 500% | 500 min % | 500 min % | Same |
| Tensile Strength (After Aging ASTM D6319-19) | $\ge$ 14 MPa | $\ge$ 14 min MPa | $\ge$ 14 min MPa | Same |
| Ultimate Elongation (After Aging) | $\ge$ 400% | 400 min % | 400 min % | Same |
| Freedom from Holes (ASTM D5151) | AQL 2.5 Inspection Level G-1 | Passes AQL-2.5 | Passes AQL-2.5 | Same |
| Residual Powder (ASTM D6124) | $\le$ 2.0 mg/pc | $\le$ 2.0 mg/pc | $\le$ 2.0 mg/pc | Same |
| Biocompatibility Testing | | | | |
| Primary Skin Irritation Test (ISO 10993-10) | Not an irritant | Under the conditions of the test, the test article would be considered a non-irritant. | Under the condition of study not an irritant. | Same |
| Dermal Sensitization Assay (ISO 10993-10) | Not a sensitizer | Under the conditions of this study, there is no evidence of skin sensitization in guinea pigs was found. | Under the conditions of the study not a sensitizer. | Same |
| Acute Systemic Test (ISO 10993-11) | No mortality or evidence of systemic toxicity | Under the conditions of this study, there is no mortality or evidence of systemic toxicity from the extracts. The test met the test requirements. | Under the condition of study the device extracts do not pose a systemic toxicity concern. | Same |
| Material Mediated Pyrogenicity (ISO 10993-11/USP 41) | No febrile reaction; meets requirements | Under the conditions of this study, the test article would be considered no febrile reaction. The test article meets the test requirements. | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. | Same |
| In Vitro Cytotoxicity (ISO 10993-5) | Not cytotoxic (or acceptable cytotoxicity with further testing/justification) | Under the conditions of this study, the MEM test extracts would be considered cytotoxic potential. | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. | Same |
| Intracutaneous Reactivity Test (ISO 10993-10) | Polar and non-polar extract score less 1.0; requirements met | The test result showed that the polar and non-polar extract of the final test sample score is less 1.0, the requirements of the test are met. | Not available. | N/A |

A key point is that for all tested Biocompatibility characteristics, the proposed device's performance aligns with the predicate device, with one notable difference for "In Vitro Cytotoxicity" where both devices were found to be cytotoxic, but the predicate device had "Additional testing was performed to determine if this was a systemic toxicity concern," implying the cytotoxicity might have been addressed or deemed acceptable in the predicate's clearance. The proposed device's statement "would be considered cytotoxic potential" suggests a similar outcome, and the "Same" comparison indicates this was consistent with the predicate.

The study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is a non-clinical test program that evaluates the "Disposable Nitrile Examination Gloves" against recognized industry standards and FDA guidance. This is explicitly stated in section 8: "The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical Glove Guidance Manual Document, issued on January 22, 2008."

The comparison tables (Table II - Performance Testing Comparison Table and Table III - Biocompatibility Testing Comparison Table) demonstrate that the proposed device's performance meets or exceeds the specified acceptance criteria and is substantially equivalent to the predicate device.

Absence of information for AI-specific questions:

The provided document is an FDA 510(k) summary for a medical device (disposable nitrile examination gloves). It does not pertain to an AI/ML-enabled medical device. Therefore, the following information is not applicable and not present in the document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

The testing performed for this device relates to physical properties (dimensions, tensile strength, elongation, freedom from holes, residual powder) and biocompatibility (skin irritation, sensitization, systemic toxicity, pyrogenicity, cytotoxicity, intracutaneous reactivity), which are standard evaluations for such a product.

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