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Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.

The Medical surgical mask is flat pleated style mask, utilizing ear loops way for wearing, and has nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is provided non-sterile and is intended to be a single use, disposable device.

The document provided relates to a 510(k) premarket notification for a Biodegradable Medical surgical mask (K231155) and is primarily focused on demonstrating substantial equivalence to a predicate device (K201622) through non-clinical performance testing. It does not contain information about the performance of an AI/ML powered device, nor does it describe a study involving human readers or expert ground truth adjudication in the context of diagnostic accuracy.

Therefore, the requested information regarding AI/ML device acceptance criteria, sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML models is not applicable to this document.

The document reports on standard non-clinical performance tests for medical masks. Here is a table summarizing the acceptance criteria and results for these tests:

1. Table of acceptance criteria and the reported device performance:

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The biodegradable nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The gloves are offered in six sizes, extra-small (6.5"), small (7"), medium (8"), large (8.5"), extra-large (9"), extra extra-large (9.5"). Three colors are available for all size, includes blue, blue violet and green.

This document, K221983, is a 510(k) Premarket Notification for Biodegradable Powder Free Nitrile Examination Gloves. The device in question is a Class I medical device, meaning it is subject to general controls and typically does not require extensive clinical studies for clearance if substantial equivalence to a predicate device can be demonstrated.

Based on the provided text, the "device" is a Nitrile Examination Glove, not an advanced AI or diagnostic device that would involve AI-assisted reading or complex image analysis. Therefore, the questions related to AI (e.g., effect size of human readers improving with AI, standalone algorithm performance, training set size, adjudication methods, number of experts for ground truth) are not applicable to this type of medical device submission.

The "study" referenced in this document is a series of non-clinical, in-vitro laboratory tests performed to demonstrate that the glove meets established industry standards and specifications, proving its safety and performance equivalence to a legally marketed predicate device.

Here's the information extracted from the document relevant to your request, but tailored to the nature of this Class I device:

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

Width:
Extra-Small: 70 ± 10 mm
Small: 80 ± 10mm
Medium: 95 ± 10mm
Large: 110 ± 10mm
Extra-Large: 120 ± 10mm
Extra-Extra-Large: ≥120mm | Pass |
| ASTM D6319 | Physical properties (Thickness) | Thickness (mm):
Finger: ≥0.05
Palm: ≥0.08 | Pass |
| ASTM D6319 | Physical properties (Before Aging) | Tensile Strength: ≥14MPa
Ultimate Elongation: ≥500% | Pass |
| ASTM D6319 | Physical properties (After Aging) | Tensile Strength: ≥14MPa
Ultimate Elongation: ≥500% | Pass |
| ASTM D5151 | Freedom from pinholes | Meet the requirements of ASTM D5151 Test for AQL 2.5 | Pass |
| ASTM D6124 | Powder Residue | Meet the requirements of ASTM D6124

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The vinyl examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The proposed device is a powder free vinyl patient examination glove, provided as nonsterile and disposable device. The proposed device is provided with clear color. There are four sizes: small, medium, large and extra-large as options.

The provided document describes the acceptance criteria and performance data for Vinyl Examination Gloves, a Class I medical device. It does not pertain to an AI/ML-based medical device. Therefore, many of the requested fields regarding AI/ML device testing (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable.

Here's the information extracted from the document, focusing on the device performance and acceptance criteria for these physical examination gloves:

1. Table of Acceptance Criteria and Reported Device Performance

• Width (Small): 85±5mm
• Width (Medium): 95±5mm
• Width (Large): 105±5mm
• Width (Extra-Large): 115±5mm
• Thickness (Finger): ≥ 0.08mm
• Thickness (Palm): ≥ 0.08mm | Pass |
  | ASTM D5250 (Physical Properties - Before Aging) | To determine tensile strength and ultimate elongation before aging | - Tensile Strength: ≥ 11MPa
• Ultimate Elongation: ≥ 300% | Pass |
  | ASTM D5250 (Physical Properties - After Aging) | To determine tensile strength and ultimate elongation after aging | - Tensile Strength: ≥ 11MPa
• Ultimate Elongation: ≥ 300% | Pass |
  | ASTM D5151 | Freedom from pinholes | Meets the ASTM D5151 Test for AQL 2.5 requirements | Pass |
  | ASTM D6124 | Powder Residue | Meets ASTM D6124 requirements:

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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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The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The proposed devices are provided with white, black and pink color. There are six sizes, extra-small, medium, large and extra-large, extra extra-large for optional.

This is a 510(k) summary for a medical device (Nitrile Examination Gloves), not for an AI/ML powered device, therefore, the requested information elements related to AI/ML device studies (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable.

The document describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's the table of acceptance criteria and reported device performance based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. These are non-clinical bench tests on physical products, not an AI/ML test set. The tests were performed on "Lots" of the gloves (Lot1, Lot2, Lot3). The specific sample size for each test within these lots is not specified in this document but implied to be sufficient for meeting the ASTM/ISO standards. The data provenance is from non-clinical testing of the manufacturing output.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as these are objective physical and chemical tests, not requiring expert ground truth in the context of AI/ML evaluation.
3. Adjudication method for the test set: Not applicable. The results are based on objective measurements against defined standards.
4. 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 concerns a physical medical device (gloves), not an AI/ML powered device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This concerns a physical medical device (gloves), not an AI/ML powered device.
6. The type of ground truth used: For physical/chemical properties (e.g., length, thickness, tensile strength, freedom from pinholes, powder residue), the "ground truth" is the quantitative measurement obtained through standardized test methods (ASTM and ISO standards) and compared against pre-defined numerical or qualitative acceptance criteria. For biocompatibility tests (irritation, sensitization, systemic toxicity), the ground truth is established by the outcome of the biological assays as per ISO 10993 standards.
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.

The medical surgical mask (model: Black mask, Level 3) is a flat pleated style mask with ear loops, and a nose piece design for fitting the mask around the nose. The mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt-blown polypropylene. Ear loops are held to cover the users' mouth and nose by two polypropylene bands ultrasonically welded to the mask. The elastic ear loops are not made with natural rubber latex. The nose piece included in the mask is in the middle layer of the mask, to allow the user to fit the mask around their noses. The mask will be provided in black color, the colorant for the masks is Carbon black (CAS No.1333-86-4).

The subject device has 2 kinds of dimensions: 17.5 cm x 9.5 cm and 14.5 cm x 9.5 cm, and 2 kinds of protection performance: Level 1 and Level 3.

The mask is sold non-sterile and intended to be a single-use, disposable device.

The requested information pertains to a medical surgical mask, which is a physical device, not an AI/ML powered device. Therefore, acceptance criteria and study details relevant to AI/ML powered devices are not applicable.

However, based on the provided document, I can extract the acceptance criteria and performance data for the physical medical surgical mask for Level 1 and Level 3 performance, as well as biocompatibility testing.

Here's the relevant information about the acceptance criteria and the study that proves the device meets these criteria, focusing on the available context for a physical medical surgical mask:

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

Medical Surgical Mask (Level 1)

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

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 58.3minutes

Power-Free Nitrile Examination Gloves(Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, Blue/Blue violet colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in four sizes, small, medium, large and extra-large.

The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).

The provided document describes the acceptance criteria and the study conducted for "Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs" and "Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs".

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

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

The document does not specify the exact sample sizes (number of gloves or individual tests) used for each non-clinical test. It only states that "Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications."

The data provenance is from non-clinical laboratory testing conducted to established international and ASTM standards. The country of origin of the data is not explicitly stated for each test, but the devices are manufactured by GUANGDONG KINGFA SCI. & TECH.CO., LTD. in Qingyuan, Guangdong, China. The testing appears to be prospective as it was performed to verify the device's compliance.

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

This information is not applicable. The study involves non-clinical performance testing of medical devices (gloves), not a diagnostic algorithm or human-readable data necessitating expert ground truth establishment. The "ground truth" here is determined by the objective measurements and adherence to the specified ASTM and ISO standards.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data. For non-clinical device testing, the results are objectively measured against predefined criteria.

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

There was no MRMC comparative effectiveness study done. This study is for medical gloves, which are physical devices, not an AI or imaging diagnostic tool 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. This study concerns a physical medical device (gloves), not an algorithm or AI.

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

The "ground truth" for this non-clinical testing is based on objective measurements and adherence to established international standards such as ASTM D6319-19, ASTM D6978-05, ISO 10993-10:2010, and ISO 10993-11:2017. These standards define the acceptable physical properties, chemical permeation resistance, and biocompatibility of the gloves.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not a machine learning or AI algorithm development study.

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

This information is not applicable, as there is no training set for this type of device testing.

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The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

The Medical Protective Mask is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use. The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a Iron core covered with polypropylene. The dimensions of each mask are length 162±5 mm and width 102±5 mm. The dimensions of nosepiece is length 90±10 mm and width 5±0.5 mm, and the ear loop is length 185±5 mm and width 5±0.5 mm. The mask is a single use, disposable device, provided non-sterile in white color.

This document is an FDA 510(k) premarket notification for a medical protective mask. It does not describe an AI medical device or an MRMC study. Therefore, most of the requested information regarding acceptance criteria and studies proving device performance, especially those related to AI and human reader improvement, cannot be extracted from this document.

However, I can provide the acceptance criteria and reported performance for the physical and biological characteristics of the medical protective mask based on the provided text.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This table details the performance criteria for the Medical Protective Mask (Model: KF-A F02(N)) based on ASTM F2100 Level 2 standards.

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Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.

The Medical surgical mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue K6911D /CAS number: 12239-87-1), and the middle layer is made of melt blown polypropylene. Ear loops, which is held to cover the users' mouth and nose by two polyester and spandex elastic bands ultrasonic welded to the Medical surgical mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Medical surgical mask is in the middle layer of Medical surgical mask to allow the user to fit the Medical surgical mask around their noses, which is made of metallic iron wire coated with polypropylene resin. The dimensions of each Medical surgical mask are length 175±5 mm and width 95±2 mm, and the inner and outer layers' density are 25 gsm, the middle layer is 35 gsm. The dimensions of nosepiece is length 100±5 mm and width 3±0.5 mm, and the ear loop is length 175±10 mm and width 3.5±0.5 mm. The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device.

The document provided describes the acceptance criteria and performance of a Medical Surgical Mask (Model: KF-B P05) by Guangdong KINGFA Sci.&Tech.Co.,Ltd. Rather than an AI device being proven to meet acceptance criteria, this is a 510(k) summary for a medical device (a mask) demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against ASTM F2100:2019 Level 1 performance requirements.

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