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The Surgical Isolation Cover Gown is intended to protect health care persomel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Cover Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/A AMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Cover Gown is a single use, disposable medical device provided non-sterile.

The proposed device is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed device is a single use, disposable medical device provided non-sterile. The proposed device is available in nine sizes, including XS, S, M, L, XL, 2XL, 3XL, 4XL, 5XL. The barrier protection level for Surgical Isolation Cover Gown meets AAMI Level 3. The proposed device is provided in yellow.

The provided document is a 510(k) premarket notification for a medical device, specifically a "Surgical Isolation Cover Gown." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or diagnostic accuracy for an AI/ML powered device.

Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and effect sizes) is not applicable to this document. This document details the physical and biological performance characteristics of a protective garment.

However, I can extract the acceptance criteria and reported device performance from the provided tables, as well as information about the testing methodology for this type of medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance tests conducted according to recognized international and national standards.

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

• Sample Size: The document does not explicitly state the number of individual garments or test specimens used for each particular test (e.g., how many samples were used to calculate the mean Hydrostatic Pressure). However, standard testing protocols for these types of materials and products typically involve multiple specimens to ensure representative results.
• Data Provenance: The device manufacturer is "Wuhan Dymex Healthcare Co., Ltd." in Wuhan, China. The tests are reported to have been performed in accordance with international (ISO, AATCC) and national (ASTM, 16 CFR) standards. The nature of these tests (material properties) suggests they are prospective tests performed on manufactured samples.

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

• Not Applicable. This is a physical and biological performance testing of a medical device (a gown), not an AI/ML device that generates diagnostic outputs requiring expert interpretation or ground truth labeling (e.g., for images or clinical data). The "ground truth" for these tests comes from the physical/chemical measurements themselves against defined standards.

4. Adjudication Method for the Test Set:

• Not Applicable. As per point 3, there's no need for expert adjudication in these types of performance tests. The results are quantitative measurements against predefined physical/chemical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is not an AI/ML or diagnostic imaging device. MRMC studies are used to evaluate the impact of a new technology (e.g., AI assistance) on human reader performance, which is not relevant for a surgical isolation gown.

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

• Not Applicable. This is not an algorithm or software device. The "standalone" performance here refers to the gown's inherent physical and biological barrier properties, which were measured directly through the non-clinical tests.

7. The Type of Ground Truth Used:

• For physical properties (e.g., hydrostatic pressure, breaking strength, linting), the "ground truth" is established by direct measurement of the material and product characteristics against the specifications outlined in the referenced standards (e.g., ANSI/AAMI PB70, ASTM, AATCC, ISO).
• For biocompatibility (cytotoxicity, sensitization, irritation), the "ground truth" is established through laboratory testing against the criteria specified in ISO 10993 (e.g., cell viability percentages, absence of specific reactions).

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" as this is not an AI/ML device that requires machine learning model training.

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

• Not Applicable. As per point 8, there is no training set for this type of medical device submission.

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Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 3 classification.

The proposed device is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed device is single use, disposable medical devices and are provided in sterile. The surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. The barrier protection level for surgical gown met AAMI Level 3.

This document describes the non-clinical testing performed for a Surgical Gown (K211809) to demonstrate its equivalence to a predicate device. The information provided heavily focuses on physical and biological performance criteria.

Here's a breakdown of the requested information based on the provided text:

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)

The document does not explicitly state the sample sizes for each of the non-clinical tests conducted. The provenance of the data is implied to be from the manufacturer's testing, Wuhan Dymex Healthcare Co., Ltd., based in China (Wuhan, China). The tests are prospective, meaning they were conducted specifically for this submission to assess the device's performance against established standards.

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. These are non-clinical, laboratory-based tests on a physical product (surgical gown) and do not involve human expert interpretation or ground truth establishment in the way clinical studies with medical imaging or diagnoses would. The "ground truth" is defined by the objective measurement standards of the relevant ASTM, AATCC, ISO, and CFR standards.

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

Not applicable. This concept applies to clinical studies where human interpretation or diagnostic agreement is being assessed. These are objective, standardized laboratory tests.

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 submission for a surgical gown, which is a physical medical device, not an AI-powered diagnostic or assistive technology that would involve human readers.

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

Not applicable. This is a physical medical device, not an algorithm. The non-clinical tests are "standalone" in the sense that they evaluate the device's physical and biological properties objectively.

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

The "ground truth" for the non-clinical tests is established by internationally recognized and industry-accepted performance standards (e.g., ANSI/AAMI PB70:2012, 16 CFR Part 1610, AATCC 127, ASTM D5034, ISO 10993 series). The device's performance is measured against the criteria defined within these standards.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. As explained above, there is no training set for a physical surgical gown.

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The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Surgical Face Masks are blue color, single use, flat-folded masks with nose piece and ear loops or tie-on. The blue colorant is polypropylene (PP) master batch.

The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.

The tie-on is held in place over the users' mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.

The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire.

The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

The provided text is a 510(k) summary for a Surgical Face Mask. It describes the device, its intended use, and the non-clinical tests conducted to demonstrate its substantial equivalence to a predicate device.

Here's the information extracted and organized as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Fluid Resistance: 32 samples were tested.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It refers to non-clinical tests conducted to verify the device met design specifications and standards.

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

This section is not applicable as the tests performed are non-clinical (laboratory tests) and do not involve human diagnostic assessment or ground truth established by experts in the context of clinical scenarios.

4. Adjudication Method for the Test Set

This section is not applicable as the tests performed are non-clinical laboratory tests and do not involve human adjudication.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission."

6. Standalone Performance Study

Yes, a standalone performance study was done in the form of non-clinical laboratory testing. The device's performance was evaluated against established standards for medical face masks (ASTM F2100 Level 3). The results in the table above represent the algorithm-only performance against these standards, as there is no human-in-the-loop for these types of tests.

7. Type of Ground Truth Used

The ground truth used for these non-clinical tests is established by industry standards and regulatory requirements, specifically ASTM F2100, ISO 10993-5, ISO 10993-10, ASTM F1862, EN 14683, ASTM F2101, ASTM F2299, and 16 CFR 1610. These standards define the quantitative and qualitative acceptance criteria for the performance and safety characteristics of surgical face masks.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product (Surgical Face Mask), not an AI algorithm or software. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and quality control would relate to production batches, but not a training set for an algorithm.

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

This information is not applicable for the same reason as point 8; there is no training set mentioned for this medical device.

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The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Surgical Face Masks are single use, three-layer, flat –folded masks with ear loops and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The surgical face masks will be provided in yellow. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

The provided document is a 510(k) summary for a Surgical Face Mask. It outlines the acceptance criteria and performance data for the device, which is a Class II device intended to protect both patients and healthcare personnel from microorganisms, body fluids, and particulate material.

1. Table of Acceptance Criteria and Reported Device Performance

The device also underwent biocompatibility testing:

• Cytotoxicity: Accepted as non-cytotoxic. Device was reported as non-cytotoxic.
• Irritation: Accepted as non-irritating. Device was reported as non-irritating.
• Sensitization: Accepted as non-sensitizing. Device was reported as non-sensitizing.

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

The document does not explicitly state the total sample size for all tests. However, for Fluid Resistance testing, a sample size of 32 devices was used. The document does not specify the country of origin for the data or whether it was retrospective or prospective, but it implies the tests were conducted for the purpose of this submission (prospective testing for the specific device).

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

This document describes performance testing of a physical medical device (surgical face mask) against established engineering standards (e.g., ASTM, MIL-M, CFR). The "ground truth" here is not established by human experts in the sense of clinical image interpretation or diagnosis. Instead, it is determined by the results of standardized laboratory tests conducted according to defined protocols. There is no mention of human expert adjudication for these particular device performance tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are laboratory-based and yield quantitative or categorical results based on established standards, not requiring human adjudication in the traditional sense of consensus among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document states: "No clinical study is included in this submission." The evaluation is based on non-clinical performance testing against established standards.

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

Not applicable. This is not an AI/algorithm-based device. It is a physical medical device (surgical face mask). The performance evaluation is for the device itself, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on established engineering standards and regulatory requirements (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610) for surgical face mask performance, along with biocompatibility testing standards. The device's performance is measured against these objective criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical product, and its performance is evaluated through testing of manufactured units.

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

Not applicable, as there is no training set for this type of device.

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