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Y ADU Surgical Gowns are 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 surgical gowns meet the requirements for Level 2 and Level 3 classification Per ANSI/AAMI PB-70.

Y ADU Surgical Gowns provide Level 2 and Level 3 protections per ANSI/AAMI PB70 standard.

Y ADU Surgical Gowns (Level 2) are made from SMMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They provide AAMI Level-2 protection.

The Level 2 Gowns have six different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL), and Super Extra large (XXXL).

SMMS is a multi-ply material consisting of layers of spunbonded and meltblown polypropyle.

The body and sleeve is made from 35g Blue SMMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. The belt is made from 35g Blue SMMS.

Y ADU Surgical Gowns (Reinforced, Level 3) are made from SMMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The chest area is reinforced with layer of PE+SPP material. They provide AAMI Level-3 protection.

The Level 3 Reinforced Gowns have six different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL), and Super Extra large (XXXL).

SMMS is a multi-ply material consisting of layers of spunbond and meltblown polypropyle.

The body and sleeve is made from 45g Blue SMMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. The belt is made from 45g Blue SMMS. The reinforced area is made from PE +SPP material.

All gowns are sterilized with ethylene oxide.

This document describes the YADU Surgical Gowns (K220092) and their conformance to safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the exact sample sizes for each specific test mentioned. However, the tests are non-clinical and conducted to verify design specifications. The data provenance is implied to be from laboratory testing performed by the manufacturer (HeNan YADU Industrial Co., Ltd.) or a testing facility following international standards (e.g., ISO, ASTM, AATCC, CPSC CFR). The tests are retrospective in the sense that they are conducted on manufactured devices to confirm their properties.

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

Not applicable. This device is a surgical gown, and its performance criteria are established by recognized international and national standards (e.g., ANSI/AAMI PB-70, ASTM F2407, ISO 10993, 16 CFR 1610) rather than expert consensus on a test set in the way a diagnostic AI device would. The "ground truth" for each criterion is the objective measurement defined by the respective standard.

4. Adjudication Method for the Test Set:

Not applicable. The evaluation relies on standardized objective test methods rather than subjective human assessment requiring adjudication.

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

No. This is a medical device (surgical gown), not a diagnostic or AI-assisted system for which MRMC studies are typically performed.

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

Not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria is based on objective measurements and results from standardized laboratory tests according to established national and international consensus standards (e.g., AATCC, ASTM, ISO, CPSC CFR). These standards define the acceptable performance limits for various physical, chemical, and biological properties relevant to surgical gowns.

8. The Sample Size for the Training Set:

Not applicable. As this is a physical medical device and not a machine learning model, there is no "training set" in the context of data used to develop an algorithm. The "development" and "design" of the gown would involve engineering principles and material science, not data training.

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

Not applicable, as there is no training set for this type of device. The design specifications and material selection would be based on existing industry knowledge, material properties, and the requirements of the relevant performance standards.

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Y ADU Surgical Masks (Model E (ear loops, sterile), Model T (tie on straps, sterile/non-sterile/) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended to be used in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile and non sterile.

The YADU Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. They have three layers structure: inner layer, and outer layer. The inner and outer layers are made of spun-bond polypropylene (SPP), and the middle layer is made of melt blown polypropylene filter. Y ADU Surgical Masks have two variants: The model with ear loop and the model with tie-on bands. The mask is held in place over the users' mouth and nose by two elastic ear loops or tie-on bands welded to the side of the mask. The ear loops are made from spandex and polyester elastic, while tie-on bands are made from SPP straps. Neither elastic ear loops nor tie-on bands are made with natural rubber latex. Y ADU Surgical Masks also have nose piece that allows the user to fit the mask around his/her nose. The nose piece is made of polyvinyl chloride coated iron wire. The Surgical Masks provide Level-1 protection per ASTM F2100 definition. They have blue color and are sold in both sterile and non-sterile versions and are intended to be single use, disposable devices.

This document is a 510(k) Pre-Market Notification for YADU Surgical Masks, demonstrating its substantial equivalence to a legally marketed predicate device. The information provided focuses on the technical performance of the surgical masks rather than an AI/ML powered device. Therefore, a direct mapping to the requested information about an AI/ML device is not fully applicable. However, I will extract relevant information from the provided text that corresponds to the structure of your request, interpreting "device" as the surgical mask in this context.

Here's an analysis of the provided text based on your request:

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

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

• Sample Size for performance tests (BFE, Particulate, Differential Pressure, Synthetic Blood): The reported results for BFE, Particulate Penetration, and Synthetic Blood are for 3 production lots. For Differential Pressure (non-sterile), N=32 is explicitly stated. For Synthetic Blood, 32/32 passes indicate a sample size of 32 per lot. For Flammability, 32/32 IBE also indicates a sample size of 32 per lot.
• Data Provenance: The tests are "Non-clinical tests" conducted to verify design specifications. The document states a "Summary of 510k safety and effectiveness information is being submitted." This implies the data is generated specifically for this submission and is likely from laboratory testing of the manufactured devices, not from real-world patient data. The manufacturer is HeNan YADU Industrial Co., Ltd. in China.

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

This section is not applicable to the provided document. The "ground truth" for surgical masks refers to their measured physical and biological performance against standardized test methods (e.g., ASTM F2100, ISO 10993). These are objective laboratory measurements, not expert interpretations of clinical data. Therefore, experts establishing ground truth in the sense of medical diagnoses are not involved.

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

This section is not applicable to the provided document. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where a consensus among human experts is required for a diagnosis or finding. The performance of a surgical mask is determined by objective laboratory tests, not by expert 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 section is not applicable to the provided document. An MRMC study is relevant for evaluating the performance of AI/ML systems in conjunction with human readers, particularly in diagnostic imaging. This document describes a physical medical device (surgical mask) and does not involve AI assistance or human interpretation.

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

This section is not applicable to the provided document. This refers to the performance of an AI algorithm operating independently of human input. The document describes a physical medical device (surgical mask) and does not involve any algorithms.

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

The "ground truth" for the surgical masks is established through objective laboratory measurements against recognized international and national standards (e.g., ASTM, EN, ISO). These standards define specific test methods and performance thresholds for bacterial filtration, particulate filtration, differential pressure, fluid resistance, flammability, and biocompatibility (cytotoxicity, sensitization, irritation).

8. The sample size for the training set

This section is not applicable to the provided document. Surgical masks are not AI/ML devices and therefore do not have "training sets."

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

This section is not applicable to the provided document, as there is no training set for a surgical mask.

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