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The AAMI4 Isolation Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed AAMI4 Isolation Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB 70:2012, Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The AAMI4 Isolation Gown is a single use, disposable medical device provided non-sterile.

The proposed device, AAMI4 Isolation Gown, is intended to protect health care personnel and patients 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. There is one model of AAMI4 Isolation Gown: 4015T. And the proposed AAMI4 Isolation Gown is available in one product size: U. The barrier protection level for AAMI4 Isolation Gown meets AAMI Level 4. The proposed device consists of five components: 1) Basic Gown, 2) Belt, 3) Cuff, 4) Hook-and-loop Velcro and 5) Seam Sealing Tape. The gown is made of polypropylene and polyethylene laminating. The gown is blue in color.

The provided document is a 510(k) summary for a medical device called "AAMI4 Isolation Gown." This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving human readers or AI assistance. Therefore, information regarding human readers, AI assistance, effect size, standalone algorithm performance, and sample size for training sets is not available in this document.

Here's the information that can be extracted from 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 specify the exact sample sizes for each test. It refers to "test sample" for each methodology. The tests were performed in accordance with international and US standards. The manufacturer is Hubei Xinxin Non-woven Co., Ltd. from Xiantao, Hubei, China. The data provenance is non-clinical laboratory testing; it does not involve human data, thus the terms "retrospective" or "prospective" are not applicable.

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. The ground truth for these non-clinical tests is established by the specified industry and regulatory standards, not by human experts.

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

Not applicable. This is a non-clinical performance and biocompatibility study, not a clinical study requiring human 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

No, an MRMC comparative effectiveness study was not done. This document does not describe studies involving human readers or AI.

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

Not applicable. This document describes the testing of a physical medical device (an isolation gown), not an algorithm.

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

The ground truth for the performance tests (Flammability, Hydrostatic pressure, Water impact, Breaking strength, Tearing strength, Linting, Seam strength, Viral barrier) is defined by the technical specifications and requirements within the referenced industry standards (e.g., 16 CFR Part 1610, AATCC 127, ASTM D5034, ISO 9073-10, ASTM D1683/D1683M, ASTM D5587, ASTM F1671/F1671M-13).

The ground truth for the biocompatibility tests (Cytotoxicity, Sensitization, Irritation) is defined by the requirements and methodologies within the ISO 10993 series of standards (ISO 10993-5, ISO 10993-10).

8. The sample size for the training set

Not applicable. This document describes the testing of a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. There is no training set for a physical medical device.

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Isolation Gown, Model 4005 and 4022, is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not in the operating room. In addition, the Isolation Gown, Model 4005 and 4022 meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gown, Model 4005 and 4022, is a single use, disposable medical device provided non-sterile.

Protective Gown, Model 4021, is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. The Protective Gown, Model 4021, is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.

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The provided text is related to the FDA clearance of "Isolation Gown" and "Protective Gown" products. It is a 510(k) premarket notification letter, which establishes substantial equivalence to a predicate device. This type of clearance does not involve a study to prove a device meets acceptance criteria in the way a medical AI/software device would.

Instead, for these types of physical medical devices (gowns), the "acceptance criteria" are typically defined by recognized standards related to their physical properties and barrier performance. The "study that proves the device meets the acceptance criteria" would be laboratory testing against those standards.

Based on the provided text, here's what can be extracted and interpreted in the context of an AI/software device's performance study:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical gown and not an AI/software device, the "acceptance criteria" are material and performance standards, not typical AI metrics like sensitivity, specificity, or AUC.

For the Protective Gown, Model 4021, no specific AAMI level is claimed in the "Indications for Use" section provided.

Regarding the Absence of AI/Software Device Specific Information:

The rest of the requested information (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, training ground truth) is not applicable to this S10(k) clearance document for physical gowns. These are metrics specifically used for evaluating and clearing AI and software as a medical device (SaMD) products, which are fundamentally different from the personal protective equipment described here.

This document serves as an FDA clearance letter confirming substantial equivalence to a legally marketed predicate device, primarily based on the device's intended use and compliance with relevant performance standards (like AAMI PB70 for the isolation gown). It does not contain details about clinical studies or AI algorithm performance validation.

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

XX0009 Ear loop Level: Level 1, Level 2 and Level 3
XX0008 Tie-on Level: Level 1, Level 2 and Level 3
XX0006 Tie-on with shield Level: Level 1, Level 2 and Level 3
XX0005 Ear loop with shield Level: Level 1, Level 2 and Level 3

The surgical masks are single use, flat-pleated masks that are provided in blue. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter is made of one layer of meltblown polypropylene filter. The Surgical Masks are available in four types due to different configurations, including ear loop, tie-on, ear loop with shield and tie-on with shield. Detail configurations of them are presented in Table 1 Surgical Masks Description. The ties are made of spunbond polypropylene and the ear loops are made of spandex. The shield is made of PET. The nose piece is made of iron wire and polypropylene. Users can adjust the nose piece according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The proposed devices are provided in non-sterile. The proposed devices contain four (4) types of masks: XX0009, XX008, XX0006 and XX0005. Each of these types have three different levels, level 2, and level 3. Therefore, the proposed devices have 12 models in toto, and detailed model information is provided in Table 1.

The provided text is a 510(k) Summary for Surgical Masks (K212120), focusing on demonstrating substantial equivalence to a predicate device (K160269) through non-clinical testing. It does not describe a study involving an AI (Artificial Intelligence) or medical imaging device, nor does it involve a multi-reader multi-case (MRMC) study. Therefore, many of the requested details, such as human reader improvement with AI assistance, ground truth establishment for AI training/test sets, or the number of experts for adjudication, are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria, specifically for the surgical masks.

Acceptance Criteria and Device Performance for Surgical Masks (Based on Non-Clinical Tests)

1. Table of Acceptance Criteria and Reported Device Performance

The non-clinical tests were conducted to verify that the proposed device met all design specifications. The performance levels (Level 1, Level 2, Level 3) refer to classifications defined by ASTM F2100: 2019 "Standard Specification for Performance of Materials Used in Medical Face Masks."

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