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Halyard Tri-Layer AAMI 3 Isolation Gowns are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for healthcare personnel and patients from microorganism transfer, body fluids, and particulate matter. The gowns are non-sterile, single use, and meet AAMI PB70:2012 level 3 Liquid Barrier performance requirements. Not intended for use in the operating room.

The Halyard Tri-Layer AAMI 3 Isolation Gown ("Isolation Gown") is a single use gown, supplied non-sterile. The gowns come in the following sizes: Large, X-Large. These surgical gowns are apparel that are intended to be worn by healthcare professionals to protect from varying levels of fluid contact (low to moderate). These surgical gowns meet the AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, Level 3 Requirements. These Isolation Gowns are manufactured from three-layer full length polypropylene SMS material, with neck tape, elastic cuffs, and waist belt closure systems.

The provided document details the non-clinical testing performed on the Halyard Tri-Layer AAMI 3 Isolation Gowns to demonstrate their substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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Copioumed Chemotherapy Isolation Gown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate. Copioumed Chemotherapy Isolation Gown is non-sterile and for single use only.

Copioumed Chemotherapy Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).

Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration.

The Copioumed Chemotherapy Isolation Gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-20 "Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact." Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes. *:

Carmustine [3.3 mg/ml] >480
Cisplatin [1.0 mg/ml] >480
Cyclophosphamide [20 mg/ml] >480
Cytarabine Hydrochloride [100 mg/ml] >480
Dacarbazine [10 mg/ml] >480
Daunorubicin Hydrochloride [5 mg/ml] >480
Doxorubicin Hydrochloride [2 mg/ml] > 480
Etoposide [20 mg/ml] >480
Fluorouracil [50 mg/ml] >480
Ifosfamide [50 mg/ml] > 480
Methotrexate [25 mg/ml] >480
Mitomycin C [0.5 mg/ml] >480
Mitoxantrone [2.0 mg/ml] >480
Paclitaxel [6 mg/ml] >480
Thiotepa [10 mg/ml] >480
Vincristine Sulfate [1 mg/ml] >480

*No permeation was detected at either the minimum detectable permeation or 0.1 ug/cm2/min

Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration. This device is non-sterile and for single use only. Copioumed Chemotherapy Isolation Gown is a Polypropylene Gown laminated with Polyethylene and Knit cuff in three styles: Tie neck closure, Velcro neck closure and Sticker neck closure.

This document pertains to the 510(k) premarket notification for the "Copioumed Chemotherapy Isolation Gown," a Class II medical device. The information provided outlines the device's technical specifications, indications for use, and a comparison to predicate and reference devices, supported by non-clinical testing.

Here's an analysis of the acceptance criteria and study proving the device meets these criteria, as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is primarily evaluated against recognized standards for protective apparel and chemotherapy drug permeation. The criteria and results are summarized in section "L. SUMMARY OF NON-CLINICAL TESTING" on page 14.

Chemotherapy Drug Permeation Resistance (detailed from page 3, 6, and 8):
The device was evaluated for resistance to permeation based on ASTM F739-20. The acceptance criterion for each drug was a breakthrough time of >480 minutes, with "No permeation was detected at either the minimum detectable permeation or 0.1 µg/cm²/min." The device met this criterion for all 16 listed chemotherapy drugs:

• Carmustine [3.3 mg/ml]: >480 min
• Cisplatin [1.0 mg/ml]: >480 min
• Cyclophosphamide [20 mg/ml]: >480 min
• Cytarabine Hydrochloride [100 mg/ml]: >480 min
• Dacarbazine [10 mg/ml]: >480 min
• Daunorubicin Hydrochloride [5 mg/ml]: >480 min
• Doxorubicin Hydrochloride [2 mg/ml]: >480 min
• Etoposide [20 mg/ml]: >480 min
• Fluorouracil [50 mg/ml]: >480 min
• Ifosfamide [50 mg/ml]: >480 min
• Methotrexate [25 mg/ml]: >480 min
• Mitomycin C [0.5 mg/ml]: >480 min
• Mitoxantrone [2.0 mg/ml]: >480 min
• Paclitaxel [6 mg/ml]: >480 min
• Thiotepa [10 mg/ml]: >480 min
• Vincristine Sulfate [1 mg/ml]: >480 min

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

The document does not specify the exact sample sizes (e.g., number of gowns or material samples) used for each specific non-clinical test. It only states that the tests were performed "under the test conditions" for biocompatibility and that results for physical tests (e.g., breaking strength, tearing strength) are given as means and standard deviations, implying multiple samples were tested.

The data provenance is from non-clinical laboratory testing. The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective, beyond acknowledging that these are test results supporting a 510(k) submission. Given it's a 510(k) submission to the US FDA from a Taiwanese company (Copioumed International Inc.), the testing would have been conducted to meet US regulatory requirements, likely in certified labs.

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

This submission is for a physical medical device (isolation gown) and relies entirely on non-clinical laboratory testing against recognized industry standards (ASTM, AAMI, ISO, AATCC, CFR). Therefore:

• No human experts were used to establish ground truth in the context of clinical interpretation (e.g., radiologists for imaging data).
• The "ground truth" is defined by the numerical criteria outlined in the referenced performance standards. The qualifications of the personnel conducting these laboratory tests would be that they are trained and competent in performing the specific standard tests in accredited laboratories. The document does not provide details on these personnel.

4. Adjudication Method for the Test Set

Not applicable. Since the evaluation is based on non-clinical, objective laboratory tests with defined quantitative pass/fail criteria, there is no team of experts adjudicating results in the way one would for clinical data or imaging interpretations. The tests yield objective measurements that are compared against a pre-defined standard's requirements.

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

No. This is a 510(k) submission for an isolation gown, not a software or AI-assisted diagnostic tool. MRMC studies are not relevant for this type of device.

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

Yes, in a sense. The "performance" of this device is its physical and chemical barrier properties and material strength. These are assessed in laboratory settings without human intervention in the loop beyond the initial setup and analysis of the test apparatus. The tests are designed to measure the inherent properties of the gown material and construction.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation is based on defined quantitative and qualitative criteria set by recognized consensus standards (e.g., AAMI PB70:2012 for liquid barrier performance, ASTM F739-20 for chemotherapy drug permeation, various ASTM standards for material strength, and ISO 10993 for biocompatibility). These standards specify the methodology and acceptance criteria for demonstrating the device's protective capabilities.

8. The Sample Size for the Training Set

Not applicable. This device is an isolation gown, not an AI/ML-based device that requires a training set. The evaluation is based on physical and chemical testing of the final product.

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

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

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Disposable Isolation Gowns are 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. This Disposable Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices; provided non-sterile.

Disposable Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is a polypropylene and polyethylene (PP+PE) compound non-woven fabric. The color of the gown is blue. The gown has long sleeves with cuffs and neck fasten belts. There are seam tapes above the sleeves and where the sleeves meet the body. The seam tape is ethylene-vinyl acetate (EVA). The material of cuff is polyester and it is elastic.

The body and sleeve of the Disposable Isolation Gowns are constructed from a blue PP+PE compound non-woven fabric and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a Disposable Isolation Gown. The Disposable Isolation Gown is a single use, disposable medical device.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

Device: Disposable Isolation Gown (K223467)

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 Hydrostatic pressure test and Water impact resistance, the acceptance criteria state "32 of 32 samples pass each location." This implies a sample size of 32 for these specific tests.
  • Specific sample sizes for other non-clinical tests (e.g., seam strength, tensile strength, tear strength, lint generation, flammability, biocompatibility) are not explicitly stated in this document beyond the general "sample" or "test sample." However, these types of tests typically involve testing multiple units or specimens to ensure reproducibility and statistical validity according to the referenced standards.
• Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that the manufacturer is based in China, it is highly probable that the testing was conducted there. All tests described are non-clinical tests, which are typically conducted in a controlled laboratory setting (i.e., not on human subjects), and thus the retrospective/prospective distinction is not applicable in the same way it would be for a clinical trial.

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 as the studies are entirely non-clinical (laboratory-based performance and material property testing). There are no human experts establishing a "ground truth" for diagnostic or clinical interpretation. The "ground truth" for these tests comes from adherence to established international and national standards (e.g., ASTM, ISO, AAMI, AATCC, CPSC CFR) for material properties and barrier performance.

4. Adjudication method for the test set:

• This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., image reading) where there might be disagreement among experts. Since these are non-clinical, objective laboratory tests against pre-defined numerical or qualitative criteria, there is no need for 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:

• No, an MRMC comparative effectiveness study was not conducted. This device is a disposable isolation gown, and the submission focuses on its physical and barrier properties, not on an AI-assisted diagnostic or interpretive tool that would involve human readers.

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

• No, a standalone algorithm-only performance study was not conducted. This device is manufactured personal protective equipment (PPE), not software or an AI algorithm. The performance evaluation is based on material and product testing against established engineering and safety standards.

7. The type of ground truth used:

• The "ground truth" for these non-clinical tests is based on established testing standards and regulatory requirements. This includes:
  • Material properties: Tensile strength, tear strength, seam strength, lint generation, flammability, all measured against specific ASTM and ISO standards with predefined passing criteria.
  • Barrier performance: Hydrostatic pressure and water impact resistance, measured against AAMI PB70:2012 (Level 3) and AATCC standards.
  • Biocompatibility: Cytotoxicity, irritation, and sensitization, measured against ISO 10993 standards with "not cytotoxic," "not an irritant," and "not a sensitizer" as the ground truth.
  • Shelf-life stability: Demonstrated by meeting all performance requirements after accelerated aging, with the original acceptance criteria serving as the ground truth for stability.

8. The sample size for the training set:

• This information is not applicable as the device is a physical product (disposable isolation gown), not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.

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

• This information is not applicable for the reason stated above.

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Disposable Isolation Gowns are 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. This Disposable Isolation Gowns meet the requirements of AAMI Level 3 barrier protection for a surgical isolation gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices, provided non-sterile.

Disposable Isolation Gowns are designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is Polypropylene(PP) non-woven with polyethylene(PE) lamination. It is a kind of Non- Reinforced isolation gown. The sleeve and body of the Disposable Isolation Gowns are constructed from a blue PP&PE (non-woven fabric, PE lamination) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Isolation Gowns are single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations with 6 sizes, S,M,L,XL,XXL,and XXXL.

The provided text describes the acceptance criteria and performance data for a medical device, specifically Disposable Isolation Gowns. However, it is not an AI/ML powered medical device. Therefore, the requested information pertaining to AI/ML model performance, such as sample sizes for test sets, data provenance, expert consensus for ground truth, MRMC studies, or training set details, is not applicable to this document.

The document focuses on demonstrating the substantial equivalence of the proposed isolation gowns to a legally marketed predicate device based on their physical properties, barrier performance, and biocompatibility.

Here's the relevant information that can be extracted, presented in the requested format where applicable:

Acceptance Criteria and Reported Device Performance for Disposable Isolation Gowns

1. Table of Acceptance Criteria and Reported Device Performance

Points 2-9 are not applicable as this is not an AI/ML medical device submission.

• 2. Sample size used for the test set and the data provenance: Not applicable. The tests are for physical and biological properties of the gowns, not an AI/ML model. The testing is based on standard methods for material properties. The provenance is internal testing by the manufacturer (Xiamen Probtain Medical Technology Co., Ltd. in China).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical and biological tests is defined by established international standards (ISO, ASTM, AATCC, CPSC).
• 4. Adjudication method for the test set: Not applicable. Results are quantitative measurements against defined 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: Not applicable. This is not an AI/ML device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
• 7. The type of ground truth used: For physical and barrier performance, the "ground truth" is defined by the acceptance criteria specified in the referenced industry standards (e.g., AAMI PB70:2012, ASTM, ISO, AATCC, CPSC 16 CFR). For biocompatibility, it's the biological response observed under standardized test conditions (e.g., non-cytotoxic, non-irritating, non-sensitizing).
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary: The provided document is a 510(k) submission for a non-AI/ML medical device (disposable isolation gowns). The "study" proving the device meets acceptance criteria consists of a battery of non-clinical, laboratory-based tests of the product's physical, barrier, and biocompatibility properties, demonstrating compliance with recognized standards. The concept of an "AI/ML model" and associated metrics (training/test sets, human readers, ground truth creation for AI) does not apply to this submission.

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Disposable Isolation Gowns are 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. This Disposable Isolation Gown meets the requirements of AAMI Level 3 barrier protection for a surgical isolation gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices, provided sterile.

Disposable Isolation Gowns are designed for the medical personnel use in medical environment, not intended for use in the operating room. The employed material is Polypropylene(PP) non-woven with polyethylene(PE) lamination. It is a kind of Non- Reinforced isolation gown. The Disposable Isolation Gowns are constructed from a blue PP&PE (non-woven fabric, PE lamination) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Isolation Gowns are blue color, sterilized by ethylene oxide gas , single use, disposable medical device that will be provided in a variety of sterile packaging configurations with 6 sizes, S,M,L,XL,XXL,and XXXL

The provided document describes the acceptance criteria and the results of non-clinical tests for the "Disposable Isolation Gowns" (K223411) from Xiamen Probtain Medical Technology Co., Ltd.

Here's the requested information:

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

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The Paneffort AAMI Level 3 Isolation Gowns are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Paneffort AAM Level 3 Isolation Gowns meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.

The Paneffort AAMI Level 3 Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code FYC. The Paneffort AAMI Level 3 Isolation Gown is a single use, disposable medical device provided non-sterile. Paneffort AAMI Level 3 Isolation Gown is offered in one color (blue) and six different sizes of Small, Medium, Regular/Large, X-Large, 2X-Large, and 3X-Large. Each model is constructed of a nonwoven Spunbond-Meltblown-Spunbond (SMS) material that is tested according to ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3.

The Paneffort AAMI Level 3 Isolation Gown consists of one critical zone throughout the entire gown including seams, but excluding cuffs, hems, and bindings as per AAMI PB70:2012. It is a protective tape sealed gown along with other design features like tieneck, elastic cuffs, and belt tie, that meets AAMI PB70 Level 3 barrier performance for protective apparel.

This document describes the non-clinical testing performed on the Paneffort AAMI Level 3 Isolation Gown to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Water Resistance (Hydrostatic Pressure): The reported performance shows individual sample failures within each lot (3 out of 32 in Lot 1, 3 out of 32 in Lot 2, and 2 out of 32 in Lot 3). However, the "Conclusion" column for this test still states "The test meets the Acceptance Criteria." This implies that the passing condition is based on an Allowable Quality Level (AQL) or a specific sampling plan where a certain number of defects are permitted within the sample size while still meeting the overall acceptance criteria (Ac: 3, Re: 4; AQL: 4%).

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

• Sample Sizes:
  • Bursting Strength, Basis Weight, Linting Test, Air Permeability, Tensile Strength/Breaking Strength, Tearing Strength, Seam Strength, Flammability, Water Vapour resistance: 32 samples each from 3 different lots (total 96 samples per test).
  • Water Resistance: Hydrostatic Pressure and Impact Penetration: Lot 1: 74 pieces; Lot 2: 72 pieces; Lot 3: 72 pieces (total 218 pieces across 3 lots for each test).
• Data Provenance: The document does not explicitly state the country of origin for the testing data. However, the manufacturer is Paneffort (Cambodia) Garment Co. Ltd., and the specification developer is Paneffort, LLC (USA). The testing standards are international (ASTM, AATCC, ISO, CFR), suggesting tests were conducted in reputable labs, but the specific location of the test facilities is not provided. The data is retrospective, as it was collected to support a 510(k) submission for a device that has already been manufactured and tested.

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

• Not Applicable. This study is a non-clinical performance testing of a physical medical device (isolation gown) against established engineering and material science standards. It does not involve human interpretation of data or diagnostic tasks where expert ground truth would be required. The "ground truth" here is objective measurement against specified criteria.

4. Adjudication Method for the Test Set:

• Not Applicable. As no expert review or human interpretation for diagnosis is involved, there is no adjudication method in the traditional sense. The pass/fail criteria are defined by the testing standards and AQLs.

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

• No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images). This submission is for a physical medical device (isolation gown) and does not involve human readers or diagnostic cases.

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 product. The performance reported is that of the gown itself, as tested in a lab environment.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is based on established industry and regulatory standards for protective apparel. This includes:
  • ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities (specifically Level 3).
  • Various ASTM, AATCC, ISO, and CFR standards for material properties and flammability.
  • ISO 10993 for biocompatibility.
• The tests generate objective, measurable data that is compared directly to the numerical acceptance criteria defined in these standards.

8. The Sample Size for the Training Set:

• Not Applicable. This device does not use machine learning or AI, and therefore does not have a "training set." The performance is inherent to its physical design and materials, verified through non-clinical testing.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown (Model number: IL4036YKTP-L4) is intended to provide barrier protection and protect healthcare personnel and patients from the transfer of microorganisms, body fluids and particulate material. CoverU Disposable Gown with Tape meets the requirements of AAMI Level 4 barrier protection for a surgical isolation gown per ANSI/ AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Not intended for use in the operating room. CoverU Disposable Gown with Tapes is a single use, disposable medical device provided non-sterile.

The CoverU Disposable Gown with Tape - Chemo Gown (Model number IL-4036YKTP-CM) is intended to provide barrier protection and protect healthcare personnel and patients from the transfer of microorganisms, body fluids and particulate material. CoverU Disposable Gown with Tape meets the requirements of AAMI Level 4 barrier protection for a surgical isolation gown per ANSI/ AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Not intended for use in the operating room. CoverU Disposable Gown with Tapes is a single use, disposable medical device provided non-sterile. The gowns have been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12, Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact. Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes *:

Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etopside [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 lfosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480 Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480 Docetaxel [10mg/ml] >480 Oxaliplatin [5mg/ml] >480 Leucovorin [10mg/ml] >480

*No permeation was detected at either the minimum detectable permeation or 0.1 ug/cm2/min

The CoverU Disposable Gown with Tape is constructed of PPSB Coated PE materials with the color in yellow. It is sealed the seam by Adheresive tape provide protection from liquid borne. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. Tie at the neck and waist for secure protection AAMI level 4 standard provides high performance on hydrostatic pressure and fluids impact.

The CoverU Disposable Gown with Tape is sold in one size, non-sterile and is intended to be a single use, disposable device, and does NOT contain any drugs or biologics and not made with natural rubber latex. The two gown models are exact the same gowns, except the chemo-drug labeling claim. one is intended to protect workers from high fluid level (blood body fluids etc.) and blood borne pathogen, and the other is intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration. Ten (10) pieces of CoverU Disposable Gown with Tape are packaged in a plastic bag and ten bags are outer packaging with a paper carton box. These gowns are offered in a universal size.

The provided document is a 510(k) premarket notification for a medical device, specifically a disposable gown. The acceptance criteria and the proof of meeting those criteria are detailed in the non-clinical performance testing section.

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

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

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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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The Isolation Gowns are 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. In addition, The Isolation Gowns meet 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 and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical non-sterile.

The Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC. The Isolation Gown is offered in two colors (yellow and blue) and each color is offered in five sizes (S, M, L, XL and XXL) for a total of ten models. Each model is constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. The Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations.

The provided text describes the acceptance criteria and the results of non-clinical tests for an Isolation Gown. This is a medical device, specifically protective apparel, and not an AI/ML device. Therefore, the questions related to AI/ML device studies, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable to this document.

Here's the relevant information based on the provided text for the Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)):

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

2. Sample sized 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 specific test but indicates that tests were performed on "Yellow Isolation Gown XXL" and "Blue Isolation Gown XXL". The tests are non-clinical, related to material properties of the gown. Data provenance (country of origin, retrospective/prospective) is not provided as this is an evaluation of a physical medical device, not a data-driven model.

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. This is a physical medical device (isolation gown), not an AI/ML device relying on expert interpretation for ground truth. Ground truth is established by physical and chemical testing standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical medical device, not an AI/ML device requiring adjudication of 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. This is a physical medical device, not an AI/ML device.

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 AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth is based on established international and national standards for performance and safety of protective apparel and medical devices. Specifically:

• ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use In Health Care Facilities (for liquid barrier performance)
• AATCC 127-2018e (Water Resistance: Hydrostatic Pressure Test)
• AATCC 42-2017 (Water Resistance: Impact Penetration Test)
• ASTM D 5034-2009 (2017) (Breaking Strength and Elongation)
• ASTM D 5587-2015 (Tearing Strength)
• ASTM D1683/D1683M-2017 (2018) (Seam Strength)
• ISO 9073-10:2003 (Lint and other particles generation)
• ASTM F 1868-2017 (Thermal and Evaporative Resistance)
• 16 CFR Part 1610 (Flammability Test)
• ISO 9073-1:1989 (Mass Per Unit Area)
• ISO 10993-1:2018, ISO 10993-5, ISO 10993-10 (Biocompatibility)

8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML device that requires a training set with established ground truth.

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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.

Not Found

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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