Search Results

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.

Ask a specific question about this device

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

Ask a specific question about this device

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

Ask a specific question about this device

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

Ask a specific question about this device