Search Results

The Disposable Surgical Gown Rk-3011C is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the 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 Disposable Surgical Gown Rk-3011C surgical gowns met the requirements for Level 3 classification.

This is a single use, disposable device(s), provided non-sterile. The Surgical Gowns is to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.

The proposed surgical gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relablers for further packaging and Ethylene Oxide (EO) sterilization.

The gown is manufactured with four layers: the inner and outer layers are made of spun-bond polypropylene and the middle layers are made of melt blown polypropylene. All gowns are reinforced with polypropylene and microporous reinforcement material. The proposed surgical gown is only available in the available sizes of the proposed surgical gown are M, L, XL, and XXL.

The cuffs are composed of cotton and terylene. The back is open with ties to secure the gown.

The provided text describes the acceptance criteria and the study results for a medical device, specifically a "Disposable Surgical Gown Rk-3011C".

Here's the requested information:

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

2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for each test. The tests are non-clinical (laboratory-based) and are likely performed on a representative sample of the surgical gowns. The data provenance is not explicitly mentioned but implies standard laboratory testing for medical devices, which is generally global in applicability.

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 study involved non-clinical performance testing against established physical and chemical standards, not expert assessments of clinical outcomes or images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the study involved non-clinical performance testing against objective, measurable standards, not subjective assessments requiring 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 is not applicable. The device is a surgical gown, and the study focuses on its physical and chemical properties, not artificial intelligence or human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a surgical gown, and the study focuses on its physical and chemical properties, not algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this study is defined by established international and national standards for surgical gowns, such as ASTM, AATCC, ANSI/AAMI, and ISO. These standards provide objective, measurable criteria for physical properties (e.g., tensile strength, tear strength, water resistance) and biological safety (e.g., biocompatibility, residuals).

8. The sample size for the training set
This is not applicable. The device is a physical product (surgical gown) and does not involve a training set as would be used for AI or machine learning models.

9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device and study.

Ask a specific question about this device