(169 days)
The Sterile View Barrier Hood/Gown with Hytrel is intended as disposable surgical apparel to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
The Barrier Hood/Gown with Hytrel is a sterile surgical gown, manufactured from Dexter paper and Sontara polyester fabric with a Hytrel polymeric coating. The Dexter paper is used for the hood and gown back. The Sontara/Hytrel material is used on the gown front and sleeves. A molded, polycarbonate face shield is sealed to the hood material. The Sontara/Hytrel material is fluid resistant but vapor transmissive. The gown therefore protects the wearer from fluid borne pathogens, while maintaining "breathability". The Barrier Hood/Gown with Hytrel is available in three sizes: size 1, size 2 and size 2 long. Testing has shown that the Sontara/Hytrel material of the Barrier Hood/Gown with Hytrel passes ASTM standard tests ES-21 for resistance to synthetic blood and ES-22 for resistance to penetration by blood borne pathogens using viral penetration as a test system.
The provided text describes a medical device, the DePuy Sterile View Barrier Hood/Gown with Hytrel, which is surgical apparel. The information focuses on its intended use, design, and comparison to substantially equivalent devices. However, the text does not contain information about acceptance criteria, detailed study designs, sample sizes for test or training sets, ground truth establishment, expert involvement, or any data related to AI performance or MRMC studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or AI-related studies based solely on the provided text.
The closest I can get to "acceptance criteria" are the performance standards the device is claimed to meet, which are:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| ASTM ES-21 for resistance to synthetic blood | Passes |
| ASTM ES-22 for resistance to penetration by blood-borne pathogens using viral penetration as a test system | Passes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given text.
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):
This information is not provided in the given text, and is not applicable as this is a physical barrier device, not an AI or diagnostic device that would require expert-established ground truth in a clinical context. The "ground truth" here would be the physical properties of the material and its ability to prevent penetration.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the given text, and is not applicable to material performance testing.
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 information is not provided in the given text. This device is not an AI device, so an MRMC study related to AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the given text. This device is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance would be the results of standardized material property tests (ASTM ES-21 and ES-22) which assess the physical barrier capabilities against fluids and pathogens. It's not data derived from expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set:
This information is not provided in the given text. A "training set" is not applicable as this is not an AI device.
9. How the ground truth for the training set was established:
This information is not provided in the given text. A "training set" and its ground truth establishment are not applicable as this is not an AI device.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.