(202 days)
JOYKEY Surgical Gowns (Sterile) are single use article of surgical apparel 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.
JOYKEY Surgical Gowns (Sterile) are non-reinforced surgical Gowns manufactured from non-woven fabric. The surgical Gown is supplied sterile and for single use only.
The provided text describes a 510(k) premarket notification for JOYKEY Surgical Gowns (Sterile). This type of device is classified as medical apparel, which falls under general controls and performance standards rather than requiring a complex clinical study with AI components. Therefore, many of the requested categories in your query (e.g., sample size for test set, number of experts for ground truth, MRMC study, AI improvement effect size, training set insights) are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Standard | Reported Device Performance (Conforms To) |
|---|---|
| ASTM F1670-03 | Barrier properties against blood and body fluids |
| ASTM D1424 | Physical specifications (related to tear resistance, flexibility) |
| ASTM D5034 | Physical specifications (related to tensile strength, elongation) |
| NFPA Standards | Flammability standards |
| ISO 10993 series | Biological standards (biocompatibility) |
| ISO 11137 | Gamma Sterilization standard |
Note: The specific performance values or thresholds for each standard are not detailed in the provided summary, only that the device conforms to them.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission refers to "bench testing" which implies laboratory tests on samples of the gown material rather than a clinical "test set" with patient data. The provenance of the test materials is not specified, but they are manufactured by JOYKEY INDUSTRYIAL LTD. in Hong Kong. The testing is retrospective in the sense that the results were generated prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth for surgical gowns is established by adherence to recognized national and international performance standards (e.g., ASTM, ISO, NFPA) through laboratory testing, not expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable. As ground truth is based on laboratory test results against established material standards, there is no need for an adjudication method as would be used in an imaging or diagnostic study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A MRMC study is not relevant for surgical gowns. This type of study is typically performed for AI-assisted diagnostic devices to evaluate the impact of the AI on human readers' performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This device is not an algorithm or AI system. It is a physical medical device (surgical gown).
7. The Type of Ground Truth Used
The ground truth used for proving the device meets acceptance criteria is compliance with established national and international performance standards for physical characteristics, barrier properties, flammability, biocompatibility, and sterility. This is demonstrated through objective laboratory (bench) testing.
8. The Sample Size for the Training Set
Not applicable. There is no AI component in this device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI component or training set, this information is not relevant.
§ 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.