(251 days)
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/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, SMS Standard Surgical Gown with Reinforcement met the requirements for Level 3 classification; BVB Surgical Gown and BVB Splicing Surgical Gown met the requirements for Level 4 classification.
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The provided document K192290 refers to the 510(k) premarket notification for surgical gowns. This type of regulatory document typically focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing related to the physical properties of the device (such as barrier protection), rather than clinical studies involving detailed AI/algorithm performance metrics, expert adjudication, or reader studies as implied by your request.
Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.
However, I can extract the relevant acceptance criteria and reported performance for the surgical gowns from the document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are based on the ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The document specifies that the surgical gowns met the requirements for certain levels.
| Acceptance Criteria (ANSI/AAMI PB70:2012 Classification Level) | Reported Device Performance |
|---|---|
| Level 3 (Liquid Barrier Performance) | SMS Standard Surgical Gown with Reinforcement met the requirements for Level 3 classification. |
| Level 4 (Liquid Barrier Performance) | BVB Surgical Gown and BVB Splicing Surgical Gown met the requirements for Level 4 classification. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not explicitly stated in the provided document. The 510(k) summary would typically refer to compliance with standards like ANSI/AAMI PB70:2012, which includes specific testing methodologies and sample size requirements for evaluating barrier performance. However, the exact number tested by the manufacturer for this submission is not detailed here.
- Data provenance: The testing would have been conducted by the manufacturer, Xuchang Zhengde Environstar Medical Products Co., Ltd, or a contracted testing laboratory, to demonstrate compliance with the ANSI/AAMI standard. No information on country of origin of data or retrospective/prospective nature is given beyond the company's origin (China).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device's performance is evaluated through physical and material property testing against a standard (ANSI/AAMI PB70:2012), not clinical interpretation by medical experts.
4. Adjudication method for the test set
Not applicable. This is not a study requiring expert adjudication of results. Performance is determined by standardized laboratory tests.
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/algorithm-based device and no MRMC study on human reader performance is relevant or was conducted for this submission.
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.
7. The type of ground truth used
The "ground truth" for this device's performance is defined by the standardized test methods and performance requirements outlined in ANSI/AAMI PB70:2012. This standard specifies how to measure liquid barrier performance (e.g., impact penetration and hydrostatic pressure tests for Level 3; viral penetration resistance for Level 4) and the criteria for classifying a gown into a specific level.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that utilizes a training set.
9. How the ground truth for the training set was established
Not applicable. Refer to point 8.
§ 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.