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proMedical Surgical gowns are intended 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 micro-organisms, body fluids, and particulate matter.

proMedical Surgical Gowns are disposable, single use, sterile surgical gowns manufactured from non-woven spunbond-meltblown-spunbond polypropylene or spun-laced fabrics. Gowns are provided as listed below.

This document is a 510(k) clearance letter for "ProMedical Surgical Gowns". This type of document typically provides regulatory approval based on substantial equivalence to a predicate device, rather than detailed acceptance criteria and a study proving performance against those criteria.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in these specific FDA clearance letters. These details are usually part of the 510(k) submission itself, which is not publicly released in its entirety.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the device was found to be as safe and effective as a legally marketed predicate device, not that a new study against specific acceptance criteria for a novel device was conducted or detailed here.

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proMedical Products Co. LTD intends to market Non-sterile surgical gowns identified in 21 CFR 878.4040 as medical devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from the transfer of microorganisms, bodily fluids and particulate material.

Surgical Gowns

This document is an FDA 510(k) clearance letter for "Surgical Gowns" (K042111) and does not contain information about the acceptance criteria or a study proving that a device meets those criteria, as typically found in a clinical study report or a summary of safety and effectiveness (SSE).

Instead, this letter:

• Confirms substantial equivalence: It states that the device is substantially equivalent to legally marketed predicate devices.
• Specifies regulation information: It lists the regulation number, name, and product code.
• Outlines general regulatory requirements: It reminds the applicant about various FDA regulations they must comply with, such as annual registration, labeling, and good manufacturing practices.
• Includes "Indications for Use": This section describes the intended purpose of the surgical gowns (protection from microorganisms, bodily fluids, and particulate material) but does not provide specific performance metrics or acceptance criteria from a study.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone), or training set information from the provided text. This type of information would typically be detailed in the 510(k) submission itself or a separate study report, not in the FDA's clearance letter.

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