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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.

| No. | Model
Number | Name | Size | Category |
|-----|-----------------|---------------------------------------------|-------------------------------------|------------|
| 1 | 18-001 | OR Spunlace Gown, Standard | Medium, Large, X-large,
XX-Large | Standard |
| 2 | 18-101 | OR Spunlace Gown, with Fabric Reinforcement | Medium, Large, X-large,
XX-Large | Reinforced |
| 3 | 18-201 | OR Spunlace Gown, with Poly Reinforcement | Medium, Large, X-large,
XX-Large | Reinforced |
| 4 | 18-301 | OR SMS Gown, Standard | Medium, Large, X-large,
XX-Large | Standard |
| 5 | 18-401 | OR SMS Gown, with Fabric Reinforcement | Medium, Large, X-large,
XX-Large | Reinforced |
| 6 | 18-501 | OR SMS Gown, with Poly Reinforcement | Medium, Large, X-large,
XX-Large | Reinforced |

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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