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The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate material.

The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) meets the level 2 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) have been validated using an ethylene oxide sterilization process. The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.

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This document is a 510(k) summary for a medical device, specifically a Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2). It outlines the FDA's determination of substantial equivalence. However, it does not contain information related to software algorithm performance, clinical study acceptance criteria, or the details of a study proving a device meets such criteria.

The document primarily focuses on:

• Regulatory Clearance: The FDA's decision that the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: The intended purpose of the surgical gowns (protection from microorganisms, body fluids, particulate matter) and their compliance with ANSI/AAMI PB70:2012 for liquid barrier performance (Level 2).
• Sterilization Method: Validation of ethylene oxide (EtO) sterilization.
• Device Models: A list of different models based on size, sterility, and whether they include hand towels and wrap.

Therefore, I cannot provide the requested information about acceptance criteria and study details from the provided text, as this document is a regulatory approval letter, not a performance study report.

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Surgical Drapes (EO Sterilized) is a single use product used as a protective barrier for patient, such as to isolate a site of surgical incision from microbial and other contamination.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for "Plus Surgical Drapes (EO Sterilized), PMDB-XXX," indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.

The document discusses:

• The FDA's review and determination of substantial equivalence.
• Regulatory classifications and requirements.
• Contact information for various FDA divisions.
• The intended use of the surgical drapes.

It does not contain details about:

1. Acceptance criteria and reported device performance (in a table or otherwise).
2. Sample size for test set or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

These details are typically found in a 510(k) submission's performance data section, which is not included in this FDA clearance letter.

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Surgical Gowns (EO Sterilized) are worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room persomel from transfer of microorganisms, body fluids, and particulate material.

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I am sorry, but the provided text describes an FDA 510(k) clearance letter for "Plus Surgical Gowns (EO Sterilized), PMGB-XXX". This document details the FDA's determination of substantial equivalence for a medical device (surgical gowns) based on existing regulations and predicate devices.

This document does not contain any information about an AI/ML device, its acceptance criteria, or a study proving its performance. It pertains to traditional medical device clearance. Therefore, I cannot extract the requested information regarding AI device performance, sample sizes, expert qualifications, adjudication methods, or MRMC studies from this text.

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