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The TotalShield Zippered Surgical Toga and/or TotalShield Surgical Hood is for use with the TotalShield Surgical Helmet and/or TotalShield Advanced Surgical Helmet with LED lighting as the TotalShield Surgical Helmet System that is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The TotalShield Zippered Surgical Toga and/or TotalShield Surgical Hood are used with the TotalShield Surgical Helmet and/or TotalShield Advanced Surgical Helmet with LED lighting as the TotalShield Surgical Helmet System to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The TotalShield Surgical Helmet and Advanced Surgical Helmet with LED lighting have a battery powered fan, which provides a continuous flow of air in the TotalShield Surgical Hood or Zippered Surgical Toga.

The TotalShield Surgical Hood is a stand-alone head cover that may be worn with a separate surgical gown, while the TotalShield Zippered Surgical Toga is a one-piece head and body cover.

The stand-alone TotalShield Surgical Hood is identical to the hood that is incorporated into the TotalShield Zippered Surgical Toga. The TotalShield Surgical Hood or Zippered Surgical Toga must be worn over a TotalShield Surgical Helmet or Advanced Surgical Helmet with LED lighting.

The TotalShield Zippered Surgical Toga has been tested to meet the applicable AAMI PB70 standards for level 3 compliance. The AAMI standard does not cover apparel for the head. face, and eyes. Therefore, the hoods and lens are exempt from classification under the AAMI PB70:2003 standard.

The TotalShield™ Surgical Helmet System, including the TotalShield Zippered Surgical Toga and/or TotalShield Surgical Hood, is designed to be worn by surgical personnel to create a barrier and protect against contamination and exposure to infectious body fluids and harmful microorganisms. The device's performance was evaluated through a series of internal and consensus standard tests, demonstrating its equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each test in the test set. However, it indicates that "all tests passed according to predetermined acceptance criteria," suggesting that a sufficient number of samples were tested to demonstrate compliance with the referenced standards.

The data provenance is from non-clinical performance testing conducted by Zimmer Surgical, Inc. The document does not specify a country of origin for the data beyond the manufacturer's location in Dover, OH, USA. The studies are by nature prospective as they were conducted during the development process to ensure the device met safety and effectiveness standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of medical device (surgical apparel and helmet system) does not typically involve human expert interpretation for "ground truth" establishment in the same way an AI diagnostic imaging device would. The "ground truth" for the performance tests listed (e.g., flammability, sterility, material strength, barrier properties, airflow, noise, battery life) is established by adherence to recognized consensus standards (e.g., ASTM, ISO, AAMI/ANSI). Therefore, the "experts" involved would be the test engineers and laboratory personnel performing the standard tests and interpreting the results against the predefined Pass/Fail criteria of those standards. Their qualifications would be expertise in materials science, microbiology, mechanical engineering, electrical engineering, and quality assurance, relevant to the specific tests performed.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense. The "adjudication" is inherent in the Pass/Fail criteria defined by the consensus standards and the internal test methods. If a test yields a result outside the acceptable range, it fails. There's no subjective interpretation requiring an adjudication panel for these types of performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, an MRMC comparative effectiveness study was not done. This type of study applies to devices, often AI-powered, that assist human readers (e.g., radiologists) in diagnostic tasks. The TotalShield™ Surgical Helmet System is a physical barrier device for surgical personnel, not a diagnostic tool requiring human interpretation with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.

The concept of "standalone performance" in the context of an algorithm without human-in-the-loop is not applicable to this device. The TotalShield™ Surgical Helmet System is a physical product designed for human use, not an algorithm. The performance tests conducted are intrinsically "standalone" in that they evaluate the physical properties and functional aspects of the device itself (e.g., the fan's airflow, the material's barrier properties) independent of a human's judgment or interaction beyond its intended use.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on objective measurements and predefined thresholds established by recognized consensus standards (e.g., AAMI/ANSI PB70 for liquid barrier performance, ASTM standards for material properties, ISO standards for sterilization and biocompatibility). The "ground truth" is whether the device's measured performance meets or exceeds the specifications outlined in these standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The testing involved physical prototypes or production samples of the device undergoing various performance tests.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

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