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The ViVi® Toga Premium is a component of the ViVi® System and is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The ViVi® Toga Premium is a one-piece head and body cover that is worn by healthcare professionals. The ViVi® Toga Premium is a component of the ViVi® Surgical Helmet System and worn over the air-exchanging surgical helmet. The ViVi® Toga Premium is used with the ViVi® Helmet or the ViVi® Helmet HPL (High Power LED) with Light Emitting Diode (LED) light to provide a barrier between the operating environment and the surgical personnel to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

ViVi® Toga Premium is designed and has been tested to meet the applicable AAMI PB70 standards for level 4 compliance. The AAMI standard does not cover apparel for the head, face, and eyes. Therefore, the hood area and the lens are exempt from classification under this standard.

The provided FDA 510(k) clearance letter for the ViVI® Toga Premium is for a Class II surgical apparel device. This document primarily details the substantial equivalence of the ViVi® Toga Premium to a predicate device based on non-clinical performance data. It explicitly states that "No clinical evaluation is necessary for this device."

Therefore, this document does not describe a study involving an AI/Machine Learning (ML) algorithm with a test set, ground truth, expert adjudication, or MRMC studies. The device is a physical product (surgical toga/gown), and its "performance" is related to its physical properties and barrier capabilities, not diagnostic or predictive accuracy.

Given the information provided, it's not possible to fulfill the request for acceptance criteria and study details related to an AI/ML device. The "study" mentioned in the document refers to non-clinical laboratory testing of material properties.

However, I can extract the acceptance criteria and the "reported device performance" based on the provided document as it relates to this specific physical device.

Acceptance Criteria and Reported Device Performance for ViVi® Toga Premium (Surgical Apparel)

Based on the provided FDA 510(k) clearance letter for the ViVi® Toga Premium, the acceptance criteria and reported device performance relate to its physical properties and barrier capabilities, as it is a surgical apparel device and not an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the standards and tests performed, with "PASS" indicating successful compliance.

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

• Sample Size: The document does not specify the exact sample sizes (number of garments or material samples) used for each individual non-clinical test. The testing is reported as "tests were conducted and completed," indicating standard laboratory evaluations.
• Data Provenance: Not applicable in the context of clinical data. The tests are material and performance tests conducted in a laboratory setting. No geographical origin of "data" in the sense of patient data is mentioned, as this is a physical product. The manufacturer is THI Total Healthcare Innovation GmbH, based in Austria. The predicate device manufacturer is Zimmer Surgical, Inc.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This device is surgical apparel, and its "performance" is assessed through standardized physical and biological material testing, not through expert human interpretation of data like images or clinical outcomes. There is no "ground truth" in the diagnostic AI sense.

4. Adjudication Method for the Test Set

• Not applicable. As described above, there is no expert adjudication process for this type of device. Performance is determined by meeting pre-defined regulatory standards and test method specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study is a type of clinical study used to evaluate the performance of diagnostic devices (often imaging-based AI) by comparing the accuracy of multiple human readers with and without AI assistance across multiple cases. This does not apply to a surgical apparel device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

• Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

• Not applicable in the context of AI/ML. The "ground truth" for this device's performance is derived from established international and national standards (e.g., ISO, ASTM, ANSI/AAMI, CFR), which define objective physical and chemical properties and test methodologies. Meeting these standards serves as the "truth" for device functionality.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device and does not have a training set or associated ground truth.

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The ViVi® Hood is used with the ViVi® Helmet and/or ViVi® Helmet HPL as the ViVi® 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 ViVi® Helmet and ViVi® Helmet HPL has a battery powered fan, which provides a continuous flow of air in the the ViVi® Hood.

The ViVi® Hood is a stand-alone head covers that may be worn with a separate surgical gown. The ViVi® Hood, must be worn over a ViVi® Helmet or ViVi® Helmet HPL.

The ViVi" Surgical Helmet System is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The ViVi" Surgical Helmet System is composed of sterile ViVi" Hood, which is used with the unsterile ViVi" Helmet or the unsterile ViVi" Helmet HPL (High Power LED) with Light Emitting Diode (LED) light to provide a barrier between the operating environment and the surgical personnel to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. The components include a top-covering sterile surgical hood (ViVi" Hood), an air-exchanging surgical helmet (ViVi" Helmet), and an air-exchanging surgical helmet with LED light (ViVi" Helmet HPL). The surgical hood is sterilized with Ethylene Oxide (EO). The surgical hood is worn over the helmets. The unsterile accessories include a rechargeable Lithium lon battery pack, a battery holster, a 1-bay battery charger, a 4-bay battery charger, and a non-sterile set of three foam pads (ViVi® Muffle).

The provided document is a 510(k) Premarket Notification from the FDA regarding the ViVi® Surgical Helmet System. It details the device's characteristics, indications for use, and a summary of non-clinical testing. It is crucial to understand that this document describes a medical device, specifically surgical apparel, and not an AI/ML powered device or a diagnostic/imaging device. Therefore, many of the typical acceptance criteria and study methodologies applicable to AI/ML or diagnostic devices (e.g., ground truth establishment, expert adjudication, MRMC studies, standalone performance of an algorithm) are not relevant to this product.

The "study" described herein refers to non-clinical laboratory testing to ensure the safety and performance of the surgical helmet system, rather than typical clinical studies for diagnostic accuracy or treatment efficacy.

Here's an attempt to answer your questions based on the provided text, highlighting the differences where your questions pertain to AI/ML or diagnostic devices:

1. A table of acceptance criteria and the reported device performance

The document provides two tables outlining acceptance criteria and test results for the Helmet and Hood components.

Table 1: ViVi® Surgical Helmet System - Acceptance Criteria and Performance (Non-Clinical Testing)

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