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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)

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of data for an AI/ML model. The testing described is non-clinical laboratory testing of physical and functional characteristics of the device.

• Sample Size: For "Tear Resistance," "Fire protection," and "Ethylene Oxide residuals" of the hood, it states "three non-consecutive lots." Other tests do not specify exact sample sizes, often referring to "Internal Test" or simply stating "PASS" without detailing the number of units tested.
• Data Provenance: Not applicable in the context of AI/ML data sets. The tests are conducted on manufactured units of the device. There is no information about the country of origin of the data as the tests are physical/mechanical/biological performance tests, not data collection from individuals or medical records. The tests are non-clinical, so "retrospective or prospective" doesn't apply in the typical sense of clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/ML or diagnostic device where "ground truth" for a test set would be established by experts interpreting medical data (e.g., radiologists interpreting images). The "ground truth" for this device is established by objective physical, mechanical, and biological standards (e.g., specific thresholds for tear resistance, CO2 concentration, or biocompatibility).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As no expert interpretation or labeling of data for model training/testing is involved, adjudication methods are not relevant. The "ground truth" is determined by predefined, measurable physical and safety standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC comparative effectiveness study is designed for diagnostic tools, typically those involving human interpretation of medical images or data, with or without AI assistance. This device is surgical apparel with a fan system; it does not involve human "readers" or AI assistance for diagnostic tasks. The closest is a "Gesture Control" test with an average score for 'ease of use', which is a usability assessment, not an MRMC study.

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

This refers to the performance of an AI algorithm independent of human intervention. It is not applicable to a physical surgical helmet system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on predefined engineering specifications, international standards (e.g., ASTM, ISO), and regulatory requirements (e.g., 16 CFR 1610, biocompatibility standards). For example:

• Physical specifications: Measured weight, temperature/CO2 levels, noise levels.
• Mechanical specifications: Measured tensile strength, tear resistance.
• Biological specifications: Laboratory tests for biocompatibility (skin sensitization, irritation, cytotoxicity) against established thresholds.
• Usage: Battery runtime, usability scores.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product, so there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML model for this device.

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