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510(k) Data Aggregation
(449 days)
FXY
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)
| Characteristic (Component) | Requirement (Acceptance Criteria) | Reported Performance (Test Result) |
|---|---|---|
| HELMET TESTING | ||
| Weight | ≤ 500g (helmet) | PASS |
| Air Quality | ≤ 3°C temperature increase | PASS |
| ≤ 0% RH increase | PASS | |
| Below 5000 ppm CO2 concentration (at ≤ 800 ppm ambient concentration) | PASS | |
| No fogging of face shield | PASS | |
| System Size | Significant lower crown line profile than predecessor product | PASS |
| Noise | Noise level ≤ predecessor product | PASS |
| Operational runtime | Battery runtime ≥4 hours (without LED light) | PASS |
| Gesture Control | Average score for 'ease of use': ≥ "4-good" (Score table: 5 'very good' - 1 'not sufficient') | PASS |
| No score for 'ease of use' below "2-sufficient" | PASS | |
| HOOD TESTING | ||
| Tear Resistance | >10 N | PASS |
| Tensile Strength | >30 N | PASS |
| Fire protection Flammability of Clothing Textiles | Fulfil requirements for Class 1 | PASS |
| Laser resistance | No ignition | PASS |
| Ethylene Oxide residuals | EO: |
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(22 days)
FXY
The Stryker T7 Togas and Stryker T7 Hoods are components of Stryker T7 Personal Protective Equipment (PPE). These surgical devices are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker T7 Togas and Stryker T7 Hoods are sterile, single use only devices.
Stryker T7 Surgical Togas and Stryker T7 Surgical Hoods
This document is a 510(k) premarket notification letter from the FDA regarding surgical apparel (Stryker T7 Surgical Togas and Stryker T7 Surgical Hoods). It does not contain information about the acceptance criteria and study proving a device meets acceptance criteria in the context of an AI/ML medical device.
The entire document discusses the substantial equivalence determination for physical surgical garments, not a software or AI/ML device requiring performance metrics like sensitivity, specificity, or AUC, nor does it detail any study with ground truth.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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(111 days)
FXY
The Stryker Flyte Hybrid Hoods are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.
The devices are provided sterile and for single use only.
The Stryker Flyte Hybrid Hoods are intended to be worn over a Flyte Helmet to provide protection to the user's face and head region during surgery. Hoods are worn in conjunction with surgical gowns where the hood material extends beyond the user's upper back and shoulders, while the surgical gown covers the lower portion of the hood up to the user's neck.
The Stryker Flyte Hybrid Hood is comprised of 3 main parts: Hood, Filter and Lens. Stryker Flyte Hybrid Hoods are available with either a standard or peel away lens.
The devices are prescription devices, provided sterile and single use only.
This document describes the acceptance criteria and performance data for the Stryker Flyte Hybrid Hoods.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| CO₂ Level Inside the Hood (Internal test) | CO₂ Level |
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