(197 days)
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.
| Property or Characteristic | Test Method / Standard | Acceptance Criteria (Implied) | Reported Device Performance (ViVi® Toga Premium) |
|---|---|---|---|
| Flammability of clothing textiles | 16 CFR 1610 | Class 1 compliant | Class 1 compliant PASS |
| Biocompatibility: Cytotoxicity | ISO 10993-5 | Compliant | Compliant PASS |
| Biocompatibility: Sensitization | ISO 10993-10 | Compliant | Compliant PASS |
| Biocompatibility: Irritation | ISO 10993-23 | Compliant | Compliant PASS |
| Tear Resistance | ASTM D5587 | Compliant | Compliant PASS |
| Tensile Strength | ASTM D5034 | Compliant | Compliant PASS |
| Seam Strength | ASTM F88/F88M | Compliant | Compliant PASS |
| Laser Resistance | ISO 11810:2015 | Compliant | Compliant PASS |
| Linting (Lint and other particles generation in the dry state) | ISO 9073-10:2005 | Compliant | Compliant PASS |
| Water Vapor Transmission rate | ASTM E96/E96M-24A | Compliant | Compliant PASS |
| Barrier Performance (Liquid) | ANSI/AAMI PB70:2012; ASTM F1671/F1671M | Level 4 compliant | Compliant Level 4 PASS |
| Sterilization Assurance Level (SAL) | Not explicitly detailed by test method but stated as requirement | 10⁻⁶ | 10⁻⁶ |
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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.