(33 days)
The Stryker T4 Hytrel Zipper Toga is a component of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
The Stryker Personal Protection Systems include a self-contained ventilation helmet, a hood, a toga, rechargeable battery, and accessories.
The provided text describes a 510(k) summary for a surgical garment, the Stryker T4 Hytrel Zipper Toga. This document outlines the device's equivalence to previously cleared devices rather than presenting a study proving performance against specific acceptance criteria in the manner typically seen for AI/ML or diagnostic devices.
Therefore, many of the requested categories related to AI/ML or diagnostic device studies (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.
However, the submission does refer to performance tests demonstrating equivalence, which can be interpreted as meeting acceptance criteria by showing it is "equivalent to or better than" a predicate device.
Here's the information extracted and adapted to the context of this device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated by Predicate)* | Reported Device Performance (Stryker T4 Hytrel Zipper Toga) |
|---|---|
| Equivalent or better performance in barrier properties as the predicate device (Stryker Steri-Shield System). | Material used on front and sleeves shown to be equivalent to or better than the material used on the predicate device. |
| Performance demonstrated through specific tests: viral penetration, synthetic blood penetration, water resistance (impact penetration, hydrostatic pressure), flammability, and tear resistance. | The new device's material met or exceeded the performance of the predicate device's material in these specific tests. |
*The acceptance criteria are inferred from the claim of equivalence to the predicate device and the battery of tests performed.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the summary. The document states that the material was "shown to be equivalent to or better than" the predicate device's material, but it does not detail the specific sample sizes used for the penetration, resistance, or flammability tests. Given the nature of material testing, the "test set" would refer to samples of the material itself, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This is not applicable. The "ground truth" for material performance is established through standardized laboratory testing methods, not expert consensus in the human health sense.
4. Adjudication Method for the Test Set
This is not applicable. Material performance tests follow established protocols and produce objective measurements, rather than requiring expert adjudication.
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
This is not applicable. This device is a surgical garment and does not involve AI or human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a surgical garment and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through standardized laboratory material testing (e.g., viral penetration, synthetic blood penetration, water resistance, flammability, tear resistance) against the performance characteristics of an already legally marketed and accepted predicate device.
8. The Sample Size for the Training Set
This is not applicable. This device is a surgical garment and does not involve AI/ML requiring a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable. This device is a surgical garment and does not involve AI/ML.
§ 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.