(36 days)
The Stryker Steri-Shield Flyte Toga, Pullover; Stryker Steri-Shield Flyte Toga, Zippered; Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; and Stryker Steri-Shield Flyte Togas with UV Lens, Zippered are components of a personal protection system and are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.
The scope of this Special 510k material modification is limited to material changes to the gown. The toga has a hood and gown section. The hood covers the user's head. A lens is attached to the front of the hood. The gown of the toga covers the user's front, back and arms. The Stryker Steri-Shield Flyte Togas are tested to meet applicable AAMI PB70:2003 standards. The AAMI standard does not cover apparel for the head, face, and eyes. Therefore, the hoods and lens (components of the togas) are exempt from classification under the AAMI PB70:2003 standard.
Stryker Steri-Shield Flyte Toga, Pullover: The Stryker Steri-Shield Flyte Toga, Pullover is intended to be worn over any Stryker Flyte Helmet. The Stryker Steri-Shield Flyte Pullover togas provide Level 4 and Level 1 barrier protection for the critical zones as set froth in the accompanying drafted IFUs (Attachment 8 and as classified under the AAMI (Association for the Advancement of Medical Instrumentation) guidelines for barrier performance. This garment was tested for resistance to bacteriophage Phi-X174 in accordance with ASTM F1671:2003 per the AAMI Barrier Classification System and demonstrate a passing result with an AQL of 4% under Procedure A. Level 1 zones resist liquid penetration per AATCC (American Association of Textile Chemist and Colorist) 42:2000 with an AQL (acceptable quality level) of 4%. Level 4 critical zones resist liquid and viral penetration. The Stryker Steri-Shield Flyte Toga Zippered garment was tested for resistance to bacteriophage Phi-X174 in accordance with ASTM (American Society for Testing and Materials) F1671:2003 with an AQL of 4% under Procedure A. The barrier material for the Stryker Steri-Shield Flyte Toga Pullover is constructed of layers of polypropylene or polyester non-woven fabric and copolymer polyester film. The Stryker Steri-Shield Flyte Toga, Pullover will be available in a variety of sizes ranging from Small/Medium thru 3X-Large sizes.
Stryker Steri-Shield Flyte Toga, Zippered: Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; Stryker Steri-Shield Flyte Toga with UV Lens, Zippered. The Stryker Steri-Shield Flyte Toga, Zippered; Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; and Stryker Steri-Shield Flyte Togas with UV Lens. Zippered are intended to be worn over any Stryker Flyte Helmet. The Stryker Steri-Shield Flyte Togas provide protection as specified by the AAMI (Association for the Advancement of Medical Instrumentation) Barrier Classification System. Level 1 zones resist liquid penetration per AATCC (American Association of Textile Chemist and Colorist) 42:2000 with an AQL (acceptable quality level) of 4%. Level 4 critical zones resist liquid and viral penetration. The Stryker Steri-Shield Flyte Toga Zippered garment was tested for resistance to bacteriophage Phi-X174 in accordance with ASTM (American Society for Testing and Materials) F1671:2003 with an AQL of 4% under Procedure A. The Level 4 barrier material is constructed of layers of polypropylene or polyester non-woven fabric and copolymer polyester film. The Level 1 material on the back of the zippered togas is constructed of 35 gram SMMS polypropylene. The Stryker Steri-Shield Flyte Toga. Zippered will be available in a variety of sizes ranging from Small/Medium thru 3X-Large sizes.
The provided text describes a 510(k) submission for Stryker Steri-Shield Flyte Togas, which are surgical gowns. The focus of the submission is on material changes to existing products and demonstrating substantial equivalence to predicate devices, rather than a study on a new device's performance against specific acceptance criteria in a clinical setting.
Therefore, many of the requested categories for AI/medical device studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, stand-alone performance) are not applicable to this document as it's not a clinical trial of an AI-powered diagnostic or therapeutic device.
However, I can extract information related to the performance standards and testing mentioned for the Steri-Shield Flyte Togas.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| AAMI PB70:2003 standards (General) | The Stryker Steri-Shield Flyte Togas are tested to meet applicable AAMI PB70:2003 standards. (Note: The AAMI standard does not cover apparel for the head, face, and eyes; therefore, hoods and lenses are exempt). |
| AAMI Barrier Classification System - Level 1 (liquid penetration) | Level 1 zones resist liquid penetration per AATCC 42:2000 with an AQL (acceptable quality level) of 4%. The barrier material for the Pullover and the Level 1 material on the back of the zippered togas are constructed of 35 gram SMMS polypropylene. |
| AAMI Barrier Classification System - Level 4 (liquid and viral penetration) | Level 4 critical zones resist liquid and viral penetration. Tested for resistance to bacteriophage Phi-X174 in accordance with ASTM F1671:2003 with an AQL of 4% under Procedure A. The Level 4 barrier material for both Pullover and Zippered versions is constructed of layers of polypropylene or polyester non-woven fabric and copolymer polyester film. |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes performance testing against material standards, not a clinical study with a "test set" of patient data. The AQL (Acceptable Quality Level) of 4% for certain tests refers to a sampling plan for manufacturing quality control, not a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/medical device studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for these tests are the established and recognized testing methodologies and standards (AAMI, AATCC, ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a clinical test set is relevant to this document.
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
Not applicable. This is not an AI-powered device or a cognitive aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm. The device's "standalone" performance is its ability to meet the defined material barrier standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or reference standards used are established industry and regulatory standards for material performance:
- AAMI PB70:2003 (Association for the Advancement of Medical Instrumentation)
- AATCC 42:2000 (American Association of Textile Chemist and Colorist) for liquid penetration
- ASTM F1671:2003 (American Society for Testing and Materials) for resistance to viral penetration (bacteriophage Phi-X174).
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device and testing.
9. How the ground truth for the training set was established
Not applicable.
§ 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.