(172 days)
The Stryker T6 Hood; T6 Hood, Peel-away; T6 Hood, S95; T6 Toga, Pullover; T6 Toga, Zippered; and T6 Toga with Peel-away 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 Stryker T6 Hoods and Togas 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 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 T6 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 are exempt from classification under the AAMI PB70:2003 standard.
The Stryker T6 Hood, T6 Hood S95 and T6 Peel Away Hood are intended to be worn over any Stryker T6 Helmet.
The Stryker T6 Hoods with Peel-away Face Shields feature a twolayer protective lens system. When the outer lens becomes soiled, it can be peeled away to reveal another sterile lens surface to reestablish clear vision and make it unnecessary to wipe the lens.
The T6 Hood, S95 consists of higher weight non-woven material than the T6 Hood.
The Stryker T6 Toga, Pullover is intended to be worn over any Stryker T6 Helmet. The Stryker T6 Pullover togas provide Level 4 barrier protection 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. The Stryker T6 Toga, Pullover will be available in a variety of sizes ranging from Small/Medium thru 3X-Large sizes.
The Stryker T6 Toga Zippered and Stryker T6 Toga with Peelaway Lens, Zippered are intended to be worn over any Stryker T6 Helmet. The Stryker T6 Toga, Zippered and Stryker T6 Toga with Peel-away Lens, Zippered 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 T6 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 Stryker T6 Zipper Toga will be available in a variety of sizes ranging from Small/Medium thru 3X-Large sizes.
The provided text describes a 510(k) premarket notification for the Stryker T6 Hoods and Togas. This submission focuses on establishing substantial equivalence to predicate devices rather than proving novel performance through a clinical study with detailed acceptance criteria and reported performance metrics commonly associated with AI/ML devices. Therefore, the information requested regarding a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance is not directly applicable to this submission.
However, I can extract the relevant acceptance criteria and how the device's performance was compared against standards to demonstrate its intended function and equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
Since this is a sterile surgical gown and hood, the "acceptance criteria" revolve around barrier protection and resistance to contaminants, tested against established industry standards.
| Acceptance Criteria (Standard) | Reported Device Performance | Device(s) Covered |
|---|---|---|
| AAMI PB70:2003 standards | Met applicable AAMI PB70:2003 standards | Stryker T6 Togas (general statement) |
| ASTM F1671:2003 (Procedure A) for bacteriophage Phi-X174 resistance - with AQL of 4% | Passing result | Stryker T6 Toga, Pullover; Stryker T6 Toga, Zippered; Stryker T6 Toga with Peel-away Lens, Zippered |
| AATCC 42:2000 for liquid penetration - with AQL of 4% | Level 1 zones resist liquid penetration | Stryker T6 Toga, Zippered; Stryker T6 Toga with Peel-away Lens, Zippered |
| AAMI Barrier Classification System: Level 4 barrier protection (for critical zones) | Provided Level 4 barrier protection (resist liquid and viral penetration) | Stryker T6 Toga, Pullover; Stryker T6 Toga, Zippered; Stryker T6 Toga with Peel-away Lens, Zippered |
Note: The AAMI standard does not cover apparel for the head, face, and eyes, meaning the hoods and lens are exempt from classification under AAMI PB70:2003.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "An AQL of 4%" for the barrier performance tests (ASTM F1671:2003 and AATCC 42:2000). AQL (Acceptable Quality Level) is a statistical sampling term used in quality control to define the maximum percentage of defective items that is acceptable in a lot. While a specific sample size isn't explicitly stated, an AQL of 4% implies a statistical sampling plan was used to test a certain number of units from a production lot. The provenance of the data (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" for this device is based on objective measurements against established performance standards (ASTM, AATCC, AAMI) for material properties (liquid and viral penetration), not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or interpretation.
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 a medical device (surgical gown/hood), not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims ("resist liquid and viral penetration," "passing result") is the objective outcome of standardized laboratory tests against recognized industry standards (ASTM F1671:2003, AATCC 42:2000, AAMI PB70:2003).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. (See #8)
§ 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.