(92 days)
The DePuy Disposable Filter/Hood is intended to be used with the Stryker Steri-Shield System as disposable surgical apparel to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
The DePuy Disposable Filter/Hood is a single use, disposable hood with faceshield. The hood is constructed of Dexter paper with spun polypropylene filter media located at the top and back of the hood. The DePuy hood is designed to fit over the Stryker Steri-Shield helmet so that all intake and exhaust air passes through the filter material.
The provided text describes a 510(k) submission for a medical device, the DePuy Disposable Filter/Hood. However, it does not contain the kind of information typically found in a study proving a device meets acceptance criteria, especially for AI or algorithmic devices.
This submission is for a disposable surgical hood and focuses on substantial equivalence to an existing predicate device (Stryker Steri-Shield Personal Protection System and DePuy Sterile View Disposable Hood/Gown). The core of the argument for substantial equivalence is based on:
- Similar Design and Intended Use: The DePuy hood has the same hood and faceshield design, filter location, and intended use as the Stryker hood.
- Material Comparison: The only difference is the material. The DePuy hood uses Dexter paper, which is the same material as another DePuy product (Sterile View Disposable Hood/Gown).
- Comparative Testing: The submission states that "Comparative testing shows that the filtering efficiency of the DePuy filter material is as good as or better than the Stryker filter material for all particle sizes and flow rates tested."
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for AI devices) because the provided text pertains to a different type of medical device submission (a physical product based on substantial equivalence) and does not involve AI/algorithmic performance studies.
To directly answer your request based on the provided text, many of the categories are not applicable:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for Filtering Efficiency: "as good as or better than the Stryker filter material for all particle sizes and flow rates tested." (Implied, not explicitly quantified.)
- Reported Device Performance: "filtering efficiency of the DePuy filter material is as good as or better than the Stryker filter material for all particle sizes and flow rates tested."
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified (likely laboratory testing of materials, not clinical data).
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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. Ground truth in this context would be objective measurements of material filtering efficiency, not subjective expert assessment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of method is used for human expert review, not material testing.
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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 for AI devices, not a surgical hood.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is for AI devices, not a surgical hood.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Objective measurements of filtering efficiency based on standardized tests.
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The sample size for the training set:
- Not applicable. There is no AI model being trained.
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How the ground truth for the training set was established:
- Not applicable. There is no AI model being trained.
§ 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.