(210 days)
The device is a sterile, single-use, personal protective system designed to provide a barrier between the surgical team and potentially hazardous bloodborne pathogens that may be present in the operation room environment. The device also offers the patient additional protection from potential deep wound infection by preventing skin, hair and other debris entry into the wound from surgical team members
The device consists of an enclosure of drape material that is worn by members of a surgical team and is fitted to the head with an adjustable headband. A clear viewing window is provided along with an air delivery system to supply cool air under the enclosure via a fan powered by a battery pack worn on the waistband.
The provided document is a 510(k) premarket notification for a medical device (DHS Disposable Hood System). These types of documents are typically for demonstrating substantial equivalence to a predicate device and often do not include the kind of detailed study reports with specific acceptance criteria and performance metrics that would be found in a clinical trial or a more rigorous performance study for novel devices or software.
In this specific case, the submission explicitly states:
"Clinical Testing: Clinical testing was not used to establish substantial equivalence."
Therefore, based solely on the provided text, a comprehensive table of acceptance criteria and device performance based on a study cannot be generated. The "study" mentioned here is a non-clinical comparison to predicate devices, which focuses on material properties rather than clinical performance metrics in humans.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
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Cannot be generated from the provided text for clinical performance. The document explicitly states "Clinical testing was not used to establish substantial equivalence."
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However, the document lists Non-Clinical Testing that "demonstrated the device performed as well as or better than currently marketed devices." The "performance" here refers to specific material characteristic tests comparing to predicate devices. The acceptance criteria implicitly would be "performs as well as or better than predicate devices" for each of these characteristics.
Acceptance Criteria (Implied from "as well as or better than currently marketed devices") Reported Device Performance (Summary) Fabric weight comparable to or better than predicate devices Performed as well as or better than currently marketed devices Grab strength comparable to or better than predicate devices Performed as well as or better than currently marketed devices Grab elongation comparable to or better than predicate devices Performed as well as or better than currently marketed devices Trap tear comparable to or better than predicate devices Performed as well as or better than currently marketed devices Hydrohead test comparable to or better than predicate devices Performed as well as or better than currently marketed devices Spray impact comparable to or better than predicate devices Performed as well as or better than currently marketed devices Alcohol (repellency) comparable to or better than predicate devices Performed as well as or better than currently marketed devices Permeability comparable to or better than predicate devices Performed as well as or better than currently marketed devices Static decay comparable to or better than predicate devices Performed as well as or better than currently marketed devices
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for clinical data. Since no clinical testing was performed or reported, a test set for clinical data is not mentioned. For the non-clinical material testing, the sample size for individual material tests is not provided, nor is the "provenance" of such material data.
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. No clinical test set or ground truth established by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication is mentioned.
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 device is a surgical hood, not an AI-powered diagnostic device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical surgical hood, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable for clinical data. For the non-clinical material performance, the "ground truth" would be established by standardized material testing methods and comparisons to the predicate device's material properties, as the goal was substantial equivalence based on technological characteristics.
8. The sample size for the training set
- Not applicable. This is not an AI or machine learning device which would require a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI or machine learning device, so no training set or its ground truth establishment is relevant.
In summary: The provided document is a 510(k) submission focused on demonstrating substantial equivalence of a physical medical device (a surgical hood) through comparison of its technological characteristics to predicate devices. It explicitly states that no clinical testing was used, and therefore, many of the requested details pertaining to clinical study design, sample sizes, expert involvement, and ground truth are not applicable or provided in this context.
§ 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.