(236 days)
The MAXair® Surgical Helmet system is 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. The MAXair Surgical Helmet system consists of disposable surgical apparel and re-usable headgear, battery pack and accessory battery charger.
The MAXair® Surgical Helmet system consists of disposable surgical apparel and re-usable headgear, battery pack and accessory battery charger. The MAXair Surgical Helmet system is 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. The disposable, sterile surgical apparel of the MAXair system includes an electrostatically charged meltblown fabric hood/filter and a barrier toga. The barrier material is fluid resistant to protect the wearer from fluid borne pathogens. The meltblown fabric hood/filter has passed NIOSH testing (TC-21C-0775) for PAPR's and is rated HE (High Efficiency). The non-sterile, re-usable component of the Surgical Helmet system is comprised of a self contained Helmet/blower and a battery pack. The helmet has an incorporated headgear and provides air delivery. The air delivery helmet pulls air from outside the hood/filter, through the filter media, and directs it inside to the user. The system is powered by a lithium ion battery pack. The lithium ion battery pack is recharged by an accessory battery charger.
The provided text describes a 510(k) premarket notification for the MAXair® Surgical Helmet System, a device intended to protect operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material.
However, the provided text does not contain a table of acceptance criteria and reported device performance in the typical format of a study summary. Instead, it describes general claims of performance for two key components: the barrier material of the disposable apparel and the meltblown fabric hood/filter.
Therefore, the requested information will be extracted and presented based on the available text, with caveats about missing data.
Here's the analysis of the acceptance criteria and the study as described:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Component | Acceptance Criteria (Implied by Test Passed) | Reported Device Performance |
|---|---|---|
| Barrier Material | Resistance to synthetic blood (ASTM F1670) | Passed ASTM F1670 |
| Barrier Material | Resistance to penetration by bloodborne pathogens using viral penetration (ASTM F1671) | Passed ASTM F1671 |
| Hood/Filter | NIOSH PAPR testing (TC-21C-0775) for Purity/Efficiency | Passed NIOSH testing (TC-21C-0775) and rated HE (High Efficiency) |
Notes on the Table:
- The text states "Testing has shown that the barrier materials pass ASTM standard test F1670... and F1671..." and "The meltblown fabric hood/filter has passed NIOSH testing... and is rated HE." These statements imply that passing these specific tests constitutes meeting the acceptance criteria for those properties.
- No specific numerical performance metrics (e.g., filtration percentage, fluid penetration volume) are provided for these tests; only the "pass" status and the "HE" rating for the filter are mentioned.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the tests mentioned (ASTM F1670, F1671, NIOSH TC-21C-0775).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. The tests refer to established standards (ASTM, NIOSH), which are generally performed in controlled laboratory settings.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable in the context of the described testing. The 'ground truth' for these tests (ASTM F1670, F1671, NIOSH TC-21C-0775) is established by the standardized protocols themselves, which define what constitutes a "pass" or "fail" based on physical and biological challenges, not by expert consensus on clinical findings or images.
4. Adjudication Method for the Test Set
- This information is not applicable. The tests described are objective, standardized laboratory tests. There is no human interpretation or adjudication in the sense of concurring on diagnostic findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) summary. This type of study is typically relevant for diagnostic imaging devices where human readers interpret medical images. The MAXair Surgical Helmet System is a protective apparel device.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Yes, the performance described is a standalone performance of the device's components against physical/biological challenges, without human intervention in the loop of decision-making. The tests (ASTM F1670, F1671, NIOSH TC-21C-0775) evaluate the material properties and filtration efficiency of the device components directly.
7. The Type of Ground Truth Used
- The ground truth for the performance claims is based on standardized test methods and protocols. For example:
- ASTM F1670: Resistance of materials used in protective clothing to penetration by synthetic blood.
- ASTM F1671: Resistance of materials used in protective clothing to penetration by bloodborne pathogens using viral penetration.
- NIOSH TC-21C-0775: Specific NIOSH certification for Powered Air-Purifying Respirators (PAPRs), which includes criteria for filtration efficiency.
These are objective, reproducible endpoints determined by the test apparatus and procedures, not by expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
- This information is not applicable. The device described is a physical protective apparel system, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- This information is not applicable for the same reason as point 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.