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The Air Barrier System is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms at the surgical site during hip arthroplasty and posterior vertebral fusion and laminoplasty. The ABS Nozzle is intended to be used only where: (1) it can be placed on an anatomical surface with no gap between the bottom of the nozzle and the surface, (2) the incision plane is parallel with the direction of air flow, and (3) the incision dimensions are within: 6" (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable at a distance of 20 inches from the Nozzle, and effectiveness depreciates beyond this specified area.

The ABS device controls the airborne surgical environment at a specific and limited location adjacent to and over surgical incisions by emitting a non-turbulent flow of HEPA filtered air that displaces the presence of airborne colony-forming units and particulate matter within surgical site dimensions of 6" (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable outside of these dimensions and effectiveness depreciates beyond this specified area. The Air Barrier System (ABS) has two components: a Filter/Blower and an Air Delivery System. The ABS Filter/Blower filters ambient air found in a typical surgical operating room through a High Efficiency Particle Arresting (HEPA) filter. The HEPA filtered air exits the Filter/Blower from an exit port on the top of the unit. The Filter/Blower is nonsterile and reusable. The Air Delivery System, consisting of an Air Supply Hose and Nozzle, is sterile, single-use. The Nozzle portion is applied to the surgery site, on top of the incision drape and adjacent to a surgical incision. The end of the Air Supply Hose is plugged into the Filter/Blower's air exit port. HEPA filtered air then flows through the Air Supply Hose through the Nozzle and directly to the incision site.

Acceptance Criteria and Study Details for the Air Barrier System (ABS)

This document describes the acceptance criteria and the studies that demonstrate the Air Barrier System (ABS) meets these criteria, based on the provided 510(k) summary (K123006).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ABS are primarily defined by its ability to significantly reduce the presence of airborne particulate matter and microorganisms at the surgical site. The reported device performance is based on two clinical studies.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes two clinical studies, which serve as the test sets for demonstrating the device's efficacy.

Study 1 (Hip Arthroplasty):

• Sample Size: 29 patients, randomized into three groups (ABS active, ABS present but not active (sham), no ABS).
• Data Provenance: Not explicitly stated, but implies clinical setting in the US. This study was part of the previous submission [K092801]. It is retrospective information for the current submission, even if it was prospective when originally conducted for K092801.

Study 2 (Posterior Vertebral Fusion or Laminoplasty):

• Sample Size: 38 surgery cases (from 41 patients actually enrolled). Randomized into two groups (ABS device, no ABS device).
• Data Provenance: Conducted at the Michael E. DeBakey VA Medical Center (MEDVAMC), implying the United States. The study was prospective and randomized.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

For both clinical studies, the "ground truth" was established through direct measurement of airborne particulate and microorganism counts. This does not involve expert review or consensus in the typical sense of image analysis or diagnostic studies. Instead, it relies on quantitative measurements from environmental sampling.

Therefore, the concept of "number of experts used to establish the ground truth" and "qualifications of those experts" does not directly apply to this type of device performance study. The ground truth is objective, quantifiable measurements of environmental air quality parameters (CFU and particles) collected by trained personnel using standardized methods.

4. Adjudication Method for the Test Set

The studies described are not based on subjective interpretation or classification that would require an adjudication method like 2+1 or 3+1. The results are quantitative measurements of airborne particles and microorganisms. Therefore, no adjudication method was used or needed.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an environmental control system, not a diagnostic aid that would involve human readers interpreting output. The studies directly measure the physical effect of the device on the surgical environment.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence. The clinical studies performed are standalone evaluations of the device's ability to reduce airborne contamination. The device (ABS) operates without continuous human intervention during the procedure to achieve its effect. Its performance is measured directly by environmental sampling, independent of human operators' perception or interpretation.

7. The Type of Ground Truth Used

The ground truth used in both clinical studies was objective, quantitative measurements of environmental parameters:

• Colony-forming units (CFU) per cubic meter: Measured microorganisms (bacteria and fungal spores).
• Particles per cubic foot: Measured particulate matter of a specific size (≥5µm).

These measurements were collected at specific locations within and outside the ABS area of effect during actual surgical procedures.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or AI model development. The Air Barrier System (ABS) is a physical device that functions based on mechanical and filtration principles, not a software algorithm that requires training data. The studies conducted are performance validations, not model training.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" for an algorithm, this question is not applicable. The device's efficacy is demonstrated through performance studies rather than machine learning training.

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