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The Westmed, Inc. BlockAide™ Filter is designed as a disposable and single-use, bi-directional filter for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary function testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic applications.

The BlockAide™ Filter, manufactured by Westmed, Inc., is a disposable, single-use barrier type, bi-directional filter fabricated from a plastic resin that is supplied to the customer packaged and non-sterile. Fabricated with a filtering medium that is highly effective in reducing the numbers of both bacterial and viral contaminates that may be present in a patient's exhaled gas, the device's design also minimizes the resistance to air flow. The product is intended to protect both the patient and pulmonary function instruments from potential transmission of pathogens by droplets and aerosols.

The device consists of two molded plastic housings enclosing a disk of filter media. To avoid confusion, the patient housing side is made from an opaque plastic and the machine housings are fabricated from the same plastic but with different number molded into the housing to identify machine end. The numbered end fits the machine and the opaque end is for the patient side; therefore making clear definition as to which end is used for the patient and the machine.

The provided text describes the Westmed, Inc. BlockAide™ Filter, a disposable bacterial/viral filter, and its non-clinical testing to demonstrate substantial equivalence to predicate devices. The information focuses on design characteristics and performance metrics rather than a typical clinical study with human subjects.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Note: The document explicitly mentions that the BlockAide™ Filter "met the recommendations of the American Thoracic Society's Standardization of Spirometry (1994 update) for minimal recommendations for Diagnostic Spirometry Equipment with in-line filters; i.e., that the measuring equipment as attached to the filter have air flow resistance of less than 1.5cm H2O/L/s." The BFE and VFE criteria are generally accepted performance standards for such filters, even if a specific numerical "acceptance criteria" isn't explicitly stated in the document beyond the achieved performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes non-clinical bench testing rather than studies involving human subjects or clinical data. Therefore, the concept of a "test set" in the traditional clinical sense is not directly applicable.

• Sample size for testing: Not explicitly stated for each test (BFE, VFE, Airflow resistance, Biocompatibility). The tests likely involved a sufficient number of devices/samples to ensure statistical validity for the respective tests, but the exact count is not provided.
• Data Provenance: The tests would have been conducted in a laboratory setting, likely in the United States, given Westmed, Inc. is based in Tucson, AZ, USA, and the submission is to the FDA. The data is prospective in the sense that the tests were performed specifically for the 510(k) submission.

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. For non-clinical bench testing of a medical device like a filter, "ground truth" is established by adherence to recognized testing standards and validated methodologies (e.g., ISO, ASTM standards for filtration and biocompatibility, or established protocols for airflow resistance). The expertise lies in the laboratory personnel conducting these tests and their adherence to these standards. There is no mention of external experts establishing a "ground truth" for the test results themselves.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpreting ambiguous clinical data or images. This document describes objective, quantitative non-clinical tests with measurable outcomes.

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 physical filter, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical filter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance claims is derived from objective, quantifiable laboratory measurements obtained through standardized testing protocols:

• Bacterial/Viral Filtration Efficiency: Established by challenging the filter with known concentrations of bacterial or viral aerosols and measuring the reduction in concentration downstream. The "ground truth" is the measured efficiency against the challenge organism/particle.
• Airflow Resistance: Measured directly using calibrated flow and pressure sensors. The "ground truth" is the physical property of resistance to flow.
• Biocompatibility: Determined by standardized in-vitro and/or in-vivo tests as per ISO 10993-1 guidelines (cytotoxicity, sensitization, intracutaneous reactivity). The "ground truth" is the biological response observed under controlled conditions.

8. The sample size for the training set

Not applicable. The BlockAide™ Filter is a physical medical device, not a machine learning or AI model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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