(121 days)
The AstraGuard Pulmonary Function Filter is intended for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary 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 SDI AstraGuard Pulmonary Function Filter is an electrostatic polypropylene medium enclosed in a molded polystyrene shell. The highly efficient medium is ultrasonically welded to the shell body.
The provided 510(k) summary for the SDI AstraGuard Pulmonary Function Filter does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against them. The document primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's technical specifications and intended use.
However, based on the information provided, we can infer some aspects and highlight what is missing.
Here's an attempt to answer your questions based only on the provided text, recognizing significant gaps:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific acceptance criteria (e.g., a minimum filtration efficiency percentage for particles of a certain size) nor does it report the device's performance against such criteria in a quantitative table.
The device description mentions: "The highly efficient medium is ultrasonically welded to the shell body." This implies a claim of efficiency, but no specific performance metric is given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided 510(k) summary. There is no mention of a test set, sample sizes, or data provenance for performance evaluation.
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)
This information is not available in the provided 510(k) summary. As no explicit performance study with a test set generating "ground truth" is described, there's no mention of experts or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided 510(k) summary. No details about adjudication methods are present.
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
There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance. This device is a physical filter, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical filter, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not available in the provided 510(k) summary. As no explicit performance study with a test set generating "ground truth" is described, there's no mention of the type of ground truth. For a filter, "ground truth" would likely relate to objective measurements of filtration efficiency for specific microorganisms or particle sizes, rather than expert consensus on images or pathology.
8. The sample size for the training set
This information is not available in the provided 510(k) summary. As this is not an AI/machine learning device, the concept of a "training set" in this context is not applicable.
9. How the ground truth for the training set was established
This information is not available in the provided 510(k) summary, as the concept of a training set and its ground truth is not applicable to this type of device.
Summary of what the document does indicate about meeting criteria/proving performance:
The basis for market clearance of the SDI AstraGuard Pulmonary Function Filter appears to be its substantial equivalence to existing predicate devices (K934509 SDI Pulmoguard Filter, K043148 Alliance Tech Medical All Flow Filter, K934475 Koko Disposable PFT Filter II).
The "study" proving the device meets acceptance criteria, in this context of a 510(k) for a medical device filter, would primarily involve:
- Bench testing: Demonstrating that the filter physically meets design specifications and potentially functional performance similar to or better than the predicates (e.g., flow resistance, dead space, and filtration efficiency against specified pathogens or particle sizes). While not explicitly detailed in this summary, these types of tests are standard for such devices. The statement "The highly efficient medium is ultrasonically welded to the shell body" alludes to design and manufacturing ensuring efficiency.
- Comparison to Predicate Devices: The 510(k) process focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics and intended use. The fact that the device uses an "electrostatic polypropylene medium enclosed in a molded polystyrene shell" suggests a similar construction to other filters on the market.
The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This is the "proof" the device met the regulatory acceptance criteria for market clearance under the 510(k) pathway. However, the details of the specific tests and their results that underpinned this substantial equivalence claim are not included in this provided summary.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).