(318 days)
The Pall Ultipor Anesthesia Breathing Circuit System with a Breathing System Filter ("BSF") is intended for use in the administration of medical gases during anesthesia. The circuit connects the anesthesia gas machine to the patient, by means of an oronasal facemask or by a connection to an artificial airway, such as an endotracheal tube or laryngeal mask. The Pall Ultipor 25 BSF minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%.
Both the Ultipor and Zefon consist of a patient kit and a machine kit. The components of the both Ultipor's and Zefon's patient kits are: (1) the BSF; (2) face mask; and (3) mask elbow. The components of both Ultipor's and Zefon's machine kit are: (1) the reservoir bag; (2) expiratory tubing; and (3) inspiratory tubing. Ultipor and Zefon both have a gas monitoring line; this line is a component of Ultipor's machine kit and Zefon's patient kit. Both devices' machine kits connect the inspiratory and expiratory ports of the anesthesia machine to their BSF. The respective components of both devices perform the same function(s).
In addition, all of the components of the Ultipor's and Zefon's patient kits are single use and all of the components of these devices' machine kits are for use up to 24 hours, which may include use on multiple patients ("24 hour/multiple patient use"). when used with their respective patient kits.
The provided text does not contain detailed information about specific acceptance criteria and a study proving device performance in the way typically found for AI/ML medical devices. The document is a 510(k) summary for a medical device (Pall Ultipor Anesthesia Breathing Circuit System with Bacterial System filter) seeking clearance based on substantial equivalence to a predicate device.
However, based on the information provided, I can extract and infer some aspects.
Key Information from the Document:
The primary performance claim and, therefore, implied acceptance criterion, mentioned in the "Indications" and "Technological Characteristics" sections, is:
- "The Pall Ultipor 25 BSF minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%."
The document states "The 510(k) includes data showing the durability of the gas monitoring line for 24 hour/multiple use." This implies a study was conducted to demonstrate this, but no specifics about the study design, sample size, or results are provided in this summary.
Attempting to answer your questions based only on the provided text:
- Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Minimum viral and bacterial contamination efficiency of 99.999% | "minimizes viral and bacterial contamination... with a minimum efficiency of 99.999%." |
| Durability of gas monitoring line for 24-hour/multiple patient use (if applicable, though explicitly stated as "does not raise new questions of safety or effectiveness") | "The 510(k) includes data showing the durability of the gas monitoring line for 24 hour/multiple use." |
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Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "The 510(k) includes data," implying internal testing rather than external or clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This device is a physical breathing circuit with a filter, not an AI/ML algorithm requiring expert interpretation for ground truth. Performance would be assessed through laboratory testing, e.g., microbial challenge testing for filter efficiency.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This is relevant for studies involving human interpretation or subjective assessment, which is not the case for this type of device.
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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:
- No. This is not an AI/ML device, so an MRMC study is not relevant. The substantial equivalence argument is based on similar physical components and performance claims to a predicate device, not on assistance to human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The performance of the filter (99.999% efficiency) would be a standalone measurement.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the 99.999% filtration efficiency claim, the ground truth would typically be established through laboratory testing, likely using standardized methods for microbial challenge or particle filtration efficiency, with the results empirically measured against established criteria.
- For the durability of the gas monitoring line, it would be engineering or functional testing to ensure it withstands 24-hour/multiple use conditions.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
In summary: The provided document is a 510(k) summary for a physical medical device. It makes a performance claim regarding bacterial/viral filtration efficiency and mentions data supporting the durability of a gas monitoring line. However, it does not detail the specifics of any studies (like sample sizes, methods for ground truth, or expert involvement) as would be typical for an AI/ML device submission. The substantial equivalence argument relies on comparing the device's characteristics and performance to an already cleared predicate device, rather than providing extensive de novo study details in this summary.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).