(129 days)
FilterFlo™ filter is a breathing system filter which is designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anesthetic or ventilator breathing systems.
The FilterFlo™ filter may either be used on the patient side or on the device side of the ventilator / anesthetic device and is used as a hygienic measure alternatively to decontamination of breathing system and / or breathing gas conveying parts of the ventilator.
The ThermoFlo™ filter/HME is a breathing system filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchangers are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The product is the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since heated humidified are almost impossible to use. The ThermoFlo™ filter/HME should be used with patients who have a Tidal Volume between 250 - 1500 ml.
The products mentioned above are designed as disposable single patient use and should be changed at least every 24 hours.
The ARC Medical filter and filter / HME are standard breathing circuit filters or filter / HMEs.
Here's a breakdown of the acceptance criteria and study information for the ARC Medical FilterFlo™ filter and ThermoFlo™ filter/HME, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list numerical "acceptance criteria" for the filters in the way one might see for an AI algorithm. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The performance criteria are implicitly those met by the predicate devices. The study performed was comparative, showing that the proposed devices performed equivalently to these established predicate devices.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Comparative Testing) |
|---|---|---|
| BFE/VFE Filtration | Equivalent to predicate devices | Substantially equivalent to predicate devices |
| Resistance to Flow | Equivalent to predicate devices | Substantially equivalent to predicate devices |
| Internal Volume | Equivalent to predicate devices | Substantially equivalent to predicate devices |
| HME Performance | Equivalent to predicate devices | Substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of typical AI algorithm evaluation with patient data. Instead, it refers to "comparative performance testing" of the physical devices.
- Sample Size: Not explicitly stated in terms of the number of devices tested for each characteristic. It would typically involve a statistically relevant number of units for each test (e.g., n=3, n=5, or more, depending on the test standard).
- Data Provenance: This is not applicable in the sense of patient data origin. The testing would have been conducted in a laboratory or manufacturing environment. Based on the manufacturer's location (Tucker, GA, USA), the testing was likely done in the USA. This was a prospective test conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device is a physical medical device (breathing circuit filter/HME), not an AI algorithm requiring human expert ground truth for image interpretation or diagnosis. The "ground truth" here is objective physical performance measurements according to established test methods.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation involves objective physical performance measurements against established standards or predicate device performance, not subjective expert assessment requiring adjudication.
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
This is not applicable. This device is a physical breathing circuit filter/HME, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and effect size in the context of AI assistance are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This device is a physical filter/HME, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tested device performance characteristics (BFE/VFE filtration, resistance to flow, internal volume, HME performance) is based on objective physical measurements obtained through standard engineering and laboratory test methods, calibrated against established industry standards or by direct comparison to the performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of an AI algorithm for this physical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI algorithm.
§ 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).