(87 days)
The Thermovent HEPA HME breathing system filter provides bacterial and viral filtration protecting the patient and the breathing circuit or ventilator. It also provides passive heat and humidification to the patient.
The Thermovent HEPA (High Efficiency Particulate Air) HME (Heat and Moisture Exchange) breathing system filter is a single use bacterial and viral filter with 'HEPA' grade filtration properties. The filter is intended for use with ventilators, anaesthesia breathing circuits, positive breathing systems and passive spontaneous breathing intubated patients. The Thermovent HEPA is a hydrophobic filter, which acts as an effective barrier to both air and liquid borne contaminates. The filter media repels liquid and therefore prevents any liquid moving from the patient side of the device through to the ventilator circuit. To maximise the filtration surface area, the filter media is pleated before assembly into the filter housing. The Thermovent HEPA also acts as a passive, hydrophobic humidifier. The expired gasses from the patient condense on the surface of the media, while releasing latent heat and warming the filter element. On inspiration, the airflow is warmed by the filter element, while the liquefied water is vaporised, thus allowing humidified air to be returned to the patient. The Thermovent HEPA has a Luer port on the machine side of the housing to allow monitoring of the patients gasses, after filtration. The filter housing also features a peg where the user can park the gas sampling port is in use. The devices are packed individually in flexible thermoformed pouch type unit packs.
The provided document does not contain a study or detailed acceptance criteria for a device's performance. Instead, it is a 510(k) summary and FDA clearance letter for the Portex Thermovent HEPA HME Breathing Filter.
The document indicates that the device's performance was evaluated against a set of voluntary standards rather than through a specific clinical or performance study with defined acceptance criteria and statistical analysis.
Therefore, I cannot extract the requested information as it is not present in the provided text.
However, I can extract the information related to the standards the device complies with, which implicitly serve as its performance "acceptance criteria" in the context of this 510(k) submission.
Here's what can be extracted based on the provided text, focusing on the compliance with standards:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 23328-1:Draft, BS EN 13328-1:2001 (Salt test method for filtration) | The proposed device complies with this standard. |
| ISO 23328-2:2002, BS EN 13328-2:2002 (Non-filtration aspects) | The proposed device complies with this standard. |
| BS EN ISO 9360-1:2000 (Heat and moisture exchanges) | The proposed device complies with this standard. |
| ISO 594-2:1998, BS EN 20594-2:1994 (Conical fittings - Luer taper) | The proposed device complies with this standard. |
| ISO 5356-1:1996, BS EN 1281-1:1997 (Conical Connectors) | The proposed device complies with this standard. |
| Code of Federal Regulations, Title 42, Volume 1 Part 84 (Respiratory Protective Devices) | The proposed device complies with this standard. |
Regarding the other requested information (2-9), the document does not provide these details as it describes compliance with existing standards rather than a de novo study:
- 2. Sample size used for the test set and the data provenance: Not applicable/Not provided. The document refers to compliance with standards, which would involve specific tests defined by those standards, but the sample sizes for those tests are not detailed here. Data provenance is not specified.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable/Not provided, as there was no "ground truth" to establish in the context of a study described here. Compliance with standards is typically verified by testing laboratories.
- 4. Adjudication method for the test set: Not applicable/Not provided.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document does not mention an MRMC study or any comparison of human readers with/without AI assistance.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical filter, not an AI algorithm.
- 7. The type of ground truth used: Not applicable. The "ground truth" here is compliance with the specifications and performance requirements outlined in the cited standards.
- 8. The sample size for the training set: Not applicable/Not provided. This is not an AI device with a training set.
- 9. How the ground truth for the training set was established: Not applicable/Not provided.
In summary: The provided text is a 510(k) summary demonstrating substantial equivalence by showing compliance with recognized performance standards, not a report of an independent clinical or performance study with detailed acceptance criteria, ground truth establishment, or human-in-the-loop evaluations.
§ 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).