(44 days)
The AVEA Ventilator is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should be operated by properly trained clinical personnel, under the direction of a physician.
The AVEA Ventilator is a fourth generation servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its revolutionary user interface module (UIM) provides maximum flexibility wit6h simple operator interaction. It has a flat panel color LCD with real time graphic displays and digital monitoring capabilities, a touch screen for easy interaction, membrane keys and a dial for changing settings and operating parameters. A precision gas delivery engine with servo controlled active inhalation and exhalation improves performance over previous generations. The only design change is an optional Disposable Expiratory Filter / Water Trap to be used exclusively with the AVEA Ventilator.
The provided text is a 510(k) summary for the AVEA Ventilator's optional Disposable Expiratory Filter / Water Trap. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device performance claim through a clinical study with specific acceptance criteria.
The key points from the document regarding "acceptance criteria" and "study" are:
- Acceptance Criteria: The device is considered to meet acceptance criteria if it is "substantially equivalent in terms of BFE / VFE and resistance performance" to the predicate device (Clear-Guard II, K990949) and "has the same indicated use as the reusable existing filter / water trap" (integral to the AVEA Ventilator, K013642).
- Study: "Verification and Validation Testing demonstrated that the AVEA Disposable Expiratory Filter / Water Trap meets its performance requirements at both: Component Level and System Level, and, that this device is substantially equivalent to medical devices currently legally marketed in the United States."
This 510(k) summary does not provide the kind of detailed clinical study information (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) that would typically be associated with a device making a new performance claim or AI algorithm. It is a "substantial equivalence" review for a modification (an optional disposable filter) to an already cleared ventilator.
Therefore, the requested table and detailed information mostly cannot be extracted because the provided document does not contain that level of detail for this type of submission.
Here's a breakdown of what can be inferred or stated from the text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially equivalent in BFE (Bacterial Filtration Efficiency) / VFE (Viral Filtration Efficiency) performance to predicate device (Clear-Guard II - K990949). | Not explicitly quantified in this document, but the submission concludes that it "is substantially equivalent in terms of BFE / VFE" to the predicate. |
| Substantially equivalent in resistance performance to predicate device (Clear-Guard II - K990949). | Not explicitly quantified in this document, but the submission concludes that it "is substantially equivalent in terms of ... resistance performance" to the predicate. |
| Has the same indicated use as the reusable existing filter / water trap (integral to AVEA Ventilator, K013642). | Stated: "Has the same indicated use as the reusable existing filter / water trap which is integral to the AVEA Ventilator approved under K013642." The intended use remains unchanged. |
| Meets performance requirements at both Component Level and System Level. | Stated: "Verification and Validation Testing demonstrated that the AVEA Disposable Expiratory Filter / Water Trap meets its performance requirements at both: Component Level and System Level." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "Verification and Validation Testing" but does not break down the specific sample sizes used for BFE/VFE or resistance testing.
- Data Provenance: Not specified. It's likely laboratory testing rather than patient data, given the nature of the filter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is not a diagnostic device involving expert interpretation or ground truthing of clinical data in the traditional sense. Performance is based on physical and biological filtration efficiency measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable for the type of testing described (performance testing of a filter).
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
- No, an MRMC study was not done. This device is a ventilator filter, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this is a hardware device (filter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" here is the measured performance metrics (BFE, VFE, resistance) against established engineering standards and the performance of the predicate device. It's not clinical "ground truth" derived from patient outcomes or expert consensus.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).