(300 days)
The Oxylog 3000 plus is a time-cycled, volume controlled and pressure controlled emergency and transport ventilator for patients requiring mandatory or assisted ventilation with a tidal volume from 50 mL upwards.
The Oxylog 3000 plus is a time-cycled, volume controlled and pressure controlled emergency and transport ventilator for patients requiring mandatory or assisted ventilation with a tidal volume from 50 mL upwards. The Oxylog 3000 plus can be used as a stand alone unit or in a carrying system. This system protects the device and provides space for an O2 cylinder. The bags of the carrying system can be used to store accessories like a ventilation hose or mask. The carrying system can be used in ambulances and hospitals. It can be mounted by means of an universal wall holder.
This document is a 510(k) premarket notification for the Oxylog 3000 plus ventilator. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards. It does not contain information about explicit acceptance criteria for device performance in a clinical study, nor does it describe a study specifically designed to prove the device meets such criteria in terms of clinical outcomes or diagnostic accuracy. Instead, it details performance testing against technical and safety standards.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding a study proving acceptance criteria cannot be answered from the provided text.
Here's a breakdown of what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a table format with corresponding "reported device performance" in terms of clinical efficacy or diagnostic accuracy. Instead, it refers to compliance with various safety and performance standards as the basis for demonstrating that the device is "as safe, as effective, and performs as well as or better than the predicate devices."
The acceptance criteria are implicitly defined by the requirements of the standards listed, and the reported device performance is stated as having "met" these requirements.
| Acceptance Criterion (implicitly by standard compliance) | Reported Device Performance (as stated) |
|---|---|
| IEC 60601-1:2006 (Basic safety & essential performance) | Met (implied by "all system and design requirements...have been met") |
| IEC 60601-1-2:2007 (EMC requirements) | Met (implied by "all system and design requirements...have been met") |
| ISO 10651-3:1997 (Emergency & transport ventilators) | Met (implied by "all system and design requirements...have been met") |
| IEC 60601-1-6:2004 (Usability) | Met (implied by "all system and design requirements...have been met") |
| IEC 60601-1-8:2006 (Alarm systems) | Met (implied by "all system and design requirements...have been met") |
| ISO 14971:2007 (Risk management) | Met (implied by "all system and design requirements...have been met") |
The "study" that proves the device meets these criteria is referred to as "verification and validation testing." The document states: "The results of all verification and validation testing demonstrate that all system and design requirements for the Oxylog 3000 plus have been met. Qualification included hazard analysis, system level qualification and verification / validation testing."
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 provided in the document. The testing described is against technical standards, not typically a clinical trial with a "test set" of patient data.
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 provided in the document. Ground truth as typically understood in clinical studies (e.g., for diagnostic accuracy) is not applicable here as the submission describes engineering and performance testing against standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are relevant for clinical studies, not typically for compliance testing against engineering standards.
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 information is not provided and is not applicable. The Oxylog 3000 plus is a ventilator, not an AI-assisted diagnostic or interpretation device that would involve human "readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. The device is a ventilator, not an algorithm being evaluated for standalone performance. Its functions (like AutoFlow) are integral to the device's operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the verification and validation testing, the "ground truth" would be the defined parameters and requirements within each of the listed IEC and ISO standards. For example, electrical safety requirements (IEC 60601-1-2), ventilation performance specifications (ISO 10651-3), or usability criteria (IEC 60601-1-6). The device's performance is measured against these established technical benchmarks.
8. The sample size for the training set
This information is not provided and is not applicable. Training sets are generally associated with machine learning or AI model development, which is not described for this ventilator.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the same reasons as #8.
§ 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).