(25 days)
The PB 540 Ventilator is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 5 kg who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support, as prescribed by an attending physician:
- Positive Pressure ventilation
- Assist/Control, SIMV, or CPAP modes of ventilation
- Breath types including Volume, Pressure Control and Pressure Support.
The ventilator is suitable for use in institutional, home, and transport settings. It is not intended for use as an emergency transport ventilator.
The PB 540 Ventilator gas delivery system is composed of a flow generator capable of supplying a sufficient range of flows and pressures that is then controlled by a three-way valve enabling piloting of the expiration valve. The flow generator is a low-inertia micro-turbine driven by a brushless electric motor and the valve is a proportional electronically driven valve.
These two actuators are controlled according to specific control algorithms by a microprocessor receiving information from the pressure and flow sensors built into the ventilator.
The provided 510(k) summary for the PB 540 Ventilator does not describe an AI/ML device or a study involving acceptance criteria in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it's for a traditional medical device (a ventilator) and discusses performance in terms of functional testing and compliance with regulatory guidelines.
Therefore, the requested information elements related to AI device performance evaluation (such as sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) are not applicable to this document.
Here's an interpretation based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from text) | Reported Device Performance |
|---|---|
| Functional specifications | "The device passed all tests," confirming it meets its stated performance specifications. |
| Applicable portions of "Draft Reviewer Guidance for Ventilators" (July 1995) | "The device passed all applicable tests," confirming compliance. |
| "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005) | "The devices passed all tests," indicating compliance with software guidance. |
| Safe operation in intended environment | Concluded to "operate safely in its intended environment." |
| Effectiveness in fulfilling intended use | Concluded to "be effective in fulfilling the intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for any "test sets" in the context of diagnostic performance. The testing described is functional and compliance-based for a physical device, not an AI model.
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)
- Not applicable as this is not an AI/ML diagnostic device and no "ground truth" in this context was established. Performance was assessed against predefined functional and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm-only device. The "standalone" performance implied refers to the ventilator itself meeting its functional specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The concept of "ground truth" as used in AI/ML performance evaluation is not relevant here. The "truth" for this device's performance is its ability to meet engineering specifications, functional requirements, and regulatory standards.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires 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).