(265 days)
The Blease 900 Series Ventilators are advanced, microprocessorcontrolled, pneumatically driven ventilators, which have been designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.
The Spacelabs Healthcare (Spacelabs) Blease 900 Series Ventilators (Blease 900) are advanced, microprocessor-controlled, pneumatically driven ventilators, which have been designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.
The unit houses the electronic and pneumatic control systems. It sets the desired ventilatory parameters and generates alarm, warning and status messages. The control unit also calculates and implements the functions necessary to drive the bellows pneumatically.
The bellows assembly consists of a base and a bellows housing.
The Spacelabs Blease 900 are designed for use with a circle-type absorber, and is ideally suited to both low- and high-flow applications.
The provided text describes the Spacelabs Healthcare Blease 900 Series Ventilators, a medical device. However, it does not contain a study that proves the device meets specific acceptance criteria in the way this request asks (e.g., performance metrics compared against thresholds for an AI/software device).
Instead, the document details performance testing related to electrical safety, electromagnetic compatibility, and general performance in accordance with recognized standards, which are a form of acceptance criteria for medical devices.
Here's an attempt to answer the questions based on the available information, noting when specific details are not present in the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Electrical Safety: IEC 60601-1: 2005 (General requirements for basic safety and essential performance) | The Spacelabs Blease 900 complies with the Standards. |
| Electromagnetic Compatibility: IEC 60601-1-2: 2007 (Collateral standard: Electromagnetic compatibility - Requirements and tests) | The Spacelabs Blease 900 complies with the Standards. |
| Performance Testing (Shipping Containers and Systems): ASTM D4169-05 (Standard practice for performance testing of shipping containers and systems) | The Spacelabs Blease 900 complies with its predetermined specification and with the applicable Standards. |
| Intended Use Safety & Effectiveness: | Safe and effective when used in accordance with its intended use and labeling. |
| Substantial Equivalence: | Considered substantially equivalent to the predicate device (K101850). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This information is not provided in the document. The testing described appears to be device-specific, likely involving a single or small number of units, rather than a clinical study with a patient test set.
- Data Provenance: This information is not provided. The testing would have been conducted by or for the manufacturer (Spacelabs Healthcare Ltd., UK with manufacturing in Issaquah, WA, USA).
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 applicable/provided. The testing described is performance testing against engineering and safety standards, not a clinical study involving expert interpretation of data or images. "Ground truth" in this context would likely be defined by the technical specifications and standards themselves, and the experts would be engineers or testing personnel verifying compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for establishing expert consensus on medical findings, which is not the type of testing described here.
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 comparative effectiveness study was not done. This device is a ventilator, not an AI/software diagnostic tool that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- This device is a hardware-based ventilator, not a standalone algorithm. Performance testing was done on the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance testing described is established by international and national standards (IEC 60601-1, IEC 60601-1-2, ASTM D4169-05) and the device's predetermined internal specifications. The device's functionality is compared against these engineering and safety benchmarks.
8. The sample size for the training set
- This information is not applicable. This device is a conventional medical device (ventilator), not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable as there is no training set for this type of device.
§ 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).