(56 days)
Model # ECD05-A:
The EnsoETM is a thermal regulating device, intended to:
- · connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient's temperature,
· allow enteral administration of fluids, and
· provide gastric decompression and suctioning.
Model # ECD06-A
The EnsoETM is a thermal regulating device, intended to:
· connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient's temperature, and
· provide gastric decompression and suctioning.
The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to raise or maintain a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression, drainage, and enteral administration of fluids, thereby maintaining the functionality of the standard orogastric tube. Raising or maintaining patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the exchanger. A third central lumen connects to wall standard gastric decompression or, in some models, an enteral administration system to allow enteral administration of fluids. The device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with a duration of use of 72 hours or less.
The provided text is a 510(k) premarket notification for a medical device called EnsoETM. It describes the device's indications for use, technological characteristics, and non-clinical performance testing. However, it does not contain information about acceptance criteria, a specific study that proves the device meets these criteria, or details regarding the methodologies for establishing ground truth, MRMC studies, or training sets typical of studies for AI/ML-based medical devices.
The document discusses the EnsoETM, which is an esophageal thermal regulation device, not an AI/ML diagnostic or image-analysis device. The "performance testing" mentioned refers to engineering tests, specifically "coolant lumen flow rate," to demonstrate compatibility with a heat exchanger, not clinical performance in terms of diagnostic accuracy or reader improvement.
Therefore, I cannot extract the information required by your prompt regarding acceptance criteria and study details for an AI/ML device from this document. The prompt's requirements (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are relevant to the evaluation of AI/ML software as a medical device, which is not what this 510(k) pertains to.
§ 870.5910 Esophageal thermal regulation device.
(a)
Identification. An esophageal thermal regulation device is a prescription device used to apply a specified temperature to the endoluminal surface of the esophagus via an external controller. This device may incorporate a mechanism for gastric decompression and suctioning. The device is used to regulate patient temperature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting materials must be demonstrated to be biocompatible.
(2) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Mechanical integrity testing.
(ii) Testing to determine temperature change rate(s).
(iii) Testing to demonstrate compatibility with the indicated external controller.
(iv) Shelf life testing.
(3) Animal testing must demonstrate that the device does not cause esophageal injury and that body temperature remains within appropriate boundaries under anticipated conditions of use.
(4) Labeling must include the following:
(i) Detailed insertion instructions.
(ii) Warning against attaching the device to unintended connections, such as external controllers for which the device is not indicated, or pressurized air outlets instead of vacuum outlets for those devices, including gastric suction.
(iii) The operating parameters, name, and model number of the indicated external controller.
(iv) The intended duration of use.