(140 days)
Model #: ECD01-A:
The Esophageal Cooling Device is a thermal regulating device, intended to:
- connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and
- provide gastric decompression and suctioning.
Model #: ECD02-A:
The Esophageal Cooling Device is a thermal regulating device, intended to:
- connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient
temperature, and - provide gastric decompression and suctioning.
The Esophageal Cooling Device (ECD) is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to modulate a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage and maintain the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the ECD to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction and is used for standard gastric decompression. The ECD is made of standard medical-grade silicone. It is a single-use, disposable, nonimplantable device.
The provided text is a 510(k) summary for the Esophageal Cooling Device (ECD). It details the device's characteristics, indications for use, and a comparison to a predicate device, along with a list of non-clinical performance tests. However, this document does not describe acceptance criteria for a device's performance in terms of metrics like sensitivity, specificity, accuracy, or any performance targets against a ground truth.
Instead, the "acceptance criteria" can be inferred as the successful completion of various engineering and safety tests, and the "study" is the non-clinical performance testing conducted by the manufacturer. These tests are primarily to demonstrate that the device is safe, functions as intended, and is substantially equivalent to a previously cleared device.
Therefore, many of the requested fields cannot be directly answered from the given input, as the document focuses on regulatory clearance for a physical medical device, not a diagnostic or AI-driven system that would typically undergo studies with performance metrics against a ground truth.
Here's an attempt to answer the questions based on the provided text, while acknowledging its limitations for certain categories:
1. A table of acceptance criteria and the reported device performance
Since this document describes a physical medical device (Esophageal Cooling Device) and the "studies" are non-clinical engineering and safety tests, the acceptance criteria are generalized to "suitability for intended use" rather than specific numerical performance metrics typically seen for diagnostic devices or AI systems.
| Acceptance Criteria (Inferred from Test Objective) | Reported Device Performance |
|---|---|
| Biocompatibility: Materials suitable for intended use | "All materials used to manufacture the ECD are suitable for the intended use." |
| Tensile Force: Suitable for insertion/removal | "ECD is suitable for insertion into and removal from the esophagus." |
| Burst Strength: Suitable for normal operating pressures | "ECD is suitable for normal operating pressures." |
| Ultimate Material Strength: Suitable for specified operating conditions | "ECD is suitable for normal operating pressures under worst-case manufacturing conditions." |
| Leakage: Prevention of stomach filling with coolant | "ECD is suitable for preventing the patient's stomach from filling with coolant." |
| Resistance to Vacuum: Suitable for normal operating pressures | "ECD is suitable for normal operating pressures." |
| Flow Rate: Maintenance of thermal transfer capabilities | "ECD is suitable for maintaining thermal transfer capabilities." |
| Packaging Integrity: Maintenance of cleanliness | "ECD packaging is suitable for maintaining the cleanliness of the ECD." |
| Overall: No new questions of safety or effectiveness (compared to predicate) | "The ECD01-A and ECD02-A have technological characteristics that do not raise new questions of safety or effectiveness when compared to the predicate device." |
| Shelf Life: Increased from 1 year to 3 years | "Non-clinical performance testing was also conducted to show the technological characteristics of the subject devices are suitable to increase the shelf life from 1 year to 3 years." |
2. Sample sized 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 (e.g., number of devices tested) for the non-clinical performance tests. These are typically engineering tests, likely involving a small number of physical samples from manufacturing lots. Data provenance in terms of country of origin or retrospective/prospective is not applicable as these are laboratory/benchtop tests, not human studies.
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. This device is not an imaging or diagnostic device that requires expert ground truth establishment for a test set. The "ground truth" here is based on engineering specifications and existing regulatory standards for medical device safety and performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to studies where expert opinions (e.g., medical image interpretations) are being adjudicated. For engineering tests of a physical device, results are typically determined by measurement against established standards, not expert consensus or adjudication.
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, nor is it a device that involves "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For biocompatibility, the ground truth is established by ISO 10993 standards (e.g., cell viability for cytotoxicity, irritation scores for irritation). For mechanical tests (tensile, burst, strength, leakage, vacuum, flow rate), the ground truth is established by industry-accepted engineering standards and internal specifications derived from the device's intended use and comparison to the predicate device. The ultimate "ground truth" for regulatory clearance is "substantial equivalence" to the predicate device in terms of safety and effectiveness.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and prior device models.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set." The design and testing are based on engineering principles and regulatory guidances relevant to medical devices.
§ 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.