(91 days)
The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.
The Belmont Hyperthermia Pump combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid perfusion of warmed fluid. It can raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician. The system monitors fluid temperature, patient temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A touch screen displays flow rate, total fluid pumped, output fluid temperature, target temperature, patient temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation.
The provided text describes the Belmont Hyperthermia Pump, but does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and study particulars for a medical device. This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial with performance metrics and ground truth establishment against specific acceptance criteria.
However, based on the nonclinical tests described, I can infer some aspects and present the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from "Summary of Nonclinical Tests") | Reported Device Performance |
|---|---|
| Pumping Accuracy: Ability to pump fluids accurately over the full range of flow rate and operating conditions (different input fluid temperatures, different back pressure, ambient temperature changes). | Performed within specification. |
| Warming Capability: Ability to warm fluid to the desired target temperature over the full range of flow rate and operating conditions. | Performed within specification. |
| Safety and Alarm Functionality: Ability to detect and alarm at unsafe or ineffective operating conditions (operator errors, sensor failures, internal system malfunctions). | Performed within specification, including sounding an audible alarm, stopping heating, and pumping at all unsafe conditions. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "nonclinical tests" but does not detail the number of units tested, the number of test scenarios, or the quantity of data generated.
- Data Provenance: Not specified. These are nonclinical (bench) tests, so there's no patient data or country of origin mentioned. The tests were conducted internally by Belmont Instrument Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a study involving expert-established ground truth for diagnostic or prognostic purposes. The performance was measured against engineering specifications and safety parameters.
4. Adjudication method for the test set
- Not applicable. This is not a study requiring adjudication of expert interpretations. Device performance was evaluated against defined engineering specifications.
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 a medical device (hyperthermia pump), not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Applicable in principle, as the device operates largely autonomously to maintain temperature and flow. The "nonclinical tests" described represent standalone performance evaluations of the device's functions (pumping, warming, alarming) against its internal specifications. The document states it "performed within specification in all of the above tests."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the nonclinical tests, the "ground truth" or reference standard would be the engineering specifications and design requirements of the device for pumping accuracy, temperature control, and safety alarm thresholds.
8. The sample size for the training set
- Not applicable. This is a conventional medical device, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).