(126 days)
The intended use of the PERFORMER HT is to provide isolated hyperthermic perfusion in the thoracic or peritoneal cavity by means of extra-corporeal circulation of warmed, physiologically compatible sterile solution, according to a protocol to be selected by the physician.
The device must be used by a qualified medical professional who is experienced in the operation of this or similar equipment.
The PERFORMER HT is a prescription electromechanical device intended to provide isolated hyperthermic perfusion in the thoracic or peritoneal cavity by means of extracorporeal circulation of warmed. physiologically compatible sterile solution.
The PERFORMER HT equipment is designed to:
- operate the treatment execution by means of a color touch-screen display .
- . control the temperature of solution perfused to the Patient through the extracorporeal circuit
- control the flow rates of roller pumps .
- control the volume in the extracorporeal circuit and Patient's body cavity .
- monitor Patient's body cavity temperatures .
- monitor the extracorporeal circuit pressures .
- . detect air in the circuit
- change the fluid path in the extracorporeal circuit by means of 2 two-ways pinch valves .
The Central Information Display (CID) enables the User to interact with the PERFORMER HT equipment. The touch-screen display allows the User to:
- inout Patient information .
- operate the various treatment phases
- display treatment parameters (e.g, flows, pressures, temperatures) .
- set treatment parameters .
- . set alarm limits
- display graphical trending of temperature probes connected to the HTS module
- · read alarm and alert messages
The PERFORMER HT is intended to be used with the HANG&GO HT BASIC, a disposable, single use kit intended to circulate and filtrate the clear solutions in the thoracic or abdominal cavity.
The HANG&GO HT BASIC includes all necessary lines and accessories for the treatment execution:
- · circulation line
- ·. heater bag
- · reservoir
- · table pack (Patient inlet and outlet lines) with thermal protections
The HANG&GO HT BASIC is supplied sterile, packaged in a proprietary-design container, and is intended to be used only with the PERFORMER HT.
The Performer HT is a prescription electromechanical device for isolated hyperthermic perfusion. It circulates warmed, physiologically compatible sterile solution in the thoracic or peritoneal cavity. It controls solution temperature and flow rates, monitors volumes/pressures/temperatures, and detects air. The device is intended for use by qualified medical professionals.
Here's an analysis of its acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device should do) | Reported Device Performance (What the device does) |
|---|---|
| Ability to heat and pump fluids accurately over the full range of flow rate and operating conditions. | Performed within specifications. |
| Ability to maintain fluid temperature over the full range of fluid flow rates. | Performed within specifications. |
| Ability to control pressures, volumes, and flow rate accuracy over the full range of fluid flow rate within operating temperature and pressure range. | Performed within specifications. |
| Ability to detect and alarm at unsafe or ineffective operating conditions (e.g., operator errors, sensor failures, system malfunctions). | Performed within specifications. |
| Ability to mitigate against known or predictable operator errors. | Performed within specifications. |
| Ability to store parameters and data in non-volatile memory. | Performed within specifications. |
| Compliance with various recognized standards for: |
- Quality management (ISO 14971, EN ISO 13485, EN ISO 14971)
- Packaging and labeling (EN 980, EN 1041, ASTM D4169-04a)
- Biocompatibility (AAMI ANSI ISO 10993 series)
- Electrical safety (IEC 60601 series)
- Sterility (AAMI ANSI ISO 11135, ISO 11607 series, ASTM F1980-07, AAMI ANSI ISO 11737)
- Human Factors (IEC 62366, EN 62366)
- Software (IEC 62304, EN 62304) | The PERFORMER HT is designed to, complies with, and has been tested to, the FDA Recognized Consensus Standards listed in the table. |
| Software ability to meet performance specifications. | Verified through described tests at unit, integration, and system level for all functions, actuators, and parameters. |
| User interface optimization and mitigation of user- and patient-safety risks concerning human factors. | Demonstrated that task-risks and errors have been identified, addressed, and either eliminated or reduced in a simulated use environment. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" for a specific test set in the context of clinical trials or retrospective studies on actual patient data. The testing primarily involved non-clinical tests conducted on the PERFORMER HT system (equipment and disposable).
Data Provenance: The tests were performed by the manufacturer, RanD S.r.l. in Italy, as part of their 510(k) submission. Therefore, the data provenance is from the manufacturer's testing environment and simulated use, and it is prospective in the sense that the tests were designed and executed to evaluate the device's performance against pre-defined specifications. It is not patient or clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this medical device primarily relates to its engineering specifications, safety standards, and functional performance as verified through non-clinical testing. There is no mention of a ground truth established by human experts in a diagnostic or clinical context. The "ground truth" is defined by the technical specifications and recognized consensus standards that the device is tested against.
4. Adjudication Method for the Test Set
Not applicable in the traditional sense. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers (e.g., radiologists) interpret medical images or data, and their interpretations are compared against a consensus ground truth.
In this case, the device's performance was evaluated against predefined engineering specifications and recognized standards. The "adjudication" would involve technical experts (engineers, quality assurance personnel) verifying that the test results met these objective criteria.
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. This is not an AI/CAD (Computer-Aided Detection/Diagnosis) device, nor is it a device that is typically evaluated through MRMC studies. The PERFORMER HT is an electromechanical device for hyperthermic perfusion.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The performance tests described comprehensively evaluate the PERFORMER HT system (equipment and disposable) in its standalone capacity, to ensure it meets its functional and safety specifications. Even though it's an electromechanical device and not an algorithm, the tests assess its "standalone" operational capabilities without human intervention beyond initiating and monitoring the tests. The human factors study separately assessed user interaction, but the core performance tests were for the device itself.
7. The Type of Ground Truth Used
The ground truth used for the non-clinical tests is based on pre-defined engineering specifications, recognized consensus standards, and established operational parameters. For example:
- Temperature control: The ability to heat and maintain fluid temperature within a specified range defines the ground truth for this function.
- Flow rate accuracy: The specified acceptable deviation from target flow rates serves as the ground truth.
- Alarm functionality: The system's response to simulated unsafe conditions (e.g., sensor failure) according to its design is the ground truth.
- Compliance with standards: The requirements outlined in international and European standards (e.g., ISO 14971, IEC 60601-1) form the ground truth for safety, quality, and electrical compatibility.
8. The Sample Size for the Training Set
Not applicable. This device is an electromechanical system, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development. The device's design and functionality are based on engineering principles and validated through testing, not learned from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, 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).