(479 days)
The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician with prescription privileges determines that temperature therapy is necessary or desirable.
Indications for use for the Altrix system include:
a. Maintain pre-set body temperature as determined by the physician
b. Maintain normal body temperature during surgical procedures
c. For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units
d. Adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients
The Altrix Precision Temperature Management System components include the controller, reusable hose set(s), thermal transfer devices, patient temperature probes and reusable adaptor cable(s). The controller regulates water temperatures between 4.0° C (39.2° F) and 40.0° C (104.0° F) and circulates the heated or cooled water via hose set(s) through the thermal transfer device(s). A graphical display provides the user an interface for selecting desired water or patient temperature settings, operating modes, help menus and other key parameters. Visual indicators are displayed to inform the user of system status or when the user must confirm a setting selection. The system's water temperature and flow outputs are monitored to ensure optimal system operation.
The controller can supply water to an individual or multiple thermal transfer devices simultaneously with each of these circuits monitored separately. Three operating modes are available to facilitate patient care: Automatic, Manual and Monitor. The patient temperature probe is used with the controller to provide closed loop feedback for automatic patient temperature management and monitoring. The controller alarms activate visual and audible indications for when safety parameters are exceeded or it detects system function or performance irregularities. The Altrix system also includes the ability to provide a patient temperature output reference signal to be connected to a non-specific third party device/system.
The provided document is a 510(k) premarket notification for the Altrix Precision Temperature Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device (Medi-Therm Hyper/Hypothermia System) through a comparison of technological characteristics and non-clinical bench testing.
Therefore, the acceptance criteria and study information requested typically associated with clinical performance studies (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training) are not fully available or directly applicable in the same way as they would be for a device that relies on clinical performance data for its clearance.
Here's a breakdown of the information that is available, and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (like sensitivity, specificity, accuracy) using a clinical dataset. Instead, the "acceptance criteria" for this premarket notification are demonstrated through:
- Substantial Equivalence: The primary acceptance criterion is that the Altrix device is substantially equivalent to the predicate device (Medi-Therm Hyper/Hypothermia System) in terms of indications for use, technological characteristics, safety, and performance.
- Compliance with Standards: The device must comply with relevant recognized safety and performance standards.
- Successful Bench Testing: Non-clinical bench testing must successfully verify the device's function and performance to specified engineering requirements.
Table of Performance (derived from "Technological Characteristics and Substantial Equivalence Summary" and "Bench and Standards Testing"):
| Category / Criterion | Acceptance Criteria (Predicate or Standard) | Reported Device Performance (Altrix) |
|---|---|---|
| Indications for Use | Same as Medi-Therm | Same as Medi-Therm |
| Temperature Control Range - Water | 4 - 42° C (Medi-Therm) | 4.0 - 40.0° C |
| Controller Accuracy - Water Temperature | ± 0.8° C (Medi-Therm) | ± 0.3° C |
| Display Accuracy - Water Temperature | ± 0.3° C (Medi-Therm) | ± 0.2° C |
| Settings Range - Patient Temperature | 30 - 41° C (Medi-Therm) | 32.0 - 38.0° C |
| Controller Accuracy - Patient Temperature | ± 0.5° C (Medi-Therm) | ± 0.3°C (25.0° - 45.0° C) |
| Patient Temperature Display Accuracy | ± 0.3° C (Medi-Therm) | ± 0.3° ( 25.0° - 45° C) |
| High Water Temperature Limit (Software) | 43° C (Medi-Therm) | >42.5° C |
| Water Temperature Deviation Alarm | No (Medi-Therm) | Yes; ±0.8° C |
| General Safety Standard Compliance | UL 416 (Medi-Therm) | ANSI/AAMI ES60601-1:2005(R)2012 and A1 2012, C1: 2009/(R)2012 and A2:2010/(R)2012 (and other specific IEC/ISO standards listed) |
| EMC/EMI Standard Compliance | EN60601-1-2 (Medi-Therm) | IEC60601-1-2 |
| Bench Testing (General) | Successful verification of functions and performance to specified requirements | Successfully verified warming/cooling performance, mechanical/thermal overload, controller abuse, environmental, fluid intrusion, packaging. Disinfection validated. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable in a clinical sense. The device relies on non-clinical bench testing, not a clinical "test set" of patient data. The provenance of the bench testing data would be from Stryker Medical's internal labs.
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. No clinical test set with human-established ground truth was used for this 510(k) clearance, as clinical testing was deemed not required.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set requiring adjudication was used.
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, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a temperature management system, not an algorithm, and its performance is evaluated through engineering and functional testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical bench testing, the "ground truth" refers to engineering specifications, physical measurements (e.g., temperature, flow rates), and compliance with recognized industry standards. These are objective, measurable criteria.
8. The sample size for the training set
- Not Applicable. There is no mention of a training set as this is not a machine learning/AI device.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).