(90 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 Temperature Management Wraps are the patient contact accessory for the Altrix Precision Temperature Management System. The Wraps are applied around the patient's thigh and torso. The Wraps are made from multiple layers of materials sealed together. A hose is used to connect the Wraps to the Altrix controller device.
The provided document is a 510(k) premarket notification for a medical device called "Altrix Temperature Management Wraps". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study typically associated with AI/ML-based medical devices (e.g., studies for diagnostic accuracy, sensitivity, specificity, or human improvement with AI assistance).
The device in question, a temperature management wrap, is a physical device that circulates temperature-controlled water for body temperature regulation. It is not an AI/ML-driven diagnostic or assistive device. Therefore, the questions about MRMC studies, standalone algorithm performance, expert ground truth adjudication, training set sizes, and deep learning model specific criteria are not applicable to the information contained in this 510(k) submission.
This document primarily assesses the device's safety and performance through non-clinical bench testing and compliance with recognized standards, and compares its technological characteristics to a legally marketed predicate device.
Given this context, I will address the relevant points based on the provided text, and explicitly state when a question is not applicable.
Acceptance Criteria and Device Performance (for a physical temperature management wrap)
Since this is a physical device aiming for substantial equivalence to a predicate, the "acceptance criteria" are primarily established by compliance with recognized safety and performance standards for thermal regulating systems and demonstration of equivalent physical and functional characteristics to the predicate. The "reported device performance" refers to the successful completion of these tests.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance (Study Outcome) |
|---|---|---|
| Compliance to Safety & Essential Performance Standards | Adherence to relevant sections of: |
- ANSI/AAMI ES60601-1:2005 (R)2012 and A1 2012, C1: 2009(R) 2012 and A2:2010/(R)2012 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance)
- IEC80601-2-35: 2009 (Safety and Essential Performance of Heating Devices Using Blankets, Pads or Mattresses) | "Altrix Wraps were designed and/or tested to be in compliance with the relevant sections of the following standards: ... AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009(R)2012 And A2:2010/(R)2012 ... IEC 80601-2-35 Ed 2.0 - 2009-10 ... The results of the non-clinical bench and standards testing concluded Altrix Wraps are substantially equivalent to the predicate device." |
| Biocompatibility | Adherence to ISO 10993 series (ISO 10993-1, ISO 10993-5, ISO 10993-10) | "Biocompatibility: ISO 10993-1; ISO 10993-5; ISO 10993-10" (under Predicate Comparison Table indicating "Same" as predicate). "Altrix Wraps were designed and/or tested to be in compliance with the relevant sections of the following standards: ... AAMI / ANSI / ISO 10993-1:2009/(R) 2013 ... AAMI / ANSI / ISO 10993-5:2009/(R) 2014 ... AAMI / ANSI / ISO 10993-10:2010." The results concluded substantial equivalence. |
| Device Function & Performance | Expected performance in temperature warming/cooling, mechanical overload conditions, environmental stability, and packaging integrity. | "Non-Clinical bench testing was successfully completed to verify Altrix Wraps function and performance to specified requirements. Bench testing included temperature warming and cooling performance, mechanical overload conditions, environmental, and packaging." |
| Risk Management | Compliance with ISO 14971 (Application of Risk Management To Medical Devices) | "Altrix Wraps were designed and/or tested to be in compliance with the relevant sections of the following standards: ISO 14971 Second Edition 2007-03-01 - Medical Devices - Application Of Risk Management To Medical Devices." The results concluded substantial equivalence. |
| Substantial Equivalence to Predicate Device (Rapr-Round) | The device should have the same intended/indications for use, basic principles of operation, basic design, operational characteristics, and comparable technological characteristics, or any differences do not raise new questions of safety and effectiveness. | "The Altrix Wraps and Rapr Round share the same basic principles of operation, intended/indications for use, basic design, operational and technical characteristics. The Altrix Wraps are substantially equivalent to the predicate Rapr·Round." The comparison table (Table 5-1) explicitly states "Same" for Indications for Use, Anatomical Site, Sterility, Basic Safety and Essential Performance Standards, Basic Safety and Essential Performance for Heating Devices, and Biocompatibility. The material is noted as "Different" but this was addressed through testing to still demonstrate equivalence overall. The conclusion states: "Based on Altrix Wraps' technological characteristics, completed non-clinical bench testing and comparison with the predicate device, we conclude that Altrix Wraps are substantially equivalent to the predicate Rapr·Round device." |
Addressing Specific Questions (in the context of this device type):
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A table of acceptance criteria and the reported device performance: See the table above. The "acceptance criteria" here are largely defined by adherence to recognized standards and successful outcomes of non-clinical bench tests demonstrating equivalent performance to the predicate.
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable in the context of human data or AI model testing. The "test set" here refers to the physical samples of the Altrix Temperature Management Wraps and components used for various non-clinical bench tests (e.g., temperature warming/cooling performance, mechanical overload, environmental, packaging), and material samples for biocompatibility testing. The specific number of wraps/components tested for each bench test is not specified in this summary, which is typical for a 510(k) summary as detailed test protocols and results are in the full submission, not the public summary.
- Data Provenance: Not applicable as this is not a study involving human patient data or AI algorithm performance on such data. The data originates from internal engineering and biocompatibility laboratory testing conducted by Stryker Medical.
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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 does not involve subjective assessment or diagnostic interpretation where "ground truth" established by human experts is required (as it would be for an AI diagnostic algorithm). The "ground truth" for this device is based on objective, quantifiable physical properties, performance metrics, and adherence to engineering and safety standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method.
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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/ML device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" (or basis for verification) for this physical device is primarily:
- Objective Engineering Specifications: Defined performance parameters for temperature regulation, mechanical durability, etc.
- Recognized Industry Standards: Compliance with ISO and ANSI/AAMI standards for medical electrical equipment, heating devices, biocompatibility, and risk management.
- Predicate Device Characteristics: The established safety and performance profile of the legally marketed predicate device (Altrix Precision Temperature Management System - Rapr-Round).
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The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model.
§ 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).