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The Allon 2001 version 5 is intended to maintain pre- set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. This system can be used with adult and pediatric patients.

Device Description

The Allon 2001 vesion 5 system consists of the following elements:

Temperature controlled disposable garment
Body sensors
Connecting flexible water pipes
Heating/Cooling Unit
The system is operated by circulating water by a pump in a closed loop between the device and a disposable garment worn by the patient. The water circulates through the heating/ cooling unit. Temperature (body) sensors are placed on the patient and in the rectum, nasopharynx or esophageal to measure core temperature. The operator selects the desired patient core temperature and the unit operates in an automatic mode. Patient temperature is controlled and maintained at any set point between 30-40°C using a feedback loop and sensors placed on the patient's body.
The heating/cooling unit is based on a solid-state thermo-electric device, which operates as a heat pump. The system is intrinsically safe, due to the characteristics of the thermo-electric device, heating capacity drops off as the Thermo Electro Cooler (TEC) temperature rises. Hence, if for any reason, flow of coolant is interrupted, the TEC will overheat and the power output will fall, thus limiting water temperature rise.
The disposable garment is provided in a variety of shapes and sizes, which are manufactured of the same materials and by the same process as those already cleared under K001546, K992386 and K003349.

AI/ML Overview

This submission describes the Allon 2001 version 5 Thermal Regulating System, a device intended to maintain pre-set body temperature as determined by a physician, including during surgical procedures, for adult and pediatric patients in various hospital settings.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a formal, quantifiable manner for clinical performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices (Allon 2001 - K003349 and Cincinnati Subzero - Blanketrol II) by comparing functional and safety specifications.

The table below summarizes the key performance specifications listed for the Allon 2001 version 5 and its predicate devices:

Feature / Criterion	Allon 2001 / CSZ - Blanketrol (Predicate)	Allon 2001 version 5 (New Device)
Equipment Design
Dimensions	26cm X 53cm X 52cm (Allon 2001)	26cm W X 62.5cm D X 94cm H
Weight	33 Kg (without water in reservoir)	The same
Mobility	Mobile with four wheels	The same
Power max.	500 W max.	The same
Input power	120/230 V ac with isolation transformer	The same
Water tank	6 liter	The same
Control System
Water out temp'	13-40.8 °C	The same
Set Point temp'	30-40 °C	The same
Flow rate	0.2-1.25Lpm	The same
Pressure rate	0.1-1.3 bar	The same
Safety System
High primary temp'	41°C (Allon 2001) / 45 °C (CSZ)	42 °C
High secondary temp'	42°C (Allon 2001) / 46 °C (CSZ)	44 °C
High third temp'	44°C (Allon 2001) / N/A (CSZ)	N/A
Low primary temp'	10 °C	The same
Pressure valve	Yes	The same
Safety Alert / Alarms
Dislodged sensor	Yes	The same
Incorrect Patient temp' setting	Yes	The same
High/Low patient temp' limit	Yes	The same
Out of normothermia	Yes	The same
High/Low water temp' limit	Yes	The same
Low water	Yes	The same
Low water flow	Yes	The same
Water blocking	Yes	The same
Non - Operating Pump	Yes	The same
Monitoring/Indicators
Water out temp'	Yes	The same
Not enough water in tank	Yes	The same
Water in temp'	Yes	The same
Patient Surface Temp.	Yes	The same
Patient core Temp.	Yes	The same
Water pressure	Yes	The same
Graphic presentation	Yes	Modified, after changing machine interface lay-out display
Operating Buttons
Set Point temp'	Yes	The same
Silence Alarm	Yes	The same

Note: The submission aims to demonstrate substantial equivalence, meaning the new device is as safe and effective as the predicate devices. The "acceptance criteria" here are implicitly met if the device's specifications are equivalent or improved without raising new safety or effectiveness concerns compared to the legally marketed predicates.

2. Sample size used for the test set and the data provenance

The document does not describe a clinical study with a "test set" in the context of diagnostic accuracy or performance on patient data. This is a temperature regulating medical device, and the submission focuses on engineering specifications and comparison to predicate devices, not on a clinical trial with a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" establishment by experts on a test set is described for this type of device submission. The device's performance is assessed against technical specifications and comparison to existing devices, not a clinical gold standard review.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication is described.

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 device is a thermal regulating system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The ground truth for this device's safety and effectiveness is established through adherence to engineering design principles, international standards (implied via safety features), and comparison to the established performance and safety profiles of predicate devices that have been deemed safe and effective for their intended use.

8. The sample size for the training set

Not applicable. The submission does not describe a machine learning model or a "training set."

9. How the ground truth for the training set was established

Not applicable.

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K Number

K003349

Device Name

ALLON 2001 MODIFIED

Manufacturer

MTRE ADVANCED TECHNOLOGY LTD.