(214 days)
The IOB Temperature Management system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.
The IOB Temperature Management System consists of the IOB warming unit and the IOB warming blankets. The IOB warming unit draws ambient- temperature air through a 0.2 micron air filter. The filtered air is warmed to a selected temperature. The warmed air enters the IOB Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient. The warming unit has three temperature settings of 32°C, 38°C, and 43°C. These temperature settings are servo-controlled by a thermistor placed at the end of hose where the hose connects to the blanket. The unit can also delivers ambient-temperature air. The temperature indicated on the control panel is the temperature of air being delivered to the blanket at the end of the hose. A control thermistor in the warming unit adjusts the power applied to the heater to maintain the selected temperature. This enables the system to maintain the selected temperature under variations in ambient temperature. Besides, the warming unit has high and low air flow for choose.
The IOB Warming Blankets in this submission are the following:
Torso IOB-001 Lower Body IOB-002 Upper Body IOB-003 Full Body IOB-004 Pediatric Underbody IOB-005 Adult Underbody IOB-006 Pediatric Full Body IOB-007 Full Body Surgical IOB-008 Large Pediatric Underbody IOB-009 Spinal Underbody IOB-010 Lithotomy Underbody IOB-011 Pediatric Lower Body IOB-012 Pediatric Long IOB-014 Cath Lab IOB-015 Surgical Access IOB-016 Chest Access IOB-017 Multi-Access IOB-018 Dual Port Torso IOB-019 Cardiac Access IOB-020 XL Upper Body IOB-021 Outpatient Care IOB-022 Cardiac IOB-023
These blankets are single-use and disposable. Each blanket consists of two lavers of non-woven polypropylene fabric coated with a layer of polyethylene. The lavers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.
The provided text is a 510(k) summary for the IOB Temperature Management System, which is a medical device for warming patients. It addresses substantial equivalence to a predicate device (Bair Hugger Temperature Management System) rather than outlining acceptance criteria and a study proving device performance in the context of an AI/ML powered device.
Therefore, the specific information requested about acceptance criteria and studies demonstrating performance as would be expected for an AI/ML driven diagnostic or assistive technology (e.g., sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not present in the provided document.
The document focuses on the physical and functional characteristics of a thermal regulating system and its blankets, demonstrating its equivalence to a legally marketed predicate device.
However, I can extract the safety and performance characteristics mentioned in the document, which serve a similar purpose of demonstrating the device's suitability for its intended use, even if they are for a physical device rather than an AI/ML algorithm.
Here's the information that can be extracted, framed to best fit your request:
Acceptance Criteria and Study for the IOB Temperature Management System (as applicable to a physical thermal regulating device)
Since the IOB Temperature Management System is a physical device (a thermal regulating system) and not an AI/ML powered diagnostic or assistive technology, the typical "acceptance criteria" and "study" framework for AI/ML performance metrics (like sensitivity, specificity, AUC, etc.) and related study design details (sample size for test/training, ground truth methods, expert adjudication, MRMC) does not apply.
Instead, the provided document outlines the general "Safety and Performance Characteristics" and their verification methods to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Characteristic) | Reported Device Performance (Verification Method) |
|---|---|
| Temperature Uniformity | "Temperature uniformity tests show equivalence between the IOB warming blankets and the predicate." |
| Shelf-Life | "Accelerated stability tests show three years shelf-life of the IOB warming blankets." |
| Electrical Safety / EMC | "Electrical safety/EMC testing... show that the device meets its design specifications, performs as intended." |
| Software Validation | "Software validation show that the device meets its design specifications, performs as intended." |
| Biocompatibility | "Biocompatibility testing (cytotoxicity, irritation and sensitivity) according to ISO 10993 for a limited contact device was demonstrated to be suitable for the intended use of the product." |
2. Sample size used for the test set and the data provenance
- Not applicable / Not specified in the provided document for the types of tests described (temperature uniformity, accelerated stability, electrical safety, software validation, biocompatibility). These tests typically involve a defined number of units or samples under specific conditions rather than patient "test sets" as understood for AI/ML evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Information not provided. The ground truth for these device performance tests is based on objective measurements and established standards (e.g., precise temperature readings, material degradation, electrical standards, ISO biocompatibility standards) rather than expert consensus on diagnostic interpretations.
4. Adjudication method for the test set
- Not applicable / Information not provided. Adjudication methods are not relevant for these types of engineering and material performance tests.
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 a physical device, not an AI/ML diagnostic. A MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical device, not an AI/ML algorithm.
7. The type of ground truth used
- For Temperature Uniformity: Objective physical measurements against a standard for thermal performance (implied).
- For Shelf-Life: Objective laboratory testing for material degradation and functional integrity over time (accelerated aging).
- For Electrical Safety/EMC: Compliance with international safety standards (IEC60601-1, IEC 60601-1-2) through objective measurements.
- For Software Validation: Verification against design specifications and functional requirements.
- For Biocompatibility: Adherence to ISO 10993 standards (cytotoxicity, irritation, sensitivity) through laboratory testing.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or corresponding ground truth establishment mentioned for this device.
§ 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).