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The FilteredFlo Warming Blanket is intended to be used with the IOB-507 patient warming system. The IOB-507 Temperature Management system is indicated for hypothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use.

The FilteredFlo warming blankets are used with the IOB Temperature Management System (previously cleared K231596) that draws ambient- temperature air through a 0.2 micron particulate air filter. The filtered air is warmed to a selected temperature. The warmed air enters the FilteredFlo 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 FilteredFlo warming blankets in the submission are the following:

FF-243 ADULT/PACU BLANKET
FF-244 PEDIATRIC BLANKET
FF-246 INFANT UNDERBODY BLANKET
FF-247 LARGE PEDIATRIC UNDERBODY BLANKET
FF-248 ADULT UNDERBODY BLANKET
FF-443 UPPER BODY BLANKET
FF-442 LOWER BODY BLANKET
FF-344 TORSO BLANKET
FF-145 WARMING TUBE BLANKET

These blankets are single-use and disposable. Each blanket consists of two layers of nonwoven polypropylene fabric coated with a layer of polyethylene. The layers 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 document is a 510(k) summary for a medical device called "FilteredFlo Warming Blankets." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information related to software, artificial intelligence (AI), diagnostic performance, or extensive clinical studies that would typically have the requested details about acceptance criteria for AI models, human reader studies, ground truth establishment, or training/test set sizes.

The "studies" mentioned are primarily non-clinical tests to demonstrate that the new warming blankets perform equivalently to existing ones in terms of physical characteristics and safety, not diagnostic accuracy or AI performance.

Therefore, I cannot provide the requested information for acceptance criteria and studies related to AI or diagnostic performance, as these are not relevant to the "FilteredFlo Warming Blankets" device as described in this 510(k) submission.

Here's a breakdown of what can be extracted from the document, tailored as much as possible to your request, but highlighting the absence of AI/diagnostic-specific details:

Device: FilteredFlo Warming Blankets (models FF-243, FF-244, FF-246, FF-247, FF-248, FF-443, FF-442, FF-344, FF-145)

Intended Use: "The FilteredFlo Warming Blanket is intended to be used with the IOB-507 patient warming system. The IOB-507 Temperature Management system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use."

1. A table of acceptance criteria and the reported device performance

   Since this is a thermal regulating system and not an AI or diagnostic device, the "acceptance criteria" are related to physical and functional equivalence to a predicate device, specifically in terms of temperature uniformity, package integrity, and lack of leaks.

   Acceptance Criteria	Reported Device Performance
   Temperature Uniformity	All test results show temperature uniformity "equivalence" between the FilteredFlo Warming Blankets and the predicate at different IOB Warmer settings.
   Simulated Transport Testing (ASTM D4169)	No package damage was observed. All products held integrity after the transport testing.
   Bubble Testing (ASTM F2096) (Leakage)	No leakage was found.
   Biocompatibility	Tests for biocompatibility were reported in the previously cleared K231596 (predicate device's clearance). The proposed device is implicitly accepted as biocompatible based on previous clearance.
   Material Design and Indication for Use Equivalence	The proposed device's material design and Indications for Use are deemed "Substantially Equivalent" to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not explicitly stated for each test, but implied to be a representative sample of the different blanket models. These are physical product tests, not data-driven studies with "test sets" in the AI sense.
   • Data Provenance: Not specified, but these are laboratory/bench tests performed by the manufacturer or their contractors.

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. "Ground truth" in this context refers to established engineering standards and physical measurements, rather than expert diagnostic consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   Not applicable. These are engineering and physical product tests, not qualitative assessments requiring adjudication. The results are based on objective measurements against defined 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

   Not applicable. This device is a warming blanket, not an AI or diagnostic tool. No MRMC study was performed or is relevant.

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

   Not applicable. This is a physical medical device, not an algorithm.

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

   The "ground truth" for demonstrating performance is derived from established engineering standards (e.g., ASTM standards for transport and bubble testing) and physical measurements (e.g., temperature measurements for uniformity). Comparison to the predicate device's cleared performance serves as the benchmark for "equivalence."

8. The sample size for the training set

   Not applicable. This device does not involve a "training set" for an algorithm.

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

   Not applicable.

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