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The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances.

The °MEQU °M Warmer System consists of three components:

• a single-patient use, disposable warmer unit
• a multi-patient, reusable, rechargeable battery pack for powering the warmer
• a reusable charger for recharging the battery pack.
  The warmer contains a sterile fluid path with standard Luer lock connectors allowing it to be connected in the infusion fluid line. The fluid path includes a parylene coated aluminium heating chamber in which fluids passing through the warmer are heated. Heat is generated using resistive heating elements, using power supplied by the rechargeable battery pack.
  The warmer contains the electronics and software to control the temperature of the chamber and thus the temperature of the outgoing fluid.
  Remaining power in the battery pack is indicated to the user during use. When depleted, the battery pack can be re-charged using the charger.

The provided text does not include information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the °M Warmer System, which is a medical device designed to warm fluids for intravenous administration, not an AI or software as a medical device (SaMD).

Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document discusses performance in the context of non-clinical studies for a traditional medical device (like sterilization, electrical safety, biocompatibility, and heater safety testing) and concludes that the device is substantially equivalent to a predicate device. It explicitly states, "The claim of substantial equivalence is not based on an assessment of clinical performance data." and also "The software control the heating process and the operation of the device." which refers to the embedded software within the warmer, not an AI or diagnostic algorithm.

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