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The infusion/blood warmer model ANIMEC AM-2S is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated in intravenous administration sets for intermittent use and low flow rate applications at 1 to 12ml/min. The AM-2S is available in two sizes: 4mm channel for I.V. administration sets and a 5mm channel for blood administration sets.

The infusion/blood warmer model ANIMEC AM-2S is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated in intravenous administration sets for intermittent use and low flow rate applications at 1 to 12ml/min. The AM-2S is available in two sizes: 4mm channel for I.V. administration sets and a 5mm channel for blood administration sets.

The provided document describes an FDA 510(k) premarket notification for infusion/blood warmers (Animec, Models AM-2S-4 and AM-2S-5). It establishes substantial equivalence to a predicate device but does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a more comprehensive technical document for a medical device.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details (effect size).
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is primarily an FDA clearance letter and an "Indications For Use" statement, not a scientific or clinical study report.

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