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The TECOTHERM NEO is a temperature management system for pediatric patients, indicated for controlling and monitoring patient's temperature through conductive heat transfer.

The TECOTHERM NEO is designed for controlled cold & heat treatment procedures and application of specific cold and heat doses to neonate and babies. The system applies cold and heat to total body, body parts and areas depending on therapy target by means of mattresses and/wrap. The main application is Total Body Treatment of Children up to body mass of 50 kg. TECOTHERM NEO consists of a unique cold & heat generating device, applied parts like mattresses/wrap, interconnecting hoses (tubing set), accessories. Applied parts are connected to the device via hoses by self- sealing quickdisconnect couplings. The patient is provided with cold or heat according to the therapy target in a fully controlled way by a circulating fluid. This physiologic safe water- based fluid is cooled or warmed in the device and flows through the mattress or wrap continuously supplying the patient with therapeutically prescribed doses. Patient temperatures are measured with approved calibrated probes connected to the TECOTHERM NEO device. Temperature data is permanently communicated to the device Operational System. Circulation of thermalizing fluid to provide cold and heat, accurately reaching set points and operating at set point temperatures accurately with max. deviation of +/-0.3 °C, monitoring the treatment, and alarming when exceeding or falling below temperature limits are performances of TECOTHERM NEO. TECOTHERM NEO is a system with built-in physiologic closed loop circuit PCLC. TECOTHERM NEO is electronically divided into an Operational System and a Controlling System. Both sub systems are micro computer (uC) based. Both uC communicate permanently to ensure safe and proper operation according to therapy needs. A comfortable user MENU will guide the operator to the treatment modes, advise how to proceed the treatment and how to manage treatment details.

The provided document is a 510(k) premarket notification for the TECOTHERM NEO device, which is a temperature management system for pediatric patients. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a statistical performance against specific acceptance criteria in the way an AI/ML device would be evaluated for diagnostic accuracy.

Therefore, the document does not contain the information requested for a study proving a device meets acceptance criteria related to diagnostic performance or accuracy, particularly concerning AI/ML algorithms.

Here's why and what information is missing based on the prompt's requirements:

• No Diagnostic Acceptance Criteria: The TECOTHERM NEO is a thermal regulating system, not a diagnostic device. Its "performance" refers to its ability to control temperature within certain ranges and its safety features, not its ability to accurately classify or predict a medical condition.
• No AI/ML Component: The device description does not indicate the use of any AI or machine learning algorithms. Its operation is described as having a "physiologic closed loop circuit" and being "micro computer (uC) based."
• Performance Testing vs. Clinical Study: The "Performance Testing" section describes material biocompatibility, design verification/validation, and durability testing, along with references to European market experience and a separate "Toby trial" for the therapy type, not a direct study of the TECOTHERM NEO's performance relative to diagnostic metrics.

Given this, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance (for diagnostic accuracy): The "Comparative Analysis" table lists specifications and alarm thresholds, which are closer to engineering parameters and safety features than diagnostic performance metrics (e.g., sensitivity, specificity, AUC).
2. Sample size used for the test set and the data provenance: Not applicable as there's no diagnostic test set.
3. Number of experts used to establish the ground truth and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, effect size: Not applicable.
6. If a standalone (algorithm only) performance was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document serves as a regulatory submission demonstrating substantial equivalence for a physical medical device based on its functional specifications and safety attributes, not on diagnostic accuracy metrics or AI/ML performance.

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