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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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The Medi-Therm is intended for use in supplying warm or cold water at controlled temperatures via water circulating blankets or body wraps for the application of regulating patient temperature in situations where a physician determines that temperature therapy is necessary and desirable.

Indications for use for the Medi-Therm thermal regulating system include:
a. To maintain pre-set body temperature as determined by the physician
b. To maintain normal body temperature during surgical procedures
c. For use in all hospital areas including invasive and coronary care units, in operating, recovery and emergency rooms, in burn units and on medical/surgical floors
d. This system can be used with adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients

The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket/s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system.

The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.

The provided document is a 510(k) summary for the Gaymar Medi-Therm Hyper/Hypothermia System. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the technological characteristics, intended use, and general safety and effectiveness.

Based on the provided text, there is no information available regarding a study that assesses device performance against specific acceptance criteria in the format you requested (e.g., diagnostic accuracy metrics like sensitivity, specificity, or reader improvement with AI).

The document mentions "Bench testing was conducted to confirm the MTA6900 and MTA7900 and their disposable accessories operate as described in this submission and therefore are as safe and effective as the predicate devices to which it claims substantial equivalence." The types of bench testing listed are:

• Temperature Control Performance
• Temperature Stability and Flow
• Biocompatibility (ISO 10993-5; ISO10993-10; 16 CFR 1500)
• Ship Testing (ISTA 1A)

However, the document does not provide:

• Specific acceptance criteria for these tests (e.g., "temperature control performance must maintain patient temperature within +/- 0.5°C").
• Reported device performance against such criteria in a quantitative table.
• Details about sample sizes, data provenance, ground truth establishment, expert involvement, or MRMC studies. The context of this device (a thermal regulating system) does not typically involve the kinds of diagnostic accuracy studies (MRMC, standalone, human-in-the-loop) that would require such detailed information on ground truth, expert consensus, and reader performance.

Therefore, I cannot populate the table or answer most of your specific questions as the necessary information is not present in the provided 510(k) summary. The document focuses on demonstrating that the device meets safety and performance standards generally expected for its product classification and is substantially equivalent to existing devices through engineering and functional comparisons, not clinical performance metrics in the way a diagnostic AI device would be evaluated.

Table of Acceptance Criteria and Reported Device Performance:

Detailed Study Information (Based on the document):

1. Sample size used for the test set and the data provenance: Not applicable/not provided. The document refers to "Bench testing," which implies laboratory-based tests rather than patient data test sets.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth establishment with experts is typically for diagnostic devices assessing images or other complex data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not mentioned and is not typically relevant for a thermal regulating system.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This refers to diagnostic algorithm performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not provided. For bench testing, the "ground truth" would be the expected physical or electrical output/behavior based on design specifications or industry standards.
7. The sample size for the training set: Not applicable/not provided. This device is not described as involving machine learning or algorithms that require a "training set" in the context of data analysis. Its "microprocessor control" refers to conventional programming.
8. How the ground truth for the training set was established: Not applicable/not provided.

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