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Full range from slow feed to rapid, high flow infusion of:

• crystalloid, colloid, or blood product, including packed red blood cells, as volume . replacement for patients suffering from blood loss due to trauma or surgery
• warmed fluid to rewarm patients after surgery or for hypothermia .

warmed fluid for irrigation in urology procedures .

The Smisson-Cartledge TIS-1200 Thermal Infusion System is a portable tabletop or polemount device intended for use in the ambulance, medical helicopter, hospital emergency room and operating room environments. (See Exhibits A and B for photographs and drawings) The system consists of an infusion device and a compatible single-use sterilized disposable set with supply lines capable of interfacing with intravenous (IV) bags or optional-use cardiotomy equipment. It also includes a footswitch to allow hands-free user-controlled stopping and starting of fluid delivery. The Smisson-Cartledge TIS-1200 Thermal Infusion System is a volumetric pump capable of continuous infusion (up to approximately 100 L at a rate of from 10 mL per hour to 1200 mL per minute) and discrete bolus delivery. When the system is set to Bolus mode, the user can select a predetermined delivery volume and a default or adjustable rate and deliver a fixed bolus of up to 1 L. When connected to alternating current (AC) power, the Smisson-Cartledge TIS-1200 Thermal Infusion System can deliver fluids at body temperature in certain modes. It can also be set to run on battery power with heating capabilities disabled to allow transport of the patient. A lithium-ion battery pack provides power backup. The unit (infusion pump) and Large Volume Reservoir Holder are provided non sterile. The Disposable Cassette Kit and Large Volume Reservoir are provided sterile, non-pyrogenic and are single-use only. They are sterilized by Ethylene Oxide (EO) sterilization method.

The provided document is a 510(k) summary for the Smisson-Cartledge TIS-1200 Thermal Infusion System. It details the device's indications for use, similarities and differences to predicate devices, and a summary of testing. However, the document does not contain the specific acceptance criteria or detailed study results that fully describe device performance against those criteria.

Therefore, I cannot fully answer your request.

Here's a breakdown of what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated in a quantifiable or tabular format within this document. The document mentions "performance / bench testing as summarized within the 510(k)", but the summary itself does not contain the detailed results or criteria.
• Reported Device Performance: The document only makes a general statement: "These conclusions were verified in performance / bench testing as summarized within the 510(k)." No specific data points, measures, or statistical results are provided.

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

• Missing. The document does not specify any sample sizes for test sets, nor does it mention data provenance (country of origin, retrospective/prospective). The testing referred to seems to be bench testing, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The testing described appears to be bench testing of the device's physical and functional properties, not an evaluation against a "ground truth" established by clinical experts in the way that would apply to, for example, an AI diagnostic device evaluating medical images.

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

• Not applicable. See point 3.

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 an infusion system, not an AI or diagnostic tool that would involve human readers or an MRMC study.

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

• Not applicable. This device is a medical hardware system, not an algorithm.

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

• Not applicable. As a hardware device, its "ground truth" would be engineering specifications and functional parameters, which are evaluated through bench testing. The document states "The Smisson-Cartledge TIS-1200 Thermal Infusion System has the same indications for use, principles of operation, and mechanical characteristics as the predicate devices...These conclusions were verified in performance / bench testing." This implies adherence to established engineering standards or performance benchmarks of predicate devices.

8. The sample size for the training set:

• Not applicable. This is a hardware infusion system, not a machine learning model, so there is no concept of a "training set."

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

• Not applicable. See point 8.

In summary: The provided document is a regulatory submission for a physical medical device (an infusion pump). The "study" mentioned is "performance / bench testing" which verified that the device's characteristics align with predicate devices. It does not refer to clinical trials with human subjects, AI model validation, or expert consensus on ground truth in the way your questions imply for AI/diagnostic devices. To answer your questions fully, a different type of document (e.g., a detailed test report or clinical study report) would be required.

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