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The Smisson-Cartledge Biomedical ThermaCor® 1200 Rapid Thermal Infusion System is indicated for use over a full range of flow rates from slow feed to rapid, high flow infusion of: crystalloid, colloid, or blood product, including packed red blood cells [not in additive . solutions and stored up to 21 days with anticoagulants], 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 ThermaCor® 1200 Disposable Sets are intended for use only with the Smisson-Cartledge Biomedical (SCB) ThermaCor® 1200 Rapid Thermal Infusion System. The Disposable Sets consist of configurations that include cassettes with tubing connectors, various patient lines, and supply lines capable of interfacing with intravenous (IV) bags or optional-use reservoir equipment. Use of the ThermaCor® 1200 Disposable Sets ensures the intended use of the ThermaCor® 1200 Rapid Thermal Infusion System is met. The ThermaCor® 1200 Disposable Sets are provided sterile, non-pyrogenic and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method.

The Smisson-Cartledge Biomedical ThermaCor® 1200 Rapid Thermal Infusion System is a portable or pole-mounted device intended for use in the hospital emergency room (ER), operating room (OR), intensive care unit (ICU), and Labor and Delivery (L&D) environments.

The system consists of an infusion device and a compatible, single patient use sterile disposable set with supply lines capable of interfacing with intravenous (IV) bags or an optional reservoir. The ThermaCor® 1200 Infuser may be used with a Footswitch (optional accessory) to allow hands-free, user-controlled delivery.

The ThermaCor® 1200 Infuser can deliver flow rates from 10 mL per Hour to 1200 mL per Minute selectable in 10mL/hr in Slow mode and 20mL/min in Rapid mode at normothermic temperatures and is intended for continuous operation. The ThermaCor® 1200 Rapid Thermal Infusion System is driven by a volumetric pump capable of variable-rate continuous infusion up to approximately 100 Liters total volume per Cassette. The system is also capable of delivering discrete bolus infusions. The user can select Bolus Mode to deliver a fixed, predetermined bolus of up to 1 Liter at a default or adjustable rate. When connected to alternating current (AC) power, the ThermaCor® 1200 Infuser can deliver fluids warmed to body temperature under most conditions. The Infuser can also run on battery power (heating capabilities will be disabled) to allow transport of the patient. A lithium-ion battery pack provides the power backup.

This document describes the acceptance criteria and study proving the device meets these criteria for the ThermaCor® 1200 Disposable Sets for the ThermaCor® 1200 Rapid Thermal Infusion System (K202461).

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on a component modification (Parylene coating on the heat exchanger) within an existing device, emphasizing that this modification did not change the performance of the Disposable Sets. Therefore, the acceptance criteria are implicitly met by demonstrating equivalency to the previously cleared device without performance degradation, and by confirming the safety of the new coating.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly specify the sample size for each individual test conducted (biocompatibility, mechanical integrity, bond strength, particulate matter, aluminum ion leaching, and heat transfer equivalency). However, it broadly states that "performance and safety testing was conducted on the ThermaCor® 1200 Disposable Sets with Parylene Coated Heat Exchangers" and "performance verification testing was conducted with the ThermaCor® 1200 Rapid Thermal Infusion System."

The provenance of the data is not explicitly stated (e.g., country of origin). The studies appear to be prospective as they were specifically conducted to evaluate the modified device for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This submission does not involve diagnostic imaging or clinical interpretation by experts to establish a "ground truth" in the traditional sense of AI/clinical studies. The ground truth here is based on objective measurements and established standards (e.g., ISO, ASTM, USP, FDA guidance for biocompatibility). Therefore, no "readers" or "experts" for ground truth establishment are applicable in this context. The testing was carried out in accordance with recognized industry standards and regulatory guidance.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study requiring human adjudication for ground truth (e.g., image interpretation). The "adjudication" is based on the results meeting predefined quantitative or qualitative standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not relevant for evaluating a material modification to an infusion system component. The submission focuses on the safety and functional equivalence of the modified component, not on human interpretive performance with or without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a medical hardware component (disposable set) and not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for evaluating the modified device stems from objective, quantitative, and qualitative measurements against established medical device standards and regulatory guidance.

• Biocompatibility: Conformance to ISO 10993 and ASTM F756 standards, and additional FDA requests, reflecting generally accepted scientific principles for material safety in contact with the body.
• Mechanical Integrity/Bond Strength: Conformance to ASTM D3359 and ISO 8536-4 standards.
• Particulate Matter: Conformance to USP standard.
• Aluminum Ion Leaching: Measured values demonstrating an improvement in safety margin compared to previous versions, implicitly against a predefined safety threshold.
• Heat Transfer Equivalency: Measurement comparing the performance of the new heat exchanger to the cleared predicate device, demonstrating equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. The "training" for the device's design and manufacturing is derived from engineering principles, prior experience with the predicate device, and regulatory standards.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm in this context.

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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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The Smisson Stabilization System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine (C2-T1) during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Smisson-Cartledge Biomedical, LLC, for the "Smisson Stabilization System." This document primarily indicates the FDA's "substantial equivalence" determination for the device, which is a regulatory classification, not a study evaluating its direct performance against acceptance criteria in the way medical software or AI devices are often assessed.

Therefore, the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided document. The letter focuses on the regulatory approval process based on comparison to a legally marketed predicate device, rather than detailed performance metrics from a specific study.

What is present and can be inferred:

• Device Name: Smisson Stabilization System
• Intended Use: Anterior interbody screw fixation of the cervical spine (C2-T1) for temporary stabilization during cervical spine fusions in patients with several conditions (degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, failed previous fusions).
• Regulatory Classification: Class II, product code KWQ.
• Predicate Device: The approval is based on substantial equivalence to legally marketed predicate devices, implying that its design and intended use are similar to devices already on the market prior to May 28, 1976, or reclassified devices. The specific predicate device(s) are not named.

Regarding the requested information, here's why it cannot be extracted from this document:

1. Acceptance Criteria and Reported Device Performance: This document does not contain a table of performance metrics or specific acceptance criteria (e.g., accuracy, sensitivity, specificity, mechanical strength tolerances) that would be a result of a direct device performance study. The "acceptance" here relates to regulatory clearance of substantial equivalence, not a direct performance benchmark.
2. Sample Sizes and Data Provenance for Test Set: No information about a test set, sample size, or data provenance is provided.
3. Number and Qualifications of Experts for Ground Truth: The concept of "ground truth" established by experts in an evaluation study is not discussed, as this document is a regulatory clearance letter.
4. Adjudication Method: Not applicable or discussed.
5. MRMC Comparative Effectiveness Study: There is no mention of a Multi-Reader Multi-Case (MRMC) study, nor is there any discussion of AI assistance or human reader improvement. This device is a physical spinal fixation system, not an AI software device.
6. Standalone Performance Study: While the device would have undergone various mechanical and biocompatibility tests (not detailed here but implied by regulatory requirements), a "standalone" performance in the context of an algorithm's output is not relevant for this type of physical implant.
7. Type of Ground Truth: The concept of "ground truth" (expert consensus, pathology, outcomes data) typical for diagnostic or AI-driven devices isn't explicitly used here. The basis for approval is substantial equivalence to a predicate, meaning its design principles and intended use are considered safe and effective because similar devices are already approved.
8. Sample Size for Training Set: Not applicable or discussed.
9. How Ground Truth for Training Set was Established: Not applicable or discussed.

In summary, the provided document is a 510(k) clearance letter for a physical medical device (spinal stabilization system), not a study report for a diagnostic or AI-powered device. Therefore, the specific details requested about performance studies, acceptance criteria, and ground truth establishment are not present in this regulatory correspondence.

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