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The iTrac c2i cervical traction system is intended for use as a conservative in patients presenting with cervicogenic pain symptoms of mechanical origin related to reduced cervical lordosis extension and altered posture. It temporarily positions the cervical spine into an extension posture of varying degrees, as determined by a clinician. This device is for prescription use only and is not provided in a sterile condition.

The iTrac™ c2i cervical traction system is intended for use as a conservative treatment alternative in patients presenting with cervicogenic pain symptoms of mechanical origin related to reduced cervical lordosis/extension and altered posture. It temporarily positions the cervical spine into an extension posture of varying degrees, as determined by a clinician. This device is for prescription use only and is not provided in a sterile condition.

Operational software controls the exertion and release of the pulling forces, operation cycle, and treatment times prescribed by the physician. The iTrac's operational components consist of software, an air compressor, three pneumatic cylinders, two electro-pneumatic regulators, a traction line and pullev system, head halter, fulcrum strap, magnetic safety release, backup flow controls, and mechanical pressure relief valves.

All accessories necessary to provide the traction to the patient are included with the device making it a ready to use traction device. A head halter captures the patient's chin during treatment and is connected to an adjustable overhead traction bar that can be manually adjusted by the doctor to the doctor-prescribed traction angle. A fulcrum strap rests on the back of the patient's neck and may be used to provide an additional anterior force. During setup, an electric lift column allows the fulcrum/traction section to be raised or lowered by the doctor to the height doctor prescribed for each patient.

For each treatment session the Doctor commands the software to implement a specific treatment time, traction force, and fulcrum force. Utilizing a piecewise linear function calculation the software generates an output signal causing the electro-pneumatic pressure controllers to adjust pressure, delivering the doctor prescribed forces to the fulcrum and traction cylinders. For safety, limits are hard coded in the software to prevent traction and fulcrum forces from exceeding the allowable limits. The software is loaded on a standard personal computer which interfaces with the device via a standard network connection; this standard connection is limited to connection only with the iTrac.

A Patient Stop Switch provides additional protection to the patient by operating independent of software to relieve all forces when pressed. When activated, the patient stop switch triggers a relay which, in turn, triggers a solenoid-controlled pneumatic valve causing a quick stop and venting of all pneumatic pressure to the cylinders. This action immediately relieves the patient of traction forces and sends a discrete output from the relay to the I/O Module, placing the treatment session into 'Pause' within the software. As an added safety measure the software requires the patient stop switch to be pressed before the start of each treatment during the treatment start protocol to ensure its functionality.

The provided document is a 510(k) summary for the iTrac c2i Cervical Traction System. It focuses on demonstrating substantial equivalence to a predicate device, the CTBox Cervical/Lumbar Traction System, rather than presenting a clinical study to prove device performance against specific acceptance criteria in the manner usually seen for AI/ML-driven devices.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of submission. The document primarily details technical specifications and safety features compared to a predicate device.

Here's an attempt to answer the questions based on the available information, noting when information is not present in the document.

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

Since this is a substantial equivalence submission for a physical medical device (traction system), "acceptance criteria" here refers to demonstrating that the new device's technical characteristics and safety features are equivalent to or better than a legally marketed predicate device. There aren't "performance metrics" in the typical sense of accuracy, sensitivity, specificity, etc., as would be the case for AI/ML diagnostic tools.

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The Decompression' of Choice (DOC) and AAAR 2K10 is a non invasive method of applying distractive forces to the spine through controlled tensions. It is designed to apply decompression (decompression is unloading due to distraction and positioning and/or as non-surgical in nature) forces to intervertebral discs. The Decompression' of Choice (DOC) and AAAR 2K10 may be used for back pain, neck pain, hemiated discs, protruding discs, degenerative disc disease, sciatica and posterior facet syndromes.

The Devices are a non surgical traction or also called decompression' systems. It accurately controls tensions designed to relax Para spinal musculature and to allow distractive- traction forces to decompress inter vertebral spinal disk space. The Devices do this by creating a negative pressure in the disc due to the distractive forces and treatment protocols. Bulges or herniation are reduced back into the center or annular part of the disc. Fibroblasts then form a matrix over the protryded area to form a "seal" over the previously injured area. The load cell constantly updates the user interface provided which controls a gear-motor/linear actuator to immediately and safely apply forces as determined by qualified healthcare personnel. The load cell feedback is also used to further verify and adjust traction forces allowing for variations in patient postures and outside influencing forces. This method of operation allows safe, continuous and smooth operation of the unit and proper comfortable and safe appliance of said forces to the patient. An extensive manual of suggested treatment protocols and safety warnings is furnished to the end user.

The provided text describes a medical device called "Decompression of Choice (DOC) and AAAR 2K10" (referred to as "Devices") which is a power traction equipment for spinal decompression. The study described focuses on proving equivalence to predicate devices rather than establishing specific performance metrics against pre-defined acceptance criteria for a novel functionality.

Here's a breakdown of the information requested, based only on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly list quantitative "acceptance criteria" for the device itself in terms of clinical efficacy or diagnostic accuracy (as would be common for AI/imaging devices). Instead, the performance testing described is focused on demonstrating the device's ability to deliver and measure specific forces accurately, which is a functional requirement for this type of equipment. The primary "acceptance" is based on substantial equivalence to predicate devices and compliance with safety standards.

Study Details

The provided text describes a functional and safety performance test, not a clinical study to assess diagnostic or therapeutic efficacy in patients.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the traditional sense of patient data. The "test set" involved the device itself being tested with a calibrated scale. No specific number of "tests" or "measurements" is provided, but it implies a series of measurements to confirm force accuracy across different settings.
   • Data Provenance: The testing was likely conducted in a controlled laboratory environment by the manufacturer or a testing facility during device development/validation. Country of origin not specified, but the applicant is from the USA (Watertown, SD). This is prospective testing of the device's physical function.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the force measurements would be the readings from the calibrated scale, which is an objective instrument. No human experts were involved in establishing this ground truth.

3. Adjudication method for the test set: Not applicable. The test involved physical measurements against a calibrated instrument.

4. 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 therapeutic power traction equipment, not an AI-assisted diagnostic or imaging device. No human reader studies were conducted or described.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is mechanical/electronic equipment, not an algorithm. Its operation inherently involves a human operator (qualified healthcare personnel) who sets the parameters.

6. The type of ground truth used: For the force measurement performance, the ground truth was objective measurements from a calibrated scale. For safety, compliance with listed safety standards served as the "ground truth." For substantial equivalence, the characteristics and performance of the predicate devices served as the comparative ground truth.

7. The sample size for the training set: Not applicable. This device does not use machine learning or AI, so there is no "training set."

8. How the ground truth for the training set was established: Not applicable. There is no training set for this device.

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