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510(k) Data Aggregation
(439 days)
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.
| Acceptance Criteria (Inferred from comparison to predicate) | Reported Device Performance (iTrac™ c2i Cervical Traction System) |
|---|---|
| Functional Equivalence | |
| Intended Use | 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. (Similar to predicate, but only for cervical). |
| Treatment Area | Cervical only. (Predicate treats Cervical or Lumbar). |
| Treatment Position | Seated. (Predicate allows Seated or Supine). |
| Lift Mechanism | Electromechanical. (Predicate uses electric). |
| Traction Force Range (Cervical) | Min. and Max. traction force = 0-20 lbs (traction force) / 0-40 lbs (fulcrum force). (Predicate's cervical traction limit is 40 lbs). |
| System Control | Computer-controlled traction system with operational software residing on a computer. (Predicate's control mechanism not detailed, but described as "Eccentric Drive Motor" and "gear motor that revolves rope hook-ups"). |
| Operational Components | Air compressor and Pneumatic cylinders, software controlled pneumatic regulator, pulley assembly to generate linear force. (Predicate uses Eccentric Drive Motor, pulley assembly, and suspended weights/ratcheting winches). |
| Traction Speed | Stepless, Continuous, Adjustable. (Predicate is Continuous and Adjustable). |
| Force Display | Actual Force / Preset Force (digital). (Predicate uses Analog weight scale). |
| Treatment Time | 5-15 min. (Predicate is 15-20 minutes). |
| Therapy Mode | Continuous. (Predicate offers Continuous and Intermittent). |
| Additional Components | The iTrac system includes the iTrac device and necessary accessories to function as a ready-to-use traction device. (Predicate provides the motorized mechanism and may be connected to a separate Traction L-Frame for accessories). |
| Safety Features | |
| Safety system for force release | Multiple protections including patient safety switch (releases all forces), manual release, unit stop button, compressor regulator, magnetic safety release, pressure release valve, backup flow control, feedback gauges. (Predicate has Manual Release, Hand held on/off switch which releases only 1-7 lb delta force). |
| Power supply | 110-120V (60Hz), 220-240V (50Hz). (Predicate is 115V (60Hz)). |
| Allowable Voltage Fluctuation | Max ±10%. (Predicate UNK). Verified through NRTL testing. |
| Casing leakage of electricity | < 100 Microamps. (Predicate UNK). Verified through NRTL testing. |
| Ground resistance | < 0.1 Ohm. (Predicate UNK). Verified through NRTL testing. |
| Electrical Classification and Type | Class I / Type B. (Predicate UNK). Verified through NRTL testing. |
| Electrical Compliance Testing | IEC 60601-1, IEC 60601-1-2 by Accredited Test Laboratory. (Predicate's motor, power cord, and on-off hand-held switch meets all UL safety standards). |
| EMC Compliance Testing | IEC 60601-1-2 by Accredited Test Laboratory. (Predicate's motor, power cord, and on-off hand-held switch meets all UL safety standards). |
| Biocompatibility | All patient contact components tested for biocompatibility to ISO 10993 standard by Accredited Test Laboratory. (Predicate uses materials previously cleared medical devices). |
| Contraindications | Detailed list of contraindications provided, similar to predicate but with additional conditions explicitly stated. (See pages 14-17 for extensive list). |
| Angle and Force Accuracy | "[A]ngle and force testing demonstrate the iTrac device specifications were met and traction forces were the same as the predicate device." (Specific values or ranges for "device specifications" and "same as predicate" are not explicitly tabulated beyond the general traction force limit comparison.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document does not describe a clinical test set in the sense of patient data. The testing is based on engineering verification and validation of the device's technical specifications and safety features.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The ground truth for this type of device submission is based on engineering standards, design specifications, and comparison to a legally marketed predicate device's established safety and effectiveness.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as there is no clinical test set requiring expert adjudication.
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 is a physical traction device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical traction device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission are:
- Engineering Specifications: The device's design specifications for force application, speed, and safety mechanisms.
- International Standards: Compliance with electrical safety (IEC 60601-1, IEC 60601-1-2) and biocompatibility (ISO 10993).
- Predicate Device Characteristics: The known, legally marketed characteristics and safety profile of the CTBox Cervical/Lumbar Traction System.
8. The sample size for the training set
Not applicable. This is a physical device, and there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
Not applicable.
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