(59 days)
The CycleTrac® Automated Cervical Traction Unit provides a primary treatment modality for the management of neck and back pain. Intermittent/static cervical traction results in cervical disk decompression (unloading due to distraction and positioning) which provides relief of pain associated with a variety of conditions involving anatomical dysfunctions of the spine, including protruding or herniated intervertebral discs, degenerative discs and acute facet problems.
The CycleTrac® CT-5000 Automated Cervical Traction Unit is a device intended to apply intermittent or static traction force to the patients' spine. Unlike other traction devices, the CycleTrac® CT-5000 attaches to a Standard 6 Foot Plinth or a 6 Foot Stationary Chiropractic Adjusting Table (not included). When the CycleTrac® CT-5000 is properly attached to the treatment table it is 26.6 inches long and stands 42 inches off the floor. The CycleTrac CT-5000 system has a total weight of 14.5 pounds. The traction force is generated by a non-powered, factory certified gas spring capable of generating up to 35 pounds of load. By adjusting the pivot point of the energized spring along the weight index bar, the traction pull force on the traction pull cord can range from 15 to 35 pounds. The engineering principle behind this change in force is the mechanical advantage created when the energized spring pivot point is adjusted along the weight index bar. As the pivot point moves further from the traction pull cord intercept, the force required to compress the energized spring decreases. As the energized spring pivot peint gets closer to the traction pull cord intercept, the mechanical advantage lessens and the force required to compress the energized spring increases. When the pivot point is next to the traction pull cord intercept. there is no mechanical advantage and the force required to compress the energized spring is equal to the maximum output of the energized spring. 35 pounds. The force required to compress the energized spring is equal to the push back force of the energized spring on the traction cord, or the traction pull force on the traction pull cord.
The motorized actuator pulls on the extension linkage attached to the weight index bar, which compresses the energized spring, parking it in the traction. To return to the traction ON position, the actuator is extended through the extension linkages attached to the weight index bar allowing the energized spring to freely extend, creating a force on the weight index bar. The force on the weight index bar is transferred to the traction pull cord placing the CT-5000 into the traction on position.
The ON-OFF intermittent cervical traction cycle is controlled by the timer. The traction treatment time, traction ON time, and the traction OFF time are pre-set on the timer. The settings are used by the timer to prompt the actuator to extend and retract, which results in the traction ON / traction OFF intermittent cervical traction cycle. Therefore, the timer and the motorized actuator do not contribute to the traction pull force on the patient. The traction pull force is generated solely by the NON POWERED, factory certified, 35 pound energized spring; the CT-5000 does not require power to generate the traction pull force.
The unique headrest design allows for 100% of the traction force toward the occiput without forehead and chin restrains and eliminates the possibility of Temporomandibular Joint problems. The headrest is made of powder coated aluminum and covered with a comfort pad to keep the patient comfortable.
This 510(k) summary for the CycleTrac® CT-5000 Automated Cervical Traction Unit does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving device performance as it relates to AI/ML or diagnostic performance. This document is for a physical medical device, a cervical traction unit, and focuses on its mechanical function and equivalence to predicate devices, rather than a diagnostic algorithm or AI system.
However, I can extract the information relevant to the device's characteristics and intended function provided in the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the terms usually expected for a diagnostic or AI device (e.g., sensitivity, specificity thresholds). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices by comparing their features and performance envelopes. The key performance characteristics highlighted for the CycleTrac® CT-5000 relate to its force generation and operational range.
| Feature/Performance Aspect | Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (CycleTrac® CT-5000) |
|---|---|---|
| Traction Pull Force Range | Comparable to predicate (Predicate: 0-50 pounds) | 15-35 pounds (Fixed by gas spring) |
| Headrest type | Able to apply traction to occiput | Unique, 100% force toward occiput without forehead/chin restraints |
| Intermittent/Static Traction | Capable of both | Capable of both |
| Operator Adjustable Settings | Yes (e.g., treatment time, ON/OFF time, angle) | Yes (treatment time, ON/OFF time, angle) |
| Safety (Emergency Stop) | Present | Emergency call cord (removable) |
| Power Requirements | Functional power input | Low voltage DC (12 volts DC, 3 amperes) from UL medically approved power supply |
| Force Control Mechanism | Provide regulated traction force | Non-powered, factory certified gas spring (35 lbs max) with mechanical advantage adjustment |
| End of Session Alert | Visual/auditory alert | Beeps repeatedly; automatically powers OFF |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document describes a physical medical device and its mechanical operation, not a diagnostic or AI system that would typically undergo testing with a "test set" of data or patient samples in the way implied by the question.
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)
This information is not applicable and therefore not provided. "Ground truth" in the context of this device would refer to its mechanical performance characteristics (e.g., force output accuracy, timing accuracy), which would likely be established through engineering tests and calibration, not by medical experts reviewing patient data for a diagnostic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods are typically used in studies involving subjective interpretation of data (e.g., imaging reads) or clinical outcomes, which is not the focus of this device's submission.
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
This information is not applicable and therefore not provided. An MRMC study is relevant to diagnostic interpretation tasks, often involving AI assistance to human readers. This device is a therapeutic physical therapy unit and does not involve "human readers" or AI assistance in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not provided. This device is a mechanical traction unit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the concept of "ground truth" as typically applied to diagnostic or AI systems is not directly relevant here. For this device, verification of its performance would involve:
- Engineering specifications and measurements: Verifying the force output (e.g., using force gauges), timing accuracy (e.g., using stopwatches/timers), and dimensions against design specifications.
- Safety testing: Ensuring electrical safety, mechanical stability, and adherence to relevant standards.
- Comparison to predicate devices: Demonstrating similar intended use and fundamental operating principles.
8. The sample size for the training set
This information is not applicable and therefore not provided. This device is not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. As it's not an AI/ML system, there is no training set or associated ground truth establishment.
Summary of the Study Discussed (Implicit in 510(k) process):
The "study" or evidence provided in a 510(k) submission for a device like the CycleTrac® CT-5000 is primarily a demonstration of substantial equivalence to legally marketed predicate devices. This is achieved through:
- Detailed Device Description: Explaining the mechanism of action, components, and how it performs its intended function.
- Comparison to Predicate Devices: Highlighting similarities in intended use, technological characteristics, and performance claims. The document explicitly lists numerous similarities (e.g., creating traction, cord transmission, occiput pull, adjustable settings, emergency call cord, "OFF" position at end of session) and differences (e.g., power input, force range, head strap use, force generation mechanism, call cord removability, headrest calibration). The argument is that the differences do not raise new questions of safety or effectiveness.
- Performance Specifications: Stating the operational parameters of the device (e.g., force range).
- Safety Considerations: Addressing how the device is safe (e.g., fixed maximum force from gas spring independent of motor, ability for patient to disengage by lifting head).
Essentially, the "study" is the submission itself, arguing that the device meets the regulatory requirements for safety and effectiveness by demonstrating it is as safe and effective as a legally marketed device. There isn't a separate clinical trial or AI performance study described in this 510(k) summary.
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).