(233 days)
The DRX9000C-SL Cervical Spinal Decompression System provides a program of treatments for relief from pain for those patients suffering with neck pain. It is designed to apply spinal decompressive forces to the spine. Conditions that may be treated include neck pain associated with herniated discs, protruding intervertebral discs, degenerative disc disease, and posterior facet syndrome.
The DRX9000C-SL Cervical Spinal Decompression System provides accurately controlled tensions designed to relax and confuse paraspinal muscles and allow distractive forces to decompress intervertebral spinal disc space. The user interface provided by the treatment computer constantly updates a servo-amplifier controlling a servo-motor to immediately and safely apply forces as determined by qualified healthcare personnel. Load-cell feedback is utilized to further verify and adjust tensile forces, allowing for variations in patient posture and outside forces such that continuous and smooth tension is experienced by the patient.
A headpiece harness is used to help distribute the applied forces evenly. Once in place, the patient is slowly reclined to a horizontal position. Following the physician's orders, the therapist localizes the pain, makes any adjustments and directs the treatment to the proper area. The DRX9000C-SL Cervical Spinal Decompression System helps to mobilize the troubled disc segment without introducing further damage to the spine.
The patient safety switch is held by the patient who at any time and for any reason may quickly pause any tensile forces. The patient safety switch is monitored and executed by two redundant systems, which will gradually reduce the tension to zero to stop the treatment and after a 5 second delay directly disable the treatment motor.
The emergency stop button is accessible to the operator who at any time and for any reason may quickly pause any tensile forces. The emergency stop button is monitored and executed by two redundant systems, which will gradually reduce the tension to zero to stop the treatment and after a 5 second delay directly disable the treatment motor.
Integral to effective spinal decompression and included in the device are continuous load-cell tensile feedback into the treatment computer, servo-amplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension plateaus transitioned into via non-linear tension change), headpiece harness, patient safety switch, and mattress.
The provided FDA clearance letter for the DRX9000C-SL Cervical Spinal Decompression System does not contain information regarding detailed acceptance criteria for device performance with specific metrics, nor does it describe a clinical study of the device proving it meets acceptance criteria.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (DRX5000) primarily through non-clinical testing and comparison of technical characteristics.
Here's a breakdown of the requested information based on the provided text, highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantifiable acceptance criteria for device performance (e.g., specific pain reduction percentages, success rates, or ranges of therapeutic effectiveness). It broadly states the device "provides a program of treatments for relief from pain" and is "designed to apply spinal decompressive forces."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | Not specified in the document in measurable terms of clinical outcome. |
The most direct "performance" metrics described relate to the device's capabilities rather than clinical outcomes:
- Traction Force: Can be varied between 0 – 50lbs pull. (This is a capability, not a clinical outcome or acceptance criterion).
- Treatment Time: Up to 30 – 45 minutes. (Again, a capability).
2. Sample Size Used for the Test Set and Data Provenance
No clinical test set is described or utilized for proving device performance. The submission explicitly states: "Clinical testing is not required for this submission. The non-clinical performance testing described above is sufficient to support substantial equivalence of the subject device to the predicate device."
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. No clinical test set requiring expert ground truth establishment was conducted or referenced.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was conducted or referenced.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document explicitly states clinical testing was not required. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be provided. This device is a mechanical traction system, not an AI-assisted diagnostic or treatment planning tool.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a mechanical device, not an algorithm, so a "standalone" or "algorithm only" performance assessment is irrelevant in this context. Its function is to apply physical forces, controlled by software, but not to provide diagnostic or interpretative output like an algorithm.
7. Type of Ground Truth Used
Not applicable in the sense of clinical outcome ground truth. The "ground truth" for this submission revolves around demonstrating that the device's technical specifications and safety standards meet regulatory requirements and are substantially equivalent to a predicate device. This is achieved through:
- Engineering and Safety Standard Conformance: Verification that the device adheres to standards like IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 & IEC 62366-1 (usability), ISO 14971 (risk management), ISO 10993-1 (biocompatibility), and IEC 62304 (software life cycle processes).
- Predicate Device Comparison: Establishing substantial equivalence by comparing technological characteristics and intended use to the DRX5000 (K023160).
8. Sample Size for the Training Set
Not applicable. This device undergoes non-clinical engineering and safety testing, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set for a machine learning model is involved.
In summary, the FDA clearance for the DRX9000C-SL Cervical Spinal Decompression System was based on non-clinical testing demonstrating conformance to recognized safety and performance standards, and a comparison of its technological characteristics and intended use to a legally marketed predicate device (DRX5000) to establish substantial equivalence. The submission explicitly states that clinical testing was not required.
§ 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).