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The DRX9000-SL True Non-Surgical Spinal Decompression System provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome and sciatica.

The DRX9000-SL True Non-Surgical 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.

An upper chest harness and a lower pelvic harness are 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 DRX9000-SL True Non-Surgical 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, dedicated and matched servo-amplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension plateaus transitioned into via non-linear tension change), two segment (upper and lower) textile patient harness, patient safety switch, and free-floating lower body mattress. The free-floating lower body mattress allows the interdiscal segments of the lumbar spine to decompress at their own rate. As tension is cycled, the lower body can extend independent of the upper body which is held in place via an upper body textile patient harness. The treatment bed and textile harness allow the patient to relax completely and require no conscious exertion on the part of the patient. Total patient relaxation encourages paraspinal muscle relaxation from both a physical and psychological standpoint and is a key to spinal decompression.

The provided FDA 510(k) clearance letter and summary for the DRX9000-SL True Non-Surgical Spinal Decompression System do not contain information related to acceptance criteria for an AI device, nor any study that proves an AI device meets such criteria.

The submission is for a medical device that applies spinal decompressive forces, and it primarily focuses on demonstrating substantial equivalence to a predicate device (DRX9000 True Non-Surgical Spinal Decompression System) through non-clinical testing of electrical safety, EMC, usability, risk management, biocompatibility, and software.

Therefore, I cannot provide the requested information, as the input document does not pertain to an AI device or a study with typical AI-related acceptance criteria.

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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."

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.

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