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1. Patients with disc protrusions.
2. Patients with mild disc herniations.
3. Patients with pinched nerves.
4. Patients with limited spinal flexibility.
5. Patients with muscle spasms.
6. Patients with spinal vertebral fixations.
7. Patients with spinal facet imbrication and fixation.
8. Patients with spinal nerve root radiculitis.
9. Patients with foraminal encroachment.

The Bass Antalgic-Trak is a multi-functional traction device. It is chair like in its appearance and The Dass Amargic Truk is a mark tull sit upon a chair or recliner. The chair/table can recline the patient 90 degrees. It maintains the patient's sitting posture during the recline. the patient 90 degrees: it maintains the parchies befores 24 inches wide by 20 inches tong by I it is seat bottom is a viry? covered assist as a seat bottom, at the knee joint, the 5 inches ticep backed by 74 men pry roomes as a calf support. The cushion continues 18 inches to support the calves. This seat-bottom section can manually rotate 80 degrees left or right, support the carves. This sout ootion socure, manually flex forward and backwards 45 degrees. manually facerary and 55 asglobal to backwards 6 inches by engaging an electric The chiller motor. This is to accommodate taller patients with longer thighs. There are 3 leather/vinyl straps that secure the patient to the seat bottom. Strap 1 securers over the iliac leather vinyl straps that secure the parent stup 3td secures over the shins. The seat back of the chair is viral 2 socures over the might is 20 inches tall and 18 inches wide and 3 inches deep Chan is villy covered done roam lead is vinyl covered dense foam. It is 12 inches tall by 8 backed with 74 men pry wood. It is mounted to the mounted to the upper portion of the chair's top frame. The headpiece has a vinyl strap to secure the forehead onto the headpiece. the chair o top the chair/table is 60 inches long. In the upright posture, the chair height is 60 which rechned, the seat-bottom is powered by an electric single-columned actuator motor. The headpiece cervical traction is powered by an electric single-columned actuator motor. The thigh extension of the seat bottom is powered by an electric single-columned actuator motor. The table/chair recline is powered by an electric single-columned actuator motor. The seat-I he table/enan footine is powered of as e cervical traction may be powered manually using foot pottom fulliour traction as foot pedal for each. The traction can be "auto" cycled using the control panel. The thigh adjustment length and table/chair recline must be engaged using the control panel. The clinician must set all functions.

This 510(k) premarket notification for the Bass Antalgic-Trak is a submission for a Class II medical device (Powered Traction Table) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through an independent study with detailed performance metrics.

Therefore, the document does not contain the information required to fill out the requested table regarding acceptance criteria and performance, nor does it describe a study that would meet the specified criteria (e.g., sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details).

This type of 510(k) summary primarily:

• Identifies the device and its manufacturer.
• States the intended use and indications for use.
• Lists predicate devices to which substantial equivalence is claimed.
• Provides a brief device description.

It does not include:

1. Acceptance criteria table or reported device performance: There are no specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, effect size) reported in this document. The submission relies on claiming equivalence to predicate devices that are already approved.
2. Sample size, data provenance for a test set: No study with a test set is described.
3. Number of experts and qualifications for ground truth: No ground truth establishment is described as there's no independent study.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not performed or reported. This would typically be for diagnostic or screening devices evaluating human reader performance with and without AI assistance.
6. Standalone performance: Not performed or reported. This device is a physical traction table, not a standalone algorithm.
7. Type of ground truth used: Not applicable as no new clinical study to establish performance metrics is described.
8. Sample size for training set: Not applicable as there is no AI algorithm being trained.
9. How ground truth for training set was established: Not applicable.

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