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The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide traction and mobilization of skeletal structures and skeletal muscles.

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide a treatment in static, intermittent, progressive and cycling distraction forces to relieve pressures on micentifies that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions.

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices with the optional EMG (a.k.a. sEMG) biofeedback feature may be used to relieve peripheral radiation/sciatica and nain associated with:
➤ Protruding discs
➤ Bulging discs
➤ Herniated discs
➤ Degenerative disc disease
➤ Posterior facet syndrome
➤ Acute facet problems
➤ Radicular pain
➤ Prolapsed discs
➤ Spinal root impingement
➤ Hypomobility
➤ Degenerative joint disease
➤ Facet syndrome
➤ Compressions fractures
➤ Joint pain
➤ Discogenic pain

EMG (a.k.a. sEMG)
Determination of the activation magnitude and timing of muscles for:
a) retraining of muscle activation
b) coordination of muscle activation
Determination of the force produced by muscle for control and maintenance of muscle contractions
Relaxation muscle training
Muscle re-education

The Chattanooga Group powered traction device consists of an electric traction treatment unit, and may be sold with the following: EMG (a.k.a. sEMG) biofeedback feature, Pull-Pattern intermittent traction preset feature, patient traction treatment table device, positioning bolster accessories, patient traction belt accessories, high volt pulsed electrotherapy device and miscellaneous traction devices and/ or accessories. The device is intended to be used in hospitals, physical therapy clinics and chiropractic clinics for treatment in static, intermittent, progressive, regressive and cyclic, distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). The device is restricted to sale by or on the order of a licensed physician or licensed practitioner.

The primary features of the Triton/ Tru-Trac/ TX/ Triton DTS Traction hardware are the traction unit (a.k.a. traction head), display screen, traction rope, mounting assembly and patient stop treatment switch.

The EMG biofeedback feature is used to detect muscle activation and relaxation for Frie ENC oferous traction therapy. The treating clinician determines the minimum muscle activation or minimum muscle relaxation threshold set point. This is done by utilizing the visual display. The intermittent traction reacts to these threshold settings and administers prescribed traction treatment. The Pull Pattern feature is a preset of intermittent traction settings, less the setting of traction force, less setting of traction time. Force and time parameters are determined by the treating clinician.

The provided information does not describe a study that proves the device meets specific acceptance criteria in terms of performance metrics or clinical outcomes. Instead, it details the submission for 510(k) premarket notification for the Triton/ Tru-Trac/ TX/ Triton DTS Traction device, which primarily relies on demonstrating substantial equivalence to legally marketed predicate devices.

The acceptance criteria mentioned are related to compliance with recognized consensus standards for medical equipment safety and electromagnetic compatibility, rather than clinical efficacy or specific performance benchmarks.

Here's a breakdown of the requested information based on the provided text, with notes where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify performance acceptance criteria related to clinical effectiveness (e.g., specific pain reduction percentages, range of motion improvements, or target success rates). The primary "performance" reported is compliance with safety and EMC standards and technical similarity to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size of Test Set: Not applicable. The submission is for a medical device seeking market clearance through substantial equivalence, not a clinical study with a test set of patient data for performance evaluation against ground truth. The "test set" here refers to the device itself being tested for compliance with technical standards.
• Data Provenance: Not applicable for a clinical test set. The data provenance described is the device's technical specifications and comparisons to predicate devices for substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. This document does not describe a study where experts established ground truth for a clinical test set. The "ground truth" for this submission revolves around established safety and EMC standards, and the technical characteristics of predicate devices.
• Qualifications of Experts: Not applicable for a clinical test set. The compliance with standards would be assessed by testing laboratories and regulatory bodies.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no mention of an adjudication process for a clinical test set in this 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The document does not describe an MRMC comparative effectiveness study.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as no MRMC study was conducted, and the device is a powered traction unit, not an AI-assisted diagnostic or interpretative system. The optional EMG biofeedback feature provides data for the clinician but isn't described as an AI-driven interpretive tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? No. The device is a physical therapy traction unit, and its function involves direct human application and interaction (clinician administering treatment, patient interacting with the device). There is no "algorithm only" performance that would be evaluated in a standalone study without human involvement.

7. Type of Ground Truth Used

• Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" is established by:
  • Regulatory Standards: Compliance with recognized safety and electromagnetic compatibility standards (UL 60601-1: 2003, IEC 60601-1-2: 2001).
  • Predicate Device Characteristics: The technical specifications and indications for use of the listed predicate devices (e.g., Triton/Tru-Trac/TX Traction, Eskotek EST Trac 401 Traction, etc.) serve as the benchmark for demonstrating substantial equivalence. The argument for substantial equivalence is based on comparing the new device's features, intended use, and technological characteristics to those of legally marketed predicate devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI-driven device that requires a training set of data for an algorithm. The device is a physical medical device.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

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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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