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The Back on Trac (BOTGEN1) and Cervi-Trac Systems are in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder).

Back on Trac
The Back on Trac (BOTGEN1) is intended for use to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder)". The device may be used to manage and reduce pain associated with the following conditions:

• facet syndrome,
• herniated disc,
• protruding disc,
• extruded disc,
• sciatica,
• spondylosis (degenerative disc disease & facet syndrome),
• joint pain.

Vibration and heat are available options that can be utilized with the Back on Trac (BOTGEN1) at the discretion of the healthcare professional. When activated, the vibration mode can provide muscle relaxation and temporary relief of minor aches and pains. The heat mode, when activated, can provide temporary relief of minor aches and pains. The local warmth temporarily stimulates local blood circulation in your lower back.

Cervi-Trac
The Cervi-Trac is intended for use as an accessory to the Back on Trac (BOTGEN1) to relieve pressures on structures that may be causing pain of skeletal or muscular origin. The Cervi-Trac accessory focuses specifically on the cervical region.

The Ergo-Flex Technologies Systems that are the subject of this premarket notification are prescription use only and are intended for use by licensed, qualified healthcare professionals, such as physicians, chiropractors, physical therapists, etc.

Ergo-Flex Back on Trac System:
The (BOTGEN1) is comprised of a reclinable therapeutic cushioned chair with back support portion and a second lower back, upper and lower leg support section that is movable in an axial direction with respect to the back support section and is also arcuately movable about a pivot axis that is perpendicular to the axial direction. The chair includes remotely controlled linear actuators to control the relative movement of the different sections of the device.

Ergo-Flex Cervi-Trac:
The Cervi-Trac (CT) is an accessory to the Back on Trac (BOTGEN1) that focuses specifically on the cervical region. The patient is not restrained by the Back on Trac arm bolsters, therefore lumbar traction is not activated by the Cervi-Trac during this therapy.

This document is a 510(k) summary for the Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac devices. It demonstrates substantial equivalence to a predicate device, as opposed to proving the device meets specific performance criteria through a clinical study. Therefore, the information requested regarding acceptance criteria, study design, ground truth establishment, and expert involvement is not applicable in the context of this document.

Here's why and what information is provided:

• 510(k) Premarket Notification: This is a regulatory pathway used to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device. It generally relies on non-clinical performance data and a comparison of technological characteristics, rather than de novo clinical efficacy studies with specific acceptance criteria that would typically be required for novel devices or those seeking a new indication.

Based on the provided document, here's what can be stated regarding the requested categories:

1. A table of acceptance criteria and the reported device performance:

   • Not Applicable. This document does not present a table of acceptance criteria and reported device performance in the way a clinical trial or performance study would. The acceptance is based on demonstrating "substantial equivalence" to a predicate device, which is achieved by showing similar intended use and technical/functional characteristics, and adherence to relevant consensus standards.
   • Instead, the document provides a "Comparison of the IFU and Technical Specifications and Performance Characteristics" (Table 1 on page 9) between the subject device and the predicate device. This table highlights similarities and differences in parameters like intended use, environment, treatment areas, electrical safety, EMC, and traction mechanism.
   • For performance, it states: "Performance testing on the Back on Trac (BOTGEN1) and Cervi-Trac Systems demonstrated the design, operational and functional parameters and safety features met the established specifications for each device and demonstrate performance substantial that is equivalent to the predicate device." However, specific numerical performance metrics are not listed as "acceptance criteria" but rather as "specifications" met.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not Applicable. The submission did not involve clinical testing to demonstrate substantial equivalence. Therefore, there are no "test sets" of patient data in the typical sense for clinical performance.
   • The "testing" mentioned refers to non-clinical performance testing and compliance with recognized consensus standards (e.g., IEC 60601-1 for electrical safety, ISO 14971 for risk management). These are tests on the device itself, not on patient samples.
   • Data provenance for such non-clinical testing is typically internal company data or reports from certified testing facilities, not patient data from specific countries or study designs.

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):

   • Not Applicable. Since no clinical test set with patient data was used to establish "ground truth" for efficacy or diagnostic performance, there were no experts establishing such ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. No clinical test set requiring adjudication was used.

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:

   • Not Applicable. No MRMC study was conducted. This device is "Power traction equipment," which is a physical therapy device, not an AI or diagnostic imaging device that would typically involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not Applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Applicable. No ground truth for clinical efficacy or diagnostic accuracy was established as part of this 510(k) submission. Substantial equivalence is based on engineering and performance characteristics compared to a predicate device, and compliance with safety standards.

8. The sample size for the training set:

   • Not Applicable. As this is not an AI/machine learning device, there is no "training set."

9. How the ground truth for the training set was established:

   • Not Applicable. There is no training set for an AI/machine learning model.

In summary, the document states:

• Clinical Performance: "Not applicable. Clinical testing was not provided to demonstrate the substantial equivalence of the Back on Trac (BOTGEN1) and Cervi-Trac." (Page 12)
• Non-Clinical Performance: The devices underwent "100% performance testing and Quality Assurance inspection" by the manufacturer, and "Performance testing...demonstrated the design, operational and functional parameters and safety features met the established specifications for each device and demonstrate performance substantial that is equivalent to the predicate device." (Page 12).
• The device was evaluated and tested by independent certified testing facilities in conformance with various consensus standards related to electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366-1), risk management (ISO 14971), and biocompatibility (IEC 10993). (Page 13)

This 510(k) clearance is based on the comparison to a legally marketed predicate device (Chattanooga Group's Triton/Tru-Trac/TX/Triton DTS Traction, K053223) and compliance with relevant safety and performance standards for mechanical devices, not on the demonstration of clinical efficacy through formal acceptance criteria and studies with human data.

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