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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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The SpineMED® System provides a program of treatments for relief from pain for those patients suffering with low back pain, neck pain or sciatica. Each treatment session consists of a physician prescribed treatment period on the SpineMED™ and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain, neck pain or sciatica. It relieves pain associated with herniated discs, bulging or protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

The SpineMED® is a multi-function Hi-Lo traction table designed to apply distraction forces to a patient's spine (Lumbar and Cervical). The powered Hi-Lo adjustments of the table surface height are designed to provide easier loading and unloading of the patient on and off the table. Maximum lift capacity and weight bearing capacity is 4001bs.

The patient lies in a supine position on the table with the legs supported with a removable knee bolster. For increased comfort during the distraction, and to provide relaxed distraction of paraspinal tissue, an infrared heating pad is incorporated into the table surface directly beneath the lumbar area. This 12 Vdc infrared element can be turned on or off during the treatment.

The upper body is restrained through a chest harness, which is then attached to the fixed upper section of the table with a mechanical safety release buckle. The lower body is restrained to the moveable lower section of the table though pelvic restraints that are designed to capture and secure the patient's iliac crest.

The removable pelvic restraints are supplied in two sizes, to accommodate different patient sizes, and are removed from the table for patient loading. The pelvic restraints are adjusted laterally to fit patient's widths through an acme screw assembly incorporated into the tilting lower section. Turn handles are attached to the acme screw on either side of the table, and allow for uniform movement of the pelvic restraints together and apart, for an operator controlled comfortable fitting to the patient.

The table is a split-table design, whereby distraction tensions are applied to the patient through the pelvic restraints during the separation of the table. The lower table section is powered by a computer-controlled 24 VDC actuator, which separates the two table sections to a maximum of eight inches. The distraction tensions and rates are continuously monitored and measured by load cells, which transfer this information to the integrated computer. A similar setting is present for the cervical setup. On top half of the split-table a cervical unit is attached, which applies tension to the high end of the spine. This unit is controlled by a 24 VDC actuator, which is controlled by the main computer. Information from the actuator is sent to the computer which displays the tension applied during the cervical treatment.

An incorporated battery backup system provides adequate system power to continue full operation of the SpineMED® in event of power failure, allowing safe continuation of treatment session. For safety, the patient is provided with an electrical hand-held patient safety switch, which when depressed, immediately interrupts the treatment session and gradually eliminates the application of force to zero under a controlled rate. A secondary safety device incorporates a mechanicallyoperated buckle for the upper harness, which the patient can control its release by simply pulling a switch integrated in the side of the table. The switch releases all distraction forces to the patient.

All treatment parameters and data are captured on the LCD screen and can be printed out to a printer and are stored electronically in the database. There are no new potential flammable materials used in the S200B/C. All material remain the same as the original 510k submission of the S100A(K030060).

The provided text describes a 510(k) premarket notification for the SpineMED® S200B/S200C device. The document focuses on demonstrating substantial equivalence to predicate devices and detailing the device's design and basic safety testing.

However, the document does not contain information regarding specific acceptance criteria for device performance in a clinical or diagnostic context, nor does it describe a study proving the device meets such criteria through metrics like sensitivity, specificity, accuracy, or reader performance. The content is primarily focused on regulatory submission requirements for a medical device that performs powered traction.

Therefore, for most of the requested information regarding acceptance criteria and performance studies, the answer will be that the information is not present in the provided text.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Provided: The document does not specify performance acceptance criteria in terms of clinical or diagnostic outcomes (e.g., pain reduction percentages, success rates, or specific physiological changes). It refers to the device's intended function (applying distraction forces to relieve pressure) but not measurable performance against a benchmark.

The document states:

• "Testing was performed to validate the functional performance of the SpineMED system. In particular, specific performance testing of the software was performed to show that the performance was met."
• "The SpineMED S200B/C has been subjected to performance testing to applicable safety, electrical, mechanical. EMC standards."

These statements indicate functional and safety testing, but not clinical performance data or acceptance criteria for such data.

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

Information Not Provided: No information is given about a "test set" in the context of clinical or diagnostic performance. The document describes functional and safety testing for the device itself, not a study involving human subjects or data sets of patient outcomes.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Information Not Provided: Since no clinical or diagnostic performance study is described with a "test set," there's no mention of experts establishing ground truth for such a study.

4. Adjudication Method for the Test Set

Information Not Provided: As no test set for clinical/diagnostic performance is described, there's no adjudication method mentioned.

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

Information Not Provided: The document does not describe an MRMC study or any study involving human readers or AI assistance. The device is a physical powered traction equipment, not an AI or diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance Study

Information Not Provided: The device is traction equipment; there is no mention of an algorithm-only performance study.

7. Type of Ground Truth Used

Information Not Provided: The document focuses on the mechanical and electrical safety and functional operation of the device. The "ground truth" referenced implicitly relates to compliance with engineering standards (IEC, UL, CAN/CSA) and internal functional test procedures for the device, rather than a clinical ground truth for diagnostic or treatment efficacy.

8. Sample Size for the Training Set

Information Not Provided: There is no mention of a "training set" in the context of machine learning or algorithm development, as the device is mechanical traction equipment.

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

Information Not Provided: No training set is mentioned, thus no ground truth establishment for it.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (powered traction equipment) to existing devices based on indications for use, design characteristics, components, size, power source, and performance in terms of safety and functional operation (e.g., software performance). It does not contain the kind of performance study data or acceptance criteria typically associated with diagnostic AI or imaging devices.

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