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The DRX9000 True Decompression System is designed to relieve pressure on structures that may be causing low back pain and sciatica. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radicular pain. Intervertebral disc decompression is achieved non-surgically through the application of logarithmic distraction tensions applied to the patient according to the Axiom protocol.

The DRX9000 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 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. The patient safety switch is held by the patient who at anytime and for any reason may quickly pause any tensile forces. This patient safety switch is monitored and executed by two redundant systems. 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 document is a 510(k) summary for the DRX9000 True Non-Surgical Spinal Decompression System. It focuses on demonstrating substantial equivalence to predicate devices for market clearance, rather than presenting a detailed clinical study with acceptance criteria and device performance as typically seen for novel medical devices or AI-driven systems.

Therefore, much of the requested information cannot be found in this specific document because it describes a substantial equivalence submission, not a study designed to prove acceptance criteria for a novel device or AI.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific quantitative acceptance criteria or detailed device performance metrics (e.g., accuracy, sensitivity, specificity, or reduction in pain scores tied to a pre-defined threshold) in the format of a clinical study outcome. The submission focuses on the device's technological characteristics being "essentially the same" as predicate devices and its inherent safety due to a lack of reported injuries.

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

This document does not describe a new clinical "test set" in the context of validating performance against specific acceptance criteria. The information provided relates to general clinical use.

• Sample Size for Test Set: Not applicable/Not specified.
• Data Provenance: The document states "Axiom Worldwide therapy has been in clinical use since 2002." This suggests real-world clinical data, but specifics on country of origin, retrospective/prospective nature, or if it constitutes a formal "test set" are not provided.

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

Since a formal "test set" with ground truth establishment for a novel performance validation is not detailed, this information is not available.

• Number of Experts: Not applicable/Not specified.
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication Method for the Test Set

As no specific test set requiring adjudication is described, this information is not applicable.

• Adjudication Method: Not applicable/Not specified.

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

This document does not mention any MRMC study. The device is a physical therapy device (non-surgical spinal decompression system), not an imaging or diagnostic aid where an MRMC study comparing human readers with and without AI assistance would be relevant.

• MRMC Study: No.
• Effect Size of Human Readers with AI vs. without AI: Not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This device is a physical therapy system requiring human operation and patient interaction. It is not an AI algorithm that would have a "standalone" performance.

• Standalone Study: No.

7. Type of Ground Truth Used

The document speaks to the "effectiveness" of the therapy in general clinical use and "relief of pain and symptoms." If any "ground truth" were inferred, it would likely be patient-reported outcomes (e.g., pain reduction, functional improvement) or physician assessments of symptom relief. However, no specific methodology for establishing ground truth is described in this submission.

• Type of Ground Truth: Not explicitly defined or used in a formal study context within this document. Effectiveness is mentioned in terms of "relief of pain and symptoms associated with herniated discs, bulging... degenerative disc disease, posterior facet syndrome and sciatica."

8. Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Any "training" would refer to the development and refinement of the mechanical system itself, not data-driven model training.

• Sample Size for Training Set: Not applicable.

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

As there is no "training set" for an AI/ML algorithm, this question is not applicable.

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of what the document does provide:

• Device Description: The DRX9000 is a non-surgical spinal decompression system.
• Intended Use/Indications for Use: To relieve pressure on structures causing low back pain and sciatica, associated with herniated discs, degenerative disc disease, posterior facet syndrome, and radicular pain.
• Predicate Devices: K022602 DRX3000 (Axiom Worldwide) and K053503 VAX-D Genesis System (VAX-D Medical Technologies).
• Basis for Clearance: Substantial equivalence to predicate devices, based on similar technological characteristics and an assessment that modifications to the DRX3000 did not impact safety and effectiveness.
• Safety Information: "over the past twelve years, not a single claim of injury has been filed."
• Clinical Use Mention: "Axiom Worldwide therapy has been in clinical use since 2002 and has been the subject of clinical studies examining its effectiveness." (However, details of these studies are not provided in this 510(k) summary).

This 510(k) submission is a regulatory filing focused on establishing substantial equivalence for market clearance, not a detailed scientific publication of a clinical trial with performance metrics against predefined acceptance criteria for a novel device or AI.

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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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