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The Model D -- Disc Force provides a program of traction type treatments for relief from pain for patients suffering with low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the Model D - Disc Force and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of inter-vertebral discs, that is, unloading due to distraction and positioning.

The main parts of the Model D are as follow:

1. The bed is a stand on / stand off type of bed that can be tilted to allow the fully clothed patient to step onto a footrest while in the vertical position and then be slowly lowered to the horizontal treatment position using a remote control hand held by the practitioner.
2. The bed is split into two cushions which slide on low friction runners only in the horizontal plane and which can be locked independently.
3. Distraction tensions are applied to the patient via a pelvic harness while the upper torso is anchored to the locked cephalic cushion via a chest harness. The lower cushion, on which the lower torso of the patient rests, is unlocked and able to slide freely, thus negating any frictional movement between the patient and the bed cushions during the application of distraction forces and ensuring the efficiency of the application of the prescribed force.
4. The distraction unit is mounted to a vertical movable platform incorporated into a support tower at the foot end of the bed. This enables the distraction tensions to be applied at differing angles (ranging from 0 to 27 degrees) to the patient.
5. The distraction unit is programmable and controlled from a control panel fitted into the tower to provide static or intermittent distraction.
6. The minimum and maximum distraction settings are 0 200 pounds.
7. Treatment parameters, such as time and tension, are continuously monitored and displayed by the control panel during set up and during treatment.
8. At the conclusion of the duration of the treatment session, the tension always returns to zero.
9. A flat panel monitor, which is incorporated in a separate section of the control tower, with headphones provides comfort and relaxation to the patient and / or educational opportunities.
10. The system incorporates a Patient Interrupt Switch; an Emergency Interrupt Switch; and a Power Switch, which, when selected independently, in tandem, or in unison, results in the immediate release of all tension.
11. The Model D will not operate if the Patient Switch is not working properly or has not been tested prior to the commencement of each treatment session.
12. If the Patient Interrupt Switch, or the Emergency Interrupt Switch is activated during a session, or power is interrupted, all treatment parameters must be manually re-entered before the treatment session will restart.

The provided text is a 510(k) notification submission for the Chirotronics Model D, a powered traction equipment device. The document details the device description, intended use, technological characteristics, and a summary of safety and effectiveness.

However, the submission does not include any acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety features.

Therefore, most of the requested information cannot be extracted from this document, as a formal study with acceptance criteria, ground truth, and statistical analysis is not present. The device relies on "Summary of Safety and Effectiveness" based on its design characteristics and comparison to predicate devices, rather than a quantifiable performance study.

Here's a breakdown of what can and cannot be answered from the provided text:

1. Table of acceptance criteria and reported device performance:

• Cannot be provided. The document does not define specific acceptance criteria or report quantifiable performance metrics from a study against such criteria. The safety and effectiveness summary lists design features and operational safeguards, but not performance outcomes in patients against predefined targets.

2. Sample size used for the test set and data provenance:

• Cannot be provided. There is no mention of a test set, study population, or data origin for evaluating the device's performance.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Cannot be provided. No ground truth establishment is described, as no performance study is detailed.

4. Adjudication method for the test set:

• Cannot be provided. No test set or adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Cannot be provided. This device is a physical therapy traction device, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related metrics are not applicable.

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

• Cannot be provided. This is not an algorithmic device in the sense of a diagnostic or analytical algorithm; it's a therapeutic physical device.

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

• Cannot be provided. No ground truth is described because no performance study is detailed. The submission focuses on device design and safety features.

8. The sample size for the training set:

• Cannot be provided. There is no mention of a training set as this is not an AI/machine learning device.

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

• Cannot be provided. Not applicable due to the nature of the device.

What the document does communicate regarding safety and effectiveness:

The document outlines safety and effectiveness characteristics based on the device's design and operational principles. These act as inherent "performance" features rather than measured outcomes from a clinical study:

Study Proving Acceptance Criteria:

Based on the provided document, no specific study proving quantitative acceptance criteria was performed or detailed. The submission relies on a "Summary of Safety and Effectiveness" which asserts that the device has been designed to be safe and effective based on its technological characteristics, operational safeguards, and substantial equivalence to legally marketed predicate devices that have "been successfully manufactured and marketed... with no evidence of MDR events."

The FDA's response (K073132) confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. This determination of substantial equivalence is based on the information provided about its design, intended use, and technological characteristics, rather than a formal clinical study with predefined acceptance criteria and performance outcomes.

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