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The DRS System provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the DRS System and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, 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 DRS System™ is designed to apply distraction forces to a patient's lumbar spine. The key elements are as follows:

1. The bed is a stand on/stand off tilt type bed that allows the fully clothed patient to stand on the bed in the vertical position. The bed and patient can then be slowly lowered to the horizontal treatment position using a remote controller hand held by the practitioner.
2. Once in the horizontal position the bed can be raised or lowered to the practitioner's preferred treatment height via the same hand held remote controller.
3. The bed is split into two cushions, each slideable in the horizontal plane only on low friction runners and each being able to be locked independently.
4. Distraction tensions are applied to the patient via a pelvic harness while the upper body of the patient is anchored to the locked upper (cephalic) cushion via a chest harness and adjustable underarm supports. The lower cushion, which is unlocked and on which the patient's lower trunk is rested, is able to slide easily thus reducing almost completely any frictional movement between patient and bed cushion when distraction tensions are applied, this concentrates virtually all the forces to the affected part of the lumbar spine.
5. The distraction unit (Vertrac) is mounted to a vertical movable platform incorporated into a support tower (Omni Tower) at the foot end of the bed. This enables the distraction tensions to be applied at differing angles to the patient (between 0 and 30 degrees).
6. The "Vertrac" unit is programmed and control panel fitted into the "Omni Tower" to give static or intermittent distraction.
7. The minimum and maximum distraction settings are 0-200 lbs.
8. Treatment parameters i.e. tensions and time are continuously monitored and shown by LCD readout at the time of treatment set up and during treatment.
9. At the conclusion of treatment time, tension always returns to zero.
10. A cassette player, which is incorporated in a separate section of the control panel, and wireless headphones together with an overhead fluorescent "black light" provide comfort and relaxation to the patient.
11. There is instantaneous release of all tensions if the patient pushes the button on the hand held Patient Safety Switch, or the Stop Button on the control panel has been pushed by the practitioner.
12. The DRS System™ will not operate if the Patient Safety Switch is not working properly or has not been tested prior to each treatment.
13. The treatment cannot be restarted when a patient activates the Patient Safety Switch or the Stop Button has been pushed during treatment unless all treatment parameters are manually re-entered into the controller.

The provided text describes a medical device, the DRS System™, which is intended to apply distraction forces to a patient's lumbar spine to relieve low back pain. However, it does not include acceptance criteria for the device's performance, nor does it detail a study that proves the device meets specific performance criteria in the way typically expected for a modern medical device submission (e.g., sensitivity, specificity, accuracy metrics).

Instead, the document is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to predicate devices, rather than proving efficacy through clinical performance metrics against predefined acceptance criteria. This type of submission relies heavily on similarities in intended use, technological characteristics, and safety profiles to already legally marketed devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text because such information is not present. The document refers to "clinical trials carried out by VAX-D" (the predicate device) and "extracts from study papers carried out using The DRS System" to endorse the principle of decompression. However, it does not provide details of these studies in terms of methodology, sample size, ground truth, or outcome metrics with respect to specific acceptance criteria for the DRS System™ itself.

Here's an analysis of what can be extracted or inferred from the provided text, while acknowledging the severe limitations in fulfilling the request for detailed acceptance criteria and a study demonstrating their achievement:

Summary of Information from the Provided Text

The document is a 510(k) Summary of Safety and Effectiveness for the DRS System™ (K981822). This type of submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove standalone clinical efficacy against specific performance targets.

1. Table of Acceptance Criteria and Reported Device Performance:

   • Not found in the document. The document does not specify quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or a measure of pain reduction against a predefined threshold). Therefore, no "reported device performance" against such criteria is provided.

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

   • Not found in the document. The document mentions "clinical trials carried out by VAX-D" (a predicate device) and "extracts from study papers carried out using The DRS System," but it does not provide details on the sample size or provenance (country of origin, retrospective/prospective) for any specific test set used in a performance study for the DRS System™.

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

   • Not found in the document. Ground truth establishment methods, number of experts, and their qualifications are not detailed for any studies mentioned.

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

   • Not found in the document. No information on adjudication methods for any test data is provided.

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

   • Not applicable. The DRS System™ is a mechanical traction device, not an AI-assisted diagnostic or interpretative system. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

   • Not applicable. As the DRS System™ is a mechanical device, the concept of a "standalone algorithm only" performance study does not apply. The device's operation is mechanical and controlled by practitioners.

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

   • Inferred (Outcomes Data for Pain Relief): The "Intended Use" states the device "provides a program of treatments for relief from pain for those patients suffering with low back pain." The "clinical trials" and "study papers" are mentioned in the context of endorsing the "principle of decompression" and further confirming the same. This strongly suggests that outcomes data related to pain relief would be the relevant "ground truth" for efficacy, but the details of how this was measured or established in the mentioned studies are absent. The cited papers are:
     • Shealy, C. Norman, and Borgmeyer, Vera (1997) Decompression, Reduction, and Stabilization of the Lumbar Spine: A Cost Effective Treatment for Lumbosacral Pain. American Journal of Pain Management, Vol. 7, p. 63-65.
     • Shealy, C. Norman, and LeRoy, Pierre L. (1998) New Concepts in Back Pain Management: Decompression, Reduction, and Stabilization. St. Lucie Press, Boca Raton, FL. Chapter 20, p. 239-257.
       These are publications that presumably contain the outcomes data.

8. The sample size for the training set:

   • Not found in the document. Since it's a mechanical device and not an AI/algorithm, the concept of a "training set" in the context of machine learning does not apply. If this refers to the data used to design or validate the device, no sample size for such a purpose is provided.

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

   • Not applicable. (See point 8).

Conclusion:

The provided 510(k) summary is designed to establish substantial equivalence for a physical medical device (traction bed) based on its mechanical principles, safety features, and similarity to existing predicate devices. It does not contain the kind of detailed performance study data, acceptance criteria, or ground truth establishment methods typically associated with software, AI, or diagnostic devices. The references to "study papers" indicate published research was used to support the principle of decompression, but the specific performance of the DRS System™ against quantitative acceptance criteria is not presented within this document.

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