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1. Patients with disc protrusions.
2. Patients with mild disc herniations.
3. Patients with pinched nerves.
4. Patients with limited spinal flexibility.
5. Patients with muscle spasms.
6. Patients with spinal vertebral fixations.
7. Patients with spinal facet imbrication and fixation.
8. Patients with spinal nerve root radiculitis.
9. Patients with foraminal encroachment.

The Bass Antalgic-Trak is a multi-functional traction device. It is chair like in its appearance and The Dass Amargic Truk is a mark tull sit upon a chair or recliner. The chair/table can recline the patient 90 degrees. It maintains the patient's sitting posture during the recline. the patient 90 degrees: it maintains the parchies befores 24 inches wide by 20 inches tong by I it is seat bottom is a viry? covered assist as a seat bottom, at the knee joint, the 5 inches ticep backed by 74 men pry roomes as a calf support. The cushion continues 18 inches to support the calves. This seat-bottom section can manually rotate 80 degrees left or right, support the carves. This sout ootion socure, manually flex forward and backwards 45 degrees. manually facerary and 55 asglobal to backwards 6 inches by engaging an electric The chiller motor. This is to accommodate taller patients with longer thighs. There are 3 leather/vinyl straps that secure the patient to the seat bottom. Strap 1 securers over the iliac leather vinyl straps that secure the parent stup 3td secures over the shins. The seat back of the chair is viral 2 socures over the might is 20 inches tall and 18 inches wide and 3 inches deep Chan is villy covered done roam lead is vinyl covered dense foam. It is 12 inches tall by 8 backed with 74 men pry wood. It is mounted to the mounted to the upper portion of the chair's top frame. The headpiece has a vinyl strap to secure the forehead onto the headpiece. the chair o top the chair/table is 60 inches long. In the upright posture, the chair height is 60 which rechned, the seat-bottom is powered by an electric single-columned actuator motor. The headpiece cervical traction is powered by an electric single-columned actuator motor. The thigh extension of the seat bottom is powered by an electric single-columned actuator motor. The table/chair recline is powered by an electric single-columned actuator motor. The seat-I he table/enan footine is powered of as e cervical traction may be powered manually using foot pottom fulliour traction as foot pedal for each. The traction can be "auto" cycled using the control panel. The thigh adjustment length and table/chair recline must be engaged using the control panel. The clinician must set all functions.

This 510(k) premarket notification for the Bass Antalgic-Trak is a submission for a Class II medical device (Powered Traction Table) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through an independent study with detailed performance metrics.

Therefore, the document does not contain the information required to fill out the requested table regarding acceptance criteria and performance, nor does it describe a study that would meet the specified criteria (e.g., sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details).

This type of 510(k) summary primarily:

• Identifies the device and its manufacturer.
• States the intended use and indications for use.
• Lists predicate devices to which substantial equivalence is claimed.
• Provides a brief device description.

It does not include:

1. Acceptance criteria table or reported device performance: There are no specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, effect size) reported in this document. The submission relies on claiming equivalence to predicate devices that are already approved.
2. Sample size, data provenance for a test set: No study with a test set is described.
3. Number of experts and qualifications for ground truth: No ground truth establishment is described as there's no independent study.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not performed or reported. This would typically be for diagnostic or screening devices evaluating human reader performance with and without AI assistance.
6. Standalone performance: Not performed or reported. This device is a physical traction table, not a standalone algorithm.
7. Type of ground truth used: Not applicable as no new clinical study to establish performance metrics is described.
8. Sample size for training set: Not applicable as there is no AI algorithm being trained.
9. How ground truth for training set was established: Not applicable.

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The DRX5000 provides a program of treatments for relief from pain for those patients suffering with low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the DRX5000 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 pain and back 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 DRX5000 is a powered traction equipment device. The bed is a stand on/stand off tilt type bed that allows the fully clothed patient to step onto a footrest while it is in near 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. The bed is split into two cushions, each slide able in the horizontal plane only on low friction runners and each being able to be locked independently. Distraction tensions are applied to the patient via a pelvic harness while the upper body of the patient is anchored to the locked upper cushion via a chest harness. 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. The traction unit is mounted to the foot of the tower and the belt pulley system is attached to a vertical movable platform incorporated into the 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). The traction unit is programmed and controlled from a control panel fitted into the tower to give static or intermittent distraction. The minimum and maximum distraction settings are 0-200 lbs. 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. At the conclusion of treatment time, tension always returns to zero. A DVD player, which is incorporated in a separate section of the control panel, and headphones provide comfort and relaxation to the patient and provides and opportunity for patient education via clinical tapes. There is instantaneous release of all tensions if the patient pushes the button on the hand held Patient Safety Switch, or the Stop Button, or Emergency Stop on the control panel has been pushed by the practitioner. The DRX5000 will not operate if the Patient Safety Switch is not working properly or has not been tested prior to each treatment. 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 the DRX5000 Traction Equipment and its 510(k) submission, primarily focusing on its equivalence to predicate devices and safety features. However, it does not include a study proving the device meets specific acceptance criteria related to its performance in relieving pain or decompressing intervertebral discs.

Instead, it relies on:

• Predicate Device Equivalence: Stating that the DRX5000 "incorporates various principles and working characteristics of the predicate devices" (3-D Active Trac and Tru-Trac 401 Traction Device).
• Reference to Existing Clinical Trials: It mentions, "Clinical trials carried out by VAX-D (K951622) endorse the principle of decompression and similar studies using similar technology have reported the same results." It then directs the reader to appendices, which are not provided in the input text.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the given document.

Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not provided. The text only references clinical trials performed by VAX-D (K951622) and "similar studies," but no details about their sample sizes or data provenance are given for these external studies, nor for any specific test set for the DRX5000 itself.

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

• Not provided.

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

• Not provided.

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:

• Not applicable. This device is traction equipment, not an AI software or imaging interpretation tool that involves human readers.

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

• Not applicable. This device is traction equipment.

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

• Not explicitly stated for the DRX5000. For the referenced VAX-D studies, it can be inferred that the "principle of decompression" led to positive "results," which likely implies patient outcomes data (e.g., pain relief, improved function).

8. The sample size for the training set:

• Not applicable/Not provided. This is physical medical equipment, not a machine learning algorithm that requires a training set.

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

• Not applicable/Not provided.

In summary, the document serves as a 510(k) submission focusing on the equivalence of the DRX5000 to existing devices and its safety features. It references clinical evidence for the underlying principle of decompression therapy in general (citing VAX-D studies), but it does not present a specific study validating the DRX5000 against detailed acceptance criteria with statistical performance metrics, sample sizes, or ground truth methodologies directly related to the DRX5000's efficacy.

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Hang Ups InvertAlign is intended to be used for inversion, a method of gravity-assisted traction that utilizes the user's own body weight. Inversion is indicated of gray intervertebral dimentions, decrease pressure on the intervetebral discs, stretch and relax muscles, and temporarily relieve back pain associated with the listed contitions.

The InvertAlign is a non-invasive traction device that utilizes gravity to apply traction. The user straddles the main shaft of the InvertAlign and while resting his seat on the base of the table frame, the user places each foot on the foot platform. The user's ankles slide between the foam padded ankle clamps. In the InvertAlign's full upright position, the user will be reclined in the supine position at approximately 10 degrees off vertical. By pulling the locking pin and locking the clamps securely to the ankles, the user or supervisor is able to manually adjust the foam clamps to form a secure but comfortable fit. The user or supervisor may then use the tilt control button to increase / decrease the angle of inversion. The InvertAlign can be stopped at any angle and is able to tilt beyond ninety degrees from horizontal to allow the user to hang and move freely at full inversion.

The provided text is a 510(k) summary for a medical device called "Hang Ups InvertAlign." This document primarily focuses on demonstrating substantial equivalence to predicate devices and describes the device's technological characteristics and intended use. It does not contain information on acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for such a study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document because it does not exist within the provided text. Similarly, I cannot answer the other questions about study specifics (sample size, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set details) as this information is not present.

The document's "Summary of Safety and Effectiveness" section focuses on the historical use of inversion and the features of the device that contribute to safety and effectiveness, rather than a formal study with acceptance criteria and measured performance.

In summary, the requested information about acceptance criteria and a study proving their fulfillment is not available in the provided 510(k) summary.

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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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