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The Healthstar Elite machine administers genuine intervertebral decompression. Each treatment session consists of a physician prescribed treatment period on the Healthstar Elite. A treatment is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. The machine can be used to relieve sciatica pain and pain associated with: bulging or herniated discs, degenerative disc disease, and posterior facet syndrome. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

This device is for prescription use only.

The Healthstar Elite is a multifunction elevation table designed to apply distraction forces to a patient's spine. The powered elevation adjustments of the table's surface height are designed to provide easier loading and unloading of the patient on and off the table.

The patient lies in a supine position on the table with either the knees bent or legs supported on an adjustable height stool creating a 90-degree bend between the calves and hamstrings. This position helps to provide comfort during distraction and to provide relaxation to the Para spine tissue during distraction.

The upper body is restrained through a chest harness, which is attached underneath the rib cage. The harness is attached to a metal spreader bar and web strap, then attached through a cam-type buckle assembly. The lower body is restrained to the moveable lower section of the table through a flexible pelvic restraint is fixed to the table's lower moveable section. Each side of the restraint can be moved in and out width wise by pushing a lever and having a stud engage into one of three numbered holes, depending on the size of the patient. The flexible restraint is designed to capture and secure the patients iliac crest.

The Healthstar Elite consists of two components:

• 1. The elevation table with traction capabilities.
• 2. An attachable control panel, which can be inserted into either side of the table.

The elevation table is controlled by a 24-volt actuator and is elevated by pushing a hand control with built in arrows indications (no label required).

The control panel allows the operator to select one of eight predetermined programs of distraction, time of treatment, pounds of distraction, and pelvic tilt angle.

The provided text is a 510(k) premarket notification for the Healthstar Elite, a powered traction equipment device. The document primarily describes the device's function, its similarities to predicate devices, and the FDA's determination of substantial equivalence.

However, the document does not contain information regarding detailed acceptance criteria, specific study designs, or performance metrics in a way that would allow for the completion of the requested table and accompanying details.

Here's a breakdown of what is not present in the provided text:

• Acceptance Criteria Table: There is no table outlining specific performance targets (e.g., accuracy, precision, safety thresholds) for the device. The document focuses on regulatory equivalence rather than quantitative performance.
• Reported Device Performance: No specific quantitative performance data (e.g., measurement accuracy of distraction force, reliability over time, patient outcome statistics) is reported.
• Study Details:
  • Sample Size (Test Set): Not mentioned.
  • Data Provenance: Not mentioned.
  • Number of Experts/Qualifications (Ground Truth): Not mentioned.
  • Adjudication Method: Not mentioned.
  • MRMC Comparative Effectiveness Study: Not mentioned. The document primarily compares the device's "principles and working characteristics" to predicate devices, not a rigorous comparative effectiveness study with human readers/operators.
  • Standalone Performance: Not explicitly stated as a separate study. The document implies the device works as intended but doesn't detail a standalone performance evaluation with specific metrics.
  • Type of Ground Truth: Not applicable, as no specific performance study is detailed with ground truth.
  • Sample Size (Training Set): Not mentioned.
  • Ground Truth Establishment (Training Set): Not applicable.

Summary of available information related to effectiveness and safety:

The "Summary of Safety and Effectiveness" section states:
"The operating principles of the Healthstar Elite permit the safe application of effective distraction tensions of the lumbar spine."
It further describes safety features like a patient handheld cut-off switch and a quick release for power failure.

Conclusion:

The provided 510(k) notification for the Healthstar Elite focuses on demonstrating substantial equivalence to predicate devices (SpineMED, DRS System, SPINA System) for regulatory approval, rather than providing a detailed performance study with quantifiable acceptance criteria and results. Therefore, it is impossible to complete the requested table and answer the study-specific questions based on the given text.

The FDA's letter states that they "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the evaluation was against existing known devices in terms of intended use, technological characteristics, and safety/effectiveness principles, rather than requiring a new, comprehensive clinical performance study with specific metrics as would be expected for a novel device or a device requiring a PMA.

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The SpineMED™ provides a program of treatments for relief from pain for those patients suffering with low back pain. 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 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. The powered High-Low adjustments of the Table surface height are designed to provide easier loading and unloading of the patient on and off the table. The patient lies in a supine position on the Table with the legs supported with a removable knee bolster. For increased comfort during 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 treatment if a patient finds the heat uncomfortable. The upper body is restrained through a chest harness, which is then attached to the fixed upper section of the Table, to a mechanical safety release buckle. The lower body is restrained to the moveable lower section of the Table through pelvic restraints that are designed to capture and secure the patient's iliac crest. The SpineMED™ System consists of two main components: (1) The Table; and (2) The Control Console. The control console provides the power and the computer control systems to drive the function of the unit, where the table is the functional component used for the treatment. Together, the components function as one unit. The Table is a split-table design, whereby distractions are applied to the patient through the pelvic restraints during the separation of the Table, resulting from the movement of the lower table section. The Pelvic Restraints are incorporated into a 10 inch section of the powered Lower Table section, which has a powered tilt function, that is designed to tilt the pelvis during treatment. This actuator driven tilting section has the ability to tilt the pelvis at a maximum of 25 degrees during treatment, to provide targeted treatment of specific spinal segments.

The provided text is a 510(k) Summary of Safety and Effectiveness for the SpineMED™ device and related FDA correspondence. It does not describe any acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics (e.g., accuracy, sensitivity, specificity, or specific physical measurements).

Instead, this document focuses on establishing substantial equivalence to predicate devices for regulatory clearance. The "study" mentioned refers to clinical trials carried out by the DRS System (a predicate device), which support the principles of decompression and the efficacy of this modality, rather than a specific performance study for the SpineMED™ itself.

Therefore, most of the requested information cannot be extracted from this document, as it is not a clinical study report or a performance validation document for the SpineMED™ specifically.

Below is the information that can be inferred or directly stated from the provided text, with notes indicating where information is absent.

Acceptance Criteria and Study for SpineMED™ (K030060)

Based on the provided 510(k) Summary, specific acceptance criteria for device performance (e.g., analytical or clinical performance metrics) and a study conducted for the SpineMED™ device itself to demonstrate meeting these criteria are not described. The document primarily relies on the substantial equivalence principle, drawing upon the established efficacy and safety of predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable. No performance study for the SpineMED™ is detailed in this document.
• Data Provenance: Not applicable. The document refers to "Clinical trials carried out by the DRS System" (a predicate device) to support the general principles of decompression, not as a test set for the SpineMED™ itself. The country of origin and prospective/retrospective nature of those DRS System trials are not mentioned.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Not applicable. As no specific performance study for the SpineMED™ is detailed, there's no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

• Not applicable. No test set or adjudication method is described for the SpineMED™ device.

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

• Was an MRMC study done? No. This type of study (common for AI/imaging devices) is not mentioned or relevant for this mechanical traction device.
• Effect size of human readers with/without AI assistance: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Was a standalone performance study done? No. This device is a physical traction table; it does not involve algorithms in the sense of AI or image analysis. Its operation is described as having "computer control systems to drive the function of the unit."

7. Type of Ground Truth Used (for any performance claim)

• Not applicable for SpineMED™'s own performance. The document states that "Clinical trials carried out by the DRS System support the principles of decompression and the efficacy of this modality." This implies that the 'ground truth' or evidence of efficacy for the modality (spinal decompression) was established through clinical outcomes in studies of the predicate device. However, specific details about how that ground truth was established (e.g., pathology, outcomes data specific to the DRS trials) are not provided here.

8. Sample Size for the Training Set

• Not applicable. The SpineMED™ is described as a powered traction table, not an AI or machine learning system that requires a "training set."

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

• Not applicable for the same reasons as above.

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