(29 days)
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:
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- The elevation table with traction capabilities.
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- 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.
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).