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The SpineMED® System provides a program of treatments for relief from pain for those patients suffering with low back pain, neck pain or sciatica. 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, neck 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 (Lumbar and Cervical). The powered Hi-Lo adjustments of the table surface height are designed to provide easier loading and unloading of the patient on and off the table. Maximum lift capacity and weight bearing capacity is 4001bs.

The patient lies in a supine position on the table with the legs supported with a removable knee bolster. For increased comfort during the 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 the treatment.

The upper body is restrained through a chest harness, which is then attached to the fixed upper section of the table with a mechanical safety release buckle. The lower body is restrained to the moveable lower section of the table though pelvic restraints that are designed to capture and secure the patient's iliac crest.

The removable pelvic restraints are supplied in two sizes, to accommodate different patient sizes, and are removed from the table for patient loading. The pelvic restraints are adjusted laterally to fit patient's widths through an acme screw assembly incorporated into the tilting lower section. Turn handles are attached to the acme screw on either side of the table, and allow for uniform movement of the pelvic restraints together and apart, for an operator controlled comfortable fitting to the patient.

The table is a split-table design, whereby distraction tensions are applied to the patient through the pelvic restraints during the separation of the table. The lower table section is powered by a computer-controlled 24 VDC actuator, which separates the two table sections to a maximum of eight inches. The distraction tensions and rates are continuously monitored and measured by load cells, which transfer this information to the integrated computer. A similar setting is present for the cervical setup. On top half of the split-table a cervical unit is attached, which applies tension to the high end of the spine. This unit is controlled by a 24 VDC actuator, which is controlled by the main computer. Information from the actuator is sent to the computer which displays the tension applied during the cervical treatment.

An incorporated battery backup system provides adequate system power to continue full operation of the SpineMED® in event of power failure, allowing safe continuation of treatment session. For safety, the patient is provided with an electrical hand-held patient safety switch, which when depressed, immediately interrupts the treatment session and gradually eliminates the application of force to zero under a controlled rate. A secondary safety device incorporates a mechanicallyoperated buckle for the upper harness, which the patient can control its release by simply pulling a switch integrated in the side of the table. The switch releases all distraction forces to the patient.

All treatment parameters and data are captured on the LCD screen and can be printed out to a printer and are stored electronically in the database. There are no new potential flammable materials used in the S200B/C. All material remain the same as the original 510k submission of the S100A(K030060).

The provided text describes a 510(k) premarket notification for the SpineMED® S200B/S200C device. The document focuses on demonstrating substantial equivalence to predicate devices and detailing the device's design and basic safety testing.

However, the document does not contain information regarding specific acceptance criteria for device performance in a clinical or diagnostic context, nor does it describe a study proving the device meets such criteria through metrics like sensitivity, specificity, accuracy, or reader performance. The content is primarily focused on regulatory submission requirements for a medical device that performs powered traction.

Therefore, for most of the requested information regarding acceptance criteria and performance studies, the answer will be that the information is not present in the provided text.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Provided: The document does not specify performance acceptance criteria in terms of clinical or diagnostic outcomes (e.g., pain reduction percentages, success rates, or specific physiological changes). It refers to the device's intended function (applying distraction forces to relieve pressure) but not measurable performance against a benchmark.

The document states:

• "Testing was performed to validate the functional performance of the SpineMED system. In particular, specific performance testing of the software was performed to show that the performance was met."
• "The SpineMED S200B/C has been subjected to performance testing to applicable safety, electrical, mechanical. EMC standards."

These statements indicate functional and safety testing, but not clinical performance data or acceptance criteria for such data.

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

Information Not Provided: No information is given about a "test set" in the context of clinical or diagnostic performance. The document describes functional and safety testing for the device itself, not a study involving human subjects or data sets of patient outcomes.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Information Not Provided: Since no clinical or diagnostic performance study is described with a "test set," there's no mention of experts establishing ground truth for such a study.

4. Adjudication Method for the Test Set

Information Not Provided: As no test set for clinical/diagnostic performance is described, there's no adjudication method mentioned.

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

Information Not Provided: The document does not describe an MRMC study or any study involving human readers or AI assistance. The device is a physical powered traction equipment, not an AI or diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance Study

Information Not Provided: The device is traction equipment; there is no mention of an algorithm-only performance study.

7. Type of Ground Truth Used

Information Not Provided: The document focuses on the mechanical and electrical safety and functional operation of the device. The "ground truth" referenced implicitly relates to compliance with engineering standards (IEC, UL, CAN/CSA) and internal functional test procedures for the device, rather than a clinical ground truth for diagnostic or treatment efficacy.

8. Sample Size for the Training Set

Information Not Provided: There is no mention of a "training set" in the context of machine learning or algorithm development, as the device is mechanical traction equipment.

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

Information Not Provided: No training set is mentioned, thus no ground truth establishment for it.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (powered traction equipment) to existing devices based on indications for use, design characteristics, components, size, power source, and performance in terms of safety and functional operation (e.g., software performance). It does not contain the kind of performance study data or acceptance criteria typically associated with diagnostic AI or imaging devices.

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