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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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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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