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clTrac is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. clTrac may be used to treat pain and symptoms associated with the following conditions: herniated discs, bulging or protruding intervertebral disc disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative joint disease, facet syndrome, compression fractures, joint pain, and discogenic pain.

The clTrac is powered traction equipment that offers both static and intermittent traction. Spinal traction is a form of decompression that relieves the pressure on the spine. Traction is a non-surgical, non-invasive and non-pharmaceutical treatment for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. The clTrac is intended to be used by healthcare professionals (HCP) on their patients. When device is operational, the applied force shall not exceed +/-10% of the target force as set by the operator. clTrac applies a specific force onto the traction cord. The applied force is set by the operator by means of the touch screen and rotary knob. A patient interrupt button is available for the patient to pause the therapy. The cl Trac is a non-invasive therapeutic device. The device consists of a console with ABS housing. The console consists of an aluminium ground plate, an ABS outer shell, a 7" touch screen and a steel central control knob. A 2.9m long cord with a plastic patient interrupt button is plugged into the console. The console is intended to be fastened to a standardized traction table using screws that are tightly screwed into its aluminium ground plate, with holes in a standardized pattern. The implemented motor-gear unit applies traction via a traction cord that is fixed into the console with a 360° swivel head with guide pulley. The traction cord is intended to be attached to hip and thoracic traction belts that are sold separately.

The provided document is an FDA 510(k) clearance letter for the clTrac device, a powered traction equipment. It focuses on demonstrating substantial equivalence to a predicate device (Eltrac 471) rather than a deep dive into specific performance study details with acceptance criteria for an AI/ML-based medical device.

Therefore, many of the requested details regarding acceptance criteria, specific study types (MRMC, standalone), sample sizes for test and training sets, expert qualifications, and ground truth establishment methods for an AI/ML device are NOT present in this document.

The document details the device's indications for use, technological characteristics, and compliance with various voluntary general and electrical safety standards. It explicitly states:

• Clinical Performance: Not applicable. This device does not require clinical testing for demonstration of substantial equivalence and safety/effectiveness."

This means the 510(k) clearance was based on non-clinical performance (bench testing, electrical safety, software validation, usability, risk management, and biocompatibility) and comparison to a predicate, not on a study demonstrating clinical performance with specific metrics like sensitivity, specificity, or reader improvement, which are typical for AI/ML device clearances.

Here's a breakdown of what can be extracted or inferred based on the provided text, and where the information is missing:

1. A table of acceptance criteria and the reported device performance

The document doesn't present "acceptance criteria" in the way one would for an AI/ML diagnostic or prognostic device (e.g., target specificity, sensitivity thresholds). Instead, it refers to compliance with established medical device standards and the device's operational specifications.

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

• Sample Size: Not applicable. No clinical test set. The performance testing was primarily bench testing and engineering verification/validation against standards.
• Data Provenance: Not applicable for clinical data. The testing mentioned (electrical safety, EMC, usability, software, risk, biocompatibility) would be performed in a lab setting by the manufacturer.

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

• Not applicable. There was no clinical test set requiring expert-established ground truth.

4. Adjudication method for the test set

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This device is a powered traction equipment, not an AI/ML diagnostic aid for human readers.

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

• No. This device is electro-mechanical, not an AI/ML algorithm. Its "performance" refers to its physical operation and safety, not an intelligent diagnostic output.

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

• Not applicable. Ground truth for an AI/ML algorithm is not relevant here. The "ground truth" for the device's functionality would be engineering specifications and measurements (e.g., force output measured by a calibrated sensor, electrical safety limits).

8. The sample size for the training set

• Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

• Not applicable.

In summary, the provided document is for a medical device clearance (clTrac, a powered traction equipment) that relies on demonstrating substantial equivalence to a predicate device and compliance with general device safety and performance standards. It explicitly states that clinical testing was "not applicable." As such, the detailed requirements for AI/ML device clearances (like test set/training set sizes, expert ground truth establishment, MRMC studies) are not relevant to this specific FDA submission and are not found in this document.

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