(279 days)
The Vibro-Trac™ is a multi-function physical therapy table intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction and muscle relaxation therapy.
The Pneumex Vibro-Trac™ is a Hi-Lo multifunction distraction/vibration table designed to apply spinal muscle relaxation through vibration. The patient lies in a supine position on the table with the knees bent and supported at a 90° angle (e.g., supported by an exercise ball). The patient wears an upper body harness, which is attached by shoulder straps and carabineers to the head traction bars at a location to provide greater or less tension, as determined by the medical practitioner. The patient wears a pelvic belt with two tensioning straps attached to either side. The tensioning straps are adjusted to provide the required amount of tension, as determined by the medical practitioner.
The provided text is a 510(k) summary for a medical device called the "Vibro-Trac™ Table," which is a multi-function physical therapy table. This document is a regulatory submission to the FDA to demonstrate substantial equivalence to a predicate device, not a scientific study reporting detailed acceptance criteria and performance metrics typically expected for AI/software-based devices.
Therefore, the requested information elements related to AI/algorithm performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are not applicable to this document as it describes a physical therapy table and not an AI or software device.
However, I can extract the information that is relevant to acceptance criteria and device performance based on the provided text, primarily focusing on the safety and effectiveness testing for a physical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC/UL 60601-1 | Device met requirement |
| CSA C22.2 No. 601.1 | Device met requirement | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Device met requirement |
| Optimal Performance | "Perform optimally during normal use" | Laboratory testing conducted to ensure this. |
| Substantial Equivalence | Similar indications for use and technological characteristics to predicate device (K063034) without raising new safety/effectiveness concerns. | Stated to be substantially equivalent. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes a physical therapy table, not an AI/software device that would typically have test sets and data provenance in this context. The "testing" refers to compliance with electrical and EMC safety standards and laboratory performance checks on the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of expert consensus, is not relevant for the testing of a physical medical device's safety and effectiveness against engineering standards.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review in clinical studies for diagnostic tools, not for engineering compliance testing of a physical device.
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
- Not Applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
- Not Applicable / Engineering Standards Compliance. For physical devices like the Vibro-Trac™, the "ground truth" for safety and effectiveness is adherence to recognized international electrical and EMC safety standards (IEC/UL 60601-1, CSA C22.2 No. 601.1, IEC 60601-1-2) and satisfactory performance in laboratory testing for its intended function.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).