(120 days)
The ELTRAC 471 Traction device, with its accessories, is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. The ELTRAC 471 Traction device may be used to treat pain and symptoms associated with the following conditions: hermiated discs, bulging or protruding intervertebral discs, degenerative 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 Eltrac 471 traction device applies forces to the spine to alleviate pain caused by a variety of pressure on muscular or skeletal structures. It exerts defined forces on the human body to alleviate pain and utilizes computer technology for programming of different kinds of traction.
This device is intended for use by professional users only, such as qualified personnel in physiotherapy, rehabilitation and adjacent areas. The device is designed with a plastic housing that holds the motor and has a full color touch screen interface on which the professional user can enter various parameters by touch. The forces from the motor are transferred to the patient by cords and connected accessories. Sequential programming is possible for programming combinations of traction which can be stored as favorites for later use.
The provided text describes the regulatory clearance for the "Eltrac 471 Traction device" based on substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific acceptance criteria through performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance against those criteria are not present.
However, I can extract the information that is available regarding regulatory requirements and the non-clinical performance evaluation.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) against which the Eltrac 471 was compared. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to recognized non-clinical standards.
The "performance" is generally described as meeting safety and functionality requirements through verification and validation tests against these standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Safety | Adheres to ISO 14971, IEC 60601-1, IEC 60601-1-2. Electronic safeguards of force and mechanical safety for maximum force limitation. Hardware mitigations protect from excessive force. Patient stop function. Remote control can decrease force but not increase it. |
| Basic Safety and Essential Performance | Adheres to IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Adheres to IEC 60601-1-2 (Electromagnetic disturbances - Requirements and tests). |
| Software Life Cycle Process | Adheres to IEC 62304. |
| Functionality | Applies forces to the spine, utilizes computer technology for programming, sequential programming possible, full color touch screen, transfers force via cords and accessories. |
| Technological Characteristics | Substantially equivalent to predicate device (Triton/Tru-Trac/TX/Triton DTS Traction devices) regarding electrical input, software control, motor-driven force delivery, safety/warning features. Minor differences in body positions, maximum treatment time (150 min vs 165 min), and force speed deemed not to raise new risks. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The non-clinical performance refers to "Verification and validation tests" conducted by Enraf-Nonius, B.V., but details about specific test sets, sample sizes, or data provenance (e.g., retrospective/prospective, country of origin) are absent. This is typical for submissions based on substantial equivalence for non-clinical devices where the "test set" would be the device itself subject to engineering and safety tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Clinical ground truth, experts, or their qualifications are not mentioned, as no clinical testing was performed or required. The "ground truth" for non-clinical tests would typically be defined by engineering specifications and standard requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for clinical studies, which were explicitly stated as "Not applicable" for this 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
This information is not applicable and not provided. This device is a physical therapy traction device, not an AI-assisted diagnostic or imaging device used by human readers/interpreters. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable in the context of typical AI algorithm-only performance. The "device" itself, the Eltrac 471, performs its function (applying traction) independently to the extent of its programming. The "non-clinical performance" section describes tests on the device's electrical, safety, and software functionality, which could be considered a form of standalone testing for the device's inherent design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance, the "ground truth" implicitly used would be engineering specifications, design requirements, and the pass/fail criteria defined by the cited international standards (ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 62304). This does not involve clinical "ground truth" like pathology or outcomes data, as no clinical studies were performed.
8. The sample size for the training set
This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "software" component refers to control software, not a learned model.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the reasons stated in point 8.
§ 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).