(196 days)
The Everyway Traction System, model EVER-TRAC ET-800 is intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses , to exert therapeutic pulling forces on the patient's body.
Everyway Traction Unit, model EVER-TRAC ET-800 is a medical device constructed for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body. For this intended operation function, ET-800 is the combination of driving moter, speed reduction gear, pulley assembly, spring, force and speed control unit... etc. All of the operational parts as above mentioned are mounted on the frame of device housing. The pulling force for ET-800 is generated by the combination of induction motor and speed reduction gear. For the operation of ET-800, the single phase AC power shall be supplied from the general wall socket of house (Note: In USA, the power supply specification is single phase, 60Hz, 120V). Basically ET-800 is a microprocessor-controlled traction system in which the operational software is built inside the control unit to properly control the exertion and release of pulling force according to the setting for applying force, operation cycle, and operation time prescribed by the physician. To ensure the safety of operation, the device was designed and constructed to provide the following safety protection: Manual release, Auto shutdown, and Safe protect. In addition, the device also provides warning alarm function for same near dangerous situations as mentioned in user's manual.
Here's an analysis of the provided 510(k) summary, specifically addressing the requested information about acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, there are no specific quantitative acceptance criteria or detailed device performance metrics reported for the Everyway Traction Unit, model EVER-TRAC ET-800. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of specific performance thresholds (e.g., force accuracy, speed range compliance) | The device passed electrical compliance and EMC compliance tests as per IEC 60601-1 and IEC 60601-1-2. |
| General safety features (manual release, auto shutdown, safe protect, warning alarms) | These features are designed into the device, implying they function as intended to meet safety objectives. |
| Substantial equivalence to predicate device (Ever Prosperous Traction System model DIGIT-TRAC 930) in technological and operational features | The document concludes that the device maintains the "same safety and effectiveness" as the predicate device, indicating that its performance in these areas is considered equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention a "test set" in the context of clinical performance or a specific dataset used for evaluating the device's therapeutic effectiveness. The tests conducted were non-clinical:
- Non-Clinical Testing: Electrical Compliance Test and EMC Compliance Test.
- Sample Size: Not applicable in the context of clinical data. These tests would typically be performed on a single or a few units of the manufactured device.
- Data Provenance: Not applicable for clinical data. The tests were performed by "accredited laboratory."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical test set or ground truth established by experts is mentioned in the provided document. The basis for clearance is substantial equivalence to a predicate device, supported by non-clinical safety testing.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. No clinical test set or adjudication process is mentioned.
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. The device is a powered traction unit, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical medical instrument, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable for clinical performance. For the safety and performance evaluation, the "ground truth" used would be the standards themselves (IEC 60601-1 and IEC 60601-1-2). The device's electrical and EMC characteristics were compared against the requirements of these standards.
8. The Sample Size for the Training Set
Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. The device is not an AI/ML algorithm that requires a training set.
Summary of the Study:
The provided document describes a 510(k) premarket notification for the Everyway Traction Unit, model EVER-TRAC ET-800. The study conducted to demonstrate the device meets acceptance criteria (specifically for market clearance via substantial equivalence) is not a clinical study. Instead, it relies on non-clinical verification activities:
- Electrical Compliance Test: According to IEC 60601-1, performed by an accredited laboratory.
- EMC Compliance Test: According to IEC 60601-1-2, performed by an accredited laboratory.
The conclusion is that these tests, along with the device's similar technological and operational features to the predicate device (Ever Prosperous Traction System model DIGIT-TRAC 930), demonstrate substantial equivalence and maintain "the same safety and effectiveness" as the cleared predicate device. No particular clinical test was conducted for this device. Therefore, the "acceptance criteria" primarily relate to compliance with specified electrical and electromagnetic compatibility standards, and the "study" is limited to these non-clinical engineering tests.
§ 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).