(52 days)
The Lumbofix® Conductive Garment:
- provides symptomatic relief and management of chronic and intractable pain in the lower back region and
- assists in the frequent and correct positioning and repositioning of pads on difficult to reach and/or large locations of the lower back.
It is intended for prescription use only.
The Lumbofix® Conductive Garment is a conductive garment intended for use in conjunction with transcutaneous electrical nerve stimulation (TENS). It aids in the placement of electrodes and secures them in place. Contents include a conductive belt, a pack of hook backed electrodes and instructions for use.
This document (K091317) is a 510(k) summary for the Lumbofix® Conductive Garment. It does not contain a study to prove acceptance criteria in the manner typically found for AI/ML-based medical devices. This device is a Class II Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, and its submission relies on substantial equivalence to a predicate device rather than a new clinical study with specific acceptance criteria that would require performance metrics like sensitivity, specificity, or accuracy.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of device submission.
Here's a breakdown of what can be extracted from the provided text based on the nature of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission for a Class II medical device, the "acceptance criteria" are not defined by specific performance metrics (like sensitivity, specificity, etc.) but rather by demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, and does not raise different questions of safety or effectiveness.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (as stated in K091317) |
|---|---|
| Same Intended Use as Predicate Device | Yes. The Indications for Use for the Lumbofix® Conductive Garment are to provide symptomatic relief and management of chronic and intractable pain in the lower back region and assist in the frequent and correct positioning and repositioning of pads on difficult to reach and/or large locations of the lower back. This aligns with standard TENS device indications. |
| Similar Technological Characteristics to Predicate Device | Yes. The submission states, "There are no new technological characteristics that could affect safety or effectiveness of the Lumbofix® Conductive Garment. Substantial Equivalence has been demonstrated as part this 510k submission." The device is a conductive garment for use with TENS. |
| Does not raise different questions of safety or effectiveness | Yes. The FDA review concluded that the device is substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission did not involve a test set for evaluating specific performance metrics of a novel algorithm or diagnostic tool. The submission is for a physical medical device (conductive garment) based on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth was established by experts for a test set in the context of an AI/ML algorithm.
4. Adjudication method for the test set
- Not Applicable. No test set requiring expert adjudication was conducted.
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 device is a conductive garment, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is not an algorithm.
7. The type of ground truth used
- Not Applicable. Ground truth in the context of diagnostic accuracy is not relevant for this device. The "truth" for this submission is whether the device meets the characteristics of a substantially equivalent TENS accessory.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm was used.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth in this context was established.
Summary from the document for context:
- Device Name: Lumbofix® Conductive Garment, Type 420 Back
- Common Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief
- Classification: Class II
- Predicate Device: Baxolve XP Conductive Garment Accessory & Lumbar Support Kit (K082190) by Bio-Medical Research Ltd.
- Justification for Equivalence: "No new clinical studies have been submitted as part of this premarket notification. The Lumbofix® Conductive Garment has been CE marked under the EU Medical Device Directive 93/42/EEC (NB No. 0366)." and "There are no new technological characteristics that could affect safety or effectiveness of the Lumbofix® Conductive Garment. Substantial Equivalence has been demonstrated as part this 510k submission."
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).