(87 days)
The Neurotech Kneehab Conductive Garment and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the quadriceps area of the leg.
The proposed Kneehab XP Conductive Garment is an integrated thigh wrap garment designed to be used in conjunction with a Neurotech stimulator and custom electrodes for the application of neuromuscular electrical stimulation (NMES) to the quadriceps muscles of the thigh. The garment is supplied with a set of four custom designed adhesive pads which may positioned on the inner garment outlines according to fit of the user. Instructions are provided in the user instructions for correct electrode placement. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.
The provided document is a 510(k) premarket notification for a medical device called the "Kneehab XP Conductive Garment." This submission aims to demonstrate substantial equivalence to previously cleared devices.
Based on the content, here's the information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document states: "No clinical or non clinical tests were performed to support substantial equivalence." This means there are no specific acceptance criteria or reported device performance metrics established for this particular submission. The basis for clearance is substantial equivalence to predicate devices, not performance against pre-defined criteria.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable, as no new clinical or non-clinical tests were performed.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: 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:
- MRMC study: No, an MRMC study was not done, as no clinical tests were performed. This device is not an AI-based system.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone study: No, a standalone study was not done. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of ground truth: Not applicable, as no new clinical or non-clinical tests were performed for this submission. The ground truth for the predicate devices would have been part of their original clearance process, but that information is not provided here.
8. The sample size for the training set:
- Sample size for training set: Not applicable, as this device submission did not involve a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Ground truth establishment: Not applicable.
Summary of the Study:
The document explicitly states: "No clinical or non clinical tests were performed to support substantial equivalence." This 510(k) submission relies entirely on demonstrating that the "Kneehab XP Conductive Garment" is substantially equivalent to legally marketed predicate devices (Kneehab XP Conductive Garment, Type 411 - K083105 and Lumbofix™ Conductive Garment - K091317) by showing that it has the same intended use and similar technological characteristics, with the only difference being that it is not packaged with a battery pack, charger, or control unit. Therefore, no new studies, acceptance criteria, or performance data were generated or required for this particular submission.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).