(148 days)
A. TENS: The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from and/ or norrmal non-commercial household work activities.
B. NMS: The device is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
The "XINIXWAVE" is a portable combined TENS and NMS dual channel device for OTC use. Housed in sturly but lightweight cabinet, the device is battery powered. The same circuitry is used to for both TENS and NMS.
The provided text does not contain detailed acceptance criteria or a study that precisely describes how the device meets those criteria with specific performance metrics. It mainly focuses on the device's substantial equivalence to a predicate device and its indications for use.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not include a table of acceptance criteria or specific performance metrics like sensitivity, specificity, accuracy, or any quantitative measures.
Instead, the "Performance Studies" section (Section 5.0) vaguely states: "Performance testing was conducted on the "XINIXWAVE" combined TENS & NMS device to demonstrate the integrity, suitability and substantial equivalence of the device." This implies that the 'acceptance criteria' were likely functional and safety benchmarks inherent in demonstrating substantial equivalence, rather than specific performance targets for, e.g., pain relief efficacy or muscle stimulation improvement through objective measures.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention any specific sample size for a test set. It refers to "Performance testing," but provides no details on the study design, number of participants, or the origin of any data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention any experts used to establish ground truth or their qualifications. Given the nature of the device (TENS and NMS for OTC use) and the focus on substantial equivalence based on technical characteristics rather than clinical performance (in terms of disease diagnosis or treatment efficacy studies with human subjects), it's highly unlikely that "ground truth experts" in the typical sense (e.g., radiologists, pathologists) were involved in evaluating a test set of data.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method. This is consistent with the lack of a defined test set and expert evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document does not describe any study involving human readers or the AI-assisted improvement effect. The "XINIXWAVE" is a physical medical device (Transcutaneous Nerve Stimulator combined with Neuromuscular Stimulator), not an AI algorithm for interpreting medical images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone (algorithm-only) performance study was not done. This device is not an AI algorithm.
7. The Type of Ground Truth Used:
The concept of "ground truth" as typically used in AI/diagnostic device evaluation (e.g., pathology, expert consensus, outcome data) is not applicable here in the same way. The performance studies mentioned were likely focused on:
- Bench testing: Verifying electrical safety, output parameters (frequency, intensity, pulse width), battery life, durability, etc.
- Comparison to predicate device: Ensuring similar physiological effects and safety profile, likely through technical specifications rather than specific clinical outcomes in a trial.
The "ground truth" for showing "integrity, suitability and substantial equivalence" would be compliance with recognized standards for electromedical devices and verification that its technical specifications align with those of the predicate device for its intended use.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable as the "XINIXWAVE" is a hardware medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as above; there is no training set for this type of device.
Summary of what the document does indicate about "performance studies":
The document uses the term "Performance Studies" to refer to testing that demonstrated the integrity, suitability, and substantial equivalence of the "XINIXWAVE" device to its predicate, the Endurance Therapeutics' T-1040 (K-060846).
- Substantial Equivalence: The primary "performance" aspect highlighted is that the device is "simply 'two products in one' as is the cited predicate device," offering choices of programs for both TENS and NMS, similar to the predicate. It also notes that the device comes with a garment belt for electrode pads, similar to the predicate.
- Integrity and Suitability: These terms generally imply tests for electrical safety, biocompatibility (if applicable to materials in contact with skin), mechanical durability, and verification that the device functions according to its technical specifications within safe limits. These types of tests are typically conducted in a laboratory setting, not on human test sets with "ground truth" in the diagnostic sense.
In conclusion, the K100441 submission for the "XINIXWAVE" does not present performance data in the typical format of acceptance criteria, test set, ground truth, and expert evaluation as would be expected for a diagnostic AI device. Instead, it relies on demonstrating substantial equivalence through technical characteristics and basic safety/functional performance testing to an already approved predicate device.
§ 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).