(301 days)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Hand held, 1.5 volt AA battery powered, single mode, single function device with ten "settings" that are controlled by means of rotating a marked disk that increases the microcurrent when rotated clockwise and decreases the microcurrent when rotated counterclockwise, directly through the device integrated electrode into the indicated region of the body. The purpose of the Quick Relax Pro is to provide a temporary relief of minor muscle pain within the indicated region of the body.
The provided text describes a 510(k) summary for a medical device called "Quick Relax Pro," a transcutaneous electrical nerve stimulator (TENS) for pain relief.
However, the provided document does NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical or analytical testing, especially not in the context of an AI/algorithm-based device as implied by the prompts' structured questions (e.g., ground truth, MRMC study, training sets).
This document focuses on:
- Device Identification and Classification: Name, applicant, contact, classification, product code, CFR reference.
- Predicate Device Comparison: Detailed comparison of the Quick Relax Pro to a legally marketed predicate device (HealthmateForever® Pro-8AB) in terms of intended use, technical characteristics (battery, isolation, output modes, waveform, software, functions), and specific parameters (voltage, current, pulse duration, frequency).
- Non-Clinical Testing: Mentions biocompatibility testing (ISO 10993-5, -10, -12), product safety testing (IEC 60601-1), and electromagnetic compatibility testing (IEC 60601-1-2). It states that the "results... were satisfactory, and serve to demonstrate the safety and effectiveness."
- Substantial Equivalence Argument: The core of the 510(k) submission, arguing that the Quick Relax Pro is substantially equivalent to the predicate device, emphasizing safety due to fewer features (no software, single mode).
- FDA Communication: The letter from the FDA stating their "substantial equivalence" determination and regulatory responsibilities.
Therefore, I cannot provide the requested information about acceptance criteria and specific performance study details for an AI/algorithm-based device because the document describes a hardware medical device (TENS unit) and its regulatory submission, not an AI or software algorithm that would involve the kind of performance studies, ground truth establishment, or training/test sets typically associated with AI/ML medical devices.
The acceptance criteria mentioned in the document are implicitly met by:
- Substantial Equivalence: The device is deemed safe and effective because its technological characteristics are substantially equivalent to a legally marketed predicate device.
- Compliance with Standards: Satisfactory results from non-clinical testing (biocompatibility, product safety, EMC) against established international standards (ISO, IEC).
There is no mention of:
- A table of acceptance criteria and reported device performance (in the context of AI/ML metrics like sensitivity, specificity, etc.)
- Sample sizes for test sets or data provenance (as no clinical performance study for an algorithm is described).
- Number of experts, their qualifications, or adjudication methods for ground truth.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth (pathology, outcomes data, etc.).
- Training set size or ground truth establishment for a training set.
The document's structure is typical for a 510(k) premarket notification for a Class II medical device, focusing on comparison to a predicate and non-clinical safety testing, rather than an AI/ML clinical validation study.
§ 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).