(265 days)
As a Transcutaneous Electronic Nerve Stimulation (TENS) device for:
the symptomatic relief of chronic intractable pain, and
as an adjunctive treatment in the management of post-surgical or post-traumatic pain.
As a Neuromuscular Electrostimulation (NMES) device for:
the relaxation of muscle spasms,
prevention or retardation of disuse atrophy,
increasing local blood circulation,
muscle re-education,
immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis
and
to maintain or increase the range of motion.
Acticare HFT/HFI is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves or muscles. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain or as a NMES device for muscle stimulation.
The provided text describes a 510(k) summary for the Bioinduction Acticare HFT/HFI device, a Transcutaneous Electronic Nerve Stimulator (TENS) and Neuromuscular Electrostimulation (NMES) device. However, it does not contain a study that establishes acceptance criteria or proves the device meets specific performance metrics in terms of clinical effectiveness or accuracy.
The document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and safety testing, rather than a clinical performance study with defined acceptance criteria.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Information that can be extracted related to testing:
The device was tested in accordance with the following non-clinical standards:
- IEC 60601-2-10:2001 (Specific requirements for nerve and muscle stimulators)
- IEC 60601-1:1988 (General requirements for safety of medical electrical equipment), Amendment 1, 1991-11, Amendment 2, 1995
- IEC 60601-1-1:2000 (Safety requirements for medical electrical systems)
- IEC 60601-1-2:2005 (EMC compatibility and additional FCC requirements)
- IEC 60601-1-4:2000 (Software for use in Medical Devices)
The conclusion states that the device has "similar technical characteristics, performances and applications" to predicate devices, and that the "information supplied in the full 510(k) application illustrates that the device does not pose any new questions of safety or effectiveness." This implies that the performance aspects assessed were primarily technical specifications as compared to the predicate devices and adherence to relevant safety standards. There is no mention of a clinical or analytical performance study that would typically define acceptance criteria based on diagnostic accuracy or efficacy.
§ 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).