(95 days)
The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A Stimulator or the Receiver Kit Freedom-8A Stimulator. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for spinal column neural stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or lower limbs including unilateral or bilateral pain. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on nerves near the dorsal column of the spine. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator) and an externally worn transmitter (Wearable Antenna Assembly (WAA)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.
The provided text is a 510(k) summary for the Stimwave Freedom Spinal Cord Stimulator (SCS) System. It details the device, its intended use, and a comparison to predicate devices, but does not contain information about a clinical study with acceptance criteria and device performance results in the format requested.
The document explicitly states in Section 10, "Clinical Performance Data":
"There was no clinical testing required to support the medical device, as the indications for use are equivalent to the legally marketed predicate devices. These types of devices, including the legally marketed predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device."
And in Section 11, "Statement of Substantial Equivalence":
"There was no clinical testing performed on this device since performance testing demonstrated similar performance as the legally marketed predicate devices, and materials for the implanted stimulator are the same as the legally marketed predicate devices."
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, as no clinical study with such data is presented in this document.
The document primarily focuses on non-clinical performance data and substantial equivalence to predicate devices based on:
- Intended Use: Stimulation of spinal cord for chronic, intractable pain of the trunk and/or lower limbs.
- Technological Characteristics & Principles of Operation: Comparison of various parameters like electrode material, stimulator body material, pulse frequency, pulse width, current/voltage regulation, waveform, and power delivery to predicate devices.
- Biocompatibility: Stating that materials remain unchanged from a previously cleared device (K141399) and meet ISO 10993-1:2009 standards.
- Non-Clinical Performance Data: A series of tests demonstrating compliance with various standards (AAMI ANSI ISO 14708-3:2008, IEC 60601-1, IEC 60529, IEC 60601-1-2) for aspects like temperature change, atmospheric pressure, external defibrillation exposure, thermal shock, leakage current, mechanical testing, ingress of water, particulate matter, and electromagnetic compatibility.
Without a clinical study, the acceptance criteria and performance tables, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted from this document.
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).