(71 days)
The ANS® A127 Lead Extension is designed to be utilized as the lead extension component of a spinal cord stimulation system (SCS) and is indicated for spinal cord stimulation in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.
The A127 Lead Extension Models 2341, 2342, 2343 and 2346 are designed to be used with the following devices: Micronet Axxess™ Lead Model 8000, 8100 and 8200 series Medtronic Pisces Quad® Lead Model 3487 Medtronic Pisces Quad® Plus Lead Model 3888 Medtronic Pisces Quad® Compact Lead Model 3887 Medtronic SpecifyTM Lead Model 3998 Medtronic Resume® II Lead Model 3587A ANS Renew® Receiver Model 3408 ANS Renew® Transmitter Model 3508
The provided text is an FDA 510(k) clearance letter for the A127 Lead Extension models. It determines that the device is substantially equivalent to legally marketed predicate devices. This type of document does not contain the detailed study information regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, or expert qualifications that you've requested.
The letter explicitly states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)..."
Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets them.
The document primarily focuses on the regulatory determination of substantial equivalence to predicate devices, rather than a detailed technical performance study against pre-defined acceptance criteria for a novel AI/software-as-a-medical-device (SaMD) product. The questions you've asked are typical for the evaluation of AI/ML-based medical devices or diagnostics, which this device (A127 Lead Extension for spinal cord stimulators) is not. It's a hardware component.
§ 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).