(97 days)
Medtronic considers nonsterile packaging of spinal cord and peripheral nerve stimulation lead accessories with appropriate labeling and instructions for sterilization by the user to be substantially equivalent in design, function, materials, and intended use to previous accessory devices.
Packaging of the nonsterile accessories will be either in kits, as separate piece parts or in bulk packaging that in no way resembles sterile packaging. The word "Nonsterile " will be obviously displayed on the packaging and instructions for sterilization will be included in the labeling.
The provided document is a 510(k) summary for Medtronic Model 3550 Accessories, submitted in 1996. This document is a pre-market notification to the FDA, asserting substantial equivalence to a predicate device. It is not a study that proves a device meets acceptance criteria, nor does it contain performance data in the way a modern medical device submission for AI or diagnostic devices would.
Therefore, I cannot provide the requested information:
- Table of acceptance criteria and reported device performance: The document only states that nonsterile packaging with instructions for sterilization is "substantially equivalent" to previous accessories. It does not provide performance metrics or acceptance criteria for the device itself (which in this case are accessories to a spinal cord/peripheral nerve stimulator).
- Sample sizes, data provenance: No study data is presented.
- Number of experts, qualifications: Not applicable as no ground truth establishment is described.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Not applicable.
- Type of ground truth: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
The document's purpose is to argue that the packaging and sterilization instructions for accessories are substantially equivalent to existing methods, making the accessories safe and effective when sterilized by the user as instructed. It's a regulatory filing, not a scientific study report.
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).