(81 days)
Model 3273/3274 Receiver and Model 3629/3630 Screener indicated for use for epidural spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS), as an aid in the treatment of chronic intractable pain of the trunk and/or limbs.
Using a commercially available Medtronic Spinal Cord Stimulation Radiofrequency (RF) Transmitter to provide the appropriate RF signal, the Model 3273/3274 Receiver, when connected to a commercially available Medtronic quadrapolar lead, will provide an electrical signal to three (3) of the four electrodes (with no signal, or "open", supplied to the fourth electrode). The Model 3273/3274 Receiver, when connected to a commercially available Medtronic quadrapolar lead, will have the ability to reduce the stimulation (voltage) of one of two electrode anodes (related to the cathode), ranging from the programmed stimulation parameter of the other anode to zero. This will allow the physician and patient to customize or balance the stimulation to optimally control pain. The Model 3629/3630 Screener is connected to the (temporary) percutaneous extension of a commercially available lead and to a commercially available Medtronic Model 3210 Transmitter for the screening period. This is the same procedure used with commercially available Medtronic Model 3627 Screener. The Model 3629/3630 Screener is basically a "receiver in a box" (the same circuitry of the Model 3273/3274 Receiver is used), so that the stimulation parameters and characteristics of the Model 3273/3274 Receiver are replicated by the screener. The Model 3273 or 3274 receiver is implanted subcutaneously, and connected to a quadrapolar stimulation lead. The Model 3629 or 3630 screener is outside the patient, and used for a period of days to deliver pulses from a Model 3210 transmitter to percutaneous wires of a quadrapolar lead.
The provided document, a 510(k) notification for the Medtronic Model 3273/3274 RF Receiver and Model 3629/3630 Screener, focuses on demonstrating substantial equivalence to predicate devices rather than a detailed performance study with explicit acceptance criteria. Therefore, several of the requested sections (e.g., sample size, expert qualifications, adjudication method, MRMC study, ground truth for training) are not applicable or cannot be extracted from this document.
However, based on the information provided, here's a breakdown of what can be inferred and what is not available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Receives appropriate RF signal from Medtronic Spinal Cord Stimulation RF Transmitter | "receive signals transmitted from a Model 3210 transmitter and antenna" | Demonstrated through electrical and functional tests. |
| Provides electrical signal to three (3) of four electrodes of a quadrapolar lead | "provide an electrical signal to three (3) of the four electrodes (with no signal, or 'open', supplied to the fourth electrode)" | Core function, demonstrated through electrical and functional tests. |
| Ability to reduce stimulation of one of two electrode anodes (related to the cathode) from programmed parameter to zero | "have the ability to reduce the stimulation (voltage) of one of two electrode anodes (related to the cathode), ranging from the programmed stimulation parameter of the other anode to zero." | Core functionality for customizability, demonstrated through electrical and functional tests. |
| Satisfactorily delivers electrical pulses to the lead | "perform satisfactorily in this environment by delivering electrical pulses to the lead." | Demonstrated through electrical and functional tests. |
| Screener replicates stimulation parameters and characteristics of the receiver | "the same circuitry of the Model 3273/3274 Receiver is used, so that the stimulation parameters and characteristics of the Model 3273/3274 Receiver are replicated by the screener." | Stated as a design principle, implying successful replication through shared circuitry. |
| Screener performs satisfactorily outside patient with percutaneous wires of a quadrapolar lead | "perform satisfactorily in this environment." | Demonstrated through electrical and functional tests. |
| Mechanical, physical, and environmental characteristics are identical to predicate devices | "Mechanical, physical and environmental characteristics of these components were not tested, because they should be identical to those of commercially available predicate devices." | Assumed based on substantial equivalence claim; no specific testing reported for these characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states, "Sufficient samples were built and tested with electrical and functional tests." However, it does not specify the numerical sample size used for testing either the Model 3273/3274 Receiver or the Model 3629/3630 Screener.
- Data Provenance: Not explicitly stated. Given it's a 510(k) for a device manufactured by Medtronic, it's highly likely the testing was conducted internally or by a contracted lab, presumably in the USA where Medtronic is based. The data would be prospective as it involves the testing of newly built devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The document describes engineering and functional tests, not an assessment requiring expert ground truth in the context of diagnostic or interpretive tasks.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used to assess the effectiveness of a diagnostic tool or intervention with and without AI assistance on human readers, which is not the purpose of this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, a standalone assessment was performed. The device's performance was evaluated through electrical and functional tests without human intervention as part of its operational loop. The tests assessed the device's ability to receive signals, deliver electrical pulses, and modulate stimulation as designed.
7. The Type of Ground Truth Used
The "ground truth" for the functional and electrical tests described was based on engineering specifications and design requirements. The devices were tested against their intended functionality (e.g., receiving signals, delivering pulses, modulating voltage to specific ranges) as defined by Medtronic's design and engineering standards for an RF receiver and screener.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. These are hardware devices, not AI algorithms that require a "training set" in the conventional sense. The "training" of the device is its manufacturing process according to design specifications.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided in the document. As stated above, these are hardware devices, not AI models with a training set and associated ground truth.
§ 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).