(469 days)
The intended use of the bifurcated y-extension is Spinal Cord Stimulation to treat chronic intractable pain.
The proposed y-extension and screening cables are identical to previously approved extensions and screening cables except for the addition of a second inline, set screw connector. The dual connectors are parallel to each other and are attached proximally in the IPG plug (extension) or at a y-junction (screening cable). The distal and proximal ends of the proposed and current extension and screening cables are identical and the only difference is the connection at the IPG plug (extension) and at the y-junction (screening cable).
The provided document does not contain information about acceptance criteria or a study that proves a device meets those criteria in the traditional sense of AI algorithm evaluation (e.g., accuracy, sensitivity, specificity for diagnostic devices).
Instead, this K953742 summary describes a medical device (Medtronic Model 7498 Bifurcated Y-extension and related screening cable) and focuses on demonstrating its substantial equivalence to previously approved devices. The "performance" mentioned refers to mechanical and safety aspects, not diagnostic or AI-driven performance.
Therefore, many of the requested fields are not applicable to this document. I will fill in the relevant information and indicate "N/A" for those not addressed by this submission.
Acceptance Criteria and Device Performance (for Substantial Equivalence)
The acceptance criteria here is "Substantially Equivalent" to predicate devices, meaning it does not raise new questions of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance (Model 7498) | Pass/Fail |
|---|---|---|
| Product Labeling Substantially Equivalent | Substantially equivalent | Pass |
| Intended Use Identical | Identical | Pass |
| Physical Characteristics Substantially Equivalent | Substantially equivalent | Pass |
| Anatomical Sites Identical | Identical | Pass |
| Target Population Identical | Identical | Pass |
| Performance Testing Substantially Equivalent | Substantially equivalent | Pass |
| Safety Characteristics Substantially Equivalent | Substantially equivalent | Pass |
| Flex Strength Requirements Met | Passed requirements | Pass |
| Tensile Strength Requirements Met | Passed requirements | Pass |
| No new questions of safety and effectiveness | No new questions identified | Pass |
2. Sample size used for the test set and the data provenance:
- Test Set Description: The "test set" here refers to the actual physical devices (Model 7498 extension and y-screening cable) that underwent nonclinical laboratory testing.
- Sample Size: Not specified (e.g., how many units were tested for flex/tensile strength).
- Data Provenance: Laboratory tests (likely internal Medtronic laboratories). No information on geographical origin or retrospective/prospective nature as would apply to clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in this context is based on engineering specifications and mechanical testing standards, not expert medical opinion on diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable to mechanical device testing for substantial equivalence.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a passive medical device (extension/cable for a spinal cord stimulator), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is a passive medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering specifications and performance standards. The "ground truth" for the nonclinical tests (flex strength, tensile strength) would be the pre-defined acceptable limits for these mechanical properties according to internal design specifications and relevant industry standards for such medical device components.
8. The sample size for the training set:
- N/A. This device does not involve a "training set" in the context of an AI/machine learning algorithm. It is a manufactured physical device.
9. How the ground truth for the training set was established:
- N/A. Not applicable.
§ 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).