(54 days)
The Medtronic Model 355531 Multi-Lead Trialing Cable (MLTC) is indicated for use with Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) systems for the treatment of intractable pain of the trunk or limbs.
The Medtronic Model 355531 Multi-Lead Trialing Cable serves as an electrical connection between an external, temporary power source (e.g. screener or external neurostimulators) and a Medtronic neurostimulation lead or extension.
The provided submission describes the Medtronic Model 355531 Multi-Lead Trialing Cable and its substantial equivalence to a predicate device. The primary focus of the testing detailed is on verifying design and performance requirements, as well as biocompatibility and sterilization, rather than clinical performance metrics in the way an AI/ML device would be evaluated.
Here's an analysis based on the information provided, addressing your requested categories where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design Verification Testing | All specified design and performance requirements were met. |
| Design Validation Testing | The device was found to meet user needs and intended uses. |
| Sterilization (100% Ethylene Oxide (EtO)) | The device is labeled Sterile and will use the same 100% Ethylene Oxide (EtO) sterilization process as the predicate device. |
| Biocompatibility (consistent with ISO 10993) | All device materials and components were assessed and found to be compliant with ISO 10993-1. |
| Indications for Use | The indications for use are equivalent to the predicate device: treatment of intractable pain of the trunk or limbs via SCS and PNS systems. |
| Fundamental Technology | The fundamental technology is equivalent to the predicate device: external neurostimulation delivered to lead electrodes. |
| Lead Slots/Design | The subject device facilitates electrical connection between ENS and multiple leads (2 octapolar plus 4 quadrapolar; 16 active electrodes), which is a design difference from the predicate's single octapolar lead (8 active electrodes), but this difference does not negate substantial equivalence based on the provided text. |
2. Sample size used for the test set and the data provenance
The document indicates "Design Verification Testing and Design Validation Testing were performed," and "All materials were found to be compliant with ISO 10993-1" for biocompatibility. However, no specific sample sizes for these tests are mentioned. The provenance of this test data (e.g., country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This submission describes a medical device (a cable) for which performance is assessed through engineering and biological testing (sterilization, biocompatibility), rather than clinical performance requiring expert ground truth in the context of diagnoses or interpretations. Therefore, this question is not applicable in the context of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As the study focuses on design verification, validation, and material compliance rather than clinical interpretation or diagnostic accuracy, an adjudication method for a test set (like 2+1) is not applicable. The "ground truth" for these tests would be established by engineering standards, material specifications, and regulatory requirements (e.g., ISO 10993).
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 MRMC comparative effectiveness study was done. This device is a passive electrical cable, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance. Therefore, this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No standalone performance study of an algorithm was done. This is a hardware device (a cable), and the concept of an "algorithm only" performance is not relevant. Therefore, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for evaluation is based on:
- Engineering specifications and performance requirements: For design verification and validation testing.
- International standards (e.g., ISO 10993-1): For biocompatibility.
- Established sterilization protocols: For sterilization efficacy.
It does not rely on expert consensus, pathology, or outcomes data in the clinical sense, as it is a component device and not a diagnostic or treatment system with direct clinical interpretative output.
8. The sample size for the training set
This device is not an AI/ML model, so the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
This device is not an AI/ML model, so the concept of a "training set ground truth" is 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).