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The Model 3873 1 x 8 and Model 3874 1 x 8 Compact Test Stimulation Leads are indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following:

• Failed Back Syndrome or Low Back Syndrome or Failed Back;
• Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed Back Syndrome;
• Post Laminectomy Pain;
• Unsuccessful Disk Surgery;
• Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative and surgical interventions;
• Peripheral Causalgia;
• Epidural Fibrosis;
• Arachnoiditis or Lumbar Adhesive Arachnoiditis;
• Complex Regional Pain Syndtome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia; and,
• Multiple Back Surgenes

Additional Contraindication: The Medtronic Models 3873 1 x 8 and the 3874 1 x 8 Compact Test Stimulation Leads are contraindicated for long-term implantation. The lead MUST BE REMOVED within ten (10) days of implant.

The Model 3873 1 x 8 and the Model 3874 1 x 8 Compact are test stimulation lead kits. A test stimulation lead is a thin wire covered by an insulative coating, which is intended to be connected to a screening cable and an external neurostimulator (ENS). The lead has small metal electrodes near its tip through which the ENS delivers electrical stimulation to an area where pain signals will be blocked.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Medtronic Model 3873 and 3874 Test Stimulation Leads:

The provided document is a 510(k) summary and an FDA clearance letter from 2005 for the Medtronic Model 3873 1 x 8 and Model 3874 1 x 8 Compact Test Stimulation Leads. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial results with specific performance metrics and acceptance criteria as might be seen for novel devices requiring PMA (Premarket Approval).

Therefore, some of the requested information (like specific numerical acceptance criteria, data provenance, expert ground truth establishment, MRMC studies, or detailed standalone performance data) is not explicitly present in this document. The focus is on in-vitro testing and material biocompatibility to show similarity to an already approved device.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for the in-vitro tests mentioned. Since it's in-vitro testing of medical devices (leads), it would typically involve a certain number of units of the device being tested for physical and electrical parameters.
• Data Provenance: The document does not specify the country of origin of the data as these are in-vitro studies/tests. It's retrospective in the sense that the testing was completed before the submission to show equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable and not provided in this type of 510(k) submission, as it focuses on device safety and performance characteristics through engineering tests, not on diagnostic accuracy requiring expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, which are not the focus of this 510(k) summary.

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, an MRMC comparative effectiveness study was not done. This document pertains to physical medical devices (test stimulation leads), not an AI-powered diagnostic or assistive tool for human readers. Therefore, these metrics are not relevant or present.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This concept is not applicable to the device described. This is a physical lead, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the tests performed (in-vitro, sterilization, biocompatibility) would be defined by the engineering specifications, regulatory standards (like ISO 10993), and the performance characteristics of the predicate device. For example:
  • In-vitro testing: Ground truth would be adherence to pre-defined engineering specifications (e.g., tensile strength, electrical resistance, insulation integrity).
  • Sterilization: Ground truth would be the validated sterility assurance level (SAL).
  • Biocompatibility: Ground truth would be the established safety profiles for materials based on ISO 10993.

8. The sample size for the training set

• This information is not applicable as there is no "training set" in the context of this device's evaluation. This is not an AI/machine learning device.

9. How the ground truth for the training set was established

• This information is not applicable for the same reason as above.

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