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indicated for use in trial screening for SCS and PNS for chronic intractable pain of the trunk or limbs

The Medtronic Model 3628 Screener is a combination of the Model 3627 Screener and the Model 3210 Transmitter. Electrically and functionally, it is the same as the two current products combined. The new Screener allows the patient to carry one unit rather than two during the screening period.

This document is a 510(k) notification for the Medtronic Model 3628 Screener, seeking clearance from the FDA. It declares substantial equivalence to a previously cleared device (Model 3627 Screener and Model 3210 Transmitter combined).

Because this is a 510(k) for substantial equivalence and not a de novo submission for a novel device, it does not contain the level of detail regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement that would be present in a submission for a new or significantly modified device requiring such studies.

The document asserts substantial equivalence based on the following:

• Identical indications for use: "trial screening for SCS and PNS for chronic intractable pain of the trunk or limbs."
• Identical electrical and functional characteristics: "Electrically and functionally, it is the same as the two current products combined."
• Minor physical differences:
  • A larger LCD (used to display parameter information).
  • Replacement of antenna and receiver coil with an RF transformer.
  • Relocation of pushbuttons/switches for improved ease of use.

Therefore, the requested information in your prompt cannot be extracted from this document in detail. Here's a breakdown of why based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document's purpose is to declare substantial equivalence, not to present a new performance study against specific acceptance criteria. The "performance" is implicitly deemed equivalent to the predicate devices.

2. Sample sized used for the test set and the data provenance: Not provided. No specific test set or clinical study for the Model 3628 Screener is described beyond the assertion of equivalence to existing, cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment for a novel device's performance study is not detailed here as no such study is presented for the 3628.

4. Adjudication method for the test set: Not applicable/Not provided.

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: Not applicable. This device is a screener for SCS/PNS, not an AI-powered diagnostic tool. MRMC studies or AI assistance are not relevant to this type of device or its 510(k) submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device.

7. The type of ground truth used: Not applicable/Not provided.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory communication for substantial equivalence, not a detailed scientific study report. It focuses on demonstrating that the new device is fundamentally the same as already-cleared devices, with only minor COTS (Commercial Off-The-Shelf) component changes and UI improvements, rather than establishing new performance metrics.

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