FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

· Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
· Symptomatic relief of post-traumatic pain;
· Symptomatic relief of post-operative pain.

The SPRINT PNS System is not intended to treat pain in the craniofacial region.

Device Description

The Sprint PNS System is comprised of a percutaneous electrode placed via an introducer needle in proximity to a target peripheral nerve associated with a painful area and a wearable external stimulator that delivers stimulation therapy to the percutaneous electrode. The Sprint PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted through the skin via an introducer needle and remain indwelling for the duration of the therapy (up to 60 days).

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, typically used for medical devices that are substantially equivalent to a legally marketed predicate device. The core of this submission is about extending the use duration of the SPRINT Peripheral Nerve Stimulation (PNS) System from 30 to 60 days.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies, while noting the limitations of this type of document as it's not a full study report:

Key Takeaway: This document is NOT a clinical study report with detailed acceptance criteria and performance data in the traditional sense for an AI/ML device. It's an FDA premarket notification (510(k)) for a nerve stimulator, where the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device, particularly for an extended duration of use. As such, many of the requested details about AI/ML device validation (e.g., MRMC studies, training set details, ground truth for AI) are not applicable to this physical device submission.

Analysis of Acceptance Criteria and Proving Device Performance

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

Based on the document, the "acceptance criteria" for this 510(k) submission are not quantitative performance metrics for a diagnostic algorithm, but rather demonstrations of safety and efficacy for the extended use duration (up to 60 days) to prove substantial equivalence to the predicate device.

Acceptance Criterion (Implicit in 510(k))	Reported Device Performance (as described)
Safety for extended 60-day use	- "Clinical testing on the subject device includes multiple completed and ongoing studies on chronic or intractable pain, post-surgical pain, and post-traumatic pain."

"These studies have demonstrated safety of the therapy."
"Adverse events reported in the studies included skin irritation, erythema, a blister, or a mild skin tear."
All reported adverse events "were resolved with little to no intervention and resolved within a few days, and none were classified as serious."
"Clinical experience from other electrical stimulation devices intended for the relief of pain... demonstrates that there are no different or increased risks resulting from the long-term use of electrical stimulation for pain." |
| Effectiveness for extended 60-day use (non-inferiority to predicate) | - "The Sprint PNS System has the same technological characteristics as the Smartpatch PNS System."
"Extending the treatment period to 60 days also does not raise different questions of effectiveness than the predicate or significantly increase an effectiveness concern."
Note: One specific study mentioned failed to show effectiveness for post-stroke shoulder pain, but this is presented as an outlier and not against the general claim of effectiveness for the approved indications. |
| Substantial Equivalence (Overall comparability to predicate) | - "The Sprint PNS System has been shown to be substantially equivalent to the identified predicate device."
The indications for use are identical to the predicate device except for the extended duration.
Minor modifications (lead length, tapes, battery capacity) are stated not to raise new safety/effectiveness questions. |
| Non-clinical performance | - "Nonclinical testing of this device includes biocompatibility testing, electrical testing (safety and electromagnetic compatibility), system performance testing, and software verification and validation." (No specific results provided, only that testing was done). |

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

Sample Size: The document refers to "multiple completed and ongoing studies" for clinical data but does not provide specific sample sizes for these studies. It mentions one specific "randomized controlled trial" but gives no sample size for it either.
Data Provenance: Not specified. It's implicitly clinical trial data used for regulatory submission, but details like country of origin or whether studies were retrospective or prospective are not provided in this summary. The mention of "ongoing studies" suggests prospective elements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this device submission. This is a nerve stimulator, not an AI/ML diagnostic or image analysis device that requires expert review for "ground truth" establishment in the context of diagnostic accuracy. The "ground truth" for pain relief is typically patient-reported outcomes or physician assessment based on clinical criteria, not expert image annotation.

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

Not applicable for this type of device and submission. Adjudication methods like 2+1 or 3+1 are common in AI/ML image analysis studies where multiple readers determine ground truth or resolve discrepancies. This document describes clinical studies demonstrating safety and efficacy of a hardware device.

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 is not an AI-assisted diagnostic device.

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

Not applicable. This is a hardware device for nerve stimulation.

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

The "ground truth" for this device's performance relates to patient outcomes, safety (adverse events), and clinician assessment of pain relief and condition improvement. This would typically be gathered through patient-reported outcome measures (e.g., pain scores), physical examinations, and adverse event logging during the clinical trials.

8. The sample size for the training set

Not applicable as this is not an AI/ML device with a distinct "training set." Clinical data is used for demonstrating safety and efficacy.

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

Not applicable.

Summary

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).