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The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days in the back and/or extremities for:

• · 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.

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).

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.

• "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.

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The Smartpatch Peripheral Nerve Stimulation (PNS) System is indicated for up to 30 days in the back and/or extremities for:

• · 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 Smartpatch PNS System is not intended to treat pain in the craniofacial region.

The Smartpatch 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 Smartpatch 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 30 days). The diameter of the wire is 0.26mm. The wire is provided in two lengths (20cm, 40cm) with a maximum placement depth of approximately 10cm.

The provided document outlines the substantial equivalence of the Smartpatch PNS System to a predicate device and does not contain detailed acceptance criteria or a dedicated study proving performance against such criteria. The document focuses on comparing the Smartpatch PNS System's characteristics to existing devices to establish its safety and effectiveness for market entry.

However, based on the information provided regarding performance data and clinical studies, we can infer some aspects related to effectiveness, even if not explicitly defined as acceptance criteria.

Inferred Acceptance Criteria and Reported Device Performance (based on available information):

Study Information (as provided within the document):

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated for specific clinical studies. The document refers to "multiple completed and ongoing studies."
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be clinical trials conducted by the applicant, SPR Therapeutics, LLC. Whether they are retrospective or prospective is not specified, but the term "ongoing studies" implies prospective elements for some trials.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable. The document discusses clinical studies for safety and effectiveness in pain relief, which typically rely on patient-reported outcomes or objective physiological measures rather than expert consensus on images or diagnostic classifications.

3. Adjudication Method for the Test Set: Not applicable. As the studies focus on pain relief, adjudication in the sense of expert review of data for ground truth establishment is not described.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is relevant for diagnostic imaging devices where human readers interpret cases. The Smartpatch PNS System is a therapeutic device for pain relief.

5. Standalone (Algorithm Only) Performance Study: Not applicable. The Smartpatch PNS System is a physical medical device (a peripheral nerve stimulator) with human interaction in its application and use, not an algorithm operating in isolation. Its performance is intrinsically linked to patient-device interaction and physiological response.

6. Type of Ground Truth Used: The clinical studies mentioned would have used patient-reported pain scores (e.g., VAS, NRS), functional assessments, and observation of adverse events to assess safety and effectiveness. This aligns broadly with outcomes data and patient-reported outcomes.

7. Sample Size for the Training Set: Not applicable. The context of a "training set" is typically for machine learning algorithms. The provided document details a medical device (a nerve stimulator), not an AI/ML algorithm.

8. How the Ground Truth for the Training Set Was Established: Not applicable, as there is no "training set" in the context of this device and document.

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