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510(k) Data Aggregation
(89 days)
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):
| Acceptance Criteria (Inferred) | Reported Device Performance (from document) |
|---|---|
| Safety: Minimal adverse events | Clinical studies demonstrated the safety of the therapy. Adverse events reported included skin irritation, erythema, a blister, or a mild skin tear. The majority of adverse events resolved with little to no intervention and resolved within a few days, and none were classified as serious. |
| Effectiveness (Symptomatic Relief of Pain): Improvement in pain symptoms (implied) | While the document states that "no effectiveness data are required to demonstrate substantial equivalence," it mentions that "clinical testing 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." It also states, however, that "A randomized controlled trial failed to show that the Smartpatch was effective for post-stroke shoulder pain." The general statement about demonstrating safety of therapy for the pain indications implies some level of positive output from these studies, even if detailed effectiveness metrics are not presented as formal acceptance criteria within this 510(k) summary. The failure to show effectiveness for post-stroke shoulder pain indicates a specific limitation or negative finding in one particular application of the device. |
| Biocompatibility: No adverse tissue reaction | Nonclinical testing included biocompatibility testing. (Implicitly, this testing would have met certain standards, indicating no unacceptable adverse tissue reactions.) |
| Electrical Safety & Performance: Meets electrical standards | Nonclinical testing included electrical testing (safety and electromagnetic compatibility) and system performance testing. (Implicitly, these tests met relevant standards for electrical safety and device functionality.) |
| Software Functionality: Verified and validated software | Nonclinical testing included software verification and validation. (Implicitly, the software performs as intended to control the device.) |
Study Information (as provided within the document):
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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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(62 days)
Percutaneous Neuromodulation Therapy (PNT) is indicated for the symptomatic relief and management of chronic or intractable pain and/or as an adjunctive treatment in the management of post-surgical pain and post-trauma pain.
The PNT Control Unit is to be used with PNT Lumbar Safeguides for low back pain or PNT Cervical Safeguides for neck and/or upper back pain.
The Vertis PNT System is designed for delivering percutaneous electrical stimulation (termed: Percutaneous Neuromodulation Therapy -PNT ). The Vertis PNT System is intended to be used in pain management by a physician (e.g., anesthesiologists or physical medicine and rehabilitation physicians) or on the order of a physician (e.g., by a physical therapist) in a clinic environment. The device system includes 3 major components:
- the Vertis PNT Control Unit a software-driven, ● five channel, AC powered nerve stimulator which generates the electrical stimulus;
- the sterile Safeguides which are sterile, needle electrodes; ●
- the Patient Cable - which interconnects the PNT Control Unit to the electrodes
The provided text describes a 510(k) submission for a modification to an existing device, the Vertis Percutaneous Neuromodulation Therapy (PNT) System. The submission is specifically to request clearance for a new cervical electrode kit and cable and to update the labeling.
The document states that "Extensive data were provided that evaluated the use of PNT cervical electrodes and cervical percutaneous electrical stimulation. These data included the following. Data demonstrated acceptable results for the device and therapy." However, it does not provide explicit acceptance criteria, thresholds for device performance, or detailed results beyond stating that they were "acceptable."
Therefore, I cannot populate the table of acceptance criteria and reported device performance as requested. Similarly, the study itself is not described in enough detail to answer many of the subsequent questions.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Data demonstrated acceptable results for the device and therapy." |
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 for Test Set: Not specified.
- Data Provenance: The document mentions "published human clinical trial data for cervical pain management" and "post-market data for the Vertis PNT System." This suggests a combination of prospective clinical study data and retrospective post-market surveillance. The country of origin is not specified, but the applicant company is based in Seattle, Washington, USA.
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)
Not specified. The data includes "human magnetic resonance images (MRI)/ computerized tomography (CT) imaging data," which would typically involve expert interpretation, but the number or qualifications of these experts are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not specified.
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. The device is a nerve stimulation system, not an AI-powered diagnostic imaging tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (nerve stimulator) that requires human operation and interaction with a patient, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (pain management), the "published human clinical trial data for cervical pain management" likely relied on patient-reported outcomes data (e.g., pain scales, functional assessments) as the primary ground truth for efficacy. The "post-market data" would also likely include outcomes data and adverse event reporting. "Electrode performance and dimensional (bench) data" and "MRI/CT imaging data" would have engineered or expert-evaluated ground truths, respectively, but these relate to device safety and characteristics rather than clinical efficacy.
8. The sample size for the training set
Not specified. This device is a hardware system, not a machine learning algorithm, so the concept of a "training set" in the context of AI does not directly apply. If "training set" refers to data used in the design or optimization of the device, it is not detailed.
9. How the ground truth for the training set was established
Not applicable. See explanation for question 8.
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