LogoFDA 510(k) Search
K Number
K211801
Device Name
SPRINT PNS System
Manufacturer
SPR Therapeutics, Inc.
Date Cleared
2021-10-13

(125 days)

Product Code
NHI
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
K202660,K061166
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SPRINT PNS System is indicated for up to 60 days 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 region innervated by the cranial and facial nerves.

Device Description

The SPRINT PNS System is comprised of one or two percutaneous electrodes placed via introducer needles in proximity to target peripheral nerves associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode(s). The SPRINT PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted and remain indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, system programming by the clinician, and system use by the patient.

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) Pre-market Notification does not contain the information necessary to describe acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.

The document pertains to the SPRINT PNS System, which is a Peripheral Nerve Stimulator. The performance data section focuses on "nonclinical testing" (like biocompatibility, electrical safety, software V&V, etc.) and a review of "product complaint data" from commercial use.

Specifically, the document does not contain any of the following information relevant to your request:

  • Acceptance Criteria for AI/ML Performance: There are no metrics like sensitivity, specificity, AUC, or other clinical performance thresholds for an AI/ML model.
  • Study Proving AI/ML Device Performance: There is no mention of a study design (test sets, ground truth establishment, expert readers, etc.) that would typically be conducted for an AI/ML device for diagnostic or prognostic purposes.
  • Sample sizes for training or test sets for an AI/ML model: These concepts are not applicable to the SPRINT PNS system described.
  • Number of experts, their qualifications, or adjudication methods for establishing ground truth for an AI/ML test set.
  • MRMC comparative effectiveness study or standalone AI performance.
  • Type of ground truth used (pathology, outcomes data) for an AI/ML device.
  • How ground truth for a training set was established for an AI/ML model.

The document is a standard FDA 510(k) clearance for a physical medical device (a nerve stimulator) based on substantial equivalence to a predicate device, focusing on safety, technological characteristics, and existing complaint data for that type of device. It does not describe an AI/ML-driven device or its validation.

§ 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).