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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.

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.

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.

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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 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.

This document is a 510(k) summary for the SPRINT PNS System. It is a submission to the FDA seeking clearance for a medical device. The document states that the SPRINT PNS System has undergone some design modifications to improve ease of use and reliability. However, it explicitly states that none of the changes affect the intended use or fundamental functionality of the device.

Therefore, the document does not contain information on acceptance criteria for device performance or a study demonstrating the device meets these criteria. It asserts substantial equivalence to a previously cleared predicate device (K181422) based on the fact that the changes made (frequency range expansion, new cables, extended shelf life, additional hydrogel formulation) do not alter the fundamental delivery of peripheral nerve stimulation or the indications for use.

Instead of a new performance study with acceptance criteria, the document refers to:

• Nonclinical testing: biocompatibility testing, electrical testing (safety and electromagnetic compatibility), software verification and validation, system performance testing, human factors/usability testing, and sterile package integrity testing. These are typical engineering and safety tests for medical devices, but their specific results or acceptance thresholds are not detailed here.

In summary, this document does not provide the information requested regarding acceptance criteria and a study proving the device meets those criteria for the following reasons:

• No new clinical performance study: The 510(k) submission is for modifications to a previously cleared device, asserting "substantial equivalence" rather than presenting new clinical efficacy or performance data against defined acceptance criteria.
• Focus on substantial equivalence: The core argument for clearance is that the changes are minor and do not alter the fundamental safety or effectiveness of the device compared to the predicate, which presumably already demonstrated its performance.
• No specific acceptance criteria or performance metrics mentioned: The document does not define specific metrics (e.g., accuracy, sensitivity, specificity, or clinical outcome measures) that the device must achieve, nor does it present results from a study demonstrating achievement of such criteria.

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