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The SPRINT Peripheral Nerve Stimulation (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 be placed 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.

The provided document is a 510(k) summary for the SPRINT Peripheral Nerve Stimulation (PNS) System. It describes the device, its intended use, and its comparison to a predicate device. However, this document does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML medical device.

The document states: "No clinical performance data were included in support of this submission." This means that the submission for clearance of the SPRINT PNS System did not rely on clinical data to demonstrate its performance against specific acceptance criteria. Instead, it relied on nonclinical performance testing and the substantial equivalence to a previously cleared predicate device.

Therefore, I cannot fulfill your request for the information outlined in bullet points 1 through 9, as it is not present in the provided text. The SPRINT PNS System, as described, is a physical device (electrical stimulator) and is not an AI/ML medical device that would typically have acceptance criteria related to accuracy, sensitivity, specificity, and the types of studies you are asking about (e.g., MRMC studies, ground truth establishment by experts, training/test sets).

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The Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery or up to 3 days adjunctive symptomatic relief of post-operative pain following cardiac surgery.

The Primary Relief is designed to aid in the reduction of post-operative pain by the method of cranial electrical stimulation at the auricular stimulation points. The Primary Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over three days / 72 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of cranial nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 72 hours. There stimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the stimulation pattern consists of rectangular pulses with differing inter-pulse intervals. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.

Here's a breakdown of the acceptance criteria and study information for the Primary Relief device, based on the provided FDA 510(k) summary:

Description of Acceptance Criteria and Proving Study

The acceptance criteria for the Primary Relief device appear to be primarily focused on demonstrating its effectiveness in reducing post-operative pain, specifically after cardiac surgery, to support its expanded indications for use. The study aimed to show a statistically significant reduction in pain scores compared to a sham device.

1. Table of Acceptance Criteria and Reported Device Performance

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The Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery.

The Primary Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over 3 days / 72 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of cranial nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 72 hours. There are three stimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.

Here's a breakdown of the acceptance criteria and study details for the DyAnsys Primary Relief device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" in the traditional sense of specific quantitative thresholds the device needed to meet. Instead, it focuses on demonstrating substantial equivalence to a predicate device (SPRINT PNS System) and safety/effectiveness through clinical and non-clinical testing.

Here’s a table summarizing the performance aspects evaluated and the reported results:

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The First Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.

The First Relief is designed to aid in the treatment of chronic pain symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The First Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over seven days / 168 hours from the time of activation of the device.

The electrical pulse from the device will be delivered to the branches of cranial Nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 168 hours. There stimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device.

Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and the study proving it:

The provided 510(k) Summary for the "First Relief" device (K212859) describes a clinical study to support its substantial equivalence to a predicate device. However, it does not present specific quantitative acceptance criteria or reported device performance in a direct comparison table as requested. Instead, it discusses the outcomes of the clinical study, focusing on statistical significance of pain and other related scores, and states that these "demonstrated the safety of the therapy" and "showed similar improvements."

There is no mention of a "test set" and its specific characteristics (sample size, data provenance), "ground truth" establishment, "adjudication method," or "MRMC comparative effectiveness study" in the context of specific quantitative metrics for acceptance. The study is a comparative clinical trial, not an AI or imaging-based device study that would typically involve those details.

Based on the provided text, I will present the information that is available and clearly state what is not available as per your request.

1. Table of acceptance criteria and the reported device performance:

As mentioned, the document does not explicitly state quantitative acceptance criteria (e.g., "VAS score reduction of X points is acceptable") or a direct comparison table of these criteria against reported device performance, which is common for algorithm-based devices. Instead, it describes the results of a clinical trial designed to show improvement. Therefore, the "reported device performance" below reflects the observed clinical outcomes rather than directly matching pre-defined acceptance criteria.

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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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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 Pulse Generator (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 (MicroLead) is a sterile, coiled, stainless steel wire designed to be percutaneously inserted via an introducer needle 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, stimulator programming by the clinician, and stimulator use by the patient.

The provided documents do not contain information about acceptance criteria and a study proving a device meets those criteria, specifically concerning AI/algorithm performance metrics, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies.

The documents are a 510(k) premarket notification for the SPRINT Peripheral Nerve Stimulation System, which describes a medical device for pain relief, its comparison to a predicate device, and the non-clinical testing performed. It focuses on demonstrating substantial equivalence to a previously cleared device, based on similar indications for use and technological characteristics, rather than establishing performance against specific acceptance criteria through clinical studies involving human readers or AI algorithms.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test and training sets, or data provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods for test sets.
• MRMC comparative effectiveness study details (effect size of AI assistance).
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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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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