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SCS:
This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

PNS:
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation System (referred to as the "Nalu System") incorporates a miniature implantable pulse generator (IPG), powered by an externally worn Therapy Disc device. The Nalu System therapy utilizes pulsed electrical current to create an energy field that acts on peripheral nerves or central nerves to inhibit the transmission of pain signals to the brain. The Nalu System may be implanted following a successful trial period using the Nalu Neurostimulation trial system. This device is intended to be used in the spinal column as well as the peripheral nerves in arm, leg, pelvic and other areas, as is typical of other devices and treatments for the same intended use.

The Nalu System is intended for stimulation of the spinal cord or peripheral nerves for patients experiencing chronic, intractable pain. This system is indicated for pain management in adults who have severe intractable chronic pain, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu System is comprised of the following components:
• Implantables (there are no proposed changes to these components as previously provided in K221376):
o Implantable pulse generator (IPG; available either as an integrated lead unit or with separately connected lead(s)) – provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site(s).
o Leads – implantable and designed to deliver electrical pulses to the nerves via an array of four (4) or eight (8) cylindrical electrodes at the distal end.
o Surgical and Trial Tools – includes anchors, spoonbill needs, stylets, tearaway introducers, pocket tunneler, torque wrench, IPG insertion tool, straw tunneler; tools to support implantation of lead and IPG.

• Externals, Non-Sterile:
  o Externally worn controllers (for use with the permanent implant) and accessories – includes the Therapy Disc, Adhesive Clip, Wearable Garment, Therapy Disc Charger; houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer (subject of this submission).
  o Externally worn stimulator (for use with the trial lead) and accessories – includes the Trial Therapy Disc; sends signals to the percutaneous leads during the trial period by way of the Electrode Interface Cable (EIC).
  • Software (subject of this submission):
  o Clinician Programmer, Patient Remote Control – used to configure the system parameters; also manages patient records, Therapy Discs and remote controls for patients with the Nalu System; runs on Android and iOS platforms and can be optionally used to control and manage Therapy Discs over a secure Bluetooth® Low Energy connection.

The provided text is a 510(k) premarket notification for the Nalu Neurostimulation System. It details modifications made to an existing device, primarily to its external components and software, and argues for substantial equivalence to a previously cleared predicate device (K221376).

Crucially, this document does not describe a study to prove a device meets acceptance criteria related to efficacy or performance comparable to what would be found in a multi-reader, multi-case (MRMC) study or a standalone algorithm performance evaluation for an AI/ML medical device.

Instead, the "acceptance criteria" and "proof" provided are focused on engineering verification and validation to demonstrate that the modifications to the existing device do not raise new questions of safety or effectiveness, thus maintaining substantial equivalence to its predicate. The device itself is a neurostimulation system for pain relief, not an AI/ML diagnostic tool.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, effect size of human reader improvement, standalone performance, type of ground truth, training set sample size, ground truth for training set) are not applicable to this submission, as it is not for an AI/ML algorithm requiring such performance evaluations.

However, I can extract information relevant to the engineering acceptance criteria and the validation activities performed for the modified device components.

Here's a breakdown of the information that can be extracted from the provided text, and an explanation of why other requested information is not present:

Acceptance Criteria and Device Performance (Engineering/Safety Context)

The document frames its "acceptance criteria" as demonstrating that the modified device's technological characteristics are effectively the same or do not raise different questions of safety and effectiveness compared to the predicate device. The performance is then shown through various engineering and validation tests.

Study Details (Context of Engineering Validation, Not AI Performance)

1. Sample size used for the test set and the data provenance: Not applicable in the context of clinical results from a test set as would be used for an AI/ML diagnostic device. The "test set" here refers to physical units of the modified device and its software undergoing various engineering and software validation tests. Data provenance is not described in terms of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance (e.g., expert consensus on medical images) is not relevant for this engineering and software validation. The "ground truth" for these tests are largely defined by engineering specifications, regulatory standards, and functional requirements.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in studies involving human interpretation or performance, typically for diagnostic accuracy.

4. 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:

   • No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "No clinical testing was performed."
   • This device is a neurostimulation system, not a diagnostic imaging AI/ML device that assists human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable in the context of an AI/ML algorithm. The "software testing" mentioned evaluates the software's functional correctness against its specifications, not its standalone diagnostic or interpretive performance.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not applicable for an AI/ML context. For the engineering and software validation, the "ground truth" is adherence to established engineering specifications, industry standards (e.g., ISO, IEC), and regulatory guidance.

7. The sample size for the training set: Not applicable. This submission is for hardware and software modifications to a neurostimulation device, not for an AI/ML model that requires a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no AI/ML training set in this context.

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Spinal Cord Stimulation (SCS)

This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Peripheral Nerve Stimulation (PNS)

This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region.

The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation (SCS; K203547) and peripheral nerve stimulation (PNS; K203547) to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral, bilateral nerve pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord or peripheral nerve to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system.

The Nalu Neurostimulation System consists of five (5) components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site. The leads are implantable and designed to deliver electrical pulses to the nerves via an array of four (4) or eight (8) cylindrical electrodes at the distal end. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for Spinal Cord Stimulation (SCS) or Peripheral Nerve Stimulation (PNS) is performed via standard surgical tools and techniques, as described in (K203547).

This looks like a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for a novel AI device. The document mostly highlights the similarities between the subject device (K221376) and its predicate (K203547).

Based on the provided text, there is no specific AI component or algorithm mentioned, nor are there acceptance criteria or a study described to demonstrate the performance of such a component. The device is a "Nalu Neurostimulation System" which appears to be a hardware device for spinal cord and peripheral nerve stimulation. The changes referenced are related to "Clinician Programmer" software differences for therapy configuration, rather than an AI/ML algorithm that interprets data or makes diagnostic decisions.

Therefore, most of the questions you've asked about acceptance criteria, study details, ground truth, sample sizes, and involvement of experts/AI effectiveness are not applicable to this submission as it doesn't describe an AI/ML device in the context of the typical information provided if it were an AI/ML device.

Here's an attempt to answer your questions based only on the provided text, highlighting where the information is absent because the device does not appear to be an AI/ML product as you seem to be assuming:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in the form of performance metrics (e.g., sensitivity, specificity, AUC) that would be expected for an AI device. Instead, it demonstrates an acceptance of "substantial equivalence" to a predicate device by showing that the technological characteristics and indications for use are the same, and that non-clinical testing confirms safety and performance within established limits.

The tables (Table 1, Table 2, Table 3) provided in the document compare the technological characteristics and therapeutic parameters of the subject device (K221376) and its predicate device (K203547). The "reported device performance" in this context is that these characteristics are "Same as predicate" or that any differences "do not impact the safety and effectiveness of the device."

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document states, "Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu Neurostimulation system is as safe and effective as the predicate device." No clinical data (which might involve a test set, sample size, or patient data provenance) was required or submitted for this 510(k) submission, as the device's substantial equivalence was established through non-clinical testing and comparison to the predicate.

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 applicable. As no clinical study or test set for an AI/ML algorithm was conducted/submitted, there was no need for experts to establish ground truth. The device is a neurostimulation system, not an AI diagnostic or interpretive tool.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication was used.

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 device is not an AI-assisted diagnostic or interpretive tool, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an AI algorithm. Its functionality involves hardware for neurostimulation, with software controlling the programming and delivery of stimulation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. Ground truth for an AI algorithm is not relevant here as the device is not an AI/ML product. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device, validated through non-clinical engineering and performance testing.

8. The sample size for the training set

Not applicable. No AI/ML model training was described or performed for this device.

9. How the ground truth for the training set was established

Not applicable. As no training set for an AI/ML model was used, no ground truth needed to be established for it.

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For Spinal Cord Stimulation: This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

For Peripheral Nerve Stimulation: This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 day) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation, and peripheral nerve stimulation (K201618), to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral, bilateral nerve pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord or peripheral nerve to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system. The Nalu Neurostimulation System consists of several components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site. The leads are implantable and designed to deliver electrical pulses to the nerves via an array of four or eight cylindrical electrodes at the distal end. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS) is performed via standard surgical tools and techniques, as described in (K201618).

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or performance metrics in the way one might expect for a diagnostic or AI-based device's clinical performance. Instead, the submission describes the Nalu Neurostimulation System and its substantial equivalence to predicate devices, focusing on technical specifications and safety rather than a measurable clinical outcome in a performance study.

The closest to "acceptance criteria" are the parameters defining the device's operational range, and the "reported device performance" is that these parameters are within acceptable limits compared to predicate devices, demonstrating substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical performance study with a "test set" from real patient data in the context of an AI/diagnostic device. Instead, it refers to "testing" performed to support the safety and performance of the device. This testing appears to be primarily non-clinical (bench/laboratory) testing of electrical and software parameters.

Therefore, there is no mention of a sample size for a test set of patient data, nor data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The study focuses on evaluating technical parameters against established medical device safety standards and comparison to predicate devices, not on a ground truth established by medical experts for diagnostic accuracy.

4. Adjudication Method

This information is not applicable and not provided, as the submission does not involve expert review or adjudication of clinical cases for diagnostic or performance accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a neurostimulation system for pain relief, not a diagnostic imaging or AI-assisted diagnostic tool that would typically undergo MRMC studies to assess human reader improvement. The submission focuses on demonstrating substantial equivalence in technical characteristics and safety.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable. The "device" itself (Nalu Neurostimulation System) is a therapeutic electrical stimulator. The "software" changes described are modifications to its operational parameters. The performance testing referenced is likely to evaluate the hardware and software functionality as an integrated system, ensuring it operates within safe and effective limits. There isn't an "algorithm only" component in the sense of an AI interpreting inputs to provide diagnostic outputs.

7. The type of ground truth used

The "ground truth" for this submission appears to be regulatory and engineering standards, and the specifications and performance characteristics of legally marketed predicate and reference devices. The evaluation focuses on whether the subject device's technical specifications and functionality (particularly the updated software parameters) fall within the established safe and effective ranges of these comparable devices.

8. The sample size for the training set

This information is not applicable and not provided. The device is not an AI/ML model that would train on a dataset. The software changes are operational programming changes for the neurostimulator.

9. How the ground truth for the training set was established

This information is not applicable and not provided, as there is no "training set" for an AI/ML model.

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For Spinal Cord Stimulation

This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation system is consisted of five components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, through the dura, to the desired location of the spinal cord site. The leads are implantable and designed to deliver electrical pulses to the spinal cord in the epidural space via an array of eight cylindrical electrodes at the distal end. The leads may be secured in place with the Nalu Lead Anchor. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for Spinal Cord Stimulation (SCS) is performed via standard SCS surgical tools and techniques, as described in (K183047).

The provided text is a 510(k) Summary for the Nalu Neurostimulation System, which is an implanted spinal cord stimulator for pain relief. The document focuses on demonstrating substantial equivalence to a previously cleared device (K183047) and specifically addresses updated magnetic resonance imaging (MRI) conditional labeling for full-body scans.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) because it is a submission for a spinal cord stimulator, not an AI/imaging device with such metrics. Instead, the "acceptance criteria" here relate to demonstrating safety and effectiveness for a broader indication (full-body MRI scans) and substantial equivalence to the predicate device.

The reported device performance primarily focuses on the Magnetic Resonance (MR) Conditional Labeling. The previous predicate device (K183047) had MR Conditional Labeling only for local RF coils (head, foot/ankle, knee, or wrist). The current submission proposes an update to include full-body MR Conditional Labeling.

The acceptance criteria implicitly derive from the standards and guidance documents listed, ensuring that the device's behavior in an MRI environment (e.g., displacement force, magnetically induced torque, image artifacts) is safe and within established limits for full-body scans.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of an imaging AI device with a dataset of patient images. The testing conducted was primarily nonclinical performance testing (bench testing) related to MRI safety and device functionality.

• Sample Size: Not applicable in the typical sense of patient samples for an AI model. The testing involved physical devices or components. The number of hardware units tested for MRI compatibility is not specified.
• Data Provenance: Not applicable in the geopolitical or retrospective/prospective sense. The data is generated from laboratory (bench) testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this 510(k) submission. Ground truth, in the context of expert consensus, is typically established for diagnostic or screening devices evaluating medical images. This submission is for an implanted neurostimulation system, and the primary focus of the new data is on MRI compatibility for the physical device, not an interpretation of clinical findings by experts.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. Adjudication methods are used to resolve discrepancies in expert ground truth labeling.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers provide interpretations, and the AI's impact on their performance is evaluated. This 510(k) is for a physical implantable device, and the new data concerns its safety in an MRI environment.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to this device. A spinal cord stimulator does not have an "algorithm-only" performance in the sense of an AI diagnostic tool. Its performance is its ability to deliver stimulation and its safety profile, which was assessed through bench testing.

7. The type of ground truth used

The "ground truth" for the nonclinical testing primarily refers to established engineering and medical device safety standards for:

• MRI Compatibility: Defined by standards like ISO/TS 10974, ASTM F2052-15 (magnetically induced displacement force), ASTM F2213-17 (magnetically induced torque), and ASTM F2129-2013 (MR image artifacts). The "ground truth" is that the device must meet the safety limits defined by these standards when exposed to full-body MRI conditions.
• Biocompatibility: Assessed to ensure the materials are safe for implantation.
• Sterilization Validation: Ensures the device can be adequately sterilized.
• Functional Specifications: The device must meet its intended operational parameters (e.g., stimulation delivery).

8. The sample size for the training set

This information is not applicable. The device is an implanted hardware system, not an AI model trained on a dataset.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

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Moventis PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Moventis PNS is not intended to treat pain in the craniofacial region.

Moventis PNSTM is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain originating from peripheral nerves. The therapy utilizes pulsed electrical waveforms to create an electrical energy field that acts on afflicted peripheral nerves to alter the transmission of pain signals from those nerves to the brain. Moventis PNS is comprised of percutaneous Implanted Pulse Generator (pIPG) and a preprogrammed External Transmitter (ETx) worn outside the body over the general area of the pIPG to provide signal and power.

This document (K200848) is a 510(k) premarket notification for the Moventis PNS, an implanted peripheral nerve stimulator for pain relief. The submission asserts substantial equivalence to predicate devices, meaning it has the same intended use and similar technological characteristics.

The information provided primarily focuses on non-clinical performance and substantial equivalence to legally marketed predicate devices, rather than a clinical study establishing acceptance criteria and device performance in a traditional sense. The device is cleared based on demonstrating compliance with recognized standards and equivalence to existing devices, not on a new clinical trial that sets and meets specific performance metrics for the Moventis PNS.

Therefore, many of the requested elements for a study that proves the device meets acceptance criteria are not directly applicable or explicitly stated as clinical performance data in this regulatory document. However, I can extract the relevant information regarding the device's technical specifications and the non-clinical testing performed to establish its safety and effectiveness relative to predicate devices and recognized standards.

Here's an analysis based on the provided document:

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

The document does not present specific clinical acceptance criteria (e.g., target pain reduction percentages or success rates from a clinical trial) that the Moventis PNS had to meet. Instead, acceptance is based on demonstrating compliance with recognized safety and performance standards for medical devices and showing substantial equivalence to predicate devices. The "reported device performance" in this context refers to the outcomes of non-clinical testing.

• Passed cytotoxicity, sensitization, irritation, intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation (4, 8, 13 weeks), and subchronic toxicity tests.
• Materials (Pellethane 55D, Pt-Ir 90:10) have extensive record of chronic and carcinogenic safety.
• ETx is a non-contacting device.
• Meets biological safety and compatibility requirements. |
  | Electrical Safety (IEC 60601-1:2005 + A1:2012) | - ETx demonstrated compliance for electrical safety.
• pIPG prevents direct current density at electrodes above 0.75 uA/mm².
• Withstands dielectric strength testing.
• Meets electrical safety requirements. |
  | Electromagnetic Compatibility (EMC) & Wireless Coexistence (IEC 60601-1:2005 + A1:2012, IEC 60601-1-2:2014) | - ETx demonstrated compliance for electromagnetic interference and wireless coexistence.
• Moventis PNS met all acceptance criteria for emissions, low-frequency magnetic fields, immunity, electrostatic discharge, radiated RF electromagnetic fields, and magnetic fields. Operates within test limits with no physical damage and full operation.
• Meets EMC and wireless coexistence requirements. |
  | Usability (IEC 62366:2015) | - ETx demonstrated compliance, meeting acceptance criteria of usability validation plan and mitigating risks.
• Meets usability requirements. |
  | Risk Management (ISO 14971:2019) | - Risks associated with wireless communication mitigated through risk analysis, evaluation, control, and safety by design.
• Product labeling indicates medical procedures contraindicated for use.
• Gradual, long-term material changes do not result in unacceptable risks.
• Risks mitigated as far as possible. |
  | Packaging (ISO 11607-1) | - Verified to protect devices from shock, stacking, vibration, temperature, pressure, and humidity variations.
• Complies with packaging requirements. |
  | Markings (Durability and Legibility Requirements) | - Demonstrates compliance with durability and legibility requirements.
• All requirements and markings clearly identified and viewable.
• Complies with marking requirements. |
  | Sterilization (ISO 14708-3:2017 in compliance with ISO 11135:2014) | - Validated for ethylene oxide (EO) sterilization.
• Verified no unacceptable release of particulate matter at implantation.
• Meets sterilization requirements. |
  | Heating Limits | - Does not exceed heating limits.
• Protects patients from heating harm. |
  | External Influences (Defibrillation, Ultrasound, EMF) | - Demonstrated safe operation in presence of external defibrillation, ultrasound, and electromagnetic fields.
• No irreversible damage following exposure to changes in electric fields.
• pIPG functional after exposure to external defibrillation.
• Demonstrates safety under external influences. |
  | Mechanical Force Test (IEC 60601-1:2005 + A1:2012) | - Passed free-fall tests. No visible damage or functional damage.
• Mechanical testing (tensile, flex, torsion) showed pIPGs comply with mechanical design requirements.
• Meets mechanical force test criteria. |
  | Electrostatic Discharge (ESD) (IEC 60601-1:2005 + A1:2012 and IEC 60601-1-2:2014) | - Demonstrated safe operation following ESD.
• Protects from ESD damage. |
  | Atmospheric Pressure & Temperature Test (IEC 60601-1) | - No change to device specification or damage following exposure to absolute pressure or changes in temperature (including shipping/storage ranges).
• Meets atmospheric pressure and temperature test criteria. |
  | Ingress of Water (IEC 60529) | - Met visual and functional inspection passing criteria. No physical damage, fully operational.
• Satisfies ingress of water requirements. |
  | Particulate Matter (IEC 60529) | - Met visual and functional inspection passing criteria. No physical damage, fully operational.
• Satisfies particulate matter requirements. |
  | Means of Protection, Creepage Distances, Air Clearances (IEC 60601-1) | - Design analysis confirmed system satisfies requirements.
• Complies with protection requirements. |

2. Sample size used for the test set and the data provenance.

The document refers to non-clinical testing rather than a "test set" of patient data. For non-clinical performance and safety testing (e.g., electrical safety, biocompatibility, mechanical testing), the sample sizes are not explicitly stated for each test but would typically involve a sufficient number of units to demonstrate compliance with the relevant standards.

• Sample Size: Not explicitly stated for each non-clinical test, but implied to be sufficient for compliance with each standard.
• Data Provenance: All testing appears to be prospective bench and lab testing conducted by the manufacturer (Micron Medical Corporation) or contracted labs to demonstrate compliance with design requirements and international standards. No patient data (retrospective or prospective) is described as being used for performance evaluation in this 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.

This question is not applicable. No clinical "test set" requiring expert-established ground truth was used for this 510(k) submission. The evaluation focused on non-clinical performance and comparison to predicate devices, which relies on engineering and scientific expertise relevant to the standards.

4. Adjudication method for the test set.

This question is not applicable. No clinical "test set" and thus no adjudication method were described.

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.

This question is not applicable. The device is a physical medical device (peripheral nerve stimulator), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.

This question is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used.

For the non-clinical testing, the "ground truth" refers to the established requirements and specifications defined by international standards (e.g., ISO, IEC) and the device's own design inputs. The device's performance was measured against these predefined thresholds and compliance criteria, not against clinical outcomes or expert consensus on patient data.

8. The sample size for the training set.

This question is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established.

This question is not applicable, as there was no "training set."

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Spinal Cord Stimulation (SCS)

This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Peripheral Nerve Stimulation (PNS)

This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region.

The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation system has been cleared by the FDA for spinal cord stimulation (SCS; K183047) and peripheral nerve stimulation (PNS; K183579, and K191435) to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral, bilateral nerve pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord or peripheral nerve to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system.

The Nalu Neurostimulation system consists of five components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site. The leads are implantable and designed to deliver electrical pulses to the nerves via an array of four or eight cylindrical electrodes at the distal end. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for Spinal Cord Stimulation (SCS) or Peripheral Nerve Stimulation (PNS) is performed via standard surgical tools and techniques, as described in (K183047, K183579, and K191435).

The Nalu Neurostimulation System is a non-AI device, and the provided documentation is a 510(k) submission for substantial equivalence. Therefore, the questions related to AI/algorithm performance, ground truth, training sets, and expert adjudication are not applicable here.

The document discusses the Nalu Neurostimulation System, which is an implantable neurostimulation device for pain relief.

Here's the information extracted based on the provided text, focusing on the device's characteristics and the justification for substantial equivalence, which is the "study" in this context:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) process for substantial equivalence does not typically present a formal "acceptance criteria table" in the same way clinical trials for new devices might. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "performance" in this context refers to the device's technical specifications and intended clinical outcomes, which are asserted to be equivalent to the predicate.

For the Nalu Neurostimulation System (Subject Device), the performance is demonstrated by its substantial equivalence to the predicate and reference devices (K183047, K183579, K191435). The key "acceptance criteria" here implicitly are that the device meets the same safety and effectiveness profiles as the predicate.

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The SandShark Injectable Anchor (SIA) System is intended to be an accessory to the stimulator component of the Stimwave Freedom Spinal Cord Stimulator (SCS) System to secure the fascia or interspinous/supraspinous ligament.

The Stimwave Technologies Incorporated (Stimwave) SandShark Injectable Anchor (SIA) System is used to fixate the Stimwave Freedom Stimulator to surrounding tissue. The System is comprised of a carbothane anchor (SandShark Anchor) that is transferred onto the deployment handle (SandShark Injectroducer) with the Loading Rod and Loading Base. The SIA System is provided sterile. The SandShark Injectroducer is used to deploy the SandShark Anchor onto the Stimulator.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device efficacy:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a 510(k) submission for the SandShark Injectable Anchor (SIA) System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials with defined acceptance criteria for efficacy. Therefore, explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or outcomes improvements are not present in this document.

Instead, the acceptance criteria are implicit in matching the predicate device's characteristics and passing established safety and performance tests.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a premarket notification (510(k)) that focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing efficacy in a patient population.

• Sample Size for Test Set: Not applicable in the context of clinical testing with a "test set" of patients. The "test set" here refers to the actual device components and materials subjected to engineering and biocompatibility testing. The document does not specify exact numbers for these components but indicates that "Stimwave completed a number of tests for the SIA System."
• Data Provenance: The testing data is from the manufacturer, Stimwave Technologies Inc. The data is non-clinical performance data and biocompatibility data. It is internal to the company's development and testing process. No country of origin for a patient data set is given as a clinical study was not performed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This is not applicable as the submission did not involve a test set requiring expert ground truth establishment in the clinical sense (e.g., medical image interpretation). The "ground truth" for non-clinical and biocompatibility tests would be defined by the specifications of the test methods and the pass/fail criteria of those standards.

4. Adjudication Method for the Test Set

• Not applicable for this type of submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments. The tests described are objective, pass/fail engineering and biological evaluations.

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

• No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (an injectable anchor system), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone algorithm performance study was not done. This is a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the evaluations performed in this submission are:

• Established industry standards and regulatory guidance: ISO 10993-1:2009 for biocompatibility, AAMI ANSI ISO 14708-3:2008 for physical performance (temperature/pressure changes), and Blue Book Memorandum G95-1.
• Design requirements and specifications: The device was tested to verify that "the performance meets the system design requirements."
• Predicate device characteristics: Substantial equivalence is established by comparing the device's characteristics and performance to the legally marketed predicate device (K172644). The predicate device's established safety and efficacy serve as a form of "ground truth" for equivalence.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI-driven device, so there is no "training set" in that sense.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this type of device submission.

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This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region.

The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

This submission will add 4 stimulation contact options to the predicate Nalu Neurostimulation System (also referred to as the "Nalu PNS System"). The Nalu PNS System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu PNS System incorporates a miniature implanted neurostimulator, powered by an externally worn Therapy Disc device. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on the peripheral nerves to inhibit the transmission of pain signals to the brain. The Nalu PNS System may be implanted following a successful trial period using the Nalu PNS trial system.

The leads that were cleared with the Nalu PNS System featured 8 stimulation contacts. This submission will provide an optional use of leads with 4 stimulation contacts.

This document is a 510(k) premarket notification for a medical device called the "Nalu Neurostimulation System for PNS" (specifically, the 4-contact version). The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This document does NOT present a study that proves the device meets specific acceptance criteria through clinical performance data. Instead, it argues for substantial equivalence based on non-clinical performance testing because the changes are considered minor.

Therefore, many of the requested items related to clinical studies, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this submission. The "acceptance criteria" here are demonstrating substantial equivalence through non-clinical testing.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to a predicate device, primarily the Nalu Neurostimulation System (K183579). This is achieved by showing that the new device (4 Contact PNS System) has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

The document demonstrates this through comparative tables and statements rather than a traditional pass/fail clinical study.

• Number of Electrodes: 4 (vs. 8 in primary predicate).
• Lead Length: 25 cm, 40 cm (vs. 40 cm, 60 cm in primary predicate).
• Electrode Array Length: 21 mm (vs. 52 mm in primary predicate).
• Electrode Spacing: 3.0 mm (vs. 4.0 mm in primary predicate).
• Cable Features: Coiled Wires (vs. Multilumen tube in primary predicate).
• Lead Anchor: Integrated Lead Tines (vs. Separate molded silicone anchor with Ti locking mechanism in primary predicate).
  Performance: All differences are stated to "not affect safety and effectiveness of intended use" and are within parameters of other reference devices. Tested through non-clinical means. |
  | Therapeutic Attributes: Same as predicate. | Same: All parameters like pulse frequency, pulse width, current/voltage regulation, output current/voltage, waveform, pulse shape, maximum phase charge/density, net charge, average phase power/density, pulse delivery mode, current path options, software level of concern, program cycle, pulse pattern, dosage time, transmit frequency are identical to the predicate (K183579). |
  | Biocompatibility: Meet standards. | Met: Same biocompatibility reports as predicate supported this device. Materials and processes previously assessed. |
  | Sterilization: Meet standards. | Met: Ethylene Oxide sterilization, same as predicate. |
  | Electrical & Mechanical Performance: Meet specifications, safe, and effective. | Met: Verification testing included electrical and mechanical tests. Validation, performance, and usability testing demonstrated device meets user needs. Conforms to applicable standards (ISO 14708-1, ISO 14708-3, IEC 62366-1, EN ISO 14971, ISO 11607, ISO 11135-1, CISPR 11). |
  | Software Level of Concern: Moderate. | Met: Same as predicate (moderate). |
  | Human Factors and Usability: Tested and met. | Met: Testing performed. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. This submission relies on non-clinical performance testing (bench testing, verification, validation, biocompatibility) and a comparative analysis to a predicate device, as opposed to a clinical test set with a specific sample size of patients/cases.
• Data Provenance: Not applicable. There is no clinical data from patients/cases mentioned. The testing is internal (Nalu Medical) and presumably took place in the U.S.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not applicable. As there is no clinical test set requiring ground truth establishment by experts (e.g., for disease diagnosis or outcome evaluation), this information is not provided nor needed for this type of submission.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set or human interpretation requiring adjudication.

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 device is an implanted neurostimulator, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was conducted or is relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

• For Non-Clinical Testing: The "ground truth" implicitly used for non-clinical testing (electrical, mechanical, biocompatibility, sterilization) is based on established engineering principles, international standards (e.g., ISO, IEC, CISPR), and pre-defined specifications/tolerances for the device's performance. For biocompatibility, it's compliance with ISO 10993-1. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the legally marketed predicate device.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not a machine learning/AI device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable.

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The Nalu Neurostimulation System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

The trial devices are solely used for trial stimulation (no longer thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Lead Blank is an optional accessory intended to be used as a surgical aide to insert the Nalu Neurostimulation System Leads.

The Nalu Lead Blank is an optional accessory to the Nalu Neurostimulation System (also referred to as the "Nalu System"), which is used for spinal cord stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain. The Nalu Neurostimulation System incorporates a miniature implanted neurostimulator, powered by an externally worn device. The Nalu Lead Blank is an optional non-implantable surgical tool used during implant of the Nalu Neurostimulation System leads. The Nalu Lead Blank may be used to create a path for the lead in the epidural space.

This 510(k) submission is for the Nalu Lead Blank, an accessory to the Nalu Neurostimulation System, not an AI device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is not applicable to the provided text.

The document describes the device, its intended use, and establishes substantial equivalence to a predicate device (Nalu Neurostimulation System K183047) and a reference device (Stimwave Freedom 8 SCS System K170141).

The "studies" conducted are nonclinical performance tests, primarily bench testing, sterilization validation, and biocompatibility testing, along with human factors and usability testing (including a cadaver lab evaluation). Animal testing and clinical performance data were not considered necessary for this device's clearance.

Since this is not an AI/ML device, the following points of your request cannot be extracted from the provided text:

• Table of acceptance criteria and reported device performance (in the context of AI metrics like sensitivity, specificity, etc.): Not applicable for a surgical accessory. The acceptance criteria relate to mechanical and biological safety, not diagnostic performance.
• Sample size used for the test set and data provenance: While non-clinical tests were performed, the concept of a "test set" for AI evaluation isn't relevant here.
• Number of experts used to establish ground truth: Not applicable. Ground truth for a surgical tool is its physical and biological performance attributes.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not a diagnostic AI device.
• Standalone (algorithm only without human-in-the-loop performance) was done: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI sense. Ground truth here relates to engineering specifications and biological compatibility.
• Sample size for the training set: Not applicable as there's no machine learning model.
• How the ground truth for the training set was established: Not applicable.

Summary of Device Acceptance / Performance Demonstration (based on provided text):

The Nalu Lead Blank underwent the following nonclinical performance testing to demonstrate its safety and effectiveness:

1. Bench Testing: Mechanical tests to show the device met target specifications over a range of operating and storage conditions.
2. Sterilization Validation: Ensures the device can be properly sterilized.
3. Biocompatibility Testing: Followed ISO 10993-1:2009 standards.
   • Categorization: Implant tool for tissue/bone contact for a limited duration (≤ 24 hours).
   • Tests Included: Cytotoxicity, sensitization, intracutaneous reactivity, and systematic toxicity.
   • Result: Biocompatibility was demonstrated.
4. Human Factors and Usability Testing: Performed on the device, including evaluation in a Surgical Validation cadaver lab.
5. Design Controls: Nalu followed 21 CFR 820.30, ISO 14971:2007, and ISO 13485:2016 for design control processes, ensuring proper planning, evaluation, and testing.

Conclusion stated by the sponsor: "The bench and non-clinical data support the safety of the device. The verification and validation demonstrated that the Nalu Lead Blank, which is part of the Nalu Neurostimulation System, performs as intended in the specified use conditions. The results do not raise new questions of safety and effectiveness."

The acceptance criteria for this device are implicitly tied to meeting the requirements of the standards and guidance documents listed (e.g., ISO 10993-1 for biocompatibility, mechanical test specifications, usability requirements), enabling the FDA to determine substantial equivalence to previously cleared predicate devices.

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The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain.

The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A or the Receiver Kit Freedom-8A Stimulator. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for spinal column stimulation to provide therapeutic relief for chronic. intractable pain of the trunk and and/or lower limbs including unilateral or bilateral pain. The therapy utilizes pulsed electrical current to create an energy field that acts on nerves near the spinal column. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator), receiver component (Receiver), and an externally worn transmitter (Wearable Antenna Assembly (WAA)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.

This document describes the Stimwave Freedom Spinal Cord Stimulator (SCS) System, which is intended for chronic, intractable pain of the trunk and/or lower limbs. The submission (K182720) is identical to K180981 but includes updates to widen the available range of stimulation parameters for repetition rate (5 Hz to 10 kHz) and pulse width (30 us to 1000 us). No design modifications were made. The document leverages performance testing from prior submissions (K180981 and others) to demonstrate substantial equivalence to the predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a specific table of "acceptance criteria" for performance that the device must meet in terms of a benchmark metric (e.g., Sensitivity, Specificity, Accuracy for a diagnostic device). Instead, it implicitly defines acceptance criteria through compliance with design requirements and various international standards. The "device performance" is primarily demonstrated through passing these tests and showing substantial equivalence to a predicate device.

The two key parameters that were updated in this submission are:

• Repetition Rate: Increased from 5 to 1500 Hz (predicate) to 5 to 10,000 Hz (subject device).
• Pulse Width: Increased from 50 to 500 microseconds (predicate) to 30 to 1000 microseconds (subject device).

The "performance" of the device is described in terms of its ability to pass a series of non-clinical tests and, to some extent, a clinical non-inferiority study for efficacy.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The clinical study was a multicenter, prospective, randomized controlled study. The document does not explicitly state the sample size of subjects enrolled in this clinical study (test set). However, it does refer to "the percentage of subjects who responded" indicating a cohort of patients.

Data Provenance:

• Country of Origin: Not explicitly stated but implied to be US-based given the FDA submission.
• Retrospective or Prospective: The clinical study was prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a neurostimulator for pain relief, not a diagnostic device with "ground truth" established by experts in the typical sense for imaging algorithms. The clinical endpoints (pain relief as measured by VAS, ODI, PGIC scores) are patient-reported outcomes.

4. Adjudication method for the test set

Not applicable for establishing ground truth in the context of this device's function. The clinical study was a randomized controlled study comparing two stimulation frequency ranges. The primary and secondary endpoints were measured using established scales (VAS, ODI, PGIC).

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 a medical device (Spinal Cord Stimulator), not an AI-based diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone implantable stimulator, meaning it functions independently of ongoing human interpretation or algorithmic input for its stimulation delivery. The "algorithm" here refers to the stimulation parameters. The submission confirms the device's performance across an expanded range of these parameters.

The non-clinical performance data (e.g., electrical safety, mechanical robustness, MRI compatibility) are standalone tests of the device's physical and electrical characteristics. The clinical trial compared the efficacy of the device with different stimulation parameter settings (10,000 Hz vs 50-1500 Hz) in patients.

7. The type of ground truth used

The "ground truth" in the clinical study was based on patient-reported outcomes (PROs):

• Visual Analog Scale (VAS) for pain relief and severity.
• Oswestry Disability Index (ODI) scores.
• Patient Global Impression of Change (PGIC) scores.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "learning" aspect is not explicitly mentioned as part of the device's function or development process in this document. The device's operational parameters (repetition rate, pulse width) are pre-defined, although the software restricts them in prior versions. The current submission updates these software restrictions based on prior design and testing.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for an AI/ML algorithm in this context.

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