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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.

The Nalu Neurostimulation System for Peripheral Nerve Stimulation (also referred to as the "Nalu System") is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu System incorporates a miniature implantable pulse generator, 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 System may be implanted following a successful trial period using the Nalu Neurostimulation trial system. The Nalu System is comprised of 5 elements: Nalu Implantable Pulse Generator, Leads, Surgical and Trial Tools, Externally worn Therapy Disc, and Clinician Programmer and Remote Control.

This document describes a 510(k) premarket notification for the Nalu Neurostimulation System for Peripheral Nerve Stimulation. The submission aims to establish substantial equivalence to a previously cleared predicate device (K183579), primarily focusing on an update to the device's Magnetic Resonance (MR) Conditional Labeling to include full body scans.

Based on the provided text, there is no acceptance criteria table or specific study performance data for a device meeting acceptance criteria in the traditional sense of an AI/ML model for diagnostic or predictive purposes. This document is a regulatory submission for a physical medical device (implantable neurostimulator) and its associated external components and software, not an AI/ML diagnostic software. The "performance" discussed here relates to the safety and functionality of the device itself, particularly its compatibility with MRI, rather than the accuracy of a diagnostic algorithm.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the device's "performance" as presented in the context of this 510(k) submission, specifically concerning the MRI compatibility, as this is the primary change necessitating the resubmission.

Summary of Acceptance Criteria and Device (MRI) Performance:

Since this is not an AI/ML diagnostic device, the "acceptance criteria" are not framed in terms of metrics like accuracy, sensitivity, or specificity. Instead, they are related to established safety standards for medical devices, particularly regarding MRI compatibility. The "device performance" refers to the results of testing performed to ensure these safety standards are met.

1. Table of Acceptance Criteria and Reported Device Performance (Focusing on MRI Compatibility):

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

• Sample Size: The document does not specify the sample sizes used for the engineering tests (e.g., number of devices tested for MRI compatibility, displacement, torque, or artifacts). These are typically bench tests on physical units, not clinical data sets.
• Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based, non-clinical performance and bench testing.

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

• Not Applicable. This is not a study assessing the performance of a diagnostic algorithm where expert ground truth is established for medical images. The "ground truth" for this device's performance relies on engineering measurements and adherence to international and national standards (e.g., ISO, ASTM) for device safety and functionality.

4. Adjudication Method for the Test Set:

• Not Applicable. As there are no human readers or diagnostic interpretations involved in the "test set" (which consists of physical device tests), no adjudication method is necessary.

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

• No. This type of study is typically done for diagnostic imaging devices or AI tools that assist human readers. This submission is for an implantable neurostimulation system, not a diagnostic imaging or AI assistance tool.

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

• Not Applicable. There is no "algorithm only" performance being evaluated in this submission in the context of diagnostic AI. The device's functionality (e.g., electrical stimulation parameters) and safety (e.g., MRI compatibility) are evaluated.

7. The Type of Ground Truth Used:

• The "ground truth" for the device's safety and performance is established through adherence to recognized international and national consensus standards (e.g., ISO/TS 10974, ISO 14708, ASTM F2052-15, ASTM F2213-17, ASTM F2119-2013) and engineering verification and validation testing. It is not based on expert consensus on medical image interpretations or clinical outcomes data in the context of diagnostic accuracy.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a training set of data.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. (See point 8).

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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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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.

Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a 510(k) premarket notification for substantial equivalence. The core of this "study" is a comparison to predicate and reference devices, along with performance testing.

• Justification: The submission asserts that the subject device is substantially equivalent to the predicate (Nalu Neurostimulation System for SCS, K183047) and reference devices (Nalu Neurostimulation System for PNS, K183579 and K191435) because:
  • They are identical with regard to indications for use, performance, and technological characteristics, except for the increased service life of the IPG and the re-usable nature of the Therapy Disc.
  • "All of the physical and therapeutic attributes for the proposed Nalu Neurostimulation System and the predicate devices share the same technological characteristics and have no differences that would impact safety or effectiveness."
  • Risk analysis of the proposed changes (extended IPG service life, reusable Therapy disc) did not raise any questions of safety and effectiveness.
  • Performance testing was conducted by Nalu Medical, Inc. to support the safety and performance, adhering to 21 CFR 820.30, ISO 14971, and ISO 13485:2016. The test results from the predicate device are considered applicable to the subject device for unchanged aspects.

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

The document does not specify a clinical "test set" in the traditional sense of a clinical trial with a defined patient sample size. This is a 510(k) submission based on substantial equivalence, not a new clinical efficacy study. The "test set" for performance is described as "a range of testing to gather data supporting the safety and performance," including:

• No specific patient sample size is mentioned. The comparison is largely based on technical specifications and existing cleared devices.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing mentioned appears to be primarily bench testing and engineering validation (e.g., meeting standards like ISO 14971, ISO 13485) rather than patient data.

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

N/A. This is not a study assessing diagnostic accuracy or involving human interpretation of data for ground truth establishment. It's a review of a neurostimulation device for chronic pain based on its technical features and equivalence to previously cleared devices.

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

N/A. Not applicable to a 510(k) submission for a non-AI neurostimulation 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

N/A. This device does not involve AI or human "readers" assessing cases.

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

N/A. This device is not an algorithm or AI system.

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

N/A. Ground truth in the context of diagnostic performance is not relevant here. The "ground truth" for this submission is established through adherence to standards, engineering validation, and comparison to the known safety and efficacy profile of predicate devices.

8. The sample size for the training set

N/A. This is not an AI/ML device that requires a training set.

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

N/A. This is not an AI/ML device that requires a training set.

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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.

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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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 thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation System (also referred to as the "Nalu System") is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu Neurostimulation system incorporates a miniature implanted neurostimulator, powered by an externally worn Therapy Disc device. Similar to the predicate StimQ, 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 System may be implanted following a successful trial period using the Nalu Neurostimulation trial system.

The Nalu Neurostimulation System is comprised of 5 elements:

1. Nalu Implantable Pulse Generator: The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads to the desired peripheral nerve. The IPG is available in two different implant architectures: an “integrated" system with pre-attached leads and a "ported" system where leads may be attached, via connector ports. In addition, both of these versions are available in single or dual lead configurations. The hermetic IPG housing includes a ceramic enclosure and a feedthrough connected internally to a printed circuit board assembly. Wires leaving the IPG are encapsulated in polyurethane and a silicone over mold forms the final biocompatible surface of the IPG for direct patient tissue contact.
2. Leads: Leads are implantable and are designed to deliver electrical pulses to the peripheral nerve via an array of eight cylindrical electrodes at the distal end. Leads may be integrated with or connected to the IPG. Both Trial and Permanent Implant leads are available for use. The leads use polyurethane insulation with Pt/Ir electrodes. The leads may be secured in place with the Nalu Lead Anchor.
3. Surgical and Trial Tools: Implantation of the Nalu IPG and lead components for Peripheral Nerve Stimulation (PNS) is performed via standard PNS surgical techniques. The desired implant location is accessed via needle placement, followed by lead placement through an introducer. The leads are anchored and the IPG is placed in a subcutaneous pocket. Patient contacting materials include medical grade stainless steel, thermoplastic elastomers, ABS, silicone, and Urethane.
4. Externally worn Therapy Discs: Two types of Therapy Disc are available. One is to be used during the trial phase (Trial Therapy Disc), and one is to be used after permanent IPG implantation (Therapy Disc). Both devices are worn by the patient using one of the Nalu-provided options The Therapy Discs house a rechargeable lithium ion battery, and electronics including a microcontroller running software for therapy control, patient interaction and communication with Nalu's Clinician Programmer and Remote Control devices. The Therapy Disc used to power and command the implant does so wirelessly using Radio Frequency (RF) and is held in place by an adhesive clip applied to the skin or a belt/cuff worn over clothing.
5. Clinician Programmer and Remote Control: A Clinician Programmer Application is provided to configure the Trial Therapy Disc and Therapy Disc devices during surgery and programming. A Patient Remote Control Application is available to provide the patient with a convenient secondary option to control their system in addition to built-in controls on the Therapy Disc. The Clinician Programming Application runs on an Android tablet and communicates over a secure Bluetooth Low Energy link with the Trial Therapy Disc and Therapy Disc devices. The programmer is responsible for configuring the devices to deliver therapy according to clinician defined levels and patient preferences, and for managing patient and session records. The Patient Remote Control Application runs on iOS and Android platforms and offers basic control of the Trial Therapy Disc and Therapy Disc through a secure Bluetooth Low Energy link. The controls include selecting between clinician-defined therapy options (programs), turning stimulation on and off, and managing alerts.

The provided text is a 510(k) premarket notification for the Nalu Neurostimulation System for Peripheral Nerve Stimulation. It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it explicitly states that no clinical performance data was deemed necessary for this submission.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor details about sample sizes, expert ground truth establishment, adjudication, MRMC studies, or standalone algorithm performance, as these were not part of the documented submission process for this device.

The section "5.9. Clinical Performance Data" clearly 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. Note that the predicate device did not need clinical evidence to obtain a determination of substantial equivalence."

Based on the provided document, the device's acceptance was based on non-clinical performance (bench testing, animal studies, and compliance with standards).

Here's a breakdown of what can be extracted from the document regarding the device's safety and effectiveness without clinical data:

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

As no clinical study was performed for this submission, there are no "acceptance criteria" related to a clinical performance study with human subjects, nor "reported device performance" in terms of clinical outcomes. The device's performance was evaluated through non-clinical testing to demonstrate substantial equivalence to predicate devices.

Table: Performance Evaluation based on Non-Clinical Testing and Substantial Equivalence

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

• Test Set (Non-clinical):
  • Animal Study: 6 Nalu Neurostimulation IPGs and Lead systems were implanted. Data provenance is a pre-clinical study conducted by Nalu Medical (presumably in the USA, as it's an FDA submission for a US company). It's a prospective study.
  • Bench Testing: Quantities of devices or components used for electrical, mechanical, biocompatibility, sterilization, and human factors testing are not specified in numerical terms within this document. The provenance is internal testing by Nalu Medical.
• Training Set (Not applicable for this submission method): No training set data is referenced, as this is a 510(k) based on substantial equivalence to predicates, not a de novo clearance requiring clinical studies or algorithmic training data.

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

• Not applicable for clinical ground truth. For the animal study, the "ground truth" was the observed performance of the device in a living model and tissue response, assessed by the study investigators. The qualifications of these experts are not detailed in the document.
• For engineering and performance testing, the ground truth is established by the design specifications, validated test methods, and industry standards, implemented and evaluated by qualified engineers and testers.

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

• Not applicable for clinical studies. For the non-clinical and animal studies, methods like peer review of study protocols, data analysis, and report generation would be in place, but a "2+1" or "3+1" adjudication method typically refers to radiologist consensus in image-based AI studies, which is not relevant here.

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 type of study would be relevant for AI-powered diagnostic devices, which is not the case for this neurostimulation system.

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

• Not applicable. This device is a neurostimulation system, not an AI algorithm for diagnosis or interpretation. Its software controls the device's function, and its performance is evaluated in the context of device operation, not as a standalone diagnostic tool. The software was subject to verification and validation tests as per IEC 62304.

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

• For the animal study: The ground truth was based on direct observation of device performance, surgical usability, stability, tissue response, and lack of complications in the porcine model.
• For bench testing: Ground truth was based on established engineering specifications, validated test methods, and compliance with national and international standards.

8. The sample size for the training set:

• Not applicable. This submission is based on substantial equivalence and non-clinical data, not on an algorithm trained with a specific dataset.

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

• Not applicable. (See point 8).

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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 Neurostimulation system (also referred to as the "Nalu System") 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. Similar to the predicate Stimwave system, the Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord 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 is comprised of 5 elements: Nalu Implantable Pulse Generator, Leads, Surgical and Trial Tools, Externally worn Therapy Discs, and Programmer, Remote.

This document is a 510(k) premarket notification for the Nalu Neurostimulation System, indicating that clinical performance data was not required for substantial equivalence. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on human clinical data.

The acceptance criteria described in the document relate to non-clinical performance testing (bench testing, biocompatibility, and animal testing) to demonstrate safety and effectiveness relative to a predicate device.

Here's an breakdown of the information requested, based on the provided text:

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

Since no clinical acceptance criteria or performance metrics were provided in the document due to the nature of a 510(k) without clinical studies, I will summarize the general approach to substantial equivalence and the scope of non-clinical testing.

General Acceptance Criteria (Implied for 510(k) clearance): The Nalu Neurostimulation System is substantially equivalent to the predicate device (Stimwave Freedom SCS System K170141) in terms of:

• Intended Use
• Technological Characteristics
• Principles of Operation

Reported Device Performance (Non-Clinical):

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

• Test Set (Non-Clinical):
  • Animal Study: Six Nalu Neurostimulation IPGs and Lead systems were used in a porcine model. This was a prospective animal study. The specific country of origin for the animal study is not mentioned.
  • Bench Testing: The document does not specify exact sample sizes for each bench test (electrical, mechanical, software), but it implies sufficient testing was conducted to meet relevant international standards and guidance documents. This is typically prospective testing conducted in a laboratory setting.
  • Biocompatibility Testing: The number of samples for biocompatibility testing is not specified but would follow established protocols for ISO 10993. This is typically prospective testing.

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 for clinical studies. For the non-clinical tests described:
  • Animal Study: The study was conducted by researchers/veterinary staff, but the "ground truth" was established by direct observation and measurement of device performance, tissue response, and lack of complications in the porcine model. No external experts for ground truth establishment were specifically mentioned in this context.
  • Bench/Biocompatibility/Software Testing: Ground truth is established by engineering specifications, validated test methods, and compliance with recognized standards. Expertise would come from internal design and quality engineers, and potentially third-party testing laboratories, but not in the "expert medical consensus" sense.

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

• Not applicable for clinical studies. For the non-clinical tests described, adjudication methods like 2+1 or 3+1 are not used. Results are based on objective measurements and compliance with predefined specifications and standards.

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 MRMC comparative effectiveness study was done. The document explicitly 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. Note that the predicate device did not need clinical evidence to obtain a determination of substantial equivalence." This is a premarket notification (510(k)) that established substantial equivalence based on non-clinical data, not clinical performance or AI assistance for human readers.

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

• Not applicable. The Nalu Neurostimulation System is an implantable medical device for pain relief, not an AI or imaging diagnostic tool. Therefore, standalone algorithm performance is not relevant to this submission.

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

• Non-Clinical Ground Truth:
  • Bench Testing: Engineering specifications, validated test methods, and compliance with national and international standards (e.g., ISO 14708, IEC 60601 series, ISO 11135, CISPR 11).
  • Biocompatibility Testing: Standards-based evaluation (ISO 10993-1) of material interactions with biological systems.
  • Animal Study: Direct observation of surgical usability, RF communication, device stability, and histopathological tissue response in the porcine model, as interpreted by veterinary and scientific experts.

8. The sample size for the training set

• Not applicable. This device is hardware for neurostimulation, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As stated above, this device does not use an AI/ML algorithm with a training set.

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