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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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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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Model 3273/3274 Receiver and Model 3629/3630 Screener indicated for use for epidural spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS), as an aid in the treatment of chronic intractable pain of the trunk and/or limbs.

Using a commercially available Medtronic Spinal Cord Stimulation Radiofrequency (RF) Transmitter to provide the appropriate RF signal, the Model 3273/3274 Receiver, when connected to a commercially available Medtronic quadrapolar lead, will provide an electrical signal to three (3) of the four electrodes (with no signal, or "open", supplied to the fourth electrode). The Model 3273/3274 Receiver, when connected to a commercially available Medtronic quadrapolar lead, will have the ability to reduce the stimulation (voltage) of one of two electrode anodes (related to the cathode), ranging from the programmed stimulation parameter of the other anode to zero. This will allow the physician and patient to customize or balance the stimulation to optimally control pain. The Model 3629/3630 Screener is connected to the (temporary) percutaneous extension of a commercially available lead and to a commercially available Medtronic Model 3210 Transmitter for the screening period. This is the same procedure used with commercially available Medtronic Model 3627 Screener. The Model 3629/3630 Screener is basically a "receiver in a box" (the same circuitry of the Model 3273/3274 Receiver is used), so that the stimulation parameters and characteristics of the Model 3273/3274 Receiver are replicated by the screener. The Model 3273 or 3274 receiver is implanted subcutaneously, and connected to a quadrapolar stimulation lead. The Model 3629 or 3630 screener is outside the patient, and used for a period of days to deliver pulses from a Model 3210 transmitter to percutaneous wires of a quadrapolar lead.

The provided document, a 510(k) notification for the Medtronic Model 3273/3274 RF Receiver and Model 3629/3630 Screener, focuses on demonstrating substantial equivalence to predicate devices rather than a detailed performance study with explicit acceptance criteria. Therefore, several of the requested sections (e.g., sample size, expert qualifications, adjudication method, MRMC study, ground truth for training) are not applicable or cannot be extracted from this document.

However, based on the information provided, here's a breakdown of what can be inferred and what is not available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states, "Sufficient samples were built and tested with electrical and functional tests." However, it does not specify the numerical sample size used for testing either the Model 3273/3274 Receiver or the Model 3629/3630 Screener.
• Data Provenance: Not explicitly stated. Given it's a 510(k) for a device manufactured by Medtronic, it's highly likely the testing was conducted internally or by a contracted lab, presumably in the USA where Medtronic is based. The data would be prospective as it involves the testing of newly built devices.

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

This information is not applicable and not provided in the document. The document describes engineering and functional tests, not an assessment requiring expert ground truth in the context of diagnostic or interpretive tasks.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used to assess the effectiveness of a diagnostic tool or intervention with and without AI assistance on human readers, which is not the purpose of this 510(k) submission.

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

Yes, in a sense, a standalone assessment was performed. The device's performance was evaluated through electrical and functional tests without human intervention as part of its operational loop. The tests assessed the device's ability to receive signals, deliver electrical pulses, and modulate stimulation as designed.

7. The Type of Ground Truth Used

The "ground truth" for the functional and electrical tests described was based on engineering specifications and design requirements. The devices were tested against their intended functionality (e.g., receiving signals, delivering pulses, modulating voltage to specific ranges) as defined by Medtronic's design and engineering standards for an RF receiver and screener.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. These are hardware devices, not AI algorithms that require a "training set" in the conventional sense. The "training" of the device is its manufacturing process according to design specifications.

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

This information is not applicable and not provided in the document. As stated above, these are hardware devices, not AI models with a training set and associated ground truth.

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