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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 StimQ Peripheral Nerve Stimulator (PNS) 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 StimQ PNS System is not intended to treat pain in the craniofacial region. The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator Receiver Kit. 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 StimQ LLC (StimQ) StimQ Peripheral Nerve Stimulator System (System) is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. The System is comprised of an implantable stimulator (Freedom-8A, Freedom-4A or StimQ), receiver component (Receiver/RF Stylet), and an externally worn transmitter (StimQ Wearable Antenna Gear (SWAG)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for diagnostic or screening devices. Instead, it details a 510(k) premarket notification for a medical device (StimQ Peripheral Nerve Stimulator System) seeking substantial equivalence to legally marketed predicate devices.

The document primarily focuses on demonstrating that the StimQ PNS System is as safe and effective as its predicate devices, leveraging non-clinical performance data and showing identical or similar technological characteristics and materials.

Here's a breakdown based on the information available and what is not present:

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

   • The document does not provide a table of acceptance criteria with corresponding reported device performance metrics in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).
   • Instead, it lists various non-clinical tests conducted (e.g., thermal shock, leakage current, mechanical testing, MRI compatibility, ingress of water, electromagnetic compatibility) against recognized standards (e.g., AAMI ANSI ISO 14708-3, ASTM F2182-11a, IEC 60601-1, IEC 60529, IEC 60601-1-2). The "reported device performance" for these tests is generally stated as "passed all criteria," "complies with design requirements," "no irreversible damage," or "fully functional."
     • Example (from text, not a structured table):
       • Acceptance Criteria (implicit from standard): Protection from temperature change ("functional" / "safe rating" / "no physical damage" / "fully operational").
       • Reported Device Performance: "The Stimulators were functional, receiving a safe rating following post visual inspection and passed the change of temperature testing." and "The SWAG met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational."

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

   • The document does not specify sample sizes for the non-clinical tests in terms of number of devices tested. It refers generally to "all tested paths for all tested samples" or "any stimulator samples" or "all tested stylets in all tested stimulator samples."
   • The data provenance is non-clinical testing, performed by the manufacturer, leveraging data from previously cleared devices (K170141, K152178, K150517, K160600, K162161, K141399). This appears to be retrospective in terms of referencing prior submissions, and laboratory/bench testing rather than patient clinical data.

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 as there is no diagnostic test or image interpretation involved requiring expert ground truth for a test set. The tests are engineering and biological safety assessments.

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

   • This information is not applicable as there is no diagnostic test or image interpretation involved.

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 information is not applicable. The device is an implanted peripheral nerve stimulator for pain management, not an AI-assisted diagnostic tool.

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

   • This information is not applicable. The device is a physical medical device, not an algorithm. Performance testing was done on the device's physical and electrical characteristics.

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

   • For the non-clinical tests, the "ground truth" or reference is adherence to established industry standards and regulatory requirements (e.g., ISO, ASTM, IEC standards) and the product's own design specifications. For biocompatibility, it's ISO 10993-1.

8. The sample size for the training set:

   • This is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

   • This is not applicable as the device is not an AI/ML algorithm that requires a training set.

In summary: The provided document is a 510(k) submission focused on demonstrating substantial equivalence for a medical device by referencing extensive non-clinical testing performed against established standards and leveraging data from previously cleared predicate devices. It does not involve diagnostic performance metrics, clinical studies, or AI/ML components requiring the type of acceptance criteria and study details requested in the prompt.

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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 Stimulator 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.

This submission is based upon the established Stimwave product family offering additional surgical kitting options (Spare Lead Kit and Sterile Revision Kit), updates to the surgical kits (Receiver Kit and Trial Lead Kit) to include new accessory components (Needle, and RF Stylet), a new Wearable Antenna Assembly (WAA) model utilizing a Low Energy (LE) Bluetooth module, a USB battery charger, and upgrades to the WaveCrest Application.

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/or lower limbs including unilateral 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.

The Stimwave Freedom Spinal Cord Stimulator (SCS) System (K162161) sought clearance by demonstrating substantial equivalence to its predicate devices (K160600, K150517, and K141399). Therefore, the acceptance criteria and performance are primarily based on non-clinical testing verifying its components meet design requirements and applicable voluntary standards. There was no clinical testing required or performed for this submission as the device's indications for use and underlying technology were considered equivalent to the already legally marketed predicate devices with established safety and efficacy.

Here's a breakdown of the requested information:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance statistics in a pass/fail format typical for classification. Instead, it describes various performance tests and states that the device "complies" or "passed" the criteria of the respective standards. The acceptance criteria essentially align with the requirements of the listed voluntary standards and the device's design specifications for safety and functionality.

• Materials (Pellethane 55D, Pt-Ir) have extensive record of chronic and carcinogenetic safety.
• WAA is "noncontacting device" and outside the scope of ISO 10993-1:2009 for body contact.
• Conclusion: Meets biological safety and compatibility requirements. |
  | Protection from Temperature Change | AAMI ANSI ISO 14708-3:2008 | - Freedom-8A/4A Stimulator: Functional, safe rating, passed post visual inspection, and passed temperature change testing.
• WAA: Met passing criteria of visual and functional inspections, no physical damage, fully operational. |
  | Atmospheric Pressure Change | AAMI ANSI ISO 14708-3:2008 | - Freedom-8A/4A Stimulator: Functional following post testing functionality inspection, passed atmospheric pressure change testing.
• WAA: Met passing criteria of visual and functional inspections, no physical damage, fully operational. |
  | External Defibrillation Exposure | AAMI ANSI ISO 14708-3:2008 | - Freedom-8A/4A Stimulator and Receiver: Verified as functional after exposure.
• Conclusion: Complies with testing requirements. |
  | Thermal Shock | Applicable Standard (not explicitly named, implies AAMI ANSI ISO 14708-3:2008 context) | - Freedom-8A/4A Stimulator: "No irreversible damage" and fully functional, no physical anomalies present.
• Conclusion: Complies with thermal shock design requirements and applicable standard. |
  | Leakage Current | Applicable Standard (not explicitly named, implies AAMI ANSI ISO 14708-3:2008 context) | - Freedom-8A/4A Stimulator: Produced zero leakage current on all tested paths for all tested samples.
• Conclusion: Complies with leakage design requirements and applicable standard. |
  | Stylet Insertion/Withdrawal Force | Design Specifications | - Stylet within Stimulator: Required less than 2.5N insertion/withdrawal force.
• Receiver within Stimulator: Required less than 2.2N insertion/withdrawal force.
• Visual inspection confirmed no damage to stimulator samples.
• Conclusion: Complies with design specifications. |
  | Mechanical Testing | Design Requirements | - Freedom-8A/4A Stimulator: Passed all criteria of tensile and torsion testing, showing no visible damage to stimulator body or functional damage to components.
• Conclusion: Complies with all stimulator mechanical design requirements. |
  | WAA Robustness (Push, Drop, Impact, Mold Stress Relief) | IEC 60601-1 | - Determined to be robust to withstand expected damage. Met passing criteria of visual and functional inspections, showed no physical damage, fully operational.
• Conclusion: Satisifes design requirements and applicable standard. |
  | WAA Identification, Marking, Documents | IEC 60601-1 | - Analysis of labeling determined compliance with requirements. All requirements and markings clearly identified and viewable.
• Conclusion: Complies with the requirements of the standard. |
  | WAA Means of Protection, Creepage Distances, Air Clearances | IEC 60601-1 | - Analysis of design determined system satisfies requirements.
• Conclusion: Satisfies requirements of the applicable standard. |
  | Ingress of Water | IEC 60529 | - WAA: Met passing criteria of visual and functional inspections, showed no physical damage, fully operational.
• Conclusion: Satisfies design requirements and applicable standard. |
  | Particulate Matter | IEC 60529 | - WAA: Met passing criteria of visual and functional inspections, showed no physical damage, fully operational.
• Conclusion: Satisfies design requirements and applicable standard. |
  | Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | - WAA: Met all acceptance criteria for emissions, low-frequency magnetic fields, immunity, electrostatic discharge, radiated RF electromagnetic fields, electrical fast transients and magnetic fields. Operated within all test limits, showed no physical damage, and fully operational.
• Conclusion: Satisfies the standard. |
  | Software Verification | Design Requirements | - Passed all verification tests outlined.
• Design requirements for Software Verification met. |
  | Overall Compliance | National and International Standards, Design Inputs/Specifications | - Complies with applicable standards for neurostimulators, electrical safety, electromagnetic interference and compatibility, packaging, and sterilization.
• Output meets design inputs and specifications.
• Passed all testing.
• Conclusion: Substantially equivalent to legally marketed predicate devices, and differences do not raise questions of safety and effectiveness. |

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

The document primarily refers to "tested samples" for hardware components and "analysis of labeling" or "analysis of design" for other aspects. Specific sample sizes for each test are not provided. The data provenance is non-clinical, meaning it's from laboratory and engineering testing, not patient data. No country of origin is specified for the testing data itself, but the submission is from a US company (Fort Lauderdale, Florida). It is by nature retrospective since it refers to testing already completed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the submission focuses on non-clinical performance data and engineering verification. The "ground truth" here is adherence to specified voluntary standards (e.g., AAMI ANSI ISO 14708-3:2008, IEC 60601-1, IEC 60529, IEC 60601-1-2) and internal design requirements, rather than expert clinical consensus or patient-derived ground truth.

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

Not applicable. This concept (adjudication for ground truth establishment) is relevant for studies involving human interpretation or clinical data analysis where disagreements need resolution. The tests described are objective engineering and laboratory tests against predefined criteria.

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, a multi-reader multi-case comparative effectiveness study was not done. This device is a spinal cord stimulator, not an AI-assisted diagnostic or imaging system. The submission explicitly states: "There was no clinical testing required to support the medical device, as the indications for use are equivalent to the legally marketed predicate devices." and "There was no clinical testing performed on this device since performance testing demonstrated similar performance as the legally marketed predicate devices."

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

Not applicable. The device is a medical implant system; it does not involve an algorithm performing a standalone diagnostic or interpretative task. The "software" mentioned (WaveCrest Application) is for controlling the stimulator parameters, not for standalone diagnostic performance.

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

The "ground truth" in this context is the predefined requirements from voluntary international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety, AAMI ANSI ISO 14708-3 for active implantable medical devices) and the device's internal engineering design specifications. The compliance with these standards and specifications serves as the basis for demonstrating safety and effectiveness for substantial equivalence.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning or AI model that requires a training set.

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

Not applicable. As there is no AI/ML component requiring a training set, the concept of establishing ground truth for a training set does not apply.

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