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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

Data Provenance:

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

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

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

4. Adjudication method for the test set

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

7. The type of ground truth used

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

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

8. The sample size for the training set

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

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

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

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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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