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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 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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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.

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.

Here's a summary of the acceptance criteria and study information for the Stimwave Freedom Spinal Cord Stimulator (SCS) System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific sample size for a "test set" in the traditional sense of a clinical trial or a specific number of devices tested for each non-clinical performance test. Instead, it refers to "all tested samples," "all tested stylets," etc. The studies were non-clinical performance tests conducted in a laboratory setting. There is no information about the country of origin or whether hypothetical "data" was retrospective or prospective, as these are engineering tests.

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

N/A. This was a submission for a medical device where the "ground truth" for non-clinical performance is defined by compliance with established international and national standards (e.g., ISO, ASTM, IEC) and the device's own design specifications. It does not involve human experts establishing ground truth in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where expert consensus is needed to resolve discrepancies in diagnostic interpretations. These were engineering and performance tests against pre-defined criteria.

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

No. The document 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." Therefore, no MRMC comparative effectiveness study was conducted.

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

Yes, in the sense that the performance tests were conducted on the device components (Stimulator, WAA) in a standalone manner against technical specifications and standards. This is not "algorithm only" in the context of AI, but rather the device's engineering performance tests. The device itself is a spinal cord stimulator system, which implants a physical device and involves patient and clinician interaction.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests was defined by:

• International and national standards: AAMI ANSI ISO 14708-3:2008, ASTM F2182-11a, ASTM F2119-07, ASTM F2052-06, ASTM F2213-06, IEC 60601-1, IEC 60529, IEC 60601-1-2.
• Device design requirements and specifications: e.g., leakage current = zero, specific force requirements for stylet insertion/withdrawal, requirements for no visible or functional damage.
• Biocompatibility standards: ISO 10993-1:2009 and Blue Book Memorandum G95-1.

8. The Sample Size for the Training Set

N/A. This submission describes an electromechanical medical device, not an AI/machine learning algorithm that requires a training set.

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

N/A. This is not applicable to the type of device and submission described.

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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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