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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 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 SandShark Injectable Anchor (SIA) System is intended to be an accessory to the stimulator component of the Stimwave Freedom Spinal Cord Stimulator (SCS) System to secure the stimulator to the fascia or interspinous/supra-spinous ligament.

The Stimwave Technologies Incorporated (Stimwave) SandShark Injectable Anchor (SIA) System is used to fixate the Stimwave Freedom Stimulator to surrounding tissue. The System is comprised of a carbothane anchor (SandShark Anchor) that is transferred onto the deployment handle (SandShark Injectroducer) with the Loading Rod and Loading Base. The SIA System is provided sterile. The SandShark Injectroducer is used to deploy the SandShark Anchor onto the Stimulator.

The provided text describes the Stimwave SandShark Injectable Anchor (SIA) System and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria with numerical performance values relevant to AI/ML devices.

The document is a 510(k) summary for a medical device (an anchor system for spinal cord stimulators), not an AI/ML device. Therefore, the questions related to AI/ML performance metrics, sample sizes for AI/ML models, expert ground truth adjudication, MRMC studies, and standalone AI performance are not applicable to the content of this document.

The document focuses on demonstrating substantial equivalence to predicate devices through:

• Intended Use and Technological Characteristics Comparison: Showing that the SIA System has the same intended use and similar technological characteristics as existing legally marketed devices.
• Biocompatibility Data: Confirming that the materials meet biological safety and compatibility requirements (ISO 10993-1:2009).
• Non-Clinical Performance Data: Verifying that the device meets system design requirements and applicable voluntary standards for physical performance (e.g., protection from temperature change, atmospheric pressure change as per AAMI ANSI ISO 14708-3:2008).

Since the device is not an AI/ML system, the requested information in the prompt, which is tailored for AI/ML device evaluations (e.g., sensitivity, specificity, expert ground truth, training/test sets, etc.), cannot be extracted from this document.

Therefore, I am unable to provide a table of acceptance criteria and reported device performance, or details about studies proving device performance with respect to AI/ML metrics, as this information is not present in the provided text.

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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 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 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.

The provided text concerns a 510(k) premarket notification for the Freedom Spinal Cord Stimulator (SCS) System (K170141). This document primarily focuses on demonstrating substantial equivalence to a predicate device (K162161) rather than detailing a study that establishes acceptance criteria and proves the device meets those criteria from scratch.

The submission states: "This submission is identical to K162161, but includes summaries of performance testing to support MR Conditional labeling of the Freedom-8A SCS System. No modifications to the Freedom SCS System of K162161 were made in support of this submission." This indicates that the device's fundamental performance was established in the prior K162161 submission, and K170141 specifically addresses MR Conditional labeling.

Therefore, many of the requested details regarding acceptance criteria for a new study, sample sizes for test sets, expert involvement for ground truth, and adjudication methods are not present in this document as it relies on pre-existing data and a demonstration of substantial equivalence rather than a de novo clinical trial or performance study proving new criteria.

However, based on the information provided, we can extract the types of performance tests conducted and the standards against which the device was evaluated, which serve implicitly as acceptance criteria for demonstrating equivalent performance to the predicate device and for MR Conditional labeling.

Here's an attempt to answer the questions based on the provided text, highlighting where information is absent due to the nature of this 510(k) submission:

Acceptance Criteria and Device Performance (Implicit from Compliance Statements)

The document doesn't explicitly list "acceptance criteria" in a table form with numerical targets and then report performance against them for all aspects. Instead, it states compliance with various standards and successful completion of tests. The "acceptance criteria" are implied by the standards cited and the statement that the device "complies" or "passed" these tests.

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

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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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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 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 (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 (K160600) and its acceptance criteria, relying heavily on substantial equivalence to previously cleared predicate devices (K150517, K141399). Therefore, the "study that proves the device meets the acceptance criteria" largely refers to non-clinical performance data and the demonstration of equivalence to existing devices, rather than a de novo clinical trial.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of "acceptance criteria" with explicit numerical targets and corresponding "reported device performance" in a quantitative way for each criterion. Instead, it describes compliance with design requirements and applicable voluntary standards. The "reported device performance" is generally stated as "passed all criteria," "complies with," or "met the passing criteria."

However, we can infer some criteria and their met status from the non-clinical performance data section:

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

• Sample Size: The document does not specify the exact number of units tested for each non-clinical performance test (e.g., how many stimulators for thermal shock, how many WAAs for drop tests). It uses general terms like "all tested samples," "representative subassemblies," and "all tested paths for all tested samples."
• Data Provenance: The data is entirely non-clinical performance data, meaning it's derived from lab testing and analysis of the device itself.
  • It is not patient data from a specific country or collected retrospectively/prospectively.
  • A significant portion of the testing (e.g., for WAA, environmental performance, mechanical performance, biocompatibility) is "leveraged" from previous 510(k) submissions (K150517 and K141399) because the components or their relevant characteristics remained unchanged. New testing was performed where modifications or new components were introduced (e.g., specific tests for the Receiver).

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

Not applicable. This device's safety and effectiveness were demonstrated through non-clinical performance testing and substantial equivalence, not through a study involving expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

Not applicable. This was not a study requiring adjudication of expert opinions on patient data. The non-clinical tests have objective pass/fail criteria.

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

No. An MRMC study is typically associated with diagnostic imaging devices where human readers interpret medical images. This is a medical implant (spinal cord stimulator) for pain relief, and its submission relies on non-clinical performance and equivalence to predicates, not a comparative effectiveness study with human readers interpreting imaging.

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

In a sense, all the non-clinical performance testing described (environmental, mechanical, electrical safety, EMC, software verification) can be considered "standalone" in that it evaluates the device's inherent performance characteristics without human involvement in its operation/interpretation during the test, other than setting up and monitoring the test itself. There is no "algorithm" in the sense of AI being evaluated here, but rather the electro-mechanical and software functions of the device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance studies is adherence to established engineering specifications, design requirements, and recognized voluntary standards (e.g., AAMI ANSI ISO 14708-3, IEC 60601-1, IEC 60529, IEC 60601-1-2, ISO 10993-1). For biocompatibility, it's the biological response demonstrating no negative impacts as per ISO 10993-1. For the overall submission, the "ground truth" of safety and effectiveness is tied to its substantial equivalence to previously cleared predicate devices for the same intended use.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device that would require such data for its development.

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

Not applicable. No training set was used.

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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 neural stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or lower limbs including unilateral or bilateral pain. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on nerves near the dorsal column of the spine. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator) 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 provided text is a 510(k) summary for the Stimwave Freedom Spinal Cord Stimulator (SCS) System. It details the device, its intended use, and a comparison to predicate devices, but does not contain information about a clinical study with acceptance criteria and device performance results in the format requested.

The document explicitly states in Section 10, "Clinical Performance Data":
"There was no clinical testing required to support the medical device, as the indications for use are equivalent to the legally marketed predicate devices. These types of devices, including the legally marketed predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device."

And in Section 11, "Statement of Substantial Equivalence":
"There was no clinical testing performed on this device since performance testing demonstrated similar performance as the legally marketed predicate devices, and materials for the implanted stimulator are the same as the legally marketed predicate devices."

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, as no clinical study with such data is presented in this document.

The document primarily focuses on non-clinical performance data and substantial equivalence to predicate devices based on:

• Intended Use: Stimulation of spinal cord for chronic, intractable pain of the trunk and/or lower limbs.
• Technological Characteristics & Principles of Operation: Comparison of various parameters like electrode material, stimulator body material, pulse frequency, pulse width, current/voltage regulation, waveform, and power delivery to predicate devices.
• Biocompatibility: Stating that materials remain unchanged from a previously cleared device (K141399) and meet ISO 10993-1:2009 standards.
• Non-Clinical Performance Data: A series of tests demonstrating compliance with various standards (AAMI ANSI ISO 14708-3:2008, IEC 60601-1, IEC 60529, IEC 60601-1-2) for aspects like temperature change, atmospheric pressure, external defibrillation exposure, thermal shock, leakage current, mechanical testing, ingress of water, particulate matter, and electromagnetic compatibility.

Without a clinical study, the acceptance criteria and performance tables, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted from this document.

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The Stimwave Technologies Incorporated 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 pain. The FRT4-A001 device is solely used for trial stimulation (no longer than 30 days) of the permanent FRE4-A001 device.

The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for spinal column neural stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or lower limbs including unilateral or bilateral pain. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on nerves near the dorsal column of the spine. The System is comprised of an implantable stimulator (Freedom-4 Stimulator) 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 Trial Freedom-4 Stimulator.

The document describes the Stimwave Technologies Incorporated Freedom Spinal Cord Stimulator (SCS) System and provides information to support its substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting studies, formatted as requested:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding reported device performance values in a side-by-side format. Instead, it describes compliance with various national and international standards and design requirements through a series of non-clinical tests. The "reported device performance" is generally stated as having "passed," "met the criteria," or being "lower/higher than the allowable limit."

However, a comparison table (Table 5A) is provided that compares the technological characteristics of the Stimwave Freedom SCS System with three predicate devices. This table implicitly defines "acceptance" as being similar to or within the range of these predicate devices for many parameters.

Implicit Acceptance Criteria and Reported Performance (derived from Table 5A and non-clinical testing sections):

Study Details

The document refers to a "submission" rather than a single specific study. The evidence for meeting acceptance criteria is predominantly based on non-clinical performance testing and a comparison to predicate devices.

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

   • Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of device performance, but rather individual components were tested according to various standards. For example, "all tested samples" for leakage current and "all tested stylets in all tested stimulator samples" for insertion/withdrawal. The exact number of units/components tested for each non-clinical test is not specified.
   • Data Provenance: The testing was conducted by Stimwave Technologies Incorporated to verify compliance with national and international standards (AAMI ANSI ISO, ASTM, IEC). The data is prospective in the sense that the testing was performed on the Stimwave Freedom SCS System components specifically for this submission. The "data provenance" regarding the location of testing is not specified, but it's presumed to be within the manufacturer's testing facilities or accredited laboratories.

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

   • This question is not applicable in the typical sense for this submission. The "ground truth" for the non-clinical tests is established by the specific requirements and acceptance criteria of the referenced national and international standards (e.g., ISO, ASTM, IEC). These standards are developed and recognized by expert bodies in their respective fields. No adjudication by specific medical experts for interpreting test results is described; rather, results are objectively compared against predefined numerical or qualitative criteria from the standards.

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

   • "None" in the context of human expert adjudication as this was non-clinical engineering and materials testing against established standards. The review process for the submission at the FDA would involve regulatory experts assessing the manufacturer's presented data against requirements.

4. 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 study was done. This document pertains to a Spinal Cord Stimulator, a medical device that delivers electrical impulses for pain relief, not an imaging or diagnostic AI device that would involve "human readers" or AI assistance in interpretation. The nature of this device does not fit the MRMC study paradigm.

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

   • This question is not applicable. The device is a physical medical implant system, not a standalone algorithm. Its performance is inherent to its design and function, not an AI algorithm.

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

   • The "ground truth" for demonstrating substantial equivalence against legally marketed predicate devices primarily relies on:
     • Standardized Test Methods and Acceptance Criteria: As set by numerous international and national standards (e.g., ISO 10993, AAMI ANSI ISO 14708-3, ASTM F2182-11a, IEC 60601-1) for biocompatibility, safety, and performance.
     • Direct Comparison to Predicate Devices: Explicitly measuring and comparing physical and electrical parameters against established values of legally marketed devices (Table 5A).
     • Design Requirements: Manufacturer-defined design specifications and requirements that the device must meet, often derived from industry best practices and safety considerations.
   • There is no mention of pathology or outcomes data as "ground truth" for this specific 510(k) submission, as it focuses on non-clinical substantial equivalence.

7. The sample size for the training set:

   • This is not applicable. This is not an AI/ML device requiring a training set. The term "training set" is usually associated with machine learning models.

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

   • This is not applicable as there is no training set for this device.

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