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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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