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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 fascia or interspinous/supraspinous 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.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device efficacy:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a 510(k) submission for the SandShark Injectable Anchor (SIA) System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials with defined acceptance criteria for efficacy. Therefore, explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or outcomes improvements are not present in this document.

Instead, the acceptance criteria are implicit in matching the predicate device's characteristics and passing established safety and performance tests.

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

This document describes a premarket notification (510(k)) that focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing efficacy in a patient population.

• Sample Size for Test Set: Not applicable in the context of clinical testing with a "test set" of patients. The "test set" here refers to the actual device components and materials subjected to engineering and biocompatibility testing. The document does not specify exact numbers for these components but indicates that "Stimwave completed a number of tests for the SIA System."
• Data Provenance: The testing data is from the manufacturer, Stimwave Technologies Inc. The data is non-clinical performance data and biocompatibility data. It is internal to the company's development and testing process. No country of origin for a patient data set is given as a clinical study was not performed.

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

• This is not applicable as the submission did not involve a test set requiring expert ground truth establishment in the clinical sense (e.g., medical image interpretation). The "ground truth" for non-clinical and biocompatibility tests would be defined by the specifications of the test methods and the pass/fail criteria of those standards.

4. Adjudication Method for the Test Set

• Not applicable for this type of submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments. The tests described are objective, pass/fail engineering and biological evaluations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (an injectable anchor system), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance is irrelevant to this submission.

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

• No, a standalone algorithm performance study was not done. This is a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the evaluations performed in this submission are:

• Established industry standards and regulatory guidance: ISO 10993-1:2009 for biocompatibility, AAMI ANSI ISO 14708-3:2008 for physical performance (temperature/pressure changes), and Blue Book Memorandum G95-1.
• Design requirements and specifications: The device was tested to verify that "the performance meets the system design requirements."
• Predicate device characteristics: Substantial equivalence is established by comparing the device's characteristics and performance to the legally marketed predicate device (K172644). The predicate device's established safety and efficacy serve as a form of "ground truth" for equivalence.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI-driven device, so there is no "training set" in that sense.

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

• Not applicable, as there is no training set for this type of device submission.

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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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