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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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