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The KKT device is to be used in the aid of management of chronic pain due to non-congenital defects. The KKT device is to be used as part of a series of steps in the total care of the patient. The device is to be used for the treatment of vertebral motor units which appear to be fixated. The procedure can involve xray analysis that quantifies the lateral and rotational misalignments between the vertebrae. The treatment is then administered using the KKT device to deliver precise impulses at a required vector configuration.

The KKT device provides an integrated treatment system unlike manual manipulation of the upper cervical spine, applying significantly smaller forces than those applied manually. While other handheld devices have been used which employ similar treatment methods, the KKT device provides significant advancement and improvement in moments, the ANT repeatability. The device consists of a display and controller, a force application probe, and a multi-axis adjustable stand. The device is used to apply force, rotation, and vibration to a patient.

The KKT (Khan Kinetic Treatment) Device is a manipulator device intended to aid in the management of chronic pain due to non-congenital defects, specifically for the treatment of fixated vertebral motor units. It aims to deliver precise impulses at a required vector configuration, with the goal of minimizing potential harm compared to manual adjustments. The submission highlights that the device provides significant advancements in positioning, accuracy, and repeatability compared to other handheld devices and manual manipulation.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document states that the details for the reported device performance for these criteria are within the "KKT Device Technical File", which is not included in this extract. Therefore, specific numerical performance metrics are not available here. The document generally concludes the device is "safe and effective".

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

The document does not explicitly mention a specific "test set" in the context of clinical performance data involving human subjects or patient outcomes. The testing described focuses on engineering compliance (Electrical, EMC, Design Verification). Therefore, information regarding sample size, data provenance (country of origin, retrospective/prospective) for a clinical test set is not available in this submission.

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

Since no clinical test set with human subjects or patient data is explicitly detailed, there is no information provided about the number of experts used to establish a ground truth or their qualifications. The submission indicates that the device can be used in conjunction with "x-ray analysis that quantifies the lateral and rotational misalignments between the vertebrae," implying that practitioners (likely chiropractors or medical professionals) would assess these misalignments. However, this is for clinical application, not for a ground truth establishment in a study described in this document.

4. Adjudication Method for the Test Set

As there is no described clinical test set with a need for ground truth establishment by multiple experts, there is no mention of an adjudication method (e.g., 2+1, 3+1, none).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned or summarized in the provided document. The submission focuses on device safety, electrical compliance, and substantial equivalence to a predicate device, rather than comparative clinical effectiveness with human readers.

6. Standalone (Algorithm only without human-in-the loop performance) Study

The KKT device is a physical manipulative device, not an algorithm or AI system in the sense of image analysis or diagnostic support. Therefore, a standalone (algorithm only) performance study is not applicable and not mentioned. The device's operation inherently involves human interaction for patient assessment and device application.

7. Type of Ground Truth Used

For the engineering tests (Electrical, EMC, Design Verification), the "ground truth" would be established by the specifications of the relevant standards (e.g., IEC 60601-1-2 for EMC). However, for clinical effectiveness, no specific ground truth (e.g., pathology, outcomes data) is mentioned in the context of a performance study in this document. The device's use is indicated based on "x-ray analysis that quantifies the lateral and rotational misalignments," implying a diagnostic assessment made by a clinician.

8. Sample Size for the Training Set

Since the KKT device is a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" in the traditional sense is not applicable. Therefore, no sample size for a training set is provided.

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

As the concept of a training set does not apply to this device, there is no information on how its ground truth would be established.

Summary of Device Rationale and Approval:

The 510(k) submission for the Khan Kinetic Treatment Device (KKT-M1) primarily seeks to demonstrate substantial equivalence to an existing legally marketed predicate device, "The Atlas Orthogonal Percussion Instrument (K951217)." The basis for approval appears to be:

• Similar Indications for Use: Both devices are pressure-applying devices for musculoskeletal manipulation.
• Similar Technology/Operating Principles: The KKT device is described as operating on similar principles to other percussion devices but with advancements in "positioning, accuracy and repeatability" and "adjustable, modifiable forces."
• Compliance with Recognized Standards: The device was tested for electrical safety (CSA 601.1, UL 2601/60601-1, IEC 60601.1) and EMC (IEC 60601.1-2, EN55022, EN61000).
• Safety Features: The submission states that "numerous built-in mechanisms have been incorporated into the device to ensure safety" to minimize harm compared to manual adjustments.

The FDA's letter confirms that the device was found substantially equivalent to the predicate device, allowing it to be marketed. The information provided in this document focuses heavily on technical and regulatory compliance rather than extensive clinical performance data or AI model validation details.

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