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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 device can be used as part of a series of steps in the patient. The procedure involves the use of diagnostic imaging that quantifies the misalignment of vertebrae. The treatment is then administered using the KKT device to deliver impulses at a precise vector. Spinalytics is a software application which facilitates treatment using the KKT device.

Spinalytics provides an interface to manage the patient information stored in a central database. Spinalytics facilitates measuring angles and distances of relevant sketal structures in a patient, by providing the practitioner with an interface to mark the position of these structures directly on digitized X-Rays. Spinalytics then calculates standard treatment protocol parameters which can be sent directly to the KKT device. Spinalytics is an optional accessory to the KKT device and does not change the intended use of the device.

Spinalytics Application is an optional software accessory to the KKT device which facilitates the calculation of the treatment parameters, which were previously calculated manually. Qualified personnel may generate, review, verify, approve, print and export the treatment plan prior to patient treatment. Spinalytics Application also communicates directly with the KKT Device to seamlessly enter the treatment parameters into the device. The clinicians may still enter their own parameters in the Spinalytics Application which meet their own treatment and clinical protocols, if they choose.

The Spinalytics Application software is installed on a computer near the KKT Device. It can be installed on any commercial grade PC that meets the minimum hardware and operating system requirements. The computer and the KKT Device communicate over a USB cable.

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly define a table of specific numerical acceptance criteria (e.g., minimum accuracy percentages, sensitivity, specificity) for the Spinalytics software's performance in measuring angles and distances. Instead, the acceptance is broadly stated in terms of meeting software specifications and passing validation.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the test set used in the software verification and validation. It broadly mentions "specific patient/X-ray" data without quantifying the number of patients or X-rays.
• Data Provenance: Not explicitly stated. The nature of the device (measuring angles/distances on X-rays) suggests the data would be X-ray images, but their origin (country, retrospective/prospective collection) is not mentioned.

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

The document does not explicitly state the number of experts used or their qualifications for establishing ground truth for the test set. It mentions that the software facilitates measurements that were "previously calculated manually" or information "inputted by the physician," but it doesn't describe an expert-led ground truth establishment process for the validation.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) used for the test set. The focus is on software verification and validation against design specifications and calculations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not reported or performed. The document states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The evaluation described is essentially a standalone (algorithm only) performance study, focusing on the software's ability to accurately calculate parameters based on user input. The software "facilitates measuring angles and distances" by "providing the practitioner with an interface to mark the position of these structures directly on digitized X-Rays." This means the algorithm's performance is on the calculation after a human marks the points. The validation was conducted to "verify data calculations" and ensure "correct information for a specific patient/X-ray" based on these calculations.

7. Type of Ground Truth Used

The ground truth for the device's performance appears to be expert-defined manual calculations/measurements and established software design specifications. The software is validated to generate "correct information" and "verify data calculations," implying comparison to what would be considered correct through manual analysis or pre-defined rules. The text mentions that the software automates calculations that were "previously calculated manually."

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This is typical for a rule-based or calculation-based software accessory that does not employ machine learning models requiring a specific training phase.

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

Since no training set is mentioned (as the software appears to be calculation-based rather than machine learning), this question is not applicable.

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The KKT-M2 device is to be used in the aid of management of chronic pain due to noncongenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT-M2 device to deliver precise impulses at a required vector configuration.

The KKT device has been developed for the aid in management of chronic pain. More specifically, conditions of chronic pain arising from structural anomalies such as misalianments and muscle imbalances. Conditions of brain stem irritation as a result of musculoskeletal imbalances that may arise from impact. Typical conditions treated include: strains to soft tissue surrounding vertebral column, whiplash injuries to the head and neck, and biomechanical disrelationships of the axial skeleton. This device is not intended to be used in acute situations of pain management. The KKT Device's mode of action consists of low-intensity mechanical impulses applied to the treatment site in a controlled and repeatable manner. The control of the direction (vector), amplitude and duration of the impulses allows for a known, finite, and predetermined amount of force and/or energy to be applied to the treatment site. This control is predetermined and then prescribed by a qualified medical practitioner where the treatment parameters to be correlated with (or derived from) data from X-rays, imaging systems, and physiological length, strength or distance measurements and used for the patient's treatment. The treatment protocol consists of a series of pulses applied to the atlas vertebra. Each pulse consists of a constant 16Hz frequency for approximately 750msec, a frequency sweep of 50 to 80 Hz in steps of 1 Hz for one full cycle each, followed by an extension while a twist is applied through the stepper motor, then a pause for approximately 750msec before the next pulse. The number of pulses can be set by the operator as can the amplitude of the stylus vertical motion and the amount and direction of the rotation. The device consists of a treatment head supported by an electrically actuated stand. Power is supplied through a grounded receptacle to an auto sensing 24VDC power supply. All actuators and controls are powered at 24VDC or lower. The vertical tower is positioned manually by sliding on the base plate and vertical and horizontal adjustment is controlled by redundant momentary switches located on either side of the horizontal arm. The position of the treatment head is set manually using the positioning display on the LCD screen mounted on the horizontal arm. Treatment parameters for duration and intensity are entered using the same screen or automatically through Client Application software. A release mechanism is incorporated into the treatment stylus to prevent excessive pressure being applied to the patient. This mechanism is interlocked through firmware to halt treatment and raise the treatment head when activated.

The provided text does not contain information about specific acceptance criteria for the KKT-M2 device's performance in treating chronic pain, nor does it detail a study that proves the device meets such criteria. Instead, it describes a 510(k) premarket notification for a medical device (KKT-M2) intended to aid in chronic pain management. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (KKT-M1) and adherence to safety and electrical standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note for Table: The document primarily compares the KKT-M2 to its predicate KKT-M1, indicating that performance and principles of operation are similar, with improvements in design and manufacturing. No specific performance study (e.g., a clinical trial demonstrating pain reduction efficacy against a baseline or control) is described with explicit acceptance criteria for chronic pain management and corresponding reported performance. The "reported device performance" in the table above refers to the functional specifications and safety compliance as described for the KKT-M2 itself, indicating it meets its own design parameters and applicable safety standards.

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

The document does not describe a clinical study with a "test set" in the context of evaluating the device's efficacy in patients. It mentions that the device has been tested for safety and effectiveness and that there have been no adverse outcomes reported in over 10,000 KKT treatments. However, this refers to cumulative clinical experience, not a controlled study with a defined patient test set for performance evaluation against specific criteria. Details on data provenance (country of origin, retrospective/prospective) for these 10,000 treatments are not provided in this document.

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

Not applicable. The document does not describe a study that required expert-established 'ground truth' for a test set to prove the device's performance in treating chronic pain. The "diagnostic imaging that qualifies the misalignment between vertebrae" is part of the clinical procedure, not a ground truth establishment for a performance study in this context.

4. Adjudication Method for the Test Set

Not applicable. No clinical study with a test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement with AI vs. Without AI Assistance

Not applicable. This device is a mechanical manipulator, not an AI-driven diagnostic or treatment assistance tool, and no MRMC study is mentioned.

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

Not applicable. This device is a physical treatment device requiring human operation, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the purpose of performance evaluation (e.g., efficacy in chronic pain management), the document does not specify a "ground truth" used in a formal study. The primary focus of this 510(k) submission is substantial equivalence to a predicate device and compliance with safety standards rather than a de novo clinical efficacy study with defined ground truth. The "studies cited above" that "support the efficacy of the treatment" are not detailed or provided within this document. The 10,000 treatments with no adverse outcomes suggest real-world usage, but not a controlled ground-truth study.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would require a ground-truthed training set.

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

Not applicable. As above, this is not an AI/machine learning device.

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