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The SONIK MONARK 100 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 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 device to deliver precise impulses at a required vector configuration.

The SONIK MONARK 100 (SM-100) device is used for the management of chronic pain due to noncongenital defects. It operates through the delivery of low-frequency impulses onto intact skin. The device converts electrical energy into mechanical energy, which is then transmitted to the patient's tissues through the stylus tip. It employs a mode of action that involves the application of controlled and repeatable low-intensity mechanical impulses to the treatment site. The device can be used in a handheld manner or mounted to a movable arm on a cart.

The FDA 510(k) summary for the SONIK MONARK 100 device does not contain a typical "acceptance criteria and reported device performance" table as one might find for an AI/ML diagnostic device with performance metrics like sensitivity, specificity, or AUC. Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (KKT-M2) by comparing technological characteristics and verifying specific engineering performance aspects.

The "study that proves the device meets the acceptance criteria" is primarily an engineering performance verification rather than a clinical trial with patient outcomes. The acceptance criteria are implicit in the comparison to the predicate device and the successful completion of specific technical tests.

Here's an analysis based on the provided text, addressing your points where information is available:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a direct table of acceptance criteria vs. performance results in the classical sense of diagnostic accuracy. Instead, the acceptance criteria are largely met by demonstrating substantial equivalence to the predicate and by verifying specific operational parameters.

Implicit Acceptance Criteria and Reported Performance:

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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 Spinalight Atlas Percussion Instrument is to be used by a licensed Chiropractor to assist in making a Chiropractic adjustment to the atlas vertebrae. This adjustment is indicated when the doctor believes this bone to be out of alignment.

The Percussion Adjusting Instrument is comprised of a Chiropractic Adjusting Table and a support system with a percussion device, which a Chiropractor positions over his patient to deliver an adjustment to the Atlas Vertebra (C-1). After the doctor positions the patient on the table, he aligns the instrument head so that the stationary stylus is positioned to the Atlas on predetermined vectors. Once this is completed the Chiropractor activates a solenoid contained within the adjusting head which strikes the proximal end of the stationary stylus generating a percussion wave through the stylus into the transverse process of the Atlas Vertebra. The objective is to produce a movement of the Atlas toward its proper alignment under the skull. Any time the patient is being positioned on the table or headpiece the percussion head is placed in the "Safe to Move" position.

Here's a breakdown of the acceptance criteria and study information based on the provided document, addressing each of your points.

Important Note: The document describes a physical medical device (Atlas Percussion Adjusting Instrument), not an AI/software device. Therefore, many of your requested points regarding AI-specific assessments (e.g., ground truth for AI training sets, MRMC studies, AI effect size) are not applicable to this submission. The "acceptance criteria" here refer to the device's functional performance and safety, primarily in comparison to its predicate device.

Device Description

The Atlas Percussion Adjusting Instrument, Model C-1000, is a chiropractic device used by licensed chiropractors to adjust the atlas vertebrae. It consists of a chiropractic adjusting table and a support system with a percussion device. The device is designed to deliver a percussion wave through a stylus to the atlas vertebra to facilitate its movement towards proper alignment.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are framed in terms of demonstrating substantial equivalence to a predicate device (Atlas Adjusting Instrument, Model 8000, K946258) by ensuring the safety and effectiveness are not adversely impacted by the device modifications.

Given the nature of the device, the performance data focuses on demonstrating that modifications made to the new device (C-1000) do not compromise safety or effectiveness compared to the predicate.

Study Details (as applicable to a physical device)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • The document does not specify a "test set" in terms of patient data or a specific number of trials for the performance tests beyond stating "Testing was completed." The tests mentioned are engineering and functional tests on the device itself (e.g., measuring force, acoustic pressure, electrical safety) rather than clinical trials with human subjects for performance evaluation because the modifications were deemed not to impact safety or effectiveness.
   • No information on data provenance (country of origin, retrospective/prospective) is provided, as it's not a clinical study involving aggregated patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This is not an AI/image analysis device that requires expert-established ground truth for a test set. The validation revolves around engineering and functional tests of the physical device.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This is not an AI/image analysis device requiring adjudication for "ground truth."

4. 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 physical medical device, not an AI device. No MRMC study was performed.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable in the context of AI. For this device, the "ground truth" for safety and performance is based on direct physical measurements, engineering standards (e.g., EMC, electrical safety), and functional assessments demonstrating equivalence to the predicate device. The comparison is made against the known safe and effective performance of the predicate.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI model requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This is a physical medical device, not an AI model.

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The VSTAAR is a mechanical device intended to be used by chiropractors, medical doctors and other licensed health care professions for the external analysis and adjustment of the human spinal column, and for soft tissue musculoskeletal mobilization.

The VSTAAR AdjusteR is a mechanical device used by chiropractors, medical and other licensed health care professionals for the external analysis and adjustment of the human spinal column, and for soft tissue and musculoskeletal mobilization. The graphical user interface is mouse driven. All of the screens are easy to find and easy to understand. Navigating from screen to screen is quick and intuitive.

The provided text describes a 510(k) premarket notification for the VSTAAR AdjusteR device, seeking substantial equivalence to existing predicate devices. The submission focuses on non-clinical performance data and electrical safety testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the VSTAAR AdjusteR in terms of performance metrics like sensitivity, specificity, or accuracy, which are common for diagnostic or AI-driven devices. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical testing.

The performance reported is primarily confirmation of meeting design specifications and intended uses, with electrical safety and electromagnetic compatibility being verified against international standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "significant verification and validation testing" and "performance data records". However, it does not specify any sample sizes for a test set, nor does it refer to patient data or its provenance (country of origin, retrospective/prospective). The testing described is non-clinical, focusing on device performance specifications and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the document. The testing described is non-clinical laboratory testing, not human subject or diagnostic performance studies that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. As above, the testing is non-clinical and does not involve subjective assessment requiring adjudication.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The device, VSTAAR AdjusteR, is a mechanical adjusting instrument, not an AI or imaging device that would typically leverage such studies to evaluate human reader improvement with AI assistance. The document is entirely focused on the mechanical and electrical safety/performance of the device itself, not its impact on human diagnostic performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to the VSTAAR AdjusteR as described. The device is a mechanical instrument used by healthcare professionals. It is not an algorithm, nor an AI system capable of "standalone" performance in the sense of a diagnostic or assistive software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance and safety testing, the "ground truth" would be the established engineering specifications, test procedures, and international standards (e.g., IEC 60601-1, IEC 60601-1-2) that the device was tested against. The document does not describe any studies involving expert consensus, pathology, or outcomes data, as these are typically associated with clinical efficacy or diagnostic accuracy studies, which are not detailed here.

8. The sample size for the training set

This information is not applicable and not provided. The VSTAAR AdjusteR is a mechanical device, not a machine learning or AI model, thus it does not have a "training set" in that context.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the reasons stated in point 8.

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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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The Activator V-E is indicated for chiropractic adjustment of the spine and extremities. It is intended for external use only.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "Activator V-E Spinal Adjusting Instrument." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain the kind of information typically associated with a study that proves a device meets acceptance criteria using performance metrics like accuracy, sensitivity, specificity, or F1-score. This type of information is usually found in detailed clinical study reports, scientific publications, or specific sections of a 510(k) submission that describe performance testing.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. It does not necessarily require the presentation of novel clinical performance data demonstrating specific quantitative acceptance criteria in the same way a de novo application or a premarket approval (PMA) might.

Therefore, I cannot extract the requested information from this document. It does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size for test sets or data provenance for performance studies.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for test sets.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. Type of ground truth used for such studies.
8. Sample size or ground truth establishment for a training set (as this is not an AI/ML device document).

The document is purely a regulatory clearance letter acknowledging substantial equivalence based on information submitted previously by the manufacturer, but the letter itself does not detail the specific performance studies.

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MAX is indicated for chiropractic adjustment of the spine and/or extremities. MAX should be used by a licensed health care professional only. Intended for external use only.

MAX is a hand-held chiropractic adjusting instrument that features automatic battery-powered operation instead of manual thrust. The electromechanical instrument uses a plunger-like mechanism to deliver thrust for chiropractic adjustment. The instrument is intended for use by a health care professional licensed by the law of the state in which he or she practices.

The provided text describes a chiropractic adjusting instrument (MAX Adjusting Instrument) and its 510(k) summary for FDA clearance. It does not contain information about acceptance criteria for an AI/ML device, nor does it detail a study proving such a device meets acceptance criteria.

The document is a regulatory submission for a physical medical device, not a software or AI device. Therefore, the questions regarding acceptance criteria, study design for AI, sample sizes (test/training sets), expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI are not applicable and cannot be answered from the provided text.

The "Performance Data" section of the document only states:

| | Performance Data | MAX has four force settings that have been mechanically tested to deliver 75N, 125N, 175N, or 250N per thrust. The lithium-ion rechargeable battery has been tested for safety and performance. |

This indicates mechanical testing of force settings and battery safety/performance, which are standard for physical medical devices and not related to AI model evaluation.

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The Impulse iQ Adjusting Instrument is intended for chiropractic adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities, or for soft-tissue musculoskeletal mobilization by a licensed health care professional only. For external use only.

The Impulse iQ Adjusting Instrument is a hand-held electromechanical chiropractic adjusting instrument. The device has three force settings (low, medium, high), a preload-control indicator light that turns from red to green upon achieving the proper preload, and an internal accelerometer to provide closed-loop feedback controlling thrust pulse rate. The device is only intended for use from a health care professional licensed by the law of the state that he or she practices.

The provided text describes a 510(k) summary for the "Impulse iQ Adjusting Instrument" and the FDA's clearance letter. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, not on providing a detailed clinical study demonstrating the device's efficacy against specific acceptance criteria.

Therefore, the information required to populate most of the requested sections (e.g., acceptance criteria, test set details, ground truth, MRMC study, training set) is not present in the provided text.

Here's what can be extracted based on the given document:

1. A table of acceptance criteria and the reported device performance

Note: The document states "Performance Standards: None known established." This indicates that the device was not evaluated against predefined formal performance standards or acceptance criteria. The performance data provided are descriptive measurements of the device's output.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. The document describes mechanical testing of the device's force and pulse rate, not a study involving a test set of data (e.g., patient data or images).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. Ground truth establishment by experts for a test set is not relevant to the mechanical testing described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. Adjudication methods are not relevant to the mechanical testing described.

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. This device is a chiropractic adjusting instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI assistance is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical chiropractic adjusting instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided. For the mechanical performance data, the "ground truth" would be the direct measurement of force and pulse rate using calibrated equipment, not expert consensus or clinical outcomes.

8. The sample size for the training set

Not applicable/Not provided. This device does not involve machine learning or a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. This device does not involve machine learning or a training set.

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The Activator V is indicated for chiropractic adjustment of the spine and extremities. It is intended for external use only.

The Activator V is a hand-held electromechanical chiropractic adjusting instrument with a plunger-like mechanism that is intended to be used for chiropractic adjustment of the spine and extremities. The device is only intended to be used by a health care professional licensed by the state in which he or she practices. The thrust is provided by battery power rather than manual force. This makes it easier and less tiring for the chiropractor.

Here's a breakdown of the acceptance criteria and study information for the Activator V, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document indicates that the device's performance aligns with the stated acceptance criteria: "The Activator V has been mechanically tested and shown to deliver approximately 75, 125, 175 or 250 N, depending on the selected thrust setting." The rechargeable battery's safety and performance were also confirmed through manufacturer testing.

Study Information

1. Sample size used for the test set and the data provenance: The document does not specify a separate "test set" in the context of clinical data for performance evaluation in humans. The performance data provided is related to mechanical testing of the device itself, not patient outcomes. Therefore, sample size and data provenance for a human test set are not applicable or provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is the physical output of the device (thrust force), established through mechanical testing, not by expert consensus on clinical data.

3. Adjudication method for the test set: Not applicable. As the performance relates to mechanical testing of force output, an adjudication method for a clinical test set is not relevant.

4. 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 device is a chiropractic adjusting instrument; it is not an AI-powered diagnostic or interpretive tool that would involve human "readers" or an MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself performs a standalone function (delivering thrust). The "performance data" provided refers to the mechanical output of the device without human intervention beyond selecting the thrust setting.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the performance claims (thrust delivery) is based on mechanical measurements of force output.

7. The sample size for the training set: Not applicable. The Activator V is a mechanical device, not an AI or algorithmic system that requires a "training set."

8. How the ground truth for the training set was established: Not applicable, as no training set is relevant for this device.

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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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