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K Number
K072519
Device Name
ACTIVATOR V SPINAL ADJUSTING INSTRUMENT
Manufacturer
ACTIVATOR METHODS INTERNATIONAL, LTD.
Date Cleared
2007-10-23

(46 days)

Product Code
LXM
Regulation Number
N/A
Type
Traditional
Panel
PM
Reference & Predicate Devices
K003185,K010851,K023462
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (Thrust Delivery)Reported Device Performance (N)
To deliver approximately 75 N75 N
To deliver approximately 125 N125 N
To deliver approximately 175 N175 N
To deliver approximately 250 N250 N
Rechargeable battery safety and performanceTested for safety and performance by the battery manufacturer.

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.

N/A