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K Number
K112606
Device Name
ACTIVATOR V-E
Manufacturer
ACTIVATOR METHODS INTERNATIONAL LTD.
Date Cleared
2012-03-06

(180 days)

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

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

Device Description

Not Found

AI/ML Overview

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.

N/A