(213 days)
No
The description focuses on measuring and displaying force rebound data as a histogram for the chiropractor to interpret. There is no mention of the device itself performing analysis or making decisions based on the data using AI/ML algorithms. The analysis and adjustment decisions are explicitly stated as being made by the chiropractor based on their education and training.
Yes
The device is described as an "additional analysis tool" to help identify areas for "mechanical adjustments to the human spine" and also as an "adjusting tool" to apply forces for a "chiropractic adjustment." These functions indicate the device is intended for therapeutic purposes.
Yes
The device helps chiropractors "identify areas of fixation and/or subluxation of the human spine" and allows them to "view a 'map' of the dissipation and rebound of an application of a measured amount of force into the back of the patient." This information assists in determining where "an adjustive force should be applied," indicating its role in diagnosis or assessment.
No
The device description explicitly states that the Smart Adjuster consists of three distinct units, including a hardware part that functions as a control unit for a hand-held transducer unit. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Smart Adjuster interacts directly with the human body by applying and measuring force on the spine. It analyzes the mechanical response of the spine and surrounding tissues.
- Intended Use: The intended use is to help chiropractors identify areas of fixation and/or subluxation of the human spine and to perform mechanical adjustments. This is a physical interaction with the patient, not an analysis of a biological specimen.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics. It is a physical therapy/adjustment device with an analytical component based on mechanical force, not biological samples.
N/A
Intended Use / Indications for Use
This device will be used by chiropractors to as an additional analysis tool to help identify areas of fixation and/or subluxation of the human spine. Additionally, it will allow the doctors to perform mechanical adjustments to the human spine.
Product codes
Unclassified
Device Description
The Smart Adjuster is a device that is equivalent to the Force Recording and Analysis System (FRAS), 510(k) Number K940085. Below is a list of similarities and differences between the two devices. Both devices are designed to measure force rebound, display results and perform mechanical adjustments to the human spine. These types of adjustments are performed by chiropractors.
The Smart Adjuster consists of three distinct units. The first is a computer with software that controls the displays and settings of the hardware portion of the system. The hardware part of the system functions as a control unit for the hand help transducer unit. The transducer unit (head) is used by the doctor to sample the reaction of the spine and overlaying tissue to the introduction of a measured percussive force, The reaction at the site of the percussion is recorded as a rebound force. That is, part of the percussive force is absorbed and dissipated by the patient's body and part of the force is rebounded to the point of entry back to the transducer. The difference is calculated and the rebound force is recorded and displayed as a single bar component of a histogram of several contract points over the patient's back coincident with the anatomical location of the vertebral segments. This allows the doctor to view a "map" of the dissipation and rebound of an application of a measured amount of force into the back of the patient.
The chiropractor, by virtue of education and training, can determine if and where an adjustive force should be applied to the patient in order to facilitate a "chiropractic adjustment" of the patient's spine. The force can be applied with the Smart Adjuster or by any other means normally available and used by chiropractors. When using the Smart Adjuster as an adjusting tool, the chiropractor may select a measured force, up to 35 pounds, and apply that force to a very specific location, determined by education and experience, on the patient. When the "adjustment phase" of the treatment is completed, the chiropractor precisely repeats the analysis phase. This device will again record and display the results and will then compare the results, as duplicate histograms, so the pre-adjustment and post-adjustment results may be observed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
chiropractors
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Premarket Notification [510(k)] Summary
Date: September 7, 1996
JAN | 0 1997
Tamas Becse c/o Sigma Co. 175 William Pitt Way Pittsburgh, PA 15238
Phone: (412) 826-3456 Fax: (412) 826-5009
Contact Person: Tamas Becse
Trade Name: Smart Adjuster Common Name: Chiropractic Adjusting Unit Classification name: Unclassified
Equivalent Device:
Force Recording and Adjusting System (FRAS). 510(k) Number K940085. Marketed by Sense Technology, Inc.
Description of the Device:
The Smart Adjuster is a device that is equivalent to the Force Recording and Analysis System (FRAS), 510(k) Number K940085. Below is a list of similarities and differences between the two devices. Both devices are designed to measure force rebound, display results and perform mechanical adjustments to the human spine. These types of adjustments are performed by chiropractors.
The Smart Adjuster consists of three distinct units. The first is a computer with software that controls the displays and settings of the hardware portion of the system. The hardware part of the system functions as a control unit for the hand help transducer unit. The transducer unit (head) is used by the doctor to sample the reaction of the spine and overlaying tissue to the introduction of a measured percussive force, The reaction at the site of the percussion is recorded as a rebound force. That is, part of the percussive force is absorbed and dissipated by the patient's body and part of the force is rebounded to the point of entry back to the transducer. The difference is calculated and the rebound force is recorded and displayed as a single bar component of a histogram of several contract points over the patient's back coincident with the anatomical location of the vertebral segments. This allows the doctor to view a "map" of the dissipation and rebound of an application of a measured amount of force into the back of the patient.
The chiropractor, by virtue of education and training, can determine if and where an adjustive force should be applied to the patient in order to facilitate a "chiropractic adjustment" of the patient's spine. The force can be applied with the Smart Adjuster or by any other means normally available and used by chiropractors. When using the Smart Adjuster as an adjusting tool, the chiropractor may select a measured force, up to 35 pounds, and apply that force to a very specific location, determined by education and experience, on the patient. When the "adjustment phase" of the treatment is completed, the chiropractor precisely repeats the analysis phase. This device will again record and display the results and will then compare the results, as duplicate histograms, so the pre-adjustment and post-adjustment results may be observed.
1
Premarket Notification [510(k)] Summary Cont.
Intended Use of the Device:
- 1994
This device will be used by chiropractors to as an additional analysis tool to help identify areas of fixation and/or subluxation of the human spine. Additionally, it will allow the doctors to perform mechanical adjustments to the human spine.
Comparison to Existing Device:
Please see ATTACHMENT B and TABLE B provided in the original submission and the amendments provided in this correspondence.
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