(75 days)
Not Found
No
The description focuses on electromagnetic tracking and data processing, with no mention of AI or ML techniques.
No
The device is described as a "motion measuring device" that "tracks, quantifies, displays and documents the motion of the spine." Its purpose is to measure and monitor movement, not to treat or therapeutically intervene.
No
The device is described as a "motion measuring device" that "tracks, quantifies, displays and documents the motion of the spine." While it measures spinal movement, it does not state that it is used for diagnosing medical conditions or diseases. Instead, it measures and monitors motion, which is a key characteristic of a measurement or monitoring device rather than a diagnostic one.
No
The device description explicitly mentions hardware components: a transmitter, passive receivers, and a PC computer. While software is used to process the data, the system relies on physical hardware for data acquisition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to measure and analyze the motion of the human spine. This is a physical measurement of the body, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device uses electromagnetic tracking to measure the position and orientation of receivers placed on the body. This is a physical measurement technique, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
The device is a motion analysis system used to assess the physical movement of the spine. This falls under the category of medical devices used for physical assessment and monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
3D-SPINE has the same intended use as a predicate device called the CA-6000 Spine Motion Analyzer. 3D-SPINE however, uses a different technological methodology to achieve the same results as the CA-6000. The technology used in the 3D-SPINE is the same as that used in a second predicate device called the CP-2000 Compu-Plotter, a 3D contour plotting and data gathering device. 3D-SPINE combines and produces the desired indications of the CA-6000 by using the superior features of the electromagnetic tracking principle used in the CP-2000.
Product codes (comma separated list FDA assigned to the subject device)
89KZF, 87KQX
Device Description
3D-SPINE™ has been developed by Skill Technologies, Inc. as a motion measuring device. 3D-SPINE™ is a real-time three-dimensional motion analysis system that tracks, quantifies, displays and documents the motion of the spine, dynamically, accurately, instantaneously and in three-dimensions. The dynamic tests performed are; extension/flexion, lateral bending and rotation, of the cervical, thoracic, thoracolumbar and lumbar spine.
It has been designed to measure and monitor the three-dimensional angular movement of the human spine. It uses a transmitter to set up a low frequency electromagnetic field, up to a radius of 5 feet from the transmitter. Passive receivers, when brought into range of the transmitter will detect the orientation of the field and the field strength. The receivers will then report x, y and z coordinates, and pitch, yaw and roll angles at a rate of 60 samples per second to a PC computer then displays the information in the form of 3D models of the head and spine and the anqular data in the form of graphs and tables.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical, thoracic, thoracolumbar and lumbar spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
All software was tested at unit levels, incremental integrational levels. The design of the 3D-SPINE is to test the dynamic range of motion of the Cervical, Lumbar, Thoracic and Thoracolumbar spine. Test procedures and requirements were defined using the AMA guidelines as outlined in the American Medical Association -- Guides to the Evaluation of Permanent Impairment, Version 4.0 guide.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The document, "Validation of the 3D-SPINE Motion Analysis System for the Spine" confirmed that the system produces reliable and accurate measurements of the head during three cervical spine tests. The calculation methodologies used in the 3D-SPINE system are provided and verified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.1500 Goniometer.
(a)
Identification. A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.(b)
Classification. (1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.(2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of:
(i) The performance standard under part 898 of this chapter, and
(ii) The guidance entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.
0
3 1998 SEP
SKILL TECHNOLOGIES, INC.
Innovative Biomechanics & Motion Capture Systems
1202 E. Maryland Ave., Suite 1G Phoenix, Arizona 85014 USA Telephone (602) 277-7678 & Fax: (602) 277-2326
10 June, 1996
This is a summary of safety and effectiveness information included in the 510(k) Premarket Notification for the 3D-SPINE.
| REGULATORY AUTHORITY: | Safe Medical Devices Act of 1990, 21 CFR 807.92 |
|---|---|
| COMPANY NAME: | Skill Technologies,Inc. |
| 1202 E. Maryland Ave., Suite 1G | |
| Phoenix, Arizona 85014 USA | |
| Telephone (602) 277-7678 & Fax: (602) 277-2326 | |
| COMPANY CONTACT: | Stephen Cheetham |
| Sales and Marketing Manager | |
| ESTABLISHMENT REGISTRATION NUMBER: | [00000000] |
| DEVICE NAME: | 3D-SPINE A REAL-TIME 3D MOTION ANALYSIS SYSTEM FOR THE |
| Spine | |
| TRADE NAME: | 3D-SPINE |
| COMMON NAME: | Motion Analysis System (3D Dynamic Range-Of-Motion, ROM) |
| CLASSIFICATION NAME: | Spine Motion Analyzer. (Medical Device, Medical Examination, |
| AC Powered) | |
| CLASSIFICATION CODE: | 89KZF 87 KQX |
| SUBSTANTIALLY EQUIVALENT DEVICES: | 1. Orthopedic Systems Inc.'s CA-6000 Spine Motion Analyzer |
- Heustis Machine Inc.'s CP-2000 Compu-Plotter |
DESCRIPTION OF DEVICE:
3D-SPINE™ has been developed by Skill Technologies, Inc. as a motion measuring device. 3D-SPINE™ is a real-time three-dimensional motion analysis system that tracks, quantifies, displays and documents the motion of the spine, dynamically, accurately, instantaneously and in three-dimensions. The dynamic tests performed are; extension/flexion, lateral bending and rotation, of the cervical, thoracic, thoracolumbar and lumbar spine.
It has been designed to measure and monitor the three-dimensional angular movement of the human spine. It uses a transmitter to set up a low frequency electromagnetic field, up to a radius of 5 feet from the transmitter. Passive receivers, when brought into range of the transmitter will detect the orientation of the field and the field strength. The receivers will then report x, y and z coordinates, and pitch, yaw and roll angles at a rate of 60 samples per second to a PC computer then displays the information in the form of 3D models of the head and spine and the anqular data in the form of graphs
1
and tables.
Contraindications and Cautions. The patient being tested should have no metal fittings, plate, braces or pins, whether cutaneous or subcutaneous. These could affect the measurements. Additional warnings can be found in the Users Manual and the MCU Label attached to the top of the MCU.
INTENDED USE OF DEVICE:
3D-SPINE has the same intended use as a predicate device called the CA-6000 Spine Motion Analyzer. 3D-SPINE however, uses a different technological methodology to achieve the same results as the CA-6000. The technology used in the 3D-SPINE is the same as that used in a second predicate device called the CP-2000 Compu-Plotter, a 3D contour plotting and data gathering device. 3D-SPINE combines and produces the desired indications of the CA-6000 by using the superior features of the electromagnetic tracking principle used in the CP-2000.
SYSTEM ELEMENTS:
3D-SPINE (2 Sensor) Hardware Module Includes; Motion Capture Unit Includes; One Transmitter, One Passive 6DOF Receiver/Sensor, Additional Passive 6DOF Sensor, Adjustable Transmitter Support Stand, Adhesive Tape - Packet (Sensor Unit Attachment Tape), Head Sensor Support Strap, User's Manual, PC Computer - Pentium, 100MHz, (Minimum.), Isolation Transformer -- Medical Grade, and Color Ink Jet Printer.
The following items need assembly; The Transmitter Support Stand, the MCU transmitter must be attached to the Transmitter Support Stand, the sensors must be attached to the MCU must be attached to the PC computer. Both the PC computer and the MCU must be plugged in to the Isolation transformer. These assembly steps plus diagrams are listed in the Users Manual. The Adhesive Tape and the Head Sensor Support Strap must be attached to the patient when testing.
INSTRUMENTATION:
There are no system special or standard industry instruments necessary for proper use of this device
PACKAGING:
Each 3D-SPINE system will be shipped in 6 boxes:
| BOX | ITEM | PACKAGING |
|---|---|---|
| 1 | PC computer | Original Manufacturers Box |
| 2 | Monitor | Original Manufacturers Box |
| 3 | MCU (including the transmitter and sensors) | Original Manufacturers Box |
| 4 | Color Ink Jet Printer | Original Manufacturers Box |
| 5 | Transmitter Stand poles | Skill Technologies, Inc. |
| Custom Tube | ||
| 6 | Transmitter Support Stand base and | |
| transmitter plate and Users Manual | Skill Technologies, Inc. | |
| Custom Box |
The items shipped in the original boxes follow the industry standard of shipping computer items. The 3D-SPINE custom tube and box provide sufficient size and packing to prevent damage during shipping.
STERILIZATION/RE-STERILIZATION:
2
There is no sterilization or re-sterilization necessary for this device.
TESTING:
All software was tested at unit levels, incremental integrational levels. The design of the 3D-SPINE is to test the dynamic range of motion of the Cervical, Lumbar, Thoracic and Thoracolumbar spine. Test procedures and requirements were defined using the AMA guidelines as outlined in the American Medical Association -- Guides to the Evaluation of Permanent Impairment, Version 4.0 guide. The document, "Validation of the 3D-SPINE Motion Analysis System for the Spine" confirmed that the system produces reliable and accurate measurements of the head during three cervical spine tests. The calculation methodologies used in the 3D-SPINE system are provided and verified.
EQUIVALENCE:
Skill Technologies, Inc's 3D-SPINE System is a combination of two currently marketed predicate devices:
-
- CA-6000 Spine Motion Analyzer with EMG -- Computerized Anatometry Series
The following table summarizes the 3D-SPINE system compared to the CA-6000 Spine Motion Analyzer.
- CA-6000 Spine Motion Analyzer with EMG -- Computerized Anatometry Series
| PARAMETERS | 3D-SPINE | CA-6000 | SUBSTANTIAL
EQUIV. |
|------------------------------------------------------------------|----------|---------|-----------------------|
| 6 Degrees of freedom of testing for the spine. | Yes | Yes | Yes |
| Provides Real-time data acquisition | Yes | Yes | Yes |
| Range of Motion (ROM) tests (Cervical, Lumbar, and
Thoracic). | Yes | Yes | Yes |
| Real time display of motion as it occurs. | Yes | Yes | Yes |
| Provides progressive testing data for patients. | Yes | Yes | Yes |
| Compares test results to the AMA ROM Guidelines. | Yes | Yes | Yes |
| Data stored in ASCII format for ease of export. | Yes | Yes | Yes |
| Software driven. | Yes | Yes | Yes |
| Custom reports containing text, tables and graphs. | Yes | No | Yes |
| Standard reports containing text, tables and graphs. | Yes | Yes | Yes |
| Calculates acceleration | No | Yes | N/A |
| Calculates velocity | No | Yes | N/A |
| Provides EMG tracking during testing | No | Yes | N/A |
| Follows AMA Range-of-Motion Standards | Yes | Yes | Yes |
The OSI CA-6000 Spine Motion Analyzer is constructed of two interconnected mechanical linkages, joined together at a vertex. The CA-6000 uses head and body harnesses to attach the ends of each of the two mechanical linkages to the head and spine, respectively. Located at the vertex is an electro-mechanical potentiometer. When the subject wearing the device moves the potentiometer detects the physical change in the angle between the two rigid arms and converts it into an electric current. The amount of current generated by the potentiometer determines the angular change that has taken place.
The 3D-SPINE requires that a small passive receiver/sensor be attached to the forehead, using a neoprene head strap, and a second sensor attached at other specified spinal locations, using doublesided adhesive tape. The relative motion of the two sensors, as detected by the change in the field strength and orientation of the magnetic field lines, is compared and the resulting angular changes recorded.
77
3
adhered to throughout the entire phase of development. These procedure helped to assure that the 3D-SPINE is as safe and effective and substantially equivalent to the CA-6000 Spine Motion Analyzer and the CP-2000 Compu-Plotter. Quality assurance procedures will be continued and maintained with the distribution of the 3D-SPINE.
The 3D-SPINE meets the following standards; UL, ACGIH, AAMI, NFPA.
Stephen Cheatham
Date: 14, June 1996
ﺴ ، ﺳﻌﻪ
Stephen Chectham Sales and Marketing Manager