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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the 3D-SPINE device's acceptance criteria and study information:

Acceptance Criteria and Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a dedicated section with thresholds. Instead, it frames "equivalence" by comparing the 3D-SPINE's features and capabilities to a predicate device, the CA-6000 Spine Motion Analyzer. The primary "acceptance" is implicitly tied to demonstrating substantial equivalence.

Table of Acceptance Criteria (Inferred from Substantial Equivalence Comparison) and Reported Device Performance

Parameter (Inferred Acceptance Criterion)	3D-SPINE Performance (Reported Capability)
6 Degrees of freedom of testing for the spine.	Yes
Provides Real-time data acquisition	Yes
Range of Motion (ROM) tests (Cervical, Lumbar, and Thoracic)	Yes
Real time display of motion as it occurs.	Yes
Provides progressive testing data for patients.	Yes
Compares test results to the AMA ROM Guidelines.	Yes
Data stored in ASCII format for ease of export.	Yes
Software driven.	Yes
Custom reports containing text, tables and graphs.	Yes
Standard reports containing text, tables and graphs.	Yes
Follows AMA Range-of-Motion Standards	Yes
Calculates acceleration	No (Predicate had it, 3D-SPINE does not)
Calculates velocity	No (Predicate had it, 3D-SPINE does not)
Provides EMG tracking during testing	No (Predicate had it, 3D-SPINE does not)

Note: The device is considered substantially equivalent despite not having acceleration, velocity, or EMG tracking, implying these were not "critical" acceptance criteria for this specific substantial equivalence claim, or that its other superior features (electromagnetic tracking) compensated.

Study Information

The document describes a validation study, but much of the specific detail commonly found in clinical studies is not present.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "the system produces reliable and accurate measurements of the head during three cervical spine tests" but does not give the number of subjects or tests.
- Data Provenance: Not explicitly stated (e.g., country of origin). It's implied to be internal testing by Skill Technologies, Inc.
- Retrospective or Prospective: Not explicitly stated, but the nature of testing a new device would typically imply a prospective study for validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not mentioned.
- Qualifications of experts: Not mentioned.
- Adjudication method: Not mentioned (e.g., 2+1, 3+1, none). The text only says "The document, 'Validation of the 3D-SPINE Motion Analysis System for the Spine' confirmed that the system produces reliable and accurate measurements..."
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, an MRMC comparative effectiveness study was not done. This device is a measurement system, not an AI-powered diagnostic tool requiring human interpretation. The study evaluates the device's accuracy in measuring motion, not how humans interact with an AI's output.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The validation described is for the device (algorithm/system) itself in measuring motion. The statement "the system produces reliable and accurate measurements" suggests a standalone evaluation of the device's measurement capabilities.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied Ground Truth: The document states that "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." This suggests that the ground truth for "accurate measurements" would be based on established biomechanical principles and potentially reference measurements or a "gold standard" system, in conformance with these AMA guidelines. However, the exact nature of this "ground truth" (e.g., mechanical jig, another highly accurate sensor) is not specified.
Sample size for the training set:
- Not applicable / Not mentioned. This device is a motion analysis system, not a machine learning model that requires a "training set" in the conventional sense. Its "training" would be more akin to calibration and design validation.
How the ground truth for the training set was established:
- Not applicable / Not mentioned. As this is not a machine learning model, the concept of establishing ground truth for a training set does not apply here. The device's functionality is based on electromagnetic tracking principles and mathematical calculations. "Validation" involved testing its measurement accuracy against pre-defined requirements or potentially a known standard.

Summary

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3 1998 SEP

K962377

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 1GPhoenix, Arizona 85014 USATelephone (602) 277-7678 & Fax: (602) 277-2326
COMPANY CONTACT:	Stephen CheethamSales and Marketing Manager
ESTABLISHMENT REGISTRATION NUMBER:	[00000000]
DEVICE NAME:	3D-SPINE A REAL-TIME 3D MOTION ANALYSIS SYSTEM FOR THESpine
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 Analyzer2. Heustis Machine Inc.'s CP-2000 Compu-Plotter

DESCRIPTION OF DEVICE:

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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:

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 andtransmitter 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:

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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:

1. 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.

PARAMETERS	3D-SPINE	CA-6000	SUBSTANTIALEQUIV.
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, andThoracic).	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.

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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

Regulation Number and Section

§ 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.