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 Story
3D-SPINE is a real-time 3D motion analysis system for measuring spinal range-of-motion (ROM). It utilizes a transmitter to generate a low-frequency electromagnetic field and passive 6-degree-of-freedom (6DOF) receivers attached to the patient's head and spine via adhesive tape or straps. The system detects field orientation and strength to calculate x, y, z coordinates and pitch, yaw, and roll angles at 60 samples per second. Data is processed by a PC to generate 3D models, graphs, and tables comparing patient motion to AMA guidelines. Used in clinical settings to document spinal movement during extension/flexion, lateral bending, and rotation. Healthcare providers use the output to assess spinal impairment and monitor patient progress. The system replaces mechanical linkage-based analyzers with non-contact electromagnetic tracking.
Clinical Evidence
Bench testing only. Validation confirmed the system produces reliable and accurate measurements of head orientation during three cervical spine tests. Testing followed AMA guidelines (Version 4.0). Software was verified at unit, integration, and operational levels. No clinical patient trials were reported.
Technological Characteristics
Electromagnetic tracking system; consists of transmitter, passive 6DOF receivers, and PC. Operates via low-frequency electromagnetic field (5-foot radius). Connectivity: PC-based (Pentium 100MHz). Standards: UL, ACGIH, AAMI, NFPA. No sterilization required.
Indications for Use
Indicated for patients requiring dynamic range-of-motion (ROM) testing of the cervical, thoracic, thoracolumbar, and lumbar spine. Contraindicated for patients with metal fittings, plates, braces, or pins (cutaneous or subcutaneous) due to potential interference with electromagnetic measurements.
Regulatory Classification
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.
Special Controls
*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}
SEP 3 1996
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 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:** 80KZF $7 K.G.X
**SUBSTANTIALLY EQUIVALENT DEVICES:**
1. Orthopedic Systems Inc.’s CA-6000 Spine Motion Analyzer
2. 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. The computer then displays the information in the form of 3D models of the head and spine and the angular data in the form of graphs
8-2
{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 and 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 specific 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 integration levels and operational 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 orientation 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 | 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 double-sided 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.
{3}
8-6
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 Cheetham
Sales and Marketing Manager
Date: 14, June 1996
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
