Post-Traumatic joint contracture which has resulted in loss of range of motion
Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Open and closed fracture fixation
Pseudoarthrosis of long bones
Limb lengthening by epiphyseal or metaphyseal distraction
Correction of bony or soft tissue deformities
Correction of segmental bony or soft tissue defects
Joint arthrodesis
Infected fractures or nonunions

Device Description

The Taylor Spatial Frame Spatialframe.com V5.0 includes a mobile app which is a mobile medical device that aids in the communication between a patient/caregiver and physician. The Taylor Spatial Frame external fixator relies on existing Spatialframe.com software to generate a treatment schedule for limb restoration. The new Taylor Spatial Frame mobile app (iADJUST) will allow the prescribed schedule (currently provided in paper form) to be available and viewable to the patient on a mobile device. Feedback information related to schedule adherence will be available to the physician.

No changes to the hardware of the fixation device will result from the addition of the mobile app. No changes to the treatment schedule or core functionality of Spatialframe.com software will result from the addition of the mobile app.

AI/ML Overview

The provided text describes the Spatialframe.com V5.0 device, which is a mobile app designed to aid in communication between patients/caregivers and physicians regarding limb restoration treatment schedules. It's an extension of the existing Spatialframe.com software.

Based on the provided text, a detailed study proving the device meets acceptance criteria, including specific metrics and performance results, is not present. The submission primarily focuses on establishing "substantial equivalence" of the new mobile app (iADJUST) to its predicate devices.

Here's a breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics in a way that would typically be seen for a new diagnostic or AI-driven device. The key acceptance criterion appears to be "software validation has been documented to ensure that the information displayed on the mobile medical app is accurate."

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy of information displayed on the mobile medical app	"Software validation has been documented to ensure that the information displayed on the mobile medical app is accurate."
No changes to existing treatment software algorithm functionality	"No other changes to the existing treatment software algorithm (spatialframe.com) are included in this submission."
Substantially equivalent to predicate in performance and tech characteristics	"has been fully validated to ensure that it is substantially equivalent to the existing Spatialframe.com software in performance and technological characteristics."

2. Sample size used for the test set and the data provenance

The document does not mention a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The validation described is for the software displaying information, not for a clinical outcome or diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for this device would likely be the correctness of data transfer and display from the existing Spatialframe.com software, not a clinical diagnosis or interpretation by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication method is typically used for clinical endpoints or diagnostic accuracy studies, which are not described here.

5. 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 MRMC study was mentioned. The device is a communication tool for treatment schedules, not a diagnostic or interpretative AI tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a "mobile medical device that aids in the communication...". While it has software, its primary function is to facilitate communication of an existing treatment schedule. A "standalone" performance in the sense of an AI algorithm making independent decisions or interpretations is not described. Its standalone performance would be its ability to accurately display the prescribed schedule.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the software validation appears to be the existing, established treatment schedule generated by the Spatialframe.com software and the correct display of this information on the mobile app. It's about data integrity and display accuracy, not clinical ground truth in the traditional sense.

8. The sample size for the training set

Not applicable. This device is not described as a machine learning or AI model trained on a dataset. It is an application that presents pre-existing treatment schedules.

9. How the ground truth for the training set was established

Not applicable, as no training set for a machine learning model is described.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three overlapping faces.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 20, 2014

Smith and Nephew, Incorporated Mr. Martin Ostmann Regulatory Affairs Specialist II 1450 Brooks Road Memphis, Tennessee 38116

Re: K142520

Trade/Device Name: Spatialframe.com V5.0 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, OSN Dated: October 23, 2014 Received: October 27, 2014

Dear Mr. Ostmann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indications for Use Statement

510(k) Number (if known): K142520

Device Name: Spatialframe.com V5.0

Indications for Use: Smith & Nephew External Fixation Systems

1. Post-Traumatic joint contracture which has resulted in loss of range of motion
1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Open and closed fracture fixation ဒေ
1. Pseudoarthrosis of long bones
1. Limb lengthening by epiphyseal or metaphyseal distraction
Correction of bony or soft tissue deformities 6.
1. Correction of segmental bony or soft tissue defects
1. Joint arthrodesis
Infected fractures or nonunions 9.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _1

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Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	October 22, 2014
Contact Person and Address:	Martin OstmannRegulatory Affairs Specialist IIT 901-399-1809
Name of Device:	Spatialframe.com V5.0
Common Name:	Multilateral fixators and assemblies
Device Classification Name andReference:	21 CFR 888.3030 Single/Multiple component metallic bonefixation appliances and
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	KTT/OSN

Device Description

Indications for Use

1. Post-Traumatic joint contracture which has resulted in loss of range of motion
Fractures and disease which generally may result in joint contractures or loss of 2. range of motion and fractures requiring distraction
1. Open and closed fracture fixation
1. Pseudoarthrosis of long bones
1. Limb lengthening by epiphyseal or metaphyseal distraction
1. Correction of bony or soft tissue deformities
Correction of segmental bony or soft tissue defects 7.
1. Joint arthrodesis
1. Infected fractures or nonunion

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Technological Characteristics

Software validation has been documented to ensure that the information displayed on the mobile medical app is accurate. No other changes to the existing treatment software algorithm (spatialframe.com) are included in this submission.

Substantial Equivalence Information

The proposed mobile device in Spatalframe.com V5.0 is an extension of the existing class II Spatialframe.com software. The new software is intended to be used within the same indications for use; does not make any changes to the fundamental technology of the Taylor Spatial Frame fixation device or Spatialframe.com software; and has been fully validated to ensure that it is substantially equivalent to the existing Spatialframe.com software in performance and technological characteristics. The Taylor Spatial Frame Mobile App does not alter the intended use of the existing medical device. The new mobile app is designed only to make communication of the existing treatment plan more convenient for the patient and caregiver. The Taylor Spatial Frame mobile app is substantially equivalent to the existing Spatialframe.com software.

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	Spatialframe.com version 4.1(Primary Predicate)	K110069	2/8/11
Smith & Nephew, Inc.	Circular Fixation(Reference Predicate)	K093047	9/27/10

Table 1: Substantially Equivalent Predicates to the Taylor Spatial Frame Mobile App

Conclusion

Spatialframe.com V 5.0 is substantially equivalent to the existing Spatialframe.com version 4.1 cleared in K110069, and the Circular Fixation medical device cleared in K093047 in that the indications for use for these devices are identical and the core technological principles for these devices are also equivalent.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.