The OrthoHub External Fixator Software is used with Smith & Nephew Taylor Spatial Frame (TSF) rings and struts for the treatment of traumatic or reconstructive tibia deformities. It is used to generate a prescription of strut adjustments to provide to the patient.

The OrthoHub External Fixator Software is used to assist the clinician in adjusting the Smith & Nephew Taylor Spatial Frame (TSF) External Fixator by creating a patient adjustment schedule. The OrthoHub software receives x-ray images of the deformity and installed fixator hardware and produces a prescription recommending adjustments to the fixator that define a correction path for the deformity. The software is used as an accessory to the commercially available hardware as detailed in the Instructions for Use, specifically, Smith and Nephew's Taylor Spatial Frame rings and struts.

Device Description

The OrthoHub External Fixator Software is a software program used on a Macintosh Computer. The software is used to generate a prescription which details adjustments required for the treatment of traumatic or reconstructive tibia deformities when using the Smith and Nephew Taylor Spatial Frame External Fixator hardware. Users input orthogonal x-ray images of a patient's deformity taken after installation of the fixator hardware on the patient. The software creates a colored graphical representation of the bones and orthopedic fixator hardware shown in the x-rays, and the user adjusts this graphical representation so that it best matches the underlying x-rays. The user then defines a correction rate, and the software generates a prescription of strut adjustments to correct the deformity. This prescription is provided to the patient for strut adjustment during the prescription period.

AI/ML Overview

The provided document, an FDA 510(k) summary for the OrthoHub External Fixator Software, describes the device's intended use and a general verification and validation process. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics in the way requested by the prompt for an AI/CAD-like system (e.g., sensitivity, specificity, FROC analysis).

Based on the available text, here's an attempt to answer the questions, highlighting where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Software performs as intended: The software should accurately generate prescriptions for strut adjustments based on input x-rays and user-defined parameters for treating traumatic or reconstructive tibia deformities using Smith & Nephew Taylor Spatial Frame (TSF) rings and struts.	"Results of the testing confirmed that the software performs as intended.""The software produced recommended adjustments as appropriate for the inputs (patient x-rays) and user entered information (fixator hardware, time for prescription/treatment)."
Substantial Equivalence: The software's function and output should be comparable to the predicate devices (Smith & Nephew Spatialframe V4.1 Web-based Software) in providing recommended adjustments for external hardware.	"Results of performance testing through the bench testing and software verification and validation process demonstrate that the OrthoHub External Fixator Software functions as intended and is substantially equivalent to the predicate devices.""The OrthoHub External Fixator Software has the same intended use and indications and utilizes the same technology as the predicates."

Missing Information: Specific quantitative performance metrics (e.g., accuracy of measurement, deviation from gold standard, success rate of deformity correction) are not provided in this document. The "acceptance criteria" identified are general statements of functionality and equivalence rather than precise, measurable targets.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document mentions "inputs (patient x-rays)" but does not quantify how many cases or patients were used for testing.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It implicitly uses "patient x-rays" which suggests clinical data, but details are absent.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The document refers to "software verification & validation testing" and "mechanical bench top side by side comparison testing," but does not detail how ground truth or performance assessment was adjudicated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC comparative effectiveness study is not indicated as having been done. The document describes "bench testing and software verification and validation process" and comparison to predicate devices, but not a study involving human readers with and without AI assistance to measure improvement.

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

Standalone Performance: Yes, the described "Software Verification & Validation Testing" and "Mechanical Bench Top Side by Side Comparison Testing" evaluate the software's ability to 'produce recommended adjustments as appropriate for the inputs' and 'function as intended'. This implies a standalone evaluation of the algorithm's output, without explicitly detailing a human-in-the-loop component for the testing itself, though the device's ultimate use is to assist the clinician.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated as "ground truth." However, the implicit ground truth for assessing the software's accuracy would likely be:
- Validated anatomical measurements/deformity definitions: For the software to correctly "match the underlying x-rays" and "generate a prescription."
- Engineering/biomechanical principles: Against which the "recommended adjustments" are compared to determine if they are "appropriate."
- Predicate device outputs: The software's output is compared to the outputs of established predicate devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not specified. The document describes the software as performing "mathematical calculations" and creating a "graphical representation" based on user input and x-ray images. It does not suggest the use of machine learning or deep learning that would involve a "training set" in the conventional AI/CAD sense. The software appears to be rule-based or calculation-based, interpreting user inputs (x-rays, fixator hardware, correction rate) rather than learning from a dataset.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable, as there is no indication of a training set for a machine learning model.

Summary of Missing Information:

This 510(k) summary provides a high-level overview focused on establishing substantial equivalence to predicate devices, rather than a detailed performance study typically associated with AI/CAD systems. Key details regarding specific quantitative acceptance criteria, test set sizes, ground truth establishment methodologies (expert qualifications, adjudication), and the use of training data (as would be relevant for machine learning) are not present in this document. The assessment appears to be based on functional verification and validation and a qualitative comparison to existing technology.

Summary

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

August 25, 2014

OrthoHub, Incorporated Ms. Peggy McLaughlin Regulatory Consultant 999 Menlo Oaks Drive Menlo Park, California 94025

Re: K140550

Trade/Device Name: OrthoHub External Fixator Software Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: OSN Dated: July 30, 2014 Received: August 1, 201

Dear Ms. McLaughlin:

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Lori A. Wiggins -S

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

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Indications for Use

510(k) Number (if known) K140550

Device Name OrthoHub External Fixator Software

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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OrthoHub, Inc.

5.0 510(k) Summary

Submitters Name and Address

OrthoHub, Inc. 999 Menlo Oaks Drive Menlo Park CA 94025

Contact Person Peggy McLaughlin Fax: 941 827-8004 Telephone: 650 504-8501 Email: MPMAdvisors@gmail.com

Date Prepared 30 July 2014

Medical Device

Proprietary Name:	OrthoHub External Fixator Software
Common Name:	Orthopedic Software for Treatment
Classification Name:	Software for single/multiple component metallic bonefixation appliances and accessories
Classification Number:	21 CFR Sec. 888.3030
Class:	II
Product Code:	OSN

Predicate Devices

Smith & Nephew, Inc. Spatialframe V4.1 Web-based Software (K110069) Smith & Nephew, Inc. Circular Fixation System (K093047) Smith & Nephew, Inc. Taylor Spatial Frame (K970748) These devices have not been subject to a design-related recall.

No reference devices were used in this submission.

Indications For Use

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Device Description

Intended Use

The intended use of the OrthoHub External Fixator Software is identical to the software component of the predicate devices.

Comparison of the technological characteristics with the predicate device

Both the OrthoHub Software and the predicates are software which, with the input of patient specific measurements or x-ray images, provides recommended adjustments to the external hardware to treat a patient's deformity. The software performs mathematical calculations to provide a prescription for strut adjustment after the Smith & Nephew hardware has been placed on the patient and while the patient is wearing the external hardware to correct a deformity of the tibia.

The following technological differences exist between the subject and predicate devices:

. Use of a Macintosh computer (versus predicate's web-based software run in the cloud)
. Use of x-ray images of patient (versus practitioner's input of measurements from the x-ray images)

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Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Software Verification & Validation Testing

Mechanical Bench Top Side by Side Comparison Testing

Results of the testing confirmed that the software performs as intended. The software produced recommended adjustments as appropriate for the inputs (patient x-rays) and user entered information (fixator hardware, time for prescription/treatment). Results of performance testing through the bench testing and software verification and validation process demonstrate that the OrthoHub External Fixator Software functions as intended and is substantially equivalent to the predicate devices.

Conclusions

The OrthoHub External Fixator Software has the same intended use and indications and utilizes the same technology as the predicates. Performance testing and software verification and validation demonstrate that the OrthoHub External Fixator Software functions as intended. Thus, the OrthoHub External Fixator Software has been shown to be substantially equivalent to the predicate devices.

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.