Charcot Foot
Avascular necrosis of the talus
Failed total ankle arthroplasty
Trauma (malunited tibial pilon fracture)
Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease
Revision ankle arthrodesis
Neuroarthropathy
Rheumatoid arthritis
Osteoarthritis
Pseudoarthrosis
Post-Traumatic arthrosis
Previously infected arthrosis
Severe end stage degenerative arthritis
Severe defects after tumor resection
Pantalar arthrodesis

Device Description

The Shotel Ankle Arthrodesis Nail System is an implantable intramedullary system of fusion nails, bone screws, a nail cap and a set of instruments for primary ankle fusion. The curved fusion nail has 6 screw holes that can accommodate up to 6 bone screws and is available in seven (7) diameters in two configurations, left and right. The four (4) distal cross locking holes provide the surgeon with either a static or dynamic cross locking hole in alternative 90 degree orientation configurations. The 5mm fixation bone screws are offered in 27 lengths and the nail caps are available in two configurations; standard nail cap length and a plus 5 mm nail cap length affording the surgeon the ability to slightly adjust the final nail assembly length. All three implant components are manufactured from titanium Ti-6Al-4V and are single use only. Components are offered sterile and non-sterile.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Shotel Ankle Arthrodesis Nail System." It describes the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to legally marketed predicate devices.

Here's a breakdown of the requested information based on the provided text, with a strong caveat: This document is a regulatory submission for a medical implant (a nail system), not an AI/software as a medical device (SaMD) or diagnostic imaging device. Therefore, many of the requested elements (like acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or not provided in the context of this type of device.

The "performance data" referred to in this document relates to mechanical and material performance of the implant, not diagnostic accuracy or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for an implantable device)	Reported Device Performance (Summary from submission)
Material: Biocompatibility, appropriate for implant.	Manufactured from titanium Ti-6Al-4V. Pyrogen testing confirmed implants meet 20 EU/device limit.
Mechanical Strength/Durability: Withstand forces during implantation and long-term use for ankle arthrodesis.	All necessary testing (primary stiffness, fusion-site compression, primary bending stiffness, mechanical and fatigue testing) performed in accordance with ASTM F1264.
Design/Functionality: Provide stable fixation for ankle arthrodesis.	System of fusion nails, bone screws, nail cap, and instruments for primary ankle fusion. Curved nail with 6 screw holes, 4 distal cross-locking holes (static/dynamic), available in various diameters and configurations (left/right). 5mm fixation bone screws, nail caps in two configurations for length adjustment.
Sterility: If provided sterile, meets sterility standards.	Components offered sterile and non-sterile. (Implied sterility validation if sterile components are offered).

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

Test Set Sample Size: Not applicable. This is not a study assessing a diagnostic or AI device with a test set of data. The "testing" refers to physical and mechanical evaluation of the implant itself, not evaluation on patient data.
Data Provenance: Not applicable in the context of diagnostic/AI data. The materials and mechanical tests were performed on the device components.

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

Not applicable. Ground truth as typically understood for diagnostic/AI studies (e.g., expert consensus on images, pathology results) is not relevant for this mechanical device submission.

4. Adjudication method for the test set

Not applicable. There is no "test set" in the diagnostic/AI sense to adjudicate.

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

Not applicable. This is not a study involving human readers or AI assistance.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used

Not applicable in the diagnostic/AI sense. The "ground truth" for this device's performance would be established through engineering standards (e.g., ASTM F1264) and measurements comparing the device's physical properties to those standards and predicate devices.

8. The sample size for the training set

Not applicable. There is no training set as understood for AI/machine learning.

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

Not applicable. There is no training set for this device.

Summary

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

September 13, 2017

Biopro, Inc. % Al Memmolo President Convergent Clinical, Inc. 6648 Surf Crest St. Carlsbad, California 92011

Re: K163627

Trade/Device Name: Shotel Ankle Arthrodesis Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: August 10, 2017 Received: August 11, 2017

Dear Al Memmolo:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Vincent J. Devlin -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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017 See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K163627

Device Name Shotel Ankle Arthrodesis Nail System

Indications for Use (Describe)

The Shotel Ankle Arthrodesis Nail System is intended for the following:

Charcot Foot
Avascular necrosis of the talus
Failed total ankle arthroplasty ●
. Trauma (malunited tibial pilon fracture)
Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease
Revision ankle arthrodesis
Neuroarthropathy
Rheumatoid arthritis
Osteoarthritis
Pseudoarthrosis
Post-Traumatic arthrosis
Previously infected arthrosis
Severe end stage degenerative arthritis
Severe defects after tumor resection
o Pantalar arthrodesis

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

[X] Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)

[ ] Over-The-Counter Use (21 CFR 801

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FORM FDA 3881 (8/14)

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Image /page/2/Picture/35 description: The image shows the logo for BIOPRO, which stands for Biologically Oriented Prostheses. Below the logo, the text "Shotel Ankle Arthrodesis Nail System" is displayed. The logo and text are in a simple, professional font.

Premarket Notification 510(k)

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GENERAL INFORMATION

APPLICANT:	BioPro, Inc.2929 Lapeer RoadPort Huron, MI 48060
CONTACT PERSON:	Al MemmoloConvergent Clinical, IncCarlsbad, CA 92011

Date Prepared: August 10, 2017

Device Description

TRADE NAME:	Shotel Ankle Arthrodesis Nail System
COMMON NAME:	Intramedullary Nail
PRODUCT CODE:	HSB - Rod, Fixation, Intramedullary And Accessories
CLASSIFICATION:	Class II – 21 CFR § 888.3020 – Intramedullary Fixation Rod
PREDICATE DEVICES:	Ascension® Ankle Fusion Nail System - K100925Howmedica Osteonics Asnis III Cannulated Screw System (K000080)Nexa Orthopedics Nexa Bone Screw System (K053394)

Product Description

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Image /page/4/Picture/1 description: The image shows the logo for BIOPRO, which stands for Biologically Oriented Prostheses. The logo is in black and white, with the letters "BIO" in white on a black background and the letters "PRO" in black on a white background. The letters are in a bold, sans-serif font. The logo is simple and modern.

INDICATIONS FOR USE

The Shotel Ankle Arthrodesis Nail System is intended for the following:

. Charcot Foot
Avascular necrosis of the talus
. Failed total ankle arthroplasty
Trauma (malunited tibial pilon fracture) ●
. Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease
. Revision ankle arthrodesis
. Neuroarthropathy
Rheumatoid arthritis
. Osteoarthritis
. Pseudoarthrosis
Post-Traumatic arthrosis
. Previously infected arthrosis
Severe end stage degenerative arthritis
. Severe defects after tumor resection
Pantalar arthrodesis

TECHNOLOGICAL CHARACTERISTICS

The Shotel Ankle Arthrodesis Nail System has similar physical and technological characteristics to the predicate devices since all implantable devices are manufactured from the same material and have the same principle of operation; fixation of fractures, fusions, or osteotomies, of bones.

Performance Data

All necessary testing has been performed with the Shotel Ankle Arthrodesis Nail System to assure substantial equivalence to the predicate devices. Testing included primary stiffness, fusion-site compression, primary bending stiffness and mechanical and fatigue testing in accordance with ASTM F1264. Pyrogen testing was performed on the subject implants and it was confirmed that the implants meet the 20 EU/device testing limit.

SUBSTANTIAL EQUIVALENCE

Upon reviewing the technical information provided in this submission and comparing intended use, principle of operation, performance data, and overall technological characteristics, the Shotel Ankle Arthrodesis Nail System is determined to be substantially equivalent to existing legally marketed devices.

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.