Fine Osteotomy is a system intended for osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.

Specifically,

The Fine Osteotomy tibial plates are indicated for open- and closed-wedge osteotomies of the medial tibia, treatment of bone and joint deformities, fractures, non-unions, and malalignment caused by injury or disease, such as osteoarthritis, of the proximal tibia.
The Fine Osteotomy femoral plates are indicated for open- and closed wedge osteotomies of the medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur.
Fine Osteotomy instrument guides are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.

Fine Osteotomy is a patient-specific device.

Device Description

Fine Osteotomy™ for the knee is a system for planning and performing osteotomies of the distal femur and proximal tibia, and for stabilizing the bone with bone screws and a patient-specific bone plate designed to fit the patient's anatomy. Fine Osteotomy™ consists of patient-specific surgical planning and instrument guides designed from long-standing x-ray and computed tomography (CT) images of the patient's bones, a patient-specific bone plate designed from the CT images, compression and/or locking bone screws, and manual reusable instruments. The bone plate is a patient-specific, single-use implant; the patient-specific surgical planning and instrument guides are single-use and discarded after surgery. Fine Osteotomy™ is offered in three configurations: 1) as a system of patient specific implants and single use instruments for performing the osteotomy and implanting hardware to stabilize the resection. 2) as patient specific single use instrumentation for performing an osteotomy alone, and 3) as patient specific bone plate and screws for stabilizing a bone resection or fracture.

When used as a system, Fine Osteotomy™ enables the surgeon to perform an osteotomy and stabilize the bone around the knee that matches the pre-surgical plan via the patient-specific cutting guides and bone plate designed from the patient's CT images. When the planning guides and resection instruments are used alone, Fine Osteotomy™ enables the surgeon to perform an osteotomy the bone around the knee that matches the pre-surgical plan via the patient-specific cutting guides designed from the patient's CT images. When the bone plate and screws are used alone, Fine Osteotomy™ enables the surgeon to stabilize fractured or resected bone per the pre-surgical plan using the patient's CT images in design of the Bodycad plate and use of the bone models intra operatively to guide placement of the implants and alignment of bone.

Materials: Wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6A14V ELI; ASTM F136-13) for the bone plates and screws. ADM Nylon-12 for patient specific resection quides and models.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the "Fine Osteotomy" device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list distinct "acceptance criteria" with numerical targets in the same way a diagnostic AI device might. Instead, it details that pre-clinical performance testing was conducted according to various standards and guidance documents, and the results demonstrated substantial equivalence to predicate and reference devices.

Therefore, the "acceptance criteria" are implicitly defined by compliance with these standards and the achievement of "substantial equivalence." The reported device performance is the affirmation that these criteria were met.

Acceptance Criteria (Implicit)	Reported Device Performance
Material Properties:
Compliance with ASTM F136-13 (Ti6Al4V ELI) for bone plates and screws.	Ti6A14V ELI (ASTM F136-13) used. Conforms.
Compliance with ADM Nylon-12 for patient-specific resection guides and models.	ADM Nylon-12 used. Conforms.
Mechanical Performance:
Compliance with ASTM F543 regarding metallic bone screws and washers.	Testing performed per ASTM F543. Substantial equivalence demonstrated.
Compliance with ISO 5835 (implants for osteosynthesis - screws).	Testing performed per ISO 5835. Substantial equivalence demonstrated.
Compliance with ISO 10664 (wrought titanium alloy for surgical implants).	Testing performed per ISO 10664. Substantial equivalence demonstrated.
Compliance with FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers, Performance Criteria for Safety and Performance Based Pathway".	Testing performed per FDA Guidance. Substantial equivalence demonstrated.
Mechanical bending strength characteristics of worst-case plate relative to minimum section modulus / design.	Evaluation performed using ASTM F382. Substantial equivalence demonstrated.
Biomechanical characteristics of subject devices in simulated HTO model comparable to predicate/reference devices.	Evaluation performed. Substantial equivalence demonstrated.
Software Performance:
Validation and verification of software per FDA guidance documents.	Validation and verification performed. Implies satisfactory performance.
Biocompatibility:
Evaluation of biocompatibility per ISO 10993-1.	Evaluation performed. Conforms.
Reprocessing & Stability:
Validation of reusable instrument reprocessing parameters (cleaning, sterilization).	Validation performed. Implies satisfactory performance.
Validation for dimensional stability of ADM Nylon-12 resection guides.	Validation performed. Implies satisfactory performance.
Validation for particulate debris of ADM Nylon-12 resection guides.	Validation performed. Implies satisfactory performance.
Accuracy of Correction & Implant Position (Cadaver):
Measurement of accuracy of correction and position of implants relative to surgical plan, conventional technique, and reference devices.	Cadaver simulation performed, measurements taken. Substantial equivalence demonstrated.

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

The summary does not provide specific numerical sample sizes for the mechanical testing or cadaver studies. It mentions:

"Evaluation of biomechanical characteristics of subject devices in simulated HTO model"
"Cadaver simulation of use of the Fine Osteotomy system"

The provenance of this data is implicitly from pre-clinical lab testing and cadaver studies, conducted by or for Bodycad Laboratories Inc.

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

This information is not provided in the document. For pre-clinical mechanical and cadaver studies, "ground truth" often refers to measurements against established physical standards or surgical outcomes in a simulated environment, rather than expert consensus on medical images.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes by multiple human readers, often for AI or diagnostic devices. This document describes pre-clinical engineering and cadaver testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The document focuses on pre-clinical performance and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device includes "patient-specific surgical planning and instrument guides designed from long-standing x-ray and computed tomography (CT) images." The summary mentions "Validation and verification of software per FDA guidance documents."

This indicates that the software component (which creates the patient-specific guides and plates) was evaluated in a standalone manner (algorithm only) to ensure it performs according to specifications. However, no specific performance metrics for the standalone algorithm (e.g., accuracy of measurement extraction, segmentation accuracy) are provided in this summary. The "acceptance criteria" for the software are broadly stated as "validation and verification per FDA guidance documents."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the pre-clinical studies, the "ground truth" would be established by:

Engineering Specifications/Standards: For mechanical testing (e.g., ASTM, ISO standards).
Physical Measurements: In the cadaver study, the "accuracy of correction and position of implants" would be measured directly against the pre-surgical plan and possibly conventional surgical outcomes, serving as the ground truth.
Design Specifications: For the software, the ground truth would be the intended design output when processing CT images (e.g., correct anatomical measurements, precise guide designs).

8. The Sample Size for the Training Set

This information is not provided and is likely not applicable in the traditional sense. The device is not learning from a "training set" of medical images for diagnostic purposes. Instead, the software is programmed based on algorithms to generate patient-specific designs from individual CT images. If any "training" occurred, it would be in the development and refinement of the design algorithms, not in the context of a machine learning training set for diagnostic output.

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

As above, this information is not provided and likely not applicable as there's no mention of a traditional machine learning "training set" for diagnostic classification. The software's "ground truth" would be its ability to accurately translate CT image data into precise, patient-specific surgical plans, instrument guides, and implant designs according to engineering and anatomical principles. This would be established through internal design validation and verification processes.

Summary

{0}------------------------------------------------

March 25, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

Bodycad Laboratories, Inc. % Robert Poggie President BioVera Inc. 65 Promenade Saint Louis Notre-Dame-del-L'Ile-Perrot, J7V 7P2 Canada

Re: K193614

Trade/Device Name: FINE Osteotomy around the knee Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS, HWC, PBF Dated: December 20, 2019 Received: December 26, 2019

Dear Robert Poggie:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K193614

Device Name

Fine OsteotomyTM

Indications for Use (Describe)

Specifically,

The Fine Osteotomy tibial plates are indicated for open- and closed-wedge osteotomies of the medial tibia, treatment of bone and joint deformities, fractures, non-unions, and malalignment caused by injury or disease, such as osteoarthritis, of the proximal tibia.
The Fine Osteotomy femoral plates are indicated for open- and closed wedge osteotomies of the medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur.
Fine Osteotomy instrument guides are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.

Fine Osteotomy is a patient-specific device.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K193614

510(k) SUMMARY – Fine Osteotomy™

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of Fine Osteotomy™.

A. SUBMITTERS INFORMATION

Submitter Name:	BioVera, Inc.
Submitter Address:	65 Promenade Saint-Louis, Notre-Dame-De-L'lle-Perrot, Quebec,J7V 7P2, CANADA
Contact Person:	Robert A Poggie, PhD
Phone Number:	(514) 901-0796
Fax Number:	(514) 901-0796
Date of Submission:	December 20, 2019

B. DEVICE IDENTIFICATION & MANUFACTURER

Manufacturer Name:	Bodycad Laboratories Inc.
Manufacturer Address:	2035 rue du Haut-Bord, Quebec, Quebec, G1N 4R7, Canada
Registration Number:	3012086398
Contact Name:	Guy Sevigny
Title:	Director, Regulatory Affairs
Device Trade Name:	Fine Osteotomy™
Device Common Name:	Plate, fixation, bone. Screw, fixation, bone.
Classification Name:	Plate, Fixation, Bone; screw, fixation, bone; Single/multiplecomponent metallic bone fixation appliances and accessories;Orthopaedic surgical planning and instruments guide
Classification Code:	HRS, HWC, and PBF – Class II
Classification Panel:	Orthopedic

C1. PREDICATE DEVICES

Primary Predicate Device
K081353	SYNTHES TOMOFIX MEDIAL DISTAL FEMUR PLATES

Predicate Devices
K023941	SYNTHES TOMOFIX Osteotomy System
K183011	Additive Orthopaedics Patient Specific 3D Locking Lattice Plates
K132290	MATERIALISE - Surgicase orthopaedics system, surgicaseconnect, surgicase guides

Page 1 of 4.

{4}------------------------------------------------

C2. REFERENCE DEVICES

K014155	Arthrex - Opening Wedge Osteotomy System
K191996	BC Reflex Uni

D. DEVICE DESCRIPTION

Materials: Wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6A14V ELI; ASTM F136-13) for the bone plates and screws. ADM Nylon-12 for patient specific resection quides and models.

E. INTENDED USE

Fine Osteotomy™ is a system intended for osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.

Specifically,

The Fine Osteotomy™ tibial plates are indicated for open- and closed-wedge osteotomies of the medial proximal tibia, treatment of bone and joint deformities, fractures, non-unions, and malalignment caused by injury or disease, such as osteoarthritis, of the proximal tibia.
The Fine Osteotomy™ femoral plates are indicated for open- and closed wedge osteotomies of the medial and lateral distal femur, treatment of bone and joint deformities, fractures, nonunions, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur.

{5}------------------------------------------------

Fine Osteotomy™ instrument guides are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.

Fine Osteotomy™ is a patient-specific device.

F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Fine Osteotomy™ has the same intended use and technological features as the predicate devices K023941, K081353, K183011, and K132290, and reference device K014155. Design features and clinical indications that are common to the subject, predicate, and reference devices include locking and compression cortical bone screws, compression cancellous bone screws, opening wedge for mechanical support of the bone at the ostectorny site, two or more holes superior and inferior to the osteotomy or fracture site, minimum strength for supporting and stabilizing bone during the healing period, patient-specific bone resection guides and models to assist and guide bone resection and for guiding implant placement, patient specific bone plates, and resection instruments and implants for opening and closing wedge osteotomies in the tibia and femur. Fine Osteotomy™ implants, single use instruments, and reusable instruments are provided to the user clean, and not sterile. Bodycad has validated cleaning and sterilization of Fine Osteotomy devices. Comparison of the design features with those of the predicate devices demonstrates substantial equivalence for the subject, predicate, and reference devices.

G. PERFORMANCE DATA

Pre-clinical performance testing was performed for the Osteotomy™ System per ASTM and ISO consensus standards, the scientific literature, and pre-submission Q190553. The following list summarizes the performance testing and verification activities.

. Mechanical performance testing, design, and criteria for acceptance per ASTM F543, ISO 5835, ISO 10664, and FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers, Performance Criteria for Safety and Performance Based Pathway".
. Mechanical bending strength characteristics of worst case, least strong subject plate device relative to minimum section modulus / design using ASTM F382.
. Evaluation of biomechanical characteristics of subject devices in simulated HTO model, with comparison to predicate and reference devices.
Cadaver simulation of use of the Fine Osteotomy system and measurement of accuracy of correction and position of implants relative to surgical plan, conventional technique, and reference devices.
Validation and verification of software per FDA guidance documents.
. Evaluation of biocompatibility of implants and instruments per ISO 10993-1.
Validation of reusable instrument reprocessing parameters for cleaning and sterilization, ● and for dimensional stability and particulate debris of the ADM Nylon-12 resection guides.

{6}------------------------------------------------

The results of performance testing demonstrated substantial equivalence for Fine Osteotomy subject devices relative to the predicate and reference devices.

H. CONCLUSION

Bodycad's Fine Osteotomy™ System is substantially equivalent to the identified predicate and reference devices based on similarities in indications for use, materials, design, size, technological characteristics, and performance data presented in this 510(k) notification. Fine Osteotomy™ subject components share the same intended uses and are substantially equivalent to the predicate and reference devices identified in this 510(k) notification.

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.