Fine Osteotomy™ is a system intended for open- and closed-wedge 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.

Fine Osteotomy™ disposable instrumentation is 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™ is a system for planning osteotomies of the distal femur and proximal tibia, and for stabilizing the bone with bone screws and a patient-specific bone plate that fits the patient's anatomy " consists of patient-specific surgical planning and instrument guides designed from images of the patient-specific bone plate designed from the patient's images, compression and/or locking bone screws, and class 1 reusable manual instruments. The bone plate is a patient-specific, single-use implant; the surgical planning and instrument guides are patient-specific, 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 osteotomies and implanting hardware to stabilize the resection, 2) as patient specific single use instruments alone for performing osteotomies, and 3) as a 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 and stabilize the bone around the knee that matches the pre-surgical plan using the patient-specific cutting quides and bone planning quides and resection instruments are used alone, Fine Osteotomy™ enables the surgeon to perform an osteotomy around the knee the presurgical plan using the patient-specific cutting guident'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 quide placement of the implants and alignment of bone. The Fine Osteotomy System is provided clean, not sterile to the user.

Materials: Wrought Titanium-6Alum ELI Alloy (Ti6A4V ELJ; ASTM F136-13) for the bone plates and screws, additively manufactured Nylon-12 for patient specific, single use resection guides and models.

AI/ML Overview

This FDA 510(k) summary for the Fine Osteotomy™ system (K240066) explicitly states that the technological characteristics and indications for use of the subject device are identical to its primary predicate device (K231314), with the exception of updates and additions to single-use instrumentation and shelf-life.

Therefore, the document does not contain the detailed information necessary to answer some of the questions regarding acceptance criteria and performance studies, specifically:

A table of acceptance criteria and the reported device performance: This is not provided because substantial equivalence is claimed based on identity to a cleared predicate, not on new performance data demonstrating meeting specific criteria.
Sample sized used for the test set and the data provenance: No new test set data is reported.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Based on the provided text, here is what can be extracted regarding the "study" that proves the device meets acceptance criteria:

The "study" or rather the justification for meeting acceptance criteria is a demonstration of substantial equivalence to a previously cleared predicate device.

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

The document does not provide a table of acceptance criteria and reported device performance in the context of a new clinical or non-clinical performance study. Instead, the device's acceptance is based on its substantial equivalence to a predicate device already on the market.

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

No new test set was used or described for this 510(k). The regulatory submission relies on the substantial equivalence to the predicate device K231314.

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

Not applicable, as no new test set requiring expert ground truth establishment for performance evaluation is described.

4. Adjudication method for the test set

Not applicable, as no new test set is described.

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 comparative effectiveness study is mentioned.

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

No standalone algorithm performance study is mentioned.

7. The type of ground truth used

Not applicable, as no new performance study is described. The acceptance is based on substantial equivalence.

8. The sample size for the training set

Not applicable, as no new algorithm development requiring a training set is described. The device is a patient-specific surgical guide system, not an AI/ML algorithm that identifies or diagnoses.

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

Not applicable.

Summary of "Study" to Prove Acceptance:

The provided document indicates that the Fine Osteotomy™ system (K240066) achieves acceptance (i.e., substantial equivalence to a predicate device) through the following:

Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b)):
- Verification and validation (V&V) activities included:
  - Mechanical Engineering Analysis of updated and new single-use instruments demonstrating no new worst-case scenarios.
  - Modification of Shelf-Life Referential for Fine Osteotomy Systems.

This implies that the key "study" involved analyzing the updated and new single-use instruments (from an engineering perspective) and reassessing the shelf-life, to confirm that these changes do not alter the fundamental safety and effectiveness demonstrated by the predicate device. The performance data for the core technology is implicitly referenced as that of the predicate device (K231314).

Summary

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February 9, 2024

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Bodycad Laboratories Inc. Nadine Adia Regulatory Affairs and Quality Director 2035 rue du Haut-Bord Quebec, G1N 4R7 Canada

Re: K240066 Trade/Device Name: Fine OsteotomyTM Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: PBF, HWC, HRS Dated: November 21, 2023 Received: January 9, 2024

Dear Nadine Adia:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S

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

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240066

Device Name

Fine Osteotomy TM

Indications for Use (Describe)

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.

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510(k) Summary

Prepared on: 2024-01-09

Contact Details		21 CFR 807.92(a)(1)
Applicant Name	Bodycad Laboratories Inc.
Applicant Address	2035 rue du Haut-Bord Quebec G1N 4R7 Canada
Applicant Contact Telephone	4185271388
Applicant Contact	Mrs. Nadine ADIA
Applicant Contact Email	nadia@bodycad.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	Fine Osteotomy™
Common Name	Single/multiple component metallic bone fixation appliances and accessories
Classification Name	Orthopaedic Surgical Planning And Instrument Guides
Regulation Number	21 CFR 888.3030
Product Code(s)	PBF, HRS, HWC

Legally Marketed Predicate Devices		21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K231314	Fine Osteotomy ™™	PBF

Device Description Summary

Materials: Wrought Titanium-6Alum ELI Alloy (Ti6A4V ELJ; ASTM F136-13) for the bone plates and screws, additively manufactured Nylon-12 for patient specific, single use resection guides and models.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(4)

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Fine Osteotomy™ disposable instrumentation is intended to assist in pre-operative planning and/or in quiding 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.

Indications for Use Comparison

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

(Identical)

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

Fine Osteotomy™ is a patient-specific device.

Technological Comparison

The subject device, Fine Osteotomy™, has the same indications for use, is manufactured with the same materials and processes, and has the same technological features as the primary predicate device which is Fine Osteotomy cleared in K2313 14. Except for updates and additions to single use instrumentation and shelf-life, the technological characteristics of the subject and primary predicate devices are identical. Comparison of the technological characteristics and indicated use of the subject and primary predicate devices demonstrate that the subject device is substantially equivalent to the primary predicate device, both of which are Bodycad's Fine Osteotomy.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Verification and validation (V&V) activities included the following:

• Mechanical Engineering Analysis of updated and new single use instruments demonstrated no new worst case scenarios, and

• Modification of Shelf-Life Referential for Fine Osteotomy Systems

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.