OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization implants, cast, brace).

Device Description

OSSIOfiber® Cannulated Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The OSSIOfiber® Cannulated Trimmable Fixation Nail is a fixation device made of degradable poly (L-lactide-co-D.L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from materials that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Cannulated Trimmable Fixation Nails are cannulated, supplied sterile, for single patient use only, and non-pyrogenic. They are available in several sizes: 10-70 mm long, and 2.80-4.60 mm nominal diameter (core diameter of 2.4-4.00 mm).

The OSSIOfiber® Cannulated Trimmable Fixation Nails are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.

AI/ML Overview

This document describes a medical device clearance rather than a study evaluating device performance against acceptance criteria for an AI/ML powered device. Therefore, much of the requested information regarding AI/ML studies (such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, or standalone performance results) is not applicable or present in this provided text.

Based on the provided text, the device in question is the OSSIOfiber® Cannulated Trimmable Fixation Nail. This device is a bone fixation fastener, not an AI/ML powered medical device. The document is a 510(k) summary, which outlines the substantial equivalence of this new device to legally marketed predicate devices.

Here's the relevant information that can be extracted from the provided text:

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

Since this is a 510(k) submission for a physical medical device and not an AI/ML software, "acceptance criteria" here refers to the performance of the device in mechanical testing compared to a predicate device, rather than diagnostic accuracy metrics typically seen with AI. Specific numeric acceptance criteria are not explicitly stated in the summary, but the general criterion is "at least equivalent performance" to the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Performance: Equivalent or superior flexural bending strength compared to predicate.	Mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation compared to the predicate device (OSSIO® Pin Product Family, K181180).
Mechanical Performance: Equivalent or superior pull-out strength compared to predicate.	Mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation compared to the predicate device (OSSIO® Pin Product Family, K181180).
Mechanical Performance: Equivalent or superior shear strength compared to predicate.	Mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation compared to the predicate device (OSSIO® Pin Product Family, K181180).
Biocompatibility: Meet ISO 10993 standards and be rationally justified.	Biocompatibility was established primarily based on referenced ISO 10993 data from previously cleared predicate and reference devices (K181180, K190652) and a rationale.
Degradation Profile: Characterized in-vitro degradation similar to what is expected for the material.	The in-vitro degradation profile (i.e., change in material properties) was characterized. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies.
Safety and Effectiveness: Demonstrate substantially equivalent safety and effectiveness to the predicate.	Non-clinical testing data demonstrate that the OSSIOfiber® Cannulated Trimmable Fixation Nail has a substantially equivalent safety and effectiveness profile as the predicate device.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified for the mechanical testing mentioned. The data provenance is pre-clinical studies and bench testing. The country of origin for the studies is not specified in this document.
Data Provenance: Pre-clinical studies and in-vitro mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as this is a physical device being evaluated through mechanical and pre-clinical testing, not an AI/ML diagnostic device requiring expert ground truth for image interpretation.

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

Not applicable.

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, an MRMC study was not done as this is not an AI/ML diagnostic device with human readers.

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

Not applicable as this is not an AI/ML algorithm.

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

For the mechanical tests, the "ground truth" would be the measured physical properties (e.g., strength, stiffness) as determined by standardized laboratory methods, compared against the properties of the predicate device.
For biocompatibility, the ground truth is established through adherence to ISO 10993 standards and a rationale.

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

In summary, the provided text details the FDA clearance of a physical medical device based on its substantial equivalence to an existing predicate device, primarily through mechanical and biocompatibility testing, rather than a study for an AI/ML product.

Summary

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January 6, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

OSSIO Ltd. % David McGurl Director, Regulatory Affairs MCRA, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001

Re: K203465

Trade/Device Name: OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: November 24, 2020 Received: November 24, 2020

Dear David McGurl:

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

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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 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 (QS) 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 medical devices and radiation-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,

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K203465

Device Name

OSSIOfiber® Cannulated Trimmable Fixation Nail, OSSIOfiber® Trimmable Fixation Nail, OSSIOfiber® Trimmable Fixation Nail, Cannulated Design

Indications for Use (Describe)

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

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K203465

510(k) SUMMARY

OSSIOfiber® Trimmable Fixation Nail, Cannulated Design

Submitter

Ossio Ltd.

8 HaTochen Street, Caesarea, Israel, 3079861

Phone: +972-4-9986600 Facsimile: +972-4-9986601

Contact Person: Taly Lindner Date Prepared: November 24, 2020

Name of Device: OSSIOfiber® Cannulated Trimmable Fixation Nail, OSSIOfiber® Trimmable Fixation Nail, OSSIOfiber® Trimmable Fixation Nail, Cannulated Design

Common or Usual Name: fixation, pin, smooth

Classification Name: Smooth or threaded metallic bone fixation fastener

Regulatory Class: Class II, 21 C.F.R. § 888.3040

Product Code: HTY

Primary Predicate Device

OSSIO® Pin Product Family (K181180)

Reference Devices

OSSIOfiber® Hammertoe Fixation System (K190652)

OSSIOfiber® Compression Screw (K193660)

Device Description

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The OSSIOfiber® Cannulated Trimmable Fixation Nails are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.

Indications for Use

Summary of Technological Characteristics

The OSSIOfiber® Cannulated Trimmable Fixation Nails have the same intended use, indications for use, material composition, and principles of operation, and similar design characteristics as the predicate device OSSIO® Pin Product Family (K181180) and the reference device OSSIOfiber® Hammertoe Fixation System (K190652).

The OSSIOfiber® Cannulated Trimmable Fixation Nails' material as well as the manufacturing methods are the same as that of the cleared predicate device OSSIO® Pin Product Family (K181180). Both the device and the predicate are supplied sterilized by EtO. Although there are differences with regards to shape and size and cannulation as compared to the predicate, mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation. Any differences between OSSIOfiber® Cannulated Trimmable Fixation Nail and its predicate device do not raise different questions of safety and effectiveness.

Non-Clinical Data

Flexural bending, pull-out, and shear testing were performed to verify the strength and fixation properties of the OSSIOfiber® Cannulated Trimmable Fixation Nail, and to compare them to those of the predicate device (K181180). Testing was done initially and following in-vitro degradation. The invitro degradation profile (i.e., change in material properties) was characterized.

Biocompatibility for the implants was established primarily based on the referenced ISO 10993 data from the previously cleared predicate and reference devices (K181180, K190652) as well as a rationale. A rationale was provided to support the MR safe labeling of the device.

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Conclusions

The OSSIOfiber® Cannulated Trimmable Fixation Nail is substantially equivalent to its predicate device, OSSIO® Pin Product Family (K181180). The OSSIOfiber® Cannulated Trimmable Fixation Nails have the same intended use, indications for use, material composition, and principles of operation, and similar design characteristics as the predicate device OSSIO® Pin Product Family (K181180) and the reference device OSSIOfiber® Hammertoe Fixation System (K190652). The minor differences do not alter the intended surgical use of the device and do not affect its substantial equivalence when used as labeled. Non-clinical testing data demonstrate that the OSSIOfiber® Cannulated Trimmable Fixation Nail has a substantially equivalent safety and effectiveness profile as the predicate device. Thus, the OSSIOfiber® Cannulated Trimmable Fixation Nail is substantially equivalent.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.