The KHEIRON System, including patient specific K-ROD, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON System implants are indicated as an adjunct to fusion to treat progresive spinal deformities (i.e. scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the KHEIRON Spinal Fixation System is intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

The system is intended to be used with autograft and/or allograft.

Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

K-RODs are titanium alloys bent rods, available in diameters 5.5mm and 6mm, which shape is a 3D spline designed to meet the need of specific correction of a patient.

K-RODs are to be used as a part of the KHEIRON® Spinal Fixation System (K201659) to reach intended use. KHEIRON® Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The KHEIRON® Spinal Fixation System may be used for a variety of conditions that affect the thoracic and lumbar spine. In cases in which the posterior elements are fractured, the spinal fixation system offers an excellent mean of stabilizing of a specific spinal segment. KHEIRON® Spinal Fixation System includes screws, rods and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailormade. KHEIRON pedicular screws must be used with Ø 5.5mm and Ø 6mm rods.

The K-ROD patient specific devices are available in Ø5.5 and Ø6mm.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device called the KHEIRON® Spinal Fixation System, specifically an extension for patient-specific bent rods called K-RODs.

Based on the provided text, the device in question is a spinal fixation system component (K-ROD), not an AI/software medical device. As such, the typical acceptance criteria and study designs applicable to AI/software performance evaluations (which involve metrics like sensitivity, specificity, AUC, MRMC studies, and ground truth establishment from expert reads or pathology) are not relevant to this submission.

This 510(k) submission focuses on demonstrating substantial equivalence of the new K-ROD (a physical implant) to existing predicate devices. The "acceptance criteria" here refer to mechanical and material performance standards for orthopedic implants, not diagnostic accuracy or clinical effectiveness in the way an AI algorithm would be evaluated.

Therefore, I cannot extract the information required in your request about AI/software performance studies, ground truth, expert consensus, MRMC studies, or training/test set sample sizes, because this type of study was not performed or described in this document.

Here's what can be extracted, based on the document's content, explaining why the requested information regarding AI/software performance is not applicable:

Non-Applicability of AI/Software Performance Criteria:

The KHEIRON® Spinal Fixation System and its K-ROD component are physical medical devices (implants), not software or AI-based diagnostic/assistive tools. The FDA 510(k) process for such devices primarily evaluates mechanical safety, material compatibility, and substantial equivalence to legally marketed predicate devices, rather than diagnostic accuracy or AI algorithm performance.

Therefore, the following points from your request are not applicable and are not addressed in this 510(k) submission:

Table of acceptance criteria and reported device performance for AI-specific metrics: Not relevant, as this is a physical implant.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not relevant for physical implant mechanical testing in the context of AI.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant for physical implant mechanical testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not relevant for physical implant mechanical testing.
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 relevant, as this is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant, as this is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not relevant for physical implant mechanical testing.
The sample size for the training set: Not relevant, as this is not an AI system that requires a training set.
How the ground truth for the training set was established: Not relevant, as this is not an AI system.

Information Related to the Actual Device Performance (Mechanical Testing):

While the document doesn't provide the detailed acceptance criteria and results in a table format, it states:

Acceptance Criteria & Reported Performance (General Statement): "The testing showed that the K-ROD met or exceeded acceptance criteria." (Section 12)
Sample Size: Not specified for the mechanical tests, but a specific number of samples would have been tested per standard.
Data Provenance: The tests were non-clinical, likely performed in a lab setting by the manufacturer (S.M.A.I.O.). No country of origin for "data" in the sense of patient data.
Ground Truth: For a physical device, ground truth relates to meeting established engineering and material standards.
Training Set/Ground Truth for Training: Not applicable.

Studies Performed (Non-Clinical):

The document lists the following non-clinical tests performed (Section 12):

"3-point flexion comparison between 90° rods bent with different rod bending processes (KHEIRON curved rod versus K-ROD)"
"Dynamic axial compression bending and static torsion per ASTM F1717 (K-ROD versus PASS LP patient specific rod comparison)"
"Literature review to support the addition of the patient-specific K-ROD."

Clinical Studies:

"No clinical studies were performed." (Section 13) This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical testing and comparison to predicate devices.

Summary

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June 9, 2022

S.m.a.i.o. % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401

Re: K211981

Trade/Device Name: KHEIRON® Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: June 1, 2022 Received: June 3, 2022

Dear J.D. Webb:

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

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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,

for

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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Indications for Use

510(k) Number (if known) K211981

Device Name KHEIRON® Spinal Fixation System

Indications for Use (Describe)

The system is intended to be used with autograft and/or allograft.

Pediatric pedicle screw fixation is limited to a posterior approach.

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

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510(k) Summary

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, S.M.A.I.O. is hereby submitting this 510(k) Summary.

1. Date Prepared

June 22, 2021

Submitter [510(k) owner] 2.

S.M.A.I.O. 2, Place Berthe Morisot - Parc Technologique 69800 SAINT-PRIEST FRANCE + 33 (0) 4 69 84 23 02

Primary Contact 3.

J.D. Webb 4313 W. 3800 S West Haven, UT 84401 512-590-5810 Tele e-mail: jdwebb@orthomedix.net

Submitted Device Information 4.

Trade Name: KHEIRON® Spinal Fixation System Common Name: Thoracolumbosacral Pedicle Screw System

Classification Information 5.

Classification: Class II Classification Regulation: 21 CFR 888.3070 Classification Product Code: NKB Classification Name: Thoracolumbosacral pedicle screw system Device Panel: Orthopedic

Legally Marketed Predicate Devices 6.

The K-ROD manufactured by S.M.A.I.O is substantially equivalent to the following devices currently in commercialuse:

Primary Predicate Device

Device: KHEIRON® Spinal Fixation System and more specifically its curved rods 24CR55XXX and 24CR60XXX. Company: S.M.A.I.O 510(k) number: K201659

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Additional Predicate Devices

Device: PASS LP Spinal System Company: Medicrea international 510(k) number: K140738

7. Submitted Device Description

K-RODs are titanium alloys bent rods, available in diameters 5.5mm and 6mm, which shape is a 3D spline designed to meet the need of specific correction of a patient.

The K-ROD patient specific devices are available in Ø5.5 and Ø6mm.

Reason for Submission 8.

The reason for this pre-market notification is the extension of the range of the KHEIRON® Spinal Fixation System (K201659) with patient specifically bent rods K-ROD. Those rods are bent by SMAIO before the surgery.

9. Indications for Use

The KHEIRON Spinal Fixation System, including patient specific K-ROD, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON Spinal Fixation System implants are indicated as an adjunct to fusion to treat progresive spinal deformities (i.e. scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosos, and congenital scoliosis. Additionally, the KHEIRON Spinal Fixation System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

The system is intended to be used with autograft and/or allograft.

Pediatric pedicle screw fixation is limited to a posterior approach.

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10. Substantial Equivalence

The K-ROD as part of the KHEIRON Spinal Fixation System is substantially equivalent to the predicate devices in terms of intended use, design, manufacturing materials, principles of operation, and technical characteristics and raises no new issues of safety or effectiveness.

11. Summary of the Technological Characteristics Compared to Predicate

Intended Use

The K-ROD used in association with KHEIRON Spinal Fixation System, and the predicates are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

Materials

The K-ROD uses the same material as the predicates.

Design

The K-ROD and the predicates are equivalent in terms of shape and function.

Dimensions

The K-ROD and the predicates are equivalent in their dimensions.

Strength

The K-ROD has greater or equivalent strength values compared to the predicates.

12. Non-clinical Test Summary

The following tests were performed in support of this Special 510(k):

3-point flexion comparison between 90° rods bent with different rod bending O processed (KHEIRON curved rod versus K-ROD);
Dynamic axial compression bending and static torsion per ASTM F1717 (K-ROD O versus PASS LP patient specific rod comparison);
Literature review to support the addition of the patient-specific K-ROD. O

The testing showed that the K-ROD met or exceeded acceptance criteria.

Clinical Test Summary 13.

No clinical studies were performed.

14. Conclusions: Non-clinical and Clinical

S.M.A.I.O considers the K-ROD to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials, and indications for use.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.