The MX Monoaxial Pedicle Screw is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system the MX Monoaxial Pedicle Screws are indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Device Description

The MX Monoaxial Pedicle Screw consists of pedicle screws and rods. Pedicle screws are inserted into the pedicles of the vertebrae and are available in two diameters (Ø5.5 and Ø6.2mm) and in lengths ranging from 30mm to 55mm. A rod is then placed through the screws. The rods are available in lengths ranging from 45-600mm. Two rod loading configurations are available. A closed screw is similar to the predicate screw with the head of the screw enlarged and the rod is slid through an opening in the head. A side loading configuration is similar to the closed screw except that there is an opening in the side of the screw head and the rod slid into this opening.

AI/ML Overview

The document you provided is a 510(k) summary for the Scient'x MX Monoaxial Pedicle Screw. This document describes a medical device (a pedicle screw system) and its substantial equivalence to a predicate device, based on nonclinical testing.

Therefore, there is no information present in this document about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy studies. The document focuses on the mechanical and material aspects of the device in comparison to an already approved device.

Here's why the requested information is absent and what is provided:

Acceptance Criteria/Reported Device Performance (Table): Not applicable. This device is a physical implant, and its "performance" is evaluated through mechanical testing, not diagnostic metrics like sensitivity, specificity, or AUC. The document states "Testing was performed per ASTM F1717 and is comparable to the predicate device." This is the core of their performance claim.
Sample Size for Test Set and Data Provenance: Not applicable. There is no "test set" of patient data in the context of an AI/ML algorithm or diagnostic study. The testing refers to biomechanical tests on the screws themselves.
Number of Experts and Qualifications: Not applicable. No human experts were involved in establishing ground truth for evaluating a diagnostic algorithm.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not a diagnostic imaging or AI-assisted device.
Standalone Performance: Not applicable. The device itself is a physical implant; it doesn't have "standalone algorithm performance."
Type of Ground Truth: Not applicable. There's no ground truth in the sense of a medical diagnosis. The ground truth for this type of device is compliance with mechanical standards (e.g., breaking strength, fatigue life).
Sample Size for Training Set: Not applicable. This is a physical device, not an AI model.
How Ground Truth for Training Set Was Established: Not applicable.

What the document does tell us about performance and acceptance criteria:

Acceptance Criteria (Implicit): The implicit acceptance criteria are that the MX Monoaxial Pedicle Screw performs comparably to the predicate device (Scient'x Closed Pedicle Screw system, K020245) according to specific ASTM standards.
Study Proving Device Meets Acceptance Criteria: The study involved "Nonclinical Tests" performed "per ASTM F1717." This standard (ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) specifies mechanical test methods for spinal implants. The document asserts that the results of these mechanical tests demonstrate comparability to the predicate device.

In summary, the provided text is for a physical medical device (pedicle screws) and not for an AI/ML diagnostic system. Therefore, the specific questions regarding AI/ML study design and performance metrics are not applicable and cannot be answered from this document.

Summary

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KO42964 plat- 1

NOV 2 2 2004

MX Monoaxial Pedicle Screws 510(k) Summary October 25, 2004

Submitter	Scient'xBatiment Calypso Parc Ariane 378284 GuyancourtFRANCE
Contact person	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199
Trade Name	MX Monoaxial Pedicle Screw
Common name	Posterior pedicle screw system
Classification name	Class II per 21 CFR section 888.3070
Product Code	MNI/MNH
Equivalent Device	Scient'x Closed Pedicle Screw system (K020245)

Device Description

The MX Monoaxial Pedicle Screw consists of pedicle screws and rods. Pedicle screws are inserted into the pedicles of the vertebrae and are available in two diameters (Ø5.5 and Ø6.2mm) and in lengths ranging from 30mm to 55mm. A rod is then placed through the screws. The rods are available in lengths ranging from 45-600mm. Two rod loading configurations are available. A closed screw is similar to the predicate screw with the head of the screw enlarged and the rod is s lid through an o pening in the head. A s ide loading configuration is similar to the c losed screw except that there is an opening in the side of the screw head and the rod slid into this opening.

Intended Use

The MX Monoaxial Pedicle Screw is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, k yphosis, s pinal tumor, a nd failed previous fusion (pseudarthrosis).

Summary Nonclinical Tests

Testing was performed per ATM F1717 and is comparable to the predicate device.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract bird or a series of flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2004

Mr. J. D. Webb For Scient'X c/o The OthroMedix Group Inc. 1001 Oakwood Blvd. Round Rock, Texas 78681

Re: K042964

Trade/Device Name: Scient'X MX Monoaxial Pedicle Screw System Regulation Number: 21 CFR 888.3070 (b) (1) Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNH,MNI Dated: October 25, 2004 Received: October 27, 2004

Dear Mr.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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark N Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ ( 1 of 1 )

Device Name: MX Monoaxial Pedicle Screws

Indications for Use:

The MX Monoaxial Pedicle Screw is a pedicle screw s ystem 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

Division of General, Restorative, and Neurological Devices

510(k) Number K042964

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.