The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis and failed previous fusion in skeletally mature patients.

Device Description

The M.U.S.T. Extension is intended to be used as part of the M.U.S.T. pedicle screw system (K121115, K132878) for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. pedicle screw system includes cannulated or non cannulated poly-axial pedicle screws (K121115, K132878), cannulated or non cannulated mono-axial pedicle screws (K132878), set screws (K121115), straight and pre-bent rods (K121115), and cross connectors (K132878).

The M.U.S.T. Extension introduces a new design of the pedicle screws and rods, featuring additional mechanical interfaces for dedicated instruments designed for percutaneous surgery. On the pedicle screw head (Tulip), there are four additional small grooves on the upper rim to enhance the attachment to the Percutaneous Tower. Additionally, the tip of the screw is more tapered to enhance the insertion into the bone, in case the bone tap is not used (cannulated screws only). The Rods are provided with a hexagonal interface on one extremity and a bulleted nose on the opposite, to allow insertion by means of a dedicated handle through the tissue. The Rods have new intermediate lengths and the bent rods have an increased curvature.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "M.U.S.T. Pedicle Screw System." This type of document is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through a clinical study with acceptance criteria in the same way a PMA (Premarket Approval) would.

Therefore, the requested information for acceptance criteria and a study proving the device meets these criteria in the context of an AI medical device is not directly applicable here. This document describes a traditional spinal implant, and the performance testing is focused on mechanical characteristics rather than algorithmic performance.

However, I can extract the information relevant to how the device's "performance" (mechanical integrity and equivalence) was assessed based on the provided text:

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

The document states that "design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system." It also mentions that "The M.U.S.T. Extension was compared to the worst case predicate device and it was determined that the M.U.S.T. Extension is not worst case." This implies that the acceptance criteria for each test were met if the M.U.S.T. Extension performed at least as well as or better than the worst-case predicate.

However, the specific quantitative acceptance criteria or the reported device performance values are not explicitly listed in the provided text. The document refers to the following tests (from ASTM F 1717) without providing the actual results:

Test Type	Standard	Acceptance Criteria (Implied)	Reported Device Performance
Static compression/bending yield strength	ASTM F 1717	Performance at least equivalent to worst-case predicate.	Not explicitly reported.
Fatigue compression/bending strength	ASTM F 1717	Performance at least equivalent to worst-case predicate.	Not explicitly reported.
Static compression/bending stiffness	ASTM F 1717	Performance at least equivalent to worst-case predicate.	Not explicitly reported.
Static torsion yield strength	ASTM F 1717	Performance at least equivalent to worst-case predicate.	Not explicitly reported.
Static torsion stiffness	ASTM F 1717	Performance at least equivalent to worst-case predicate.	Not explicitly reported.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the sample size for the mechanical performance testing. This information would typically be detailed in the test protocols themselves, which are not included in this summary.
Data Provenance: The testing was "conducted to written protocols," implying laboratory-based mechanical testing. The origin of the components would be Medacta International SA (Switzerland) and Medacta USA. The nature of the testing (mechanical stress, fatigue, etc.) suggests it's a prospective lab study rather than human clinical data.

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

This question is not applicable to this type of device. There is no concept of "ground truth" established by experts in the context of mechanical performance testing of a pedicle screw system. The evaluation is based on objective measurements against engineering standards.

4. Adjudication method for the test set:

Not applicable. There's no "adjudication" required for mechanical testing results; they are empirical measurements.

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:

Not applicable. This is a spinal implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness assessment was performed or is relevant.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used:

For mechanical testing, the "ground truth" is typically defined by engineering standards (e.g., ASTM F 1717) and the measured physical properties of the materials and devices.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that would have a "training set."

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

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 19, 2014

Medacta International SA % Mr. Adam Gross Medacta USA 1556 West Carroll Avenue Chicago, Illinois 60607

Re: K141988

Trade/Device Name: M.U.S.T. Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWO, KWP Dated: July 18, 2014 Received: July 22, 2014

Dear Mr. Gross:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ronald#Alean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141988

Device Name M.U.S.T. Pedicle Screw System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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:

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Image /page/3/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two blue triangles, followed by the word "Medacta" in blue. Underneath the word is a yellow line, and below that is the word "International" in a smaller font. To the right of the word "International" is a red square with a white cross in the center.

510(k) Summary

Applicant/Sponsor: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 1556 W Carroll Ave Chicago, IL 60607 Phone: (805) 910-6511 Fax: (805) 437-7553 Email: AGross@medacta.us.com
August 18, 2014 Date Prepared:

DEVICE INFORMATION

Trade/Proprietary Name: M.U.S.T. Pedicle Screw System Common Name: Pedicle screw spinal system Classification Name: Pedicle screw spinal system 21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3050 Class III Device Product Codes: MNI, MNH, NKB, KWQ, KWP

Predicate Device(s):

510(k)	Product	510(k) Holder	Clearance Date
K121115	M.U.S.T. Pedicle Screw System	Medacta International	7/18/2012
K132878	M.U.S.T. Extension	Medacta International	12/18/2013
K100952	Matrix System	Synthes Spine	8/5/2010

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Product Description

Component	Diameter	Length	Material
Solid Poly-AxialPedicle Screws	4.5, 5, 6, 7mm	20-90mm	Ti6AI4V ELI (ISO 5832-3 ASTM F 136)andCoCrMo (ISO 5832-12 ASTM F 1537)
Cannulated Poly-AxialPedicle Screws	5, 6, 7mm	25-90mm	Ti6Al4V ELI (ISO 5832-3 ASTM F 136)andCoCrMo (ISO 5832-12 ASTM F 1537)
Straight Rods	5.5mm	35-480mm	Ti6Al4V ELI (ISO 5832-3 ASTM F 136)orCoCrMo (ISO 5832-12 ASTM F 1537)
Bent Rods	5.5mm	25-150mm	Ti6Al4V ELI (ISO 5832-3 ASTM F 136)orCoCrMo (ISO 5832-12 ASTM F 1537)
Bent Rods (R100)	5.5mm	25-150mm	Ti6Al4V ELI (ISO 5832-3 ASTM F 136)orCoCrMo (ISO 5832-12 ASTM F 1537)
Dual Bent Rods	5.5mm	50-80mm	Ti6Al4V ELI (ISO 5832-3 ASTM F 136)orCoCrMo (ISO 5832-12 ASTM F 1537)

The M.U.S.T. Extension consists of the following components, which are all provided in both sterile and unsterile packaging:

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Indications for Use

The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). These devices are indicated as an adiunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis and failed previous fusion in skeletally mature patients.

Comparison to Predicate Devices

The indications for use, design features and materials of the M.U.S.T. Extension are substantially equivalent to those of the predicate devices. The substantial equivalence of the M.U.S.T. Extension implants is supported by the performance testing, materials information, and data analysis provided within this Premarket Notification.

Performance Testing

The modification to the device system to include the addition of the M.U.S.T. Extension was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system. The M.U.S.T. Extension was compared to the worst case predicate device and it was determined that the M.U.S.T. Extension is not worst case.

Geometrical and interface comparisons were performed in order to substantiate the applicability of the tests already performed on the predicate devices and to demonstrate that the M.U.S.T. Extension is not worst case compared to the predicate devices in terms of:

Static compression/bending vield strength ASTM F 1717 Fatique compression/bending strength ASTM F 1717 Static compression/bending stiffness ASTM F 1717 Static torsion vield strength ASTM F 1717 Static torsion stiffness ASTM F 1717

Conclusion:

Based on the above information, the M.U.S.T. Extension can be considered as substantially equivalent to its predicate devices.

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.