SYNTHES MATRIX MIS RODS by SYNTHES (USA)

The Synthes USS (including Matrix, USS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USS VAS variable axis components, USS Fracture, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Polyaxial, USS liiosacral, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), a posterior hook fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle scew fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5/6.0-mm parallel connectors, the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix), can be linked to the CerviFix 3.5 mm Systems (including CerviFix, Axon, and Synapse). In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems (including CerviFix, Axon, and Synapse). When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS Polyaxial, USS Hibsacral, and ClampFix).

In addition, Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Fracture, Polyaxial, USS Iliosacral, and ClampFix) can be interchanged with all USS 6.0 mm ods and transconnectors.

Device Description

The Synthes Matrix MIS Rods are spinal rods to be used as part of the Synthes Matrix System of posterior pedicle screw fixation implants. The titanium rods are available straight or curved in two bend radii and a range of lengths. The Synthes Matrix MIS rods are to be implanted via a minimally invasive approach.

The Synthes Matrix MIS Rods are intended to be used with the Synthes Matrix System Implants. The Synthes Matrix Implants consist of a family of non-cervical spinal fixation devices intended for use as a posterior pedicle screw fixation system (T1-S2), posterior hook fixation system (T1-L5) or anterolateral fixation system (T8-L5).

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Synthes Matrix MIS Rods," a spinal rod system. It is important to note that this document is for a physical medical device, not an AI/ML-driven device or software. Therefore, the questions related to AI/ML performance metrics, ground truth, experts, and training sets are not applicable to this submission.

The acceptance criteria and supporting study are described in terms of non-clinical performance to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices in design	The Synthes Matrix MIS Rods are modifications to the design of predicate devices but are substantially equivalent in design.
Substantial equivalence to predicate devices in function	The Synthes Matrix MIS Rods are modifications to the surgical technique of predicate devices but are substantially equivalent in function.
Substantial equivalence to predicate devices in material	The Synthes Matrix MIS Rods utilize materials that are substantially equivalent to those of predicate devices (titanium rods mentioned, which is common for spinal implants).
Substantial equivalence to predicate devices in intended use	The Synthes Matrix MIS Rods have an intended use that is substantially equivalent to predicate devices. The document details indications for use such as posterior pedicle screw fixation, posterior hook fixation, and anterolateral fixation for various spinal conditions.
Non-Clinical Performance demonstrating substantial equivalence	"The information provided demonstrates that the Synthes Matrix MIS Rods are substantially equivalent to the predicate devices." (Exact tests are not detailed in this summary, but would typically include mechanical testing, biocompatibility, and sterilization validations for physical implants).
Clinical performance (Not required for this device)	"Clinical data and conclusions were not needed for this device."

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

Not Applicable: This is a physical medical device. The "test set" would refer to non-clinical performance testing of the device hardware. The document states "The information provided demonstrates that the Synthes Matrix MIS Rods are substantially equivalent to the predicate devices," implying successful completion of required non-clinical tests, but it does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these engineering tests.

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

Not Applicable: As a physical medical device, there is no "ground truth" established by experts in the context of an AI/ML system's diagnostic or predictive performance. Substantial equivalence for this type of device is determined by comparing its technical characteristics and performance to legally marketed predicate devices, typically through engineering and biocompatibility testing, not expert consensus on data interpretation.

4. Adjudication method for the test set

Not Applicable: There is no adjudication method for a "test set" in the context of an AI/ML system. The assessment for this physical device relies on engineering tests and regulatory review against predicate devices.

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 physical spinal rod system, not an AI-assisted diagnostic or treatment device. Therefore, MRMC studies and "human readers improving with AI" are not relevant.

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

Not Applicable: This is a physical medical device, not an algorithm or software.

7. The type of ground truth used

Not Applicable: For this physical device, "ground truth" in the AI/ML sense (e.g., pathology, outcomes data) is not used. The "truth" for this device's acceptance is its demonstrated substantial equivalence to predicate devices through non-clinical performance data (e.g., mechanical strength, biocompatibility).

8. The sample size for the training set

Not Applicable: This is a physical medical device; there is no training set as would be used for an AI/ML model.

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

Not Applicable: There is no training set or associated ground truth for this physical medical device.

Summary

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. . . .

@ SVNTHES® Spine

ﺔ,

MAR - 9 2010

Name of Firm:	Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380
510(k) Contact:	Heather GuerinRegulatory Affairs SpecialistTelephone: 610-719-5432Facsimile: 610-719-5102Email: querin.heather@synthes.com
Date Prepared:	February 8, 2010
Trade Name:	Synthes Matrix MIS Rods
Classification:	21 CFR 888.3070 - Pedicle screw spinal systemClass IIIOrthopaedic and Rehabilitation Devices PanelProduct Code: NKB, MNH, MNI, KWQ, KWP
Predicates:	The Synthes Matrix MIS Rods are substantially equivalent to similar, previouslycleared pedicle screw spinal systems.
Device Description:	The Synthes Matrix MIS Rods are spinal rods to be used as part of the SynthesMatrix System of posterior pedicle screw fixation implants. The titanium rods areavailable straight or curved in two bend radii and a range of lengths. The SynthesMatrix MIS rods are to be implanted via a minimally invasive approach.The Synthes Matrix MIS Rods are intended to be used with the Synthes MatrixSystem Implants. The Synthes Matrix Implants consist of a family of non-cervicalspinal fixation devices intended for use as a posterior pedicle screw fixation system(T1-S2), posterior hook fixation system (T1-L5) or anterolateral fixation system (T8-L5).
Intended Use/Indications for Use:	The Synthes USS (including Matrix, USS Side-Opening, USS Dual-Opening, USSSmall Stature (which includes small stature and pediatric patients), USS VASvariable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea,Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix) are non-cervicalspinal fixation devices intended for use as posterior pedicle screw fixation systems(T1-S2/ilium), a posterior hook fixation system (T1-L5), or as an anterolateralfixation system (T8-L5). Pedicle screw fixation is limited to skeletally maturepatients with the exception of the Small Stature USS. These devices are indicatedas an adjunct to fusion for all of the following indications regardless of the intendeduse: degenerative disc disease (defined as discogenic back pain with degenerationof the disc confirmed by history and radiographic studies), spondylolisthesis,trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failedprevious fusion (pseudoarthrosis).When treating patients with Degenerative Disc Disease (DDD), transverse bars arenot cleared for use as part of the posterior pedicle screw construct.When used with the 3.5/6.0-mm parallel connectors, the Synthes USS (includingUSS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USSFracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial,USS Iliosacral, and ClampFix) can be linked to the CerviFix 3.5 mm Systems(including CerviFix, Axon, and Synapse). In addition, when used with 3.5/5.0 mmparallel connectors, the Synthes Small Stature USS can be linked to the CerviFix
	3.5 mm Systems (including CerviFix, Axon, and Synapse). When used with the5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to theSynthes USS (including USS Side-Opening, USS Dual-Opening, USS VASvariable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea,Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix).
	In addition, Synthes USS (including USS Side-Opening, USS Dual-Opening, USSVAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea,Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix) can beinterchanged with all USS 6.0 mm rods and transconnectors.
Comparison of thedevice to predicatedevice(s):	The Synthes Matrix MIS Rods are a result of modifications to the design andsurgical technique of the predicate devices. They are substantially equivalent tothe predicates in design, function, material and intended use.
- Performance Date(Non-Clinicaland/or Clinical):	Non-Clinical Performance and Conclusions:The information provided demonstrates that the Synthes Matrix MIS Rods aresubstantially equivalent to the predicate devices.Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device.

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@ SYNTHES * Spine

and the comments of the comments of

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Synthes Spine % Ms. Heather Guerin Regulatory Affairs Specialist 1302 Wrights Lane East Chester, Pennsylvania 19380

MAR - 9 2010

Re: K093668

Trade/Device Name: Synthes Matrix MIS Rods Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWQ, KWP Dated: February 08, 2010 Received: February 17, 2010

Dear Ms. Guerin:

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

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Page 2 - Ms. Heather Guerin

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events} (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.

Barbara buchin

Mark N. Melk Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K093668 Device Name: Synthes Matrix MIS Rods

Indications for Use:

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

Prescription Use × (21 CFR 801 Subpart D)

AND / OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093668

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.