Non-cervical spinal fixation devices intended for posterior, non-pedicle fixation for the following indications: degenerative disc disease ( DDD ) (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; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S 1 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 Mesa Spinal System is a top-loading, multiple component, posterior system which consists of pedicle screws, rods, hooks, and transverse connectors. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of spinal segments of the thoracic, lumbar and / or sacral spine.

AI/ML Overview

This request is about a medical device, the Mesa Spinal System, specifically the 4.0mm Screw component, and not about an AI/ML powered device. Therefore, many of the typical acceptance criteria and study design elements expected for an AI/ML device (like sample size for test/training sets, ground truth methodology, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable here.

The provided text describes a 510(k) submission for the Mesa Spinal System, which is a spinal fixation device. For such devices, the "acceptance criteria" and "study" typically revolve around demonstrating substantial equivalence to a legally marketed predicate device through engineering and biocompatibility testing, material characterization, and comparison of design features and intended use.

Here's an analysis based on the provided text, addressing the relevant points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biomechanical Performance (ASTM F1717)	"The Mesa Spinal System was biomechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717."
Material Composition (ASTM & ISO Standards)	"The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards." "It is manufactured from the same FDA recognized materials..."
Design Features and Sizing	"...the design features and sizing of the components were also compared and the Mesa System found to be substantially the same as these systems."
Intended Use	"is indicated for the same intended uses as these systems." (The specific indications are listed in the 'Intended Use' and 'Indications for Use' sections of the document).
No Adverse Effects	"There are no significant differences between the Mesa Spinal Systems currently being marketed which would adversely affect the use of the product."
Substantial Equivalence	"It is substantially equivalent to these other devices in design, function, material and intended use." (This is the overarching acceptance criterion for a 510(k) submission).

2. Sample size 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: This is not applicable in the context of this 510(k) submission. "Test set" typically refers to data used to evaluate an AI/ML model's performance on unseen data. For a spinal fixation device, performance is evaluated through material testing and biomechanical testing on representative samples of the device components, not a "test set" of patient data. The text indicates that the device was "biomechanically tested," which implies a certain number of physical samples were subjected to various tests, but the exact count is not provided.
Data Provenance: Not applicable in the AI/ML sense. The "data" here would be the results of laboratory biomechanical and material tests. The document does not specify the location where these tests were performed or if they were retrospective or prospective, as these terms are generally used for clinical studies or data collection for AI.

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. "Ground truth" and "experts" in this context are not relevant for demonstrating substantial equivalence for a spinal fixation device. Performance is determined by objective engineering and material standards (e.g., ASTM F1717).

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

Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling or diagnoses, which is not part of a spinal fixation device's 510(k) submission.

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 for AI-assisted image interpretation or diagnostic tools. The Mesa Spinal System is a physical implant, not an AI diagnostic tool.

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

Not applicable. This concept pertains to AI algorithms.

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

Not applicable. "Ground truth" as an expert-derived label or outcome is not used here. Instead, the "truth" or standard for performance is defined by established engineering and material standards (e.g., ASTM F1717 for biomechanical testing) and comparison to the predicate device's characteristics.

8. The sample size for the training set

Not applicable. There is no "training set" for physical medical devices in this context.

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

Not applicable. As there's no training set, there's no ground truth to establish for it.

Summary

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2 8061

4 2009 MAR

510(k) Summary for the Mesa Spinal System, 4.0mm Screw

This safety and offectiveness summary for the Mesa Spinal System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmotic Act.

1. Submitter : K2M, LLC 751 Miller Drive SE, Suite FI Leesburg, VA 20175
  Contact Person : Richard W. Woods K2M, LLC 751 Miller Drive SE, Suite F1 Leesburg, VA 20175 Telephone: 703-777-3155

February 26, 2008 Date Prepared:

Tradename: Mesa Spinal System, 4.0mm Screw Common Name: Spine Fixation System Classification Name: Pedicle Screw Spinal System ( 21 CFR 888.3070(b)(1) ) Spinal Interlaminal fixation orthosis ( 21 CFR 888.3050 )

3. Predicate or legally marketed devices which are substantially equivalent :

Mesa Spinal System (K2M, Inc.) �
Range Spinal System (K2M, Inc.) �
. Zodiac 4.0 Polyaxial Spinal Fixation System (Alphatec)
. Universal Spine System (Synthes )
Moss Miami Spinal System (Depuy) .
Rogozinski Spinal Rod System (United States Surgical Corporation) .
Synergy Spinal System (Interpore Cross)

4. Description of the device :

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of spinal segments of the thoracic, lumbar and / or sacral spine.

5. Intended Use:

The Mesa Spinal System is a:

Non-cervical spinal fixation device intended for posterior, non-pedicle fixation for the following indications: degenerative disc disease ( DDD ) (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.

· The Mesa Spinal System is also intended for:

Non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-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.

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Comparison of the technological characteristics of the device to predicate and legally marketed

devices :

The Mesa Spinal System was biomechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717. The design features and sizing of the components were also compared and the Mesa System found to be substantially the same as these systems. It is manufactured from the same FDA recognized materials and is indicated for the same intended uses as these systems.

There are no significant differences between the Mesa Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.

Public Health Service

MAR 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K2M. Inc. % Mr. Richard W. Woods 751 Miller Dr., S.E., Suite F1 Leesburg, VA 20175

Re: K080611

Trade/Device Name: Mesa Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNH, MNI, KWP Dated: February 25, 2009 Received: February 26, 2009

Dear Mr. Woods:

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 too 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 misting 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 of class III (PMA)
can be found in the Code of Fiders) Decedes on the coulations affecting your dev 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 100-1050.

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Page 2 - Mr. Richard W. Woods

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Millerson

Mark N. Melkerson 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: K080611

Device Name: Mesa Spinal System, 4.0mm Screw

Indications for Use:

Prescription Use X (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number L680611

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.