It is intended that this device, in any system configuration, be removed after development of solid fusion mass of spinal segments in skeletally mature patients. The ROC Lumbar Plating System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities: severe spondylolisthesis (grades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis). The ROC Lumbar Plating System is indicated for placement in L3 - S1.

Device Description

The ROC Lumbar Plating System is a spinal fixation system that consisting of a variety of nonsterile, single use implants that facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.

AI/ML Overview

This document is a 510(k) summary for the Alphatec Spine ROC Lumbar Plating System. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance data, rather than clinical performance (e.g., diagnostic accuracy or treatment efficacy). Therefore, the requested information regarding acceptance criteria, study details for device performance, expert involvement, and ground truth establishment is not entirely applicable in the context of this specific regulatory submission.

However, I can extract and interpret the available information to address your request in the most relevant way possible for this type of medical device submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating that its mechanical and dynamic performance characteristics are equivalent to, or better than, predicate devices and satisfy recognized consensus standards for posterior lumbar fixation.

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance	Demonstrated to satisfy the requirements of posterior lumbar fixation per recognized consensus standards and guidance documents.
Dynamic Performance	Demonstrated to satisfy the requirements of posterior lumbar fixation per recognized consensus standards and guidance documents.
Safety and Effectiveness	Reasonable assurance of safety and effectiveness for its intended use, based on mechanical and dynamic testing.
Substantial Equivalence	Found substantially equivalent to predicate devices based on intended use, function, general design, technological characteristics, and material composition.

Study Details for Device Performance

Sample Size used for the test set and the data provenance:
This submission relies on nonclinical performance data, specifically mechanical and dynamic testing. The document does not specify a "sample size" in terms of human subjects or patient data. Instead, it would refer to the number of device components or assemblies tested. This information is not provided in the summary document. The "data provenance" would be laboratory testing conducted by or for Alphatec Spine, not patient data from a specific country or retrospective/prospective study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. For mechanical testing, the "ground truth" is defined by established engineering standards and specifications (e.g., ASTM standards for spinal implants) and the performance of predicate devices. There wouldn't be "experts" establishing a ground truth in the same way as for diagnostic accuracy studies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods typically relate to clinical trial outcomes or image interpretation where human judgment is involved. Mechanical testing results are objective measurements against defined standards.
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 device is a spinal implant, not a diagnostic or AI-powered device. Therefore, MRMC studies and AI assistance metrics are irrelevant.
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.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the mechanical and dynamic testing, the "ground truth" is established by:
- Recognized consensus standards: These are industry-accepted standards (e.g., ISO, ASTM) that define test methods, performance requirements, and acceptable ranges for spinal implant characteristics.
- Guidance documents: Specific FDA guidance documents, such as "Spinal System 510(k)s - Guidance for Industry and FDA Staff," provide recommendations for testing to demonstrate safety and effectiveness.
- Predicate device performance: The performance of previously cleared, substantially equivalent devices serves as a benchmark.
The sample size for the training set:
Not applicable. This device does not involve machine learning or AI, so there is no training set in that context.
How the ground truth for the training set was established:
Not applicable, as there is no training set.

Summary of Non-Applicability:

It is crucial to understand that this 510(k) summary is for a physical medical implant (spinal plating system), not a diagnostic algorithm, AI-powered device, or a drug. The regulatory pathway for such a device primarily focuses on demonstrating:

Substantial Equivalence: That the device is as safe and effective as a legally marketed predicate device.
Biocompatibility: That the materials are safe for use in the human body (implicitly covered by "material composition is identical to numerous other Alphatec Spine products that have been cleared").
Mechanical Performance: That the device can withstand the forces and stresses it will encounter in the body without failure, as demonstrated by nonclinical bench testing against established standards.

Therefore, many of the questions asked, which are highly relevant for AI/ML-based diagnostic devices or clinical effectiveness studies, do not apply to this specific 510(k) submission for a spinal implant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Alphatec Spine. The logo features a stylized lowercase Greek letter alpha above the company name. The text "Alphatec Spine" is in a bold, italicized font. The logo is in black and white.

510(k) SUMMARY January 2009

Carozz8

Submitter: Alphatec Spine, Inc. APR 2 9 2009 5818 El Camino Real Carlsbad, CA 92008 Direct: (760) 494-6739 (760) 431-0289 Fax: Official Contact: Karla Schaffner, Regulatory Affairs Submissions Specialist Trade/Model Name: ROC Lumbar Plating System Pedicle Screw Spinal System Common Name: Classification Regulation: MNI - 888.3070 - Orthosis, Spinal Pedicle Fixation MNH - 888.3070 - Orthosis, Spondylolisthesis Spinal Fixation

Substantial Equivalence:

The ROC Lumbar Plating System is substantially equivalent in intended use and function to the following predicate devices.

Device Description:

Intended Use

It is intended that this device, in any system configuration, be removed after development of solid fusion mass of spinal segments in skeletally mature patients. The ROC Lumbar Plating System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities: severe spondylolisthesis (grades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment. fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis), The ROC Lumbar Plating System is indicated for placement in L3 - S1.

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510(k) Summary Alphatec Spine, Inc. ROC Lumbar Plating System

Ko90228

Technological Characteristics Comparison:

The ROC Lumbar Plating System is equivalent to the referenced devices in that it is intended to be used to provide temporary internal lumbar fixation and stabilization during bone graft healing and/or fusion mass development. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices.

Material composition is identical to numerous other Alphatec Spine products that have been cleared via the 510(k) process.

Nonclinical Performance Data:

Mechanical and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. Performance testing was performed per the recognized consensus standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry and FDA Staff. This testing documented both static and fatigue performance characteristics. This testing clearly demonstrated that the performance characteristics satisfy the requirements of posterior lumbar fixation. As a result of this testing, the ROC Lumbar Plating System is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2009

Alphatec Spine, Inc % Karla Schaffner 5818 El Camino Real Carlsbad, CA 92008

Re: K090228

Trade/Device Name: ROC Lumbar Plating System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: January 29, 2009 Received: January 30, 2009

Dear Ms. Schaffner:

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 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 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 – Ms. Karla Schaffner

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehrig

Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ROC Lumbar Plating System

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510(k) Number TBD

Alphatec Spine

Section 4 Indications for Use Statement

Kogo227 510(k) Number (if known): FBD

Device Name: ROC Lumbar Plating System

Indications for Use:

Prescription Use J X (Per 21 CFR 801.109)

Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oarlare Brienm

Division of General, Restorative, and Neurological Devices

510(k) Number K090228

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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.