The Atoll OCT Spinal System is indicated to promote fusion of the occipito-cervico-thoracic regions of the spine (Occiput - T3). The intended indications are as follows:

Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis
Spinal Stenosis
Fracture/Dislocation
Tumors
Pseudoarthrosis
Atlanto/axial fracture with instability
Occipitocervical dislocation
Revision of previous cervical and upper thoracic spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the polyaxial and standard screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. Screws are not intended for use in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The Atoll OCT Spinal System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.

Device Description

The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, occipital plates and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient physiology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F136 and ISO 5832-3. To achieve the best results. unless otherwise specifically described in another Theken Spine document, do not use the Atoll OCT Spinal System components in conjunction with components from any other manufacturer. The purpose of this submission is the addition of an occipital plate.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "Atoll™ OCT Spinal System." It is a premarket notification to the FDA to demonstrate substantial equivalence to previously cleared devices.

Based on the provided text, a detailed study proving the device meets specific acceptance criteria is NOT present. The document primarily focuses on establishing "substantial equivalence" to predicate devices rather than providing detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

Therefore, many of the requested details cannot be extracted directly from this specific 510(k) summary. I can, however, extrapolate some information based on the nature of a 510(k) submission for spinal implants.

Here's an attempt to answer as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is typically found in detailed design validation and verification reports, which are summarized in a 510(k) but not fully reproduced in the public summary. For spinal implants, acceptance criteria would generally be related to:

Acceptance Criterion	Reported Device Performance
Mechanical Strength/Fatigue Life	(Not explicitly stated in this summary. Would refer to compliance with relevant ASTM/ISO standards for spinal implants, e.g., ASTM F1717 for static and fatigue testing of spinal implant constructs, ASTM F2077 for intervertebral body fusion device testing. Performance would demonstrate the device meets or exceeds the strength of predicate devices or specified load-bearing capacities without failure for a specified number of cycles.)
Biocompatibility	(Not explicitly stated in this summary. Would refer to compliance with ISO 10993 standards and material testing. Performance would confirm the Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3 is biocompatible for long-term implantation.)
Material Composition	Meets specifications of Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3.
Design Dimensions/Tolerances	(Not explicitly stated. Would conform to engineering drawings and specifications to ensure proper fit and function.)
Sterility	(Not explicitly stated. Would be validated per ISO 11137 or other relevant standards for sterilization processes.)
Packaging Integrity	(Not explicitly stated. Would be validated to maintain sterility and device integrity until use.)
Substantial Equivalence (Overall - Key Criterion for 510(k))	Equivalent in intended use, design, and physical characteristics to predicate devices: Atoll Cervico-Thoracic System (K070638), Mountaineer OCT Spinal System (K080828), OC Fusion System (K053418). This is the primary "performance" metric for a 510(k) submission.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not specified in the provided text. For mechanical testing of medical devices like spinal implants, sample sizes are often determined by statistical power requirements to detect differences between designs or to demonstrate compliance with standards. It typically involves multiple samples for each component and construct configuration.
Data Provenance: Not specified. For mechanical testing, this data would generally be generated in a laboratory setting (in-vitro testing), potentially conducted by the manufacturer or an independent testing facility. It is not typically human clinical data (prospective or retrospective) for a 510(k) of this device type, unless a device has novel features requiring clinical data, which is not indicated here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is not applicable as the "ground truth" concept, in the way it's usually applied to AI or diagnostic devices (e.g., expert consensus on images), does not apply to the mechanical testing required for spinal implants in a 510(k). The "ground truth" for these devices is derived from engineering and scientific principles, validated testing methodologies, and compliance with recognized standards.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically for clinical outcome assessment or image interpretation, not for mechanical device testing. Results from mechanical testing are typically objective measurements against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. MRMC studies are used to assess the performance of diagnostic imaging devices or AI algorithms interpreted by human readers. This document is for a spinal implant, which does not involve human readers interpreting data in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone (algorithm-only) study was not done. This is not an AI or algorithm-based device.

7. The Type of Ground Truth Used:

As explained in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not directly applicable here. For a spinal implant, the "ground truth" for performance is based on:

Engineering Specifications: Conformance to design blueprints and material specifications.
Standardized Mechanical Testing: Results from tests conducted according to recognized ASTM/ISO standards (e.g., for static compression, torsion, fatigue). These standards define the "truth" of what constitutes acceptable mechanical performance.
Biocompatibility Testing: Results from tests conforming to ISO 10993.
Comparison to Predicate Devices: Demonstrating that the new device performs at least as well as, or is equivalent to, legally marketed predicate devices, as evaluated through these objective tests.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device, so there is no "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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A. Submitter Information

510(k) Summary (21 CFR Part 807.92)

MAR 2 7 2009

Submitter's Name: Theken Spine, LLC Establishment Registration #: 1530901 Address: 1800 Triplett Blvd. Akron, Ohio 44306 Telephone Number: 330-475-8600 Fax Number: 330-773-7697 Contact Person: Dale Davison Date Prepared: 12/23/08 B. Device Information AtollTM OCT Spinal System Trade Name: Common Name: Posterior Cervical Instrumentation Classification: Class II System with the corresponding product codes: KWP 888.3050 - Spinal Interlaminal Fixation Orthosis MNI 888.3070(b) (1) – Pedicle Screw Spinal System MNH 888.3070(b) (1) - Pedicle Screw Spinal System Predicate Devices: Theken - Atoll Cervico-Thoracic System (K070638) Comparable Device: DePuy Spine (USA) - Mountaineer OCT Spinal System (K080828) Synthes Spine (USA) OC Fusion System (K053418) Material Composition: Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3 Subject Device Description: The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, occipital plates and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient physiology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F136 and ISO 5832-3. To achieve the best results. unless otherwise specifically described in another Theken Spine document, do not use the Atoll OCT Spinal System components in conjunction with components from any other manufacturer. The purpose of this submission is the addition of an occipital plate.

Page 1 of 2

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Intended Use:

The Atoll OCT Spinal System is indicated to promote fusion of the occipito-cervicothoracic regions of the spine (Occiput - T3). The intended indications are as follows:

Degenerative Disc Disease (as identified by neck or back pain of discogenic origin a with degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis .
Spinal Stenosis .
Fracture/Dislocation �
. Tumors
Pseudoarthrosis .
Atlanto/axial fracture with instability �
Occipitocervical dislocation .
Revision of previous cervical and upper thoracic spine surgery .

The occipital bone screws are limited to occipital fixation only. The use of the polyaxial and standard screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. Screws are not intended for use in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Atoll OCT Spinal System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors

C. Substantial Equivalence

The characteristics of the Atoll OCT Spinal System are similar to the following predicate devices:

Atoll Cervico-Thoracic System (K070638) manufactured by Theken Spine. 1.
Mountaineer OCT Spinal System (K080828) manufactured by DePuy Spine. 2.
OC Fusion System (K053418) manufactured by Synthes Spine. প

Equivalence for the Atoll OCT Spinal System is based on similarities of intended use, design, and physical characteristics when compared to the predicate devices. Therefore, Theken Spine believes that there is sufficient evidence to conclude that the Atoll OCT Spinal System is substantially equivalent to existing legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are written in a circle around the eagle. The eagle is facing to the right and has three lines above it that represent feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Theken Spine LLC % Mr. Dale Davison 1800 Triplett Blvd Akron, Ohio 44306

MAR 2 7 2009

Re: K083863

Trade/Device Name: Theken Atoll OCT Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI, KWP Dated: December 23, 2008 Received: December 29, 2008

Dear Mr. Davison:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication We nave reviewed your Section 510(x) premainted is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regally manated povice Americal Device Ameral Food Drug commerce prof to May 20, 1976, the enaonable with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, merelore, market the device, baoject to the ments for annual registration, listing of the and general controls provisions of the Fect menate required in the manage inst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into e. Existins major regulations affecting your device. FDA It may be subject to such additional versions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of I ceeras concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised fill I DA s issualled of a substance of the other requirements of the Act
that FDA has made a determination that your device complies with other water that FDA has made a decornmanon that your correst by other Federal agencies. You must or any Federal statutes and regulations and intel to: registration and listing (21 Comply with an the Act 3 requirements, news 801); good manufacturing practice requirements as set a CFR Part 807), labeling (21 CFRT art 820); good if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Dale Davison

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to begin maineg of substantial equivalence of your device to a legally promatics notification: "The PDs 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 IT you ucate spocitie advices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (240) 270-0120. This, prease now as cogning regarding regarding postmarket surveillance, premarket nontact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket prease contact CDACT 3 Office of Day westions regarding the reporting of device adverse events Surveillance at (240) 270 317 17 17 DVD)), please contact the Division of Surveillance Systems (Medical Device Reporting (11271)), prec.org. information on your responsibilities under the at (240) 270 370 1. 1 0 a may acturers, International and Consumer Assistance At tolli the Dribion of (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

erely yours,

For Pete D Rumin mo
Dep Dir
r. N. Melkerson

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 (if known):

Device Name: Atoll™ OCT Spinal System

Indications For Use:

The Atoll OCT Spinal System is indicated to promote fusion of the occipito-cervico-thoracic regions of the spine (Occiput - T3). The intended indications are as follows:

Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
. Spondylolisthesis
Spinal Stenosis .
Fracture/Dislocation .
Tumors .
Pseudoarthrosis .
Atlanto/axial fracture with instability .
Occipitocervical dislocation .
Revision of previous cervical and upper thoracic spine surgery

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Atoll OCT Spinal System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.

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 ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Radtl

Division Sign-Off Division of Ceneral, Restorative, and Nearclogical Devices

Page 1 of 1 510(k) Number

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.