When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Ascent POCT System is indicated for:
a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
b) spondylolisthesis;
c) fracture/dislocation;
d) spinal stenosis;
e) atlanto-axial fracture with instability:
f) occipito-cervical dislocation;
g) tumors;
h) revision of previous cervical spine surgery

The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cable (titanium) System to be used with the Ascent Posterior Occipital Cervical Thoracic System allows for wire/cable attachment to the posterior cervical spine.

The Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Orthofix Spinal Fixation System using the Ascent Axial or Parallel Rod Connector.

Device Description

The Ascent® POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of Titanium and Cobalt Chrome allov that allow the surgeon to build a spinal implant construct. The system design is intended to promote immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical and for upper thoracic spine. Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and Songer Cables. Ascent POCT system can also be linked to Orthofix Spinal Fixation System (SFS) using the Ascent Axial or Parallel Rod Connector or Transition Rods.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Orthofix Ascent POCT System, a spinal fixation system. It describes the device, its intended use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices. This type of regulatory submission typically focuses on mechanical and material testing for medical devices, rather than AI/ML algorithm performance studies. As such, the specific information requested about AI/ML acceptance criteria and studies (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.

However, I can extract information related to the performance data presented in the document, which pertains to the mechanical performance of the device components.

Acceptance Criteria and Device Performance (Mechanical)

The acceptance criteria for the Orthofix Ascent POCT System are based on demonstrating substantial equivalence to predicate devices through mechanical testing in accordance with ASTM F2706-08 standards.

Characteristic	Standard / Test/ FDA Guidance	Acceptance Criterion	Reported Device Performance
Static Compression Bending	ASTM F2706-08	Substantially equivalent to predicate devices.	Test results demonstrated substantial equivalence to predicate devices with the same intended use, similar indications, technological characteristics, and principles of operation.
Static Torsion	ASTM F2706-08	Substantially equivalent to predicate devices.	Test results demonstrated substantial equivalence to predicate devices with the same intended use, similar indications, technological characteristics, and principles of operation.
Dynamic Compression Bending	ASTM F2706-08	Substantially equivalent to predicate devices.	Test results demonstrated substantial equivalence to predicate devices with the same intended use, similar indications, technological characteristics, and principles of operation.
Dynamic Torsion	ASTM F2706-08	Substantially equivalent to predicate devices.	Test results demonstrated substantial equivalence to predicate devices with the same intended use, similar indications, technological characteristics, and principles of operation.

Study Proving Device Meets Acceptance Criteria:

The study conducted was a series of non-clinical mechanical tests to evaluate the physical performance of the Orthofix Ascent POCT System components (specifically the new rods).

Sample size used for the test set and the data provenance:
- The document does not explicitly state the number of samples (e.g., number of rods tested) for each characteristic. It refers to "Test results," implying that multiple samples were likely tested as per ASTM F2706-08 standards.
- Data Provenance: The tests were conducted internally by Orthofix Inc. or contracted to a testing facility. The document doesn't specify the country of origin data beyond the submitter's address in Lewisville, TX, USA. These are laboratory-based, prospective tests for this specific submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For mechanical tests of this nature, "ground truth" is established by the standardized testing protocols (ASTM F2706-08). Expertise would lie in the engineers or technicians performing and interpreting the mechanical tests according to the standard.
Adjudication method for the test set:
- Not applicable. The "adjudication" in this context refers to whether the test results meet the predefined criteria of the ASTM standard and demonstrate substantial equivalence. This is typically a pass/fail determination based on quantitative measurements against thresholds defined by the standards or comparison with predicate device performance.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, this type of study is not applicable to the mechanical testing of a spinal fixation device. MRMC studies are typically used to evaluate the performance of diagnostic imaging or AI systems read by multiple human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable as the submission is not for an algorithm or AI system.
The type of ground truth used:
- For mechanical testing, the "ground truth" is generally the physical properties and performance of the device components as measured by calibrated equipment and according to established engineering standards (ASTM F2706-08). The benchmark for acceptance is the performance of the predicate devices.
The sample size for the training set:
- Not applicable. This is not an AI/ML study; therefore, there is no "training set."
How the ground truth for the training set was established:
- Not applicable.

Summary

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183

MAY 2 4 2011

Premarket Notification 510(k) Orthofix Inc. Orthofix Ascent POCT System

510(k) SUMMARY

Orthofix Ascent POCT System

Submitter Information
Name:	Orthofix Inc.
Address:	3451 Plano ParkwayLewisville, TX 75056
Telephone Number:	214.937.2000
Fax Number:	214.937.3322
Email:	darlachew@orthofix.com
Registration Number:	3008524126
Contact Person:	Darla ChewDirector of Regulatory Affairs
Date Prepared:	April 26, 2011
Name of Device
Trade Name / Proprietary	Ascent® Posterior Occipital Cervical Thoracic (POCT) System
Common Name:	Spinal Fixation System
Product Code:	KWP – Spinal Interlaminal Fixation Orthosis
Regulatory Classification:	Class II – 888.3050 – Spinal Interlaminal Fixation Orthosis
Review Panel:	Orthopedic Device Panel
Predicate Devices:	Blackstone Posterior Cervical System, K030197, SE 6-12-03Ascent POCT System, K080394, SE 3-13-08 (Plate and Rod Modifications)Firebird Spinal Fixation System, Cobalt Chrome Rods, K092624, SE 9-25-2009

Reason for 510(k) Submission: New product offering

Orthofix inc., 3451 Plano Parkway, Lewisville, Texas 75056 | 214-937-2061 www.orthofix.com

Pg 1 of 4

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KIIII183

Premarket Notification 510(k) Orthofix Inc. Orthofix Ascent POCT System

Device Description

Intended Use / Indications for Use

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Ascent POCT System is indicated for:

a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
b) spondylolisthesis;
c) fracture/dislocation;
d) spinal stenosis;
e) atlanto-axial fracture with instability:
f) occipito-cervical dislocation;
g) tumors;
h) revision of previous cervical spine surgery

The Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Orthofix Spinal Fixation System using the Ascent Axial or Parallel Rod Connector.

Orthofix inc., 3451 Plano Parkway, Lewisville, Texas 75056 | 214-937-2061 www.orthofix.com

Page 2 of 4

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Image /page/2/Picture/0 description: The image shows the text "Premarket Notification 510(k)" at the top, followed by "Orthofix Inc." and "Orthofix Ascent POCT System" below. The text is arranged in a centered format. The image appears to be a snippet from a document or presentation.

Summary of the Technological Characteristics of the Device Compared to the Predicate Device

Characteristic	Orthofix Ascent Rods	Ascent POCT System(K030197 & K080394)	Firebird SpinalFixation System,Cobalt Chrome Rods(K092624)
Function / Design	This system allows a surgeon to build a spinal implant construct.	This system allows a surgeon to build a spinal implant construct.	This system allows a surgeon to build a spinal implant construct.
Rod Configuration	Straight & Occipital	Straight & Occipital	Straight
Rod Sizes	Straight: 3.0 mm x 70, 120, 200 mm long; Occipital Rod	Straight: 3.0 mm x 70, 120, 200 mm long; Occipital Rod	Not relevant
Material	1) Cobalt Chrome Alloy, ASTM F15372) Titanium Alloy ASTM F136	Titanium Alloy ASTM F136	Cobalt Chrome Alloy, ASTM F1537

PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

Characteristic	Standard / Test/ FDA Guidance
Static Compression Bending Test	ASTM F2706-08
Static Torsion Test	ASTM F2706-08
Dynamic Compression Bending Test	ASTM F2706-08
Dynamic Torsion Test	ASTM F2706-08

Performance Data Summary

Mechanical testing of the Orthofix Ascent POCT System was conducted in accordance to ASTM F2706-08 standard for Static & Dvnamic Compression Bending test and ASTM F2706-08 standards for Static & Dynamic Torsion test. Test results demonstrated that the new, proposed Ascent rods are substantially equivalent to predicate devices that have the same intended use, similar indications, technological characteristics and principles of operation.

Substantial Equivalence

The Orthofix proposed Ascent rods are substantially equivalent in design, function, and intended use to the Orthofix Ascent POCT system rods. The original Ascent POCT System received 510(k) clearance under K030197 on June 12, 2003 with subsequent changes to the Ascent Occipital rod under K080394 SE March 13, 2008.

The Orthofix proposed Ascent rods are substantially equivalent in material composition to Firebird Spinal Fixation System, Cobalt Chrome Rods 510(k) K092624 (SE 9-25-2009).

Orthofix inc., 3451 Plano Parkway, Lewisville, Texas 75056 | 214-937-2061 www.orthofix.com

Pg 3 of 4

Page 3 of 4

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KIIII183

Premarket Notification 510(k) Orthofix Inc. Orthofix Ascent POCT System

The difference between the modified rods and the predicate devices consist of minor dimensional changes for the Ascent Occipital rod, and the addition of Cobalt Chrome rods. Based on test results, these changes do not present any new / additional issues of safety or effectiveness therefore; the Orthofix proposed Ascent rods (part of the Ascent POCT System) are substantially equivalent to the predicate devices.

Orthofix inc., 3451 Plano Parkway, Lewisville, Texas 75056 | 214-937-2061 www.orthofix.com

Page 4 of 4

Rs 4 of 4

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

Orthofix, Inc. % Ms. Darla Chew - - -Director of Regulatory Affairs 3451 Plano Parkway Lewisville, TX 75056

MAY 2 4 2011

Re: K111183

Trade/Device Name: Ascent Posterior Occipital Cervical Thoracic System (Titanium &

Cobalt Chrome Rods) Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: K WP Dated: April 26, 2011 Received: April 27, 2011

Dear Ms. Chew:

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. Darla Chew

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.

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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

E.S. Keith

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

Enclosure

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INDICATION FOR USE STATEMENT

510(k) Number (if known): K111183

Device Name: Ascent Posterior Occipital Cervical Thoracic (POCT) System (Titanium & Cobalt Chrome Rods)

Indications for Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Ascent POCT System is indicated for:

a. degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
b. spondvlolisthesis;
c. fracture/dislocation;
d. spinal stenosis;
e. atlanto-axial fracture with instability;
f. occipito-cervical dislocation;
g. tumors;
h. revision of previous cervical spine surgery

The Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Orthofix Spinal Fixation System using the Ascent Axial or Parallel Rod Connector.

Prescription Use: X (Part 21 CFR 801 Subpart D) And / Or

Over-The-Counter (Part 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)

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________ K ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! www.orthofix.com

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.