The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-Sl) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment.

The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft and requires no additional supplementary fixations. One device is used per intervertebral space.

Device Description

The Optimus Anterior Lumbar Interbody Fusion (ALIF) system is a zero profile stand-alone interbody that combines the benefits of an anterior fixation plate and fusion device. Optimus is a modular design that consists of a center fixation plate, lordotic end caps and three bone screws for anterior fixation and stability. The bone screws thread into the fixation plate and pass through the superior and inferior openings of the end caps to fixate the implant with the adjacent vertebral bodies. The device is available in two footprints, multiple heights, lordotic angles and screw lengths.

AI/ML Overview

The provided text describes a medical device, the OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System, and its performance testing to demonstrate substantial equivalence to predicate devices. It does not contain information about an AI/ML powered device, nor does it detail a clinical study with human readers or ground truth established by experts in the context of diagnostic accuracy.

Therefore, many of the requested categories are not applicable to the provided document.

Here's an analysis based on the information provided, with "N/A" for sections not covered by the text:

Acceptance Criteria and Device Performance

The device's performance was evaluated through mechanical testing to demonstrate substantial equivalence to previously cleared predicate devices. The acceptance criteria were implicit in establishing mechanical superiority or equivalence to these predicates.

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Static Compression	Mechanically superior or equivalent to predicate devices (Pillar SA and Pathway AVID) as per ASTM F2077.	Superior: The Optimus device demonstrated to be mechanically superior in static compression compared to the predicate devices.
Static Compression Shear	Mechanically superior or equivalent to predicate devices (Pillar SA and Pathway AVID) as per ASTM F2077.	Superior: The Optimus device demonstrated to be mechanically superior in static shear compared to the predicate devices.
Static Torsion	Mechanically superior or equivalent to predicate devices (Pillar SA and Pathway AVID) as per ASTM F2077.	Superior: The Optimus device demonstrated to be mechanically superior in static torsion compared to the predicate devices.
Dynamic Compression	Mechanically superior or equivalent to predicate devices (Pillar SA and Pathway AVID) as per ASTM 2077.	N/A (Superiority/Equivalence not explicitly stated for Dynamic Compression alone, but included in overall statement of mechanical testing)
Dynamic Compression Shear	Mechanically superior or equivalent to predicate devices (Pillar SA and Pathway AVID) as per ASTM 2077.	N/A (Superiority/Equivalence not explicitly stated for Dynamic Compression Shear alone, but included in overall statement of mechanical testing)
Subsidence	Mechanically equivalent to predicate devices (Pillar SA and Pathway AVID) as per ASTM F2267.	Equivalent: The Optimus device demonstrated to be mechanically equivalent in subsidence compared to the predicate devices.
Expulsion	Mechanically equivalent to predicate devices (Pillar SA and Pathway AVID) as per ASTM F04.25.02.02 (Draft standard).	Equivalent: The Optimus device demonstrated to be mechanically equivalent in expulsion compared to the predicate devices.
Overall Comparison	Substantial equivalence to predicate devices in material, design, indications for use, and performance characteristics.	Documentation provided to demonstrate substantial equivalence to predicate devices in terms of material, design, indications for use, and performance characteristics, supported by mechanical testing.

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. Mechanical testing typically involves a number of samples to ensure statistical validity, but the exact number isn't mentioned in this summary.
- Data Provenance: The data comes from mechanical testing performed on the physical device components and predicate devices, so it's laboratory-generated data, 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:
- N/A. The performance data is based on mechanical testing according to established ASTM standards, not on expert-adjudicated ground truth as would be used for AI/ML diagnostic devices. The "ground truth" here is the objective measurement of mechanical properties.
Adjudication method for the test set:
- N/A. Not applicable as this is mechanical testing, not a diagnostic study requiring expert adjudication.
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:
- No. This is not an AI-powered device, nor is it a diagnostic imaging device that would typically involve human readers. Therefore, an MRMC study and effects on human reader performance are not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical implant, not an algorithm. Therefore, standalone algorithm performance is not applicable.
The type of ground truth used:
- Physical Measurement/Standardized Testing Results: The "ground truth" for this device's performance is derived from objective physical measurements obtained through standardized mechanical testing (e.g., force, displacement, torque) performed in accordance with ASTM standards. The comparison is against previously cleared predicate devices' mechanical properties.
The sample size for the training set:
- N/A. This is a physical medical device, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for this type of device.

Summary

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APR 1 1 2014

510(k) Summay

Date Prepared

April 11th, 2014

Name of Firm

Custom Spine, Incorporated 9 Campus Drive Parsippany, NJ 07054 Phone: (973) 808-0019 Fax: (973) 808-0707

Official Correspondent

Hanaa Shahin Regulatory Affairs and Quality Assurance 9 Campus Drive Parsippany, NJ 07054 Phone: (973) 265-5042 Fax: (973) 770-7746 E-mail: hanaas@customspine.com

Establishment Number

3005129649

Device Name

Legally Marketed Trade Name: (Proposed) OPTIMUS Common Name: Lumbar stand-alone intervertebral body fusion device Device Classification: Class II Regulation Number: 21 CFR 888.3080 Device Product Codes: OVD

Predicate Devices

Custom Spine's Pathway AVID (K111726, K090566), Orthofix's Pillar SA (K081849), Spinal USA Vault (K130445, K103369), Spinal Elements Lucent (K110632), X-Spine's Calix (K112036)

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Device Description

OPTIMUS: Device Characteristics
FootprintL x W (mm)	25 x 3229 x 36
Lordotic Angles (deg)	6, 10, 14
Heights (mm)	9-13 (Posterior)
Number of Bone Screws	3
Bone Screw Diameter (mm)	5.0
Bone Screw Lengths	24-32

Indications for Use

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Materials

The following materials are used in the Optimus system:

Fixation Plates are manufactured from titanium (Ti-6Al-4V, ASTM F136) .
. End Caps are manufactured from PEEK Optima LT1 (Polyetheretherketone, ASTM F2026) and titanium (Ti-6Al-4V, ASTM F136) and are coated with plasma sprayed CP-titanium (ASTM F1580)
. Bone Screws are manufactured from titanium (Ti-6Al-4V, ASTM F136)

Performance Data

Testing was performed in accordance to the following standards:

Static Compression as per ASTM F2077
. Static Compression Shear as per ASTM F2077
. Static Torsion as per ASTM F2077
. Dynamic Compression as per ASTM 2077
. Dynamic Compression Shear as per ASTM 2077
Subsidence as per ASTM F2267
. Expulsion as per ASTM F04.25.02.02 (Draft standard)

The Optimus device demonstrated to be mechanically superior in static compression, static shear, and static torsion, compared to the previously cleared predicate devices (Pillar SA and Pathway AVID). Additionally, the Optimus device demonstrated to be mechanically equivalent in subsidence and expulsion, compared to the previously cleared predicate devices (Pillar SA and Pathway AVID)

Substantial Equivalence Statement

Documentation is provided to demonstrate that the OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is substantially equivalent to its predicate devices in terms of its material, design, indications for use, and performance characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 11, 2014

Custom Spine, Incorporated Ms. Hanaa Shahin Regulatory Affairs and Quality Assurance 9 Campus Drive Parsippany, New Jersey 07054

Re: K132596

Trade/Device Name: OPTIMUS Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: March 6, 2014 Received: March 10, 2014

Dear Ms. Shahin:

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 ffor 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 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

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Page 2 – Ms. Hanaa Shahin

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/McdicalDevices/Safetv/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Ronald-P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Section VI. INDICATIONS FOR USE STATEMENT

K132596 510(K) NUMBER: _______________________________________________________________________________________________________________________________________________________________

DEVICE NAME: _ _ _ _ _ OPTIMUS

Intended Use/Indications for Use

The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-SI) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment.

The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft, and requires no additional supplementary fixations. One device is used per intervertebral space.

Prescription Use × (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 Center for Devices and Radiological Health (CDRH)

- Dmitriev

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.