The Alamo® C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

Device Description

The Alamo C is designed for use as a cervical intervertebral body fusion device. The device is manufactured from either PEEK Optima® LT1 per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization or titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the vertebral end plates. The device is available in various axial footprints and heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges (teeth) to improve fixation and stability and prevent back out and migration.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called Alamo® C, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance data from a clinical or standalone study.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in the provided text because this is not the type of document that would typically contain such information. This 510(k) summary relies on non-clinical performance testing and comparison to predicate devices, explicitly stating that "No clinical studies were conducted."

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in the format of a table with quantitative thresholds and corresponding performance outcomes for a clinical study. Instead, it refers to performance testing conducted in accordance with specific ASTM standards to establish substantial equivalence with a predicate device.

The reported performance is qualitative:

"The results obtained demonstrate the subject Alamo C device functions as intended and is substantially equivalent to the predicate Alamo C device."

The types of tests performed were:

Static axial compression
Dynamic axial compression
Static torsion
Subsidence
Expulsion

These are non-clinical/bench testing results, not clinical performance metrics. The underlying acceptance criteria for these tests would be the pass/fail criteria defined within the referenced ASTM standards (ASTM F2077, ASTM F2267, and ASTM Draft Standard F-04.25.02.02) and likely internal company specifications for equivalence to the predicate.

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified in the document. This typically refers to the number of devices tested in the non-clinical performance evaluations.
Data Provenance: The tests were conducted internally or by a contracted lab as part of the 510(k) submission process for the new titanium version of the Alamo® C device. It's not "data provenance" in the sense of clinical patient data (e.g., country of origin, retrospective/prospective), as no clinical studies were conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as no clinical study was conducted that would require expert-established ground truth for patient outcomes or image annotations. The "ground truth" for the non-clinical tests would be the established scientific principles of mechanical testing and material properties as defined by the ASTM standards.

4. Adjudication method for the test set

Not applicable for non-clinical performance testing.

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 device is an intervertebral body fusion device, not an imaging AI diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is a physical medical implant, not an algorithm.

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

For the non-clinical performance tests, the "ground truth" is based on the engineering principles, material science, and mechanical testing standards (ASTM F2077, ASTM F2267, and ASTM Draft Standard F-04.25.02.02). The performance of the new device was compared to the predicate device, implying that the predicate's established performance served as a benchmark for equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a training set.

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

Not applicable.

Summary

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March 22, 2018

Alliance Partners, LLC Kristiina Gilkey QA/RA Manager 14206 Northbrook Drive San Antonio, Texas 78232

Re: K173128

Trade/Device Name: Alamo® C Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 16, 2018 Received: February 20, 2018

Dear Ms. Gilkey:

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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -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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Indications for Use

510(k) Number (if known)

K173128

Device Name Alamo® C

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter 5.1

Company:	Alliance Partners, LLC (dba Alliance Spine)
	14206 Northbrook Drive
	San Antonio, Texas 78232
Phone:	210-314-2525
Fax:	210-314-2524
Contact Person:	Kristiina Gilkey
Date Prepared:	March 21, 2018

5.2 Device

Name of Device:	Alamo® C
Common Name:	Intervertebral body fusion device, Cervical
Classification Name:	Intervertebral body fusion device (21 CFR 888.3080)
Regulatory Class:	Class II
Product Code:	ODP
Review Panel:	Orthopedic

5.3 Predicate Device

Primary Predicate: Alamo® C [K133321 & K112361] Additional Predicates: Life Spine Small PLATEAU® (PLATEAU-C Ti) Spacer System [K161127] Rhausler Plage™ Anterior Cervical Fusion System [K111272] Alliance Partners Nakoma® ACP [K141993]

5.4 Reason for 510(k) Submission

The purpose of this submission is to expand the Alamo C Interbody Fusion System to include a version of intervertebral body fusion devices manufactured from titanium. This modification does not affect the device's intended used or alter the device's fundamental scientific technology.

5.5 Device Description

5.6 Indications for Use

The Alamo C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is

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defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment prior to treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

5.7 Comparison of Technological Characteristics with Predicate Device

The subject Alamo C has the same intended use and similar technological characteristics to the predicate Alamo C in terms of design, dimension, function, and performance characteristics. There are no significant differences between the devices which would adversely affect the use of the product.

Additionally, the subject Alamo C devices are fabricated from similar materials of construction as the predicate Small Plateau-C Ti device, Plage device, and Nakoma ACP device.

5.8 Performance Data / Non-clinical Tests

Performance testing was conducted on the subject Alamo C device in accordance with ASTM F2077, ASTM F2267, and ASTM Draft Standard F-04.25.02.02 to establish substantial equivalency with the predicate Alamo C device. Testing included static axial compression, dynamic axial compression, static torsion, subsidence, and expulsion. The results obtained demonstrate the subject Alamo C device functions as intended and is substantially equivalent to the predicate Alamo C device.

5.9 Clinical Tests

No clinical studies were conducted.

5.10 Conclusions

Submitted data demonstrates that the subject Alamo C device is substantially equivalent to the predicate devices with regard to intended use, indications for use, design, performance, materials and technological characteristics.

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.