The Alamo T device is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.

Device Description

The Alamo T device is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. Supplemental fixation and autograft is required to facilitate fusion.

The device footprint has a hollow center to accommodate bone graft and is implanted via a transforaminal (TLIF) surgical approach. The device is available in various heights and lengths to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.

The purpose of this submission is to introduce a range of line extension sizes and make dimensional modifications to the implants and inserter instrument. The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Alamo T Intervertebral Body Fusion Device." This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as the predicate. In such submissions, the acceptance criteria and study data are presented somewhat differently than for a novel device undergoing clinical trials.

Here's an analysis based on the provided text, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission asserting substantial equivalence (SE) for modifications to an existing device and new sizes, the "acceptance criteria" are intrinsically tied to demonstrating that the new device performs similarly to, or no worse than, the predicate device, especially concerning mechanical and biological integrity. The performance is assessed against the established safety and efficacy of the predicate, rather than novel clinical endpoints.

Acceptance Criteria Category	Specific Criterion (Implied/Explicit)	Reported Device Performance and Methods
Mechanical Integrity & Safety (No new worst-case)	1. Changes in size and design modifications (e.g., new footprints, heights) do not adversely affect the mechanical stability, strength, or fatigue resistance of the implant compared to the predicate device. 2. The device's ability to maintain structural stability at the fusion site following discectomy is preserved. 3. The risk of migration or back-out is not increased.	"Finite element analysis and engineering rationale were used to demonstrate that the modifications and new sizes did not present a new worst case and that no additional testing was necessary." The FMEA (Failure Modes and Effects Analysis) would identify potential failure modes due to changes and assess their mitigation. The engineering rationale would involve comparing the mechanical characteristics of the new sizes/designs to the predicate, likely using established biomechanical principles and potentially referencing existing test data for the predicate. Specific performance metrics (e.g., stiffness, compressive strength, torsional stability) against a target (e.g., "equal to or greater than predicate") are implied but not explicitly stated in this summary.
Biocompatibility & Material Safety	The materials used (PEEK Optima® LT1 and Tantalum markers) are biocompatible and safe for long-term implantation, consistent with established materials in the predicate devices and per relevant ASTM standards.	The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. These are the same materials as the predicate. This reliance on established materials compliant with ASTM standards implies biocompatibility and material safety are met. No new testing explicitly detailed, relying on existing material characterization.
Functional Equivalence (Graft Accommodation, Fixation)	1. The hollow center accommodates bone graft effectively. 2. Inferior and superior surfaces with ridges ("pyramid pattern" and "teeth") improve fixation and stability and prevent back-out and migration. 3. Graft volume and window size are adequate and comparable to appropriate predicates.	"The device footprint has a hollow center to accommodate bone graft..." and "the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration." The document states: "Sythes OPAL was used as a predicate for graft volume and Surgical Supplies-Biolign was used as a predicate for graft windows." This indicates comparison to established functional benchmarks in similar devices. New sizes were validated using Life Spine's PLATEAU system as a "dimensional predicate." The "Teeth" feature is also compared to the predicate Alamo T.
Indicated Use & Clinical Application	The device performs its intended function for spinal fusion in skeletally mature patients with DDD at L2-S1, requiring supplemental fixation and autograft, implanted via a transforaminal approach, without altering the fundamental scientific technology or increasing risks.	"The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology." The "Indications for Use" statement is identical to the predicate (K120401). This statement implicitly confirms that the device is expected to perform equivalently in a clinical setting based on its design and material similarity and validated mechanical properties. No clinical testing was required to demonstrate substantial equivalence, implying the modifications are considered minor enough not to necessitate new human studies.
Sterilization & Radiographic Visualization	1. Sterilization method (steam by end user) is effective and validated. 2. Tantalum markers allow for adequate radiographic visualization.	Sterilization: "End User (Steam)" - stated to be the same as the predicate. Radiographic Markers: "Yes" - stated to be the same as the predicate. The use of ASTM F560 compliant tantalum implies established radiographic visibility.

Note: For 510(k) clearances, "acceptance criteria" are not always explicit performance thresholds like in a clinical trial. Instead, they are often about demonstrating that the modifications do not introduce new safety concerns or alter the fundamental technology such that the device is no longer substantially equivalent to a legally marketed predicate. The "study" described is primarily non-clinical: FMEA, FEA, and engineering rationale based on predicate comparisons.

Study Details from the Document:

Due to the nature of this 510(k) submission (a line extension with dimensional modifications), the "study" described is primarily non-clinical.

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

Test Set Sample Size: Not applicable. No physical "test set" of devices was used for direct comparative bench testing in the provided summary for performance. The "test set" here refers to the new sizes and dimensional modifications themselves that were analyzed via FMEA, FEA, and engineering rationale.
Data Provenance: The data provenance is internal engineering analysis and comparison to existing data/specifications of predicate devices. This is not external patient data (e.g., country of origin). The evaluation is based on component-level design and material properties. The analysis is prospective in the sense that it's evaluating the proposed changes before marketing, but it leverages retrospective data/knowledge from predicate devices.

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

Number of Experts: Not specified. "Engineering rationale" implies input from qualified engineers or biomechanical experts within the manufacturer's team or consultants.
Qualifications: "Quality and Regulatory Consultant" (Kellen Hills) and "Frank Morris (Alliance Partners, LLC)" are listed as contact persons. The FMEA and FEA would be conducted by engineers with relevant expertise (e.g., mechanical engineering, biomechanics). Specific qualifications are not detailed beyond their roles.

4. Adjudication Method for the Test Set:

Not applicable as there was no independent clinical or expert review of a "test set" of cases. The assessment was internal through FMEA and FEA. This is a technical assessment rather than a clinical adjudication process.

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

No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This type of study is for evaluating human performance influenced by a diagnostic aid (AI), which is not the nature of this interbody fusion device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical medical implant, not an algorithm or AI system. Therefore, "standalone performance" in the context of AI does not apply. The "standalone" performance here relates to the mechanical properties of the device itself, which were evaluated via FEA and engineering rationale, not algorithms.

7. The Type of Ground Truth Used:

For the non-clinical assessment, the "ground truth" is a combination of:
- Established mechanical properties and design specifications of the predicate devices.
- Biomechanical principles and engineering calculations.
- Regulatory standards (e.g., FDA's 2007 Special Controls guidance for Intervertebral Body Fusion Devices, ASTM F2026 for PEEK, ASTM F560 for Tantalum).
- Clinical experience and safety profiles of the predicate devices (implied by their prior clearance and market use).

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of an algorithm or AI system for a physical implant device submission like this. If we consider analogous concepts, the "training" for demonstrating substantial equivalence comes from the extensive historical data, design principles, and performance of existing predicate devices, which allows for leveraging FMEA/FEA rather than requiring de novo testing.

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

Not applicable. As there is no training set as understood in AI/algorithm development, the concept of establishing ground truth for it doesn't apply. The device's "ground truth" (its safety and effectiveness claim) is based on its similarity to legally marketed devices whose safety and effectiveness have already been established through prior regulatory review and clinical use.

Summary

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· K140303 Page 1 of 3

[As Required by 21 CFR 807.92]

Submitted By: (a)(1)

Phone: Fax:

Date:

Contact Persons Primary: Secondary:

(a)(2) Proprietary Name: Common Name:

Classification Name and Reference:

Product Code:

(a)(3) Predicate Devices: Alliance Partners, LLC 14206 Northbrook Dr. San Antonio, TX 78232 210-314-2525 210-314-2524

Feb 4, 2014/March 31, 2014

Kellen Hills (Orchid Design Consulting) Frank Morris (Alliance Partners, LLC)

Alamo T Interbody Fusion Device Intervertebral body fusion device with bone graft, lumbar 21CFR 888.3080 – Intervertebral body fusion device MAX

Allliance Partners-ALAMO T (K120401) Life Spine-PLATEAU (K111569) Synthes-OPAL (K072791) Surgical Supplies-Biolign (K130274)

Device Description: (a)(4)

Indications for Use: (a)(5)

The Alamo T device is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-

APR 2 1 2014

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S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.

(a)(6) Technological Characteristics:

The fundamental scientific technology remains unchanged between the subject and predicate Alamo T devices. Both are interbody devices, designed to contain autograft material and utilize ancillary fixation in order to achieve fusion between two vertebrae. Both subject and predicate devices are made from PEEK with tantalum markers and incorporate teeth on the inferior and superior surfaces to aid in fixation. Both devices utilize instrumentation common to spinal fusion surgery.

Additionally, Life Spine's PLATEAU system was used as a dimensional predicate to validate the new footprints and heights of the subject Alamo T. Sythes OPAL was used as a predicate for graft volume and Surgical Supplies-Biolign was used as a predicate for graft windows. See table below for a comparison of the subject and predicate devices.

	Subject Device	Predicate Devices
	Alamo T	Alamo T (K120401)	PLATEAU (K111569)
Product Code	MAX	Same
Classification	888.3080	Same
Indications/Intended use	See Sec (a)(5)	Same
Materials	PEEK Optima LT1 andTantalum (markers)	Same
Graft Opening	Large axial window	Same
Teeth	Superior and Inferiorsurfaces. Pyramid pattern.	Superior andInferior surfaces.Pyramid patternand ridge
RadiographicMarkers	Yes	Same
Footprint	11mm x 28mm x 0°lordosis11mm x 32mm x 0°lordosis	11mm x 28mm x 0°lordosis	11mm x 27mm x 0°lordosis11mm x 32mm x 0°lordosis
Height	6-14mm (11x28)8-14mm (11x32)	8-14mm	6-14mm (11x27)8-14mm (11x32)
Sterilization	End User (Steam)	Same

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(b)(1) Non-clinical testing:

A failure modes and effects analysis was conducted to evaluate the impact of the design changes. Consideration was also given to FDA's 2007 Special Controls guidance "Intervertebral Body Fusion Devices". Finite element analysis and engineering rationale were used to demonstrate that the modifications and new sizes did not present a new worst case and that no additional testing was necessary.

(b)(2) Clinical testing:

Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.

(b)(3) Conclusions:

Based on the information provided in this premarket notification, we believe that the subject Alamo T device and associated instrumentation demonstrates substantial equivalence to the identified predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is rendered in black, and the text is also in black.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 21, 2014

Alliance Partners, LLC % Orchid Design Mr. Kellen Hills Quality and Regulatory Consultant 4600 East Shelby Drive. Suite 1 Memphis. Tennessee 38118

Re: K140303

Trade/Device Name: Alamo T Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 31, 2014 Received: April 1. 2014

Dear Mr. Hills:

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. Iisting 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 - Mr. Kellen Hills

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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/ResourcesforYou/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/MedicalDevices/Safety/Reportal?roblem/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/ResourcesforYou/Industrv/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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Indications for Use

510(k) Number (if known) K140303

Device Name

Alamo T Intervertebral Body Fusion Device

Indications for Use (Describe)

The Alamo T device is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.

Type of Use (Select one or both, as applicable)

2 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 A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anton E. Dmitriev. PhD

Division of

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*Do Not send your completed form to the PRA STAFF EMAIL ADDRESS BELOW."

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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.