The Alamo T 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 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.

The device footprint has a hollow centre to accommodate bone graft to facilitate bone integration and fusion between the end plates from a transforaminal (TLIF) surgical approach. The device is available in various heights 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.

AI/ML Overview

The provided text describes the "Alamo T" intervertebral body fusion device and its regulatory submission. It focuses on demonstrating substantial equivalence to predicate devices, primarily through design, material, and mechanical testing.

There is no information in the provided document about acceptance criteria and a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or software-based medical device.

The document describes a physical medical device (an intervertebral body fusion device) and its regulatory clearance process through a 510(k) submission. This type of submission relies on demonstrating substantial equivalence to previously cleared devices (predicates) rather than establishing novel performance criteria through clinical studies in the way an AI diagnostic tool might.

Therefore, I cannot populate the requested table and answer the study-related questions as they pertain to AI or software device performance acceptance criteria and validation.

Regarding the device described (Alamo T):

The closest equivalent to "acceptance criteria" for this type of device, as indicated in the document, would be its ability to perform comparably to its predicate devices in terms of mechanical properties and material composition.

1. Table of Acceptance Criteria and Reported Device Performance (as pertains to the physical device):

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (Alamo T)
Material: PEEK Optima LT1 and Tantalum	PEEK Optima LT1 per ASTM F2026 and Tantalum markers per ASTM F560 (Same as predicates)
Mechanical Performance:	Functional as intended, showing substantial equivalence to predicate devices in:
- Static Compression	Performance results demonstrate substantial equivalence to predicates (specific values not provided, but deemed acceptable by FDA)
- Dynamic Compression	Performance results demonstrate substantial equivalence to predicates (specific values not provided, but deemed acceptable by FDA)
- Subsidence	Performance results demonstrate substantial equivalence to predicates (specific values not provided, but deemed acceptable by FDA)
- Expulsion	Performance results demonstrate substantial equivalence to predicates (specific values not provided, but deemed acceptable by FDA)
Indications for Use:	Consistent with predicate devices: DDD at one or two contiguous levels of the lumbosacral spine (L2-S1), with supplemental fixation and autograft.
Footprint/Design Features:	Blocks with one length/width, variety of heights, axial/lateral openings, rows of teeth. Radiographic markers present. (Comparible to predicates)

Regarding the study that proves the device meets the "acceptance criteria" (again, for the physical device):

The "study" or evidence provided is primarily mechanical testing and a demonstration of substantial equivalence to legally marketed predicate devices.

2. Sample size used for the test set and the data provenance:

Test Set (for mechanical testing): The document states "worst case device" was used for mechanical testing. It does not specify the exact sample size (e.g., number of devices tested for each mechanical test).
Data Provenance: Not applicable in the context of patient data. The mechanical testing would have been conducted in a laboratory setting.

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

Not applicable. Mechanical testing does not involve human expert ground truth. The "ground truth" is defined by the ASTM standards (F2077 and F2267) which specify the test methodologies and acceptable performance envelope for such devices.

4. Adjudication method for the test set:

Not applicable. Mechanical testing results are quantitative and do not require expert adjudication in the same way clinical data might. The interpretation of whether the results meet the ASTM standards and demonstrate substantial equivalence is a regulatory assessment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images, often to assess the impact of AI assistance. This document describes a physical implantable device.

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

No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

For mechanical performance: The "ground truth" is effectively the established performance thresholds and methodologies detailed in the ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Devices) and F2267 (Standard Test Method for Measuring Load-Displacement Properties of Intervertebral Body Fusion Devices) standards, against which the device's performance is compared to ensure it is within acceptable limits and comparable to predicates.
For substantial equivalence: The ground truth is the performance characteristics and indications for use of the predicate devices (Globus Medical Signature TLIF Spacer (K072970) and Genesys Spine Interbody Fusion System (K103034)).

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set of data.

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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ОСТ

5 2012

510(k) Summary

Summary of 510(k) Safety and Effectiveness

Submitted By:	Alliance Partners, LLC121 Interpark Blvd, #601San Antonio, TX 78216
Date:	July 11, 2012
Contact Person:	Jennifer PalinchikDevelopment and Regulatory Consultant
Contact Telephone:	(440) 933-8850
Device Trade Name:	Alamo T
Device Classification Name:	Intervertebral Body Fusion Device with Bone Graft,Lumbar
Device Classification:	Class II
Reviewing Panel:	Orthopedic
Regulation Number:	888.3080
Product Code:	MAX
Predicate Device:	Globus Medical Signature TLIF Spacer (K072970)Genesys Spine Interbody Fusion System (K103034)

Device Description:

Intended Use:

page 1 of 2

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Substantial Equivalence Information:

The design features, material, and indications for use of the Alamo T device are substantially equivalent to the predicate devices listed above. The safety and effectiveness is adequately supported by the substantial equivalence, material information, and analysis data provided within this Premarket Notification.

Item	Alamo T	Globus TLIF Spacer	Genesys TLIF System
Product Code	MAX	MAX	MAX, ODP, MQP
Classification Name	Intervertebral BodyFusion Device	Same	Same
Intended Use	degenerative disc disease(DDD) at one or twocontiguous levels of thelumbosacral spine (L2-S1)	Same	Same. Also intendedfor vertebral bodyreplacement
Footprint	Blocks have one lengthand width, and a varietyof heights with axial andlateral openings for bonegraft and rows of teeth.No pivoting mechanism	Blocks in a variety oflengths, widths, andheights with axial andlateral openings for bonegraft and rows of teeth.Pivoting mechanism forcontrolled articulationduring insertion	Blocks have one lengthand width, and avariety of heights withaxial and lateralopenings for bone graftand rows of teeth. Nopivoting mechanism
Graft Opening	Large axial graft window	Same plus anterior graftwindows	Same
Teeth to preventmigration	Located on superior andinferior surfaces.Pyramid pattern	Same	Same, but linear pattern
Radiographicmarkers	Yes	Yes	Yes
Axial Footprintdimensions	10 x 28mm	10 x 28mm and 11 x33mm	14 x 35mm
Device Height	8mm-14mm (1mmincrements)	7mm-17mm (1mmincrements), excluding14mm	6mm-15mm (1mmincrements)
Material	PEEK Optima LT1 andTantalum (markers)	Same	Same

Mechanical Testing:

Performance testing was conducted via the following mechanical tests per ASTM F2077 and F2267 using the worst case device: Static Compression, Dynamic Compression, Subsidence, and Expulsion. The device functioned as intended and the performance results show that the Alamo T is substantially equivalent to the predicate devices.

K120401 Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol. The logo is in black and white.

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

Alliance Partners, LLC % RP+M, LLC Ms. Jennifer Palinchik Development and Regulatory Consultant 33490 Pin Oak Parkway Avon Lake, Ohio 44012

Re: K120401

Trade/Device Name: Alamo T Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 26, 2012 Received: September 27, 2012

Dear Ms. Palinchik:

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 (reporting of medical

OCT
5 2012

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Page 2 - Ms. Jennifer Palinchik

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/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,

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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Indications for Use

510(k) Number (if known): K12 0401

Device Name: Alamo T

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K1206401

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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.