SHELL Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. SHELL Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. SHELL Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The WAVE/LOOP Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. WAVE implants are to be used with autogenous bone graft and implanted via an open posterior approach. The WAVE Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The SHELL was especially adapted to the local anatomy in order to secure the surgical result as possible. Its caudal side is flat, its cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. The A/P view is trapezoidal. There are x-ray pins at the four edges, which slightly protrude the cage in order to maximize rotational fixation.

The LOOP is a banana-shaped implant with optimized tip design and an integrated swivel joint for the instrument fixation. Both factors facilitate the implantation. The radial orientated fixation teeth define the direction of implantation and secure the implant position. LOOP is shaped with a 6° lordosis.

The WAVE is rectangular in shape. Cross section is trapezoidal with the lateral side 1mm higher than the medial. WAVE has a neutral and a 6° lordosis. The posterior end has a threaded hole for attaching insertion instruments, while the other end is solid and tapered. The WAVE cages are implanted in pairs.

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)

Function: The SHELL Cage was developed as an intercorporal implant for anterior cervical spondylodesis. The WAVE Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Posterior Lumbar Interbody Fusion (PLIF). The LOOP Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Transforaminal Lumbar Interbody Fusion (T-LIF).

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study for the AMT Interbody Fusion Devices:

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical trial report with specific acceptance criteria in the context of diagnostic performance or clinical outcomes. The "acceptance criteria" here refer to mechanical strength and similarity to predicate devices, not AI/algorithm performance.

Description of Acceptance Criteria and Study

The AMT Interbody Fusion Devices (SHELL, WAVE, LOOP Cages) demonstrate their suitability for market by undergoing nonclinical bench testing to demonstrate mechanical strength and by establishing substantial equivalence to previously cleared predicate devices. The "acceptance criteria" primarily revolve around meeting established mechanical standards for interbody fusion devices and demonstrating that the device's technological characteristics, indications for use, and materials are comparable to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Material Compliance	PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification)	The devices are made of PEEK-OPTIMA LT1 polymer, which complies with ASTM F2026.
Mechanical Strength	ASTM F2077/F2267 (Standard Test Methods for Intervertebral Body Fusion Devices)	The devices "meet required mechanical strengths" as indicated by tests performed according to ASTM F2077/F2267. Specific numerical targets or results are not provided but are stated to be met.
Indications for Use (Substantial Equivalence)	Same indications as previously cleared devices.	The SHELL, WAVE, and LOOP Cages have indications for use that are either identical or substantially similar to the predicate devices (e.g., DDD at specific spinal levels, use with autograft bone, supplemental fixation, non-operative treatment duration).
Design/Technology (Substantial Equivalence)	Similar designs and materials as previously cleared devices.	The devices are described as having "similar designs" and the "same material" (PEEK-OPTIMA LT1) as predicate devices. Variations in geometry (e.g., SHELL, LOOP, WAVE shapes) are acknowledged but deemed acceptable in comparison to predicates.

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

This document describes a pre-market notification (510(k)) for a medical device that is a physical implant, not an AI/software device. Therefore, the concept of a "test set" and "data provenance" as typically applied to AI performance studies does not directly apply here.

Test Set: Not applicable in the context of AI/algorithm performance. The "test" involved ex-vivo mechanical testing of the physical implant devices. The sample size for these mechanical tests (e.g., number of devices tested for ASTM F2077/F2267) is not specified in the summary.
Data Provenance: Not applicable in the context of AI/algorithm performance. The "data" comes from bench testing of the physical medical devices.

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

Not applicable. This device is a physical implant, and its performance is evaluated based on engineering and material standards (e.g., ASTM standards) through mechanical testing, not through expert-labeled ground truth for an algorithm.

4. Adjudication Method for the Test Set

Not applicable. There is no human annotation or adjudication process described for the mechanical testing of a physical implant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical interbody fusion device.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

No, a standalone performance study (in the context of an algorithm) was not done. This document pertains to a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for the device's technical performance is based on established engineering standards and material specifications. Specifically:

Mechanical Integrity: Compliance with ASTM F2077/F2267 as objective, quantitative benchmarks for intervertebral body fusion devices.
Material Composition: Conformance to ASTM F2026 for PEEK-OPTIMA LT1 polymer.
Substantial Equivalence: Comparison to the known characteristics (indications, materials, design principles) of existing, legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. Since there is no training set for an AI algorithm, there is no ground truth established for it.

Summary

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K080401

510(k) Summary for the AMT Interbody Fusion Devices

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the AMT Interbody Fusion Devices.

Date Prepared: February 12, 2008

1. Submitter:
  Advanced Medical Technologies AG Kasteler Strasse 11 66620 Nonnweiler-Braunhausen Germany

Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199

2.	Trade name:	SHELL/WAVE/LOOP Cages
	Common Name:	intervertebral body fusion device
	Classification Name:	intervertebral body fusion device - cervical
		Intervertebral body fusion device - lumbar
		21 CFR section 888.3080
		ODP/MAX
		Class II

Predicate or legally marketed devices which are substantially equivalent: ന്ന്

BAK/C Vista Interbody Fusion peek-optima It1, Zimmer Spine, Inc (P980048 S003) �
. BRANTIGEN I/F CAGE, DePuy Spine Inc, (P960025)
. PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE (K072120)

4. Description of the device:

Materials:

PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)

Function:

The SHELL Cage was developed as an intercorporal implant for anterior cervical spondylodesis.

The WAVE Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Posterior Lumbar Interbody Fusion (PLIF).

The LOOP Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Transforaminal Lumbar Interbody Fusion (T-LIF).

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Page 2 of 2

Intended Use:

The WAVE/LOOP Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. WAVE implants are to be used with autogenous bone graft and implanted via an open posterior approach. The WAVE Cage is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

Comparison of the technological characteristics of the device to predicate and legally marketed devices: പ്പ The AMT Interbody Fusion devices have the same indications and material, and similar designs as
previously cleared devices.

Summary of Nonclinical Tests 6.

Tests performed according to ASTM F2077/F2267 indicate that the AMT Interbody Fusion devices meet required mechanical strengths. Some of the predicate devices have a different geometry than the AMT Interbody Fusion devices and do not have some test results reported in their PMA summaries, therefore, additional acceptance values for testing will be utilized.

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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 consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2008

Advanced Medical Technologies, AG % Mr. J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681

Re: K080401

Trade/Device Name: SHELL, WAVE and LOOP Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, ODP Dated: February 12, 2008 Received: February 14, 2008

Dear Mr. Webb:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K08040

Device Name:

Indications for Use:

The WAVE Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. WAVE implants are to be used with autogenous bone graft and implanted via an open posterior approach. The WAVE Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Ogden for rkn
Division Sign Off

Division of General. Restora and Neurological Devices

510(k) Number K040401

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Indications for Use

510(k) Number (if known): _ KO8040 B

Device Name: LOOP Cage

Indications for Use:

The LOOP Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. LOOP implants are to be used with autogenous bone graft and implanted via an open posterior approach. The LOOP Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Oslen for mam

Division of General, Restora and Neurological Device

510(k) Number K080401

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Indications for Use

510(k) Number (if known): _ K080 40

Device Name:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Yuil R.P. Ogden for mkm

Division of General, Restorative. and Neurological Devices

510(k) Number

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.