The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous bone graft in patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft and are intended for bilateral placement in the lumbar spine. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Device Description

The subject TELAMON® PEEK Spinal System consists of vertebral body spacers which can be inserted between two lumbar or lumbo-sacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implant allows them to be packed with autogenous bone graft material. The TELAMON® PEEK Spinal System also includes instrumentation that enables the surgeon to implant the devices via an open or a minimally invasive posterior approach. The device sizes are available in various height and lordotic angle options. The implant devices are manufactured from medical grade polyetheretherketone (PEEK - OPTIMA® LT1) per ASTM F2026 and also contain tantalum markers per ASTM F-560 so that the position of the implant can be determined on X-ray or other imaging.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the TELAMON® PEEK Spinal System, focusing on acceptance criteria and supporting studies:

This document is a 510(k) summary for a medical device (TELAMON® PEEK Spinal System). It does not contain information about an AI/ML powered device or a clinical study in the typical sense of evaluating diagnostic accuracy or clinical outcomes through human-in-the-loop or standalone AI performance.

Instead, this 510(k) is for an interbody fusion device, which is a physical implant. The "performance data" and "acceptance criteria" discussed relate to the mechanical properties and safety of the implant, demonstrating its equivalence to existing predicate devices.

Therefore, many of the requested fields pertinent to AI/ML device evaluations (like sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.

I will provide the information that is available in the document regarding its performance criteria and the study that proves it meets them.

Acceptance Criteria and Device Performance for TELAMON® PEEK Spinal System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance
Mechanical Performance	Static compression (per ASTM F2077-03)	"Results... were found to be substantially equivalent to legally marketed devices."
	Dynamic compression (per ASTM F2077-03)	"Results... were found to be substantially equivalent to legally marketed devices."
	Static compression shear (per ASTM F2077-03)	"Results... were found to be substantially equivalent to legally marketed devices."
	Dynamic compression shear (per ASTM F2077-03)	"Results... were found to be substantially equivalent to legally marketed devices."
Subsidence Performance	Subsidence (per ASTM F2267-04)	"Results... were found to be substantially equivalent to legally marketed devices."
Material Equivalence	Device manufactured from medical grade PEEK (PEEK - OPTIMA® LT1) per ASTM F2026	"The devices are manufactured from the same material..." (in comparison to predicates)
Radiographic Visibility	Contains tantalum markers per ASTM F-560	"so that the position of the implant can be determined on X-ray or other imaging."
Design Equivalence	Shape, size, and footprint range similar to predicates	"The device designs are similar in shape, size, and footprint range."
Intended Use Equivalence	Same intended use as predicates	"The devices share the same intended use."
Sterilization Equivalence	Same sterilization methods as predicates	"...and undergo the same sterilization methods."

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

Sample Size: Not specified for individual tests. The studies were "pre-clinical studies conducted using worst case TELAMON® devices." This implies a limited number of devices were tested to represent the product line.
Data Provenance: The studies are pre-clinical (laboratory-based mechanical testing), not human or patient data. Therefore, country of origin or retrospective/prospective distinctions are not applicable in the typical sense.

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

Not Applicable. The "ground truth" here is the pass/fail criteria of standardized ASTM mechanical tests, not a clinical diagnosis or interpretation requiring expert consensus. The "experts" would be the engineers and technicians conducting the tests and performing the analysis according to the ASTM standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. This refers to clinical study data adjudication. The mechanical tests follow specific ASTM protocols. Adherence to these protocols is self-contained within the test methodology.

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 is a physical implant, not an AI/ML diagnostic or assistive device.

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

Not Applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used:

For mechanical performance: The ground truth implicitly refers to the specified performance requirements and acceptance limits defined by the ASTM standards (F2077-03 and F2267-04) for interbody fusion devices, as well as comparison to the performance of legally marketed predicate devices. The "ground truth" is that the device must meet or exceed the performance of the predicate devices under these standardized tests.

8. The sample size for the training set:

Not Applicable. There is no "training set" in the context of an AI/ML model for this physical medical device.

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

Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant to this device submission.

Summary of the Study Proving Acceptance Criteria:

The "study" that proves the TELAMON® PEEK Spinal System meets its acceptance criteria consists of pre-clinical mechanical and material testing. Specifically, the submission states:

"The following pre-clinical studies were conducted using worst case TELAMON® devices: static and dynamic compression; and static and dynamic compression shear per ASTM F2077-03; and subsidence per ASTM F2267-04."

The results of these tests, when compared to legally marketed predicate devices, demonstrated that the TELAMON® PEEK Spinal System was "substantially equivalent." This substantial equivalence, based on similar design, materials, intended use, and comparable mechanical test results, formed the basis for its 510(k) clearance by the FDA. The acceptance criterion was primarily meeting comparable performance to already-cleared predicate devices under standardized engineering tests, thereby demonstrating similar safety and effectiveness.

Summary

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K110562 Page 1 of 2

NOV - 9 2011

TELAMON® PEEK Spinal System Interbody Fusion Device 510(k) Summary February 2011

Medtronic Sofamor Danek I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Regina Holmes Contact: Senior Regulatory Affairs Specialist

II. Proprietary Trade Name: TELAMON® Spinal System

Classification Name: Intervertebral Fusion Device with Bone Graft, Lumbar

Product Code: MAX (21 CFR 888.3080)

Common Name: Interbody Fusion Device

III. Product Description

The device sizes are available in various height and lordotic angle options. The implant devices are manufactured from medical grade polyetheretherketone (PEEK - OPTIMA® LT1) per ASTM F2026 and also contain tantalum markers per ASTM F-560 so that the position of the implant can be determined on X-ray or other imaging.

IV. Indications for Use

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These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft and are intended for bilateral placement in the lumbar spine. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

V. Performance Data

The following pre-clinical studies were conducted using worst case TELAMON® devices: static and dynamic compression; and static and dynamic compression shear per ASTM F2077-03; and subsidence per ASTM F2267-04. The results of these studies were found to be substantially equivalent to legally marketed devices.

VI. Substantial Equivalence

Documentation was provided which demonstrated that the subject device is substantially equivalent to the following currently marketed devices: VERTE-STACK® Spinal System (K031780); CAPSTONE® Spinal System (K073291); CRESCENT™ Spinal System (K094025); LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015); RA Y® Threaded Fusion Cage (P950019); and Brantigan Lumbar I/F CAGE® (P960025).

VII. Conclusion

When compared to the predicate devices, it was determined that the subject device is substantially equivalent based on the following factors:

. The device designs are similar in shape, size, and footprint range.
. The devices share the same intended use.
The devices are manufactured from the same material and under go the same . sterilization methods.
The results of mechanical testing are comparable to the predicates and demonstrate . that the subject device is as safe and effective as other legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

NOV - 9 2011

Medtronic Sofamor Danek % Ms. Regina Holmes Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K110562

Trade/Device Name: TELAMON® PEEK Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 13, 2011 Received: October 14, 2011

Dear Ms. Holmes:

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

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Page 2 - Ms. Regina Holmes

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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Eiriel Keith

-fo 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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510(k) Number (if known): K110562

Device Name: TELAMON® PEEK Spinal System

Indications for Use:

The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous bone graft in patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft and are intended for bilateral placement in the lumbar spine. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Prescription Use × (Part 21 CFR 801 Subpart D)

510(k) Number_

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	K110562
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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.