The ANATOMIC PEEK™ PTC Cervical Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ANATOMIC PEEK™ PTC Cervical Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach from the C2-C3 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The ANATOMIC PEEK™ PTC Cervical Fusion System is to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The ANATOMIC PEEK™ PTC Cervical Fusion System is designed for use as a cervical interbody fusion device. These devices are manufactured from polyetheretherketone (PEEK OPTIMA™) each containing a commercially pure titanium coating along with tantalum markers. This device is to be used with autogenous and/or allogenic bone graft material (cancellous and/or corticocancellous bone chips). The ANATOMIC™ PEEK PTC Cervical Fusion System consists of hemi-cylindrical cages of various widths, heights and depths. The hollow geometry of the implants allows them to be packed with autogenous or allogenic bone graft (cancellous and/or corticocancellous bone chips) material.

AI/ML Overview

This document is a 510(k) premarket notification for the ANATOMIC PEEK™ PTC Cervical Fusion System. It is a medical device for orthopedic use, specifically an intervertebral body fusion device.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of acceptance criteria nor specific quantitative device performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) in the way one might expect for a digital health device or a device with measurable "performance" in a clinical trial sense (like an AI algorithm's score).

Instead, the "performance data" for this device revolves around demonstrating substantial equivalence to existing predicate devices. This means that the device aims to perform similarly to devices already approved for market.

The acceptance criteria for a 510(k) submission for a device like this are generally focused on demonstrating:

Similar Indications for Use: The new device treats the same condition in the same patient population.
Similar Technological Characteristics: The device is made of similar materials, uses a similar design principle, and is intended to be used in a similar surgical approach.
Performance (Bench Testing & Biocompatibility): The device meets established mechanical and material safety standards. For fusion devices, this typically includes:
- Mechanical strength/stability testing (e.g., compression, shear, torsion, fatigue)
- Expulsion resistance
- Subsidence testing
- Biocompatibility testing (ISO 10993 standards)
Clinical Performance (often indirect for 510(k)): For devices where clinical performance can be inferred from predicate devices, a comprehensive literature review or comparative analysis is often sufficient. If the device has significant differences, clinical trials might be required, but this is less common for typical 510(k)s.

Reported Device Performance (as inferred from the document):

Materials: Manufactured from polyetheretherketone (PEEK OPTIMA™) with a commercially pure titanium coating and tantalum markers. (Similar to predicate devices).
Design: Hemi-cylindrical cages of various widths, heights, and depths, with hollow geometry for bone graft material. (Similar to predicate devices).
Function: Facilitates intervertebral body fusion, provides correction and stabilization. (Similar to predicate devices).
Biocompatibility: Implied to be acceptable based on the use of standard materials like PEEK and titanium, which have established biocompatibility for implantable devices.
Mechanical Performance: Not explicitly stated with values, but the "performance data" section mentions "comprehensive literature review" for support of substantial equivalence, which would encompass the mechanical properties of similar PEEK/titanium fusion devices. The FDA's clearance implies that relevant bench testing data (which is part of such a review or submitted separately) was found acceptable and demonstrated similar performance to the predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Clinical data in the form of a comprehensive literature review was provided in support of substantial equivalence of the subject device."

Sample Size: Not applicable in the sense of a clinical test set with human patients enrolled specifically for this device. The "data" comes from published literature on similar devices and potentially from bench testing data for the current device. Therefore, no direct "sample size" of patients is reported for a specific test set.
Data Provenance: The "comprehensive literature review" would draw from various sources, likely international, academic, and clinical publications. Specific countries or study designs (retrospective/prospective) are not detailed within this summary, as it covers a broad range of existing evidence. Bench testing data, if conducted for this specific device, would be generated by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is not an AI/diagnostic device that requires expert adjudication for ground truth establishing. The "ground truth" for a fusion device centers on its mechanical stability, biocompatibility, and ability to facilitate fusion, which are assessed through engineering tests, material science, and clinical outcomes studies (often from literature for 510(k)s), rather than expert interpretation of images or patient conditions.

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

Not applicable. There's no "test set" in the context of expert adjudication for diagnostic accuracy.

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 not a diagnostic device or an AI-assisted device. MRMC studies are used to evaluate diagnostic performance.

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

Not applicable. This is a physical intervertebral body fusion device, not a software algorithm.

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

For this type of device, the "ground truth" for demonstrating substantial equivalence is multifaceted and includes:

Mechanical Bench Testing Data: Demonstrating that the device meets predefined mechanical performance standards (e.g., static and dynamic compression, shear, torsion strength, resistance to expulsion, subsidence). This forms a critical part of the safety and effectiveness profile.
Material Characterization: Verifying the composition and properties of the PEEK, titanium coating, and tantalum markers.
Biocompatibility Data: Demonstrating that the materials are safe for implantation and do not elicit adverse biological responses (e.g., cytotoxicity, sensitization, irritation).
Comparison to Predicate Devices: Showing that the materials, design, and intended use are sufficiently similar to legally marketed devices with a known safety and effectiveness profile.
Literature Review Outcomes Data: The "clinical data in the form of a comprehensive literature review" would analyze existing clinical outcomes (e.g., fusion rates, complication rates, pain reduction) of predicate or substantially similar devices to support the expected clinical performance of the new device.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the machine learning sense.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of a human figure with three faces in profile, arranged in a cascading manner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure. The text is in all caps.

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

Medtronic Sofamor Danek, USA, Incorporated Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis, Tennessee 38132

March 28, 2016

Re: K160528

Trade/Device Name: ANATOMIC PEEK™ PTC Cervical Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 8, 2016 Received: March 10, 2016

Dear Mr. Grant:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K160528

Page 1 of 1

510(k) Number (if known)

K160528

Device Name

ANATOMIC PEEKTM PTC Cervical Fusion System

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary – K160528 Medtronic Sofamor Danek ANATOMIC PEEK™ PTC CERVICAL FUSION SYSTEM March 24, 2016

Submitter	Medtronic Sofamor Danek USA1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738
Contact(s)	Lee GrantDistinguished Regulatory Affairs AdvisorDirect Telephone – 901-344-0807
Date Prepared	March 24, 2016
Common Name	Cervical Interbody Cage
Regulatory Class	Class II
Regulation Number	888.3080
Regulation Name and Device	Intervertebral Body Fusion Device
Product Classification Code	ODP
Predicate Devices	1) Valeo Spacer System-C and VALEO® II-C (K142264, SE 12/08/14 – Primary Predicate)2) ANATOMIC PEEK™ PTC Cervical Fusion System (K133653, SE 04/28/14)The predicate devices have not been subject to a design related recall
Description of Device	The ANATOMIC PEEK™ PTC Cervical Fusion System is designed for use as a cervical interbody fusion device. These devices are manufactured from polyetheretherketone (PEEK OPTIMA™) each containing a commercially pure titanium coating along with tantalum markers. This device is to be used with autogenous and/or allogenic bone graft material (cancellous and/or corticocancellous bone chips). The ANATOMIC™ PEEK PTC Cervical Fusion System consists of hemi-cylindrical cages of various widths, heights and depths. The hollow geometry of the implants allows them to be packed with autogenous or allogenic bone graft (cancellous and/or corticocancellous bone chips) material.
Indications for Use:	The ANATOMIC PEEK™ PTC Cervical Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ANATOMIC PEEK™ PTC Cervical Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The ANATOMIC PEEK™ PTC Cervical Fusion System is to be used with supplemental fixation

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	Patients should have at least six weeks of non-operative treatment prior totreatment with an intervertebral cage.
Comparison of TechnologicalCharacteristics with thePredicate Devices	Cervical interbody fusion to provide correction and stabilization duringintervertebral body fusion procedures is the technological principle for both thesubject and predicate devices. The subject device is manufactured from the samematerials noted in the previously cleared referenced devices. Both the subjectand predicate devices operate on the usage of PEEK cages inserted into the discspace along with graft material to facilitate fusion at single or multiple levels inthe cervical spine. Both the subject and predicate devices are surgicallyimplanted via an anterior approach for the same patient population. Both thesubject and predicate interbody devices are required to be used withsupplemental fixation.
Performance Data	Clinical data in the form of a comprehensive literature review was provided insupport of substantial equivalence of the subject device.
Conclusion	Based on the provided performance data, the subject device is substantiallyequivalent to the referenced predicate devices.

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.