CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE by MEDTRONIC SOFAMOR DANEK

The CORNERSTONE® PSR device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft and is to be implanted via an open, anterior approach.

Device Description

The CORNERSTONE® PSR Spinal System is designed for use as a cervical intervertebral body fusion device. The device is manufactured from medical grade polyetheretherketone (PEEK) and is to be used with autograft. The device has four degrees of lordosis. The lateral walls of the device contain openings to allow for the incorporation of bone during the fusion process. The superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates and helps in resisting backout.

AI/ML Overview

Here is an analysis of the provided text regarding the MEDTRONIC Sofamor Danek CORNERSTONE® PSR Spinal System:

The provided documents describe a Cervical Interbody Fusion Device and its substantial equivalence determination by the FDA. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical performance testing conducted to demonstrate safety and effectiveness equivalent to predicate devices. It is crucial to understand that for this type of medical device (a 510(k) submission), the "acceptance criteria" is typically performance benchmarked against legally marketed predicate devices, not clinical efficacy in terms of patient outcomes in a human study.

Here's the breakdown as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test Standard / Parameter	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance	Static Axial Compression (ASTM F2077)	Comparable to predicate devices	Found to be substantially equivalent to legally marketed devices.
	Dynamic Axial Compression (ASTM F2077)	Comparable to predicate devices	Found to be substantially equivalent to legally marketed devices.
	Static Compression Shear (ASTM F2077)	Comparable to predicate devices	Found to be substantially equivalent to legally marketed devices.
	Dynamic Compression Shear (ASTM F2077)	Comparable to predicate devices	Found to be substantially equivalent to legally marketed devices.
	Static Torsion (ASTM F2077)	Comparable to predicate devices	Found to be substantially equivalent to legally marketed devices.
	Dynamic Torsion (ASTM F2077)	Comparable to predicate devices	Found to be substantially equivalent to legally marketed devices.
	Subsidence Testing (ASTM F2267)	Comparable to predicate devices	Found to be substantially equivalent to legally marketed devices.
Material Equivalence	PEEK material	Same medical-grade PEEK as predicate devices	Manufactured from medical grade polyetheretherketone (PEEK).
Indications for Use	Clinical Application	Consistent with predicate devices	Indicated for cervical interbody fusion in skeletally mature patients at C2-C3 to C7-T1, with specific conditions (radiculopathy/myelopathy, herniated disc/osteophyte, 6 weeks non-operative treatment, supplemental fixation, autograft, anterior approach).

Note on Acceptance Criteria: For a 510(k) submission, "acceptance criteria" for a new device are primarily demonstrated by showing "substantial equivalence" to one or more legally marketed predicate devices. This means the mechanical performance of the new device is expected to be at least as safe and effective as its predicates, which is typically proven by meeting or exceeding the performance established by those predicates in relevant pre-clinical tests. The text explicitly states, "The results of these studies were found to be substantially equivalent to legally marketed devices."

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

Sample Size for Test Set: The document does not specify the exact number of devices tested for each mechanical test (static, dynamic, subsidence). It refers to "worst case CORNERSTONE® PSR devices" being tested, implying that representative samples were chosen to challenge the device's limits.
Data Provenance: The studies were "pre-clinical studies," which means they were conducted in a laboratory setting, not on human subjects. No country of origin is specified for where these pre-clinical tests were performed, but the submission is to the US FDA. The data is retrospective in the sense that the mechanical tests generate data for the specific submission, and the comparison is made to established performance benchmarks of predicate devices.

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

This question is not applicable in the context of this 510(k) submission.

Reasoning: The "test set" here refers to the physical devices undergoing mechanical stress tests, not imaging data or clinical cases requiring expert interpretation. The "ground truth" for mechanical performance is determined by physical measurements and engineering standards (e.g., ASTM F2077, ASTM F2267), not by expert consensus or interpretation of clinical data. Therefore, there were no experts used to establish "ground truth" in the way one might for diagnostic AI.

4. Adjudication Method for the Test Set

This question is not applicable in the context of this 510(k) submission.

Reasoning: Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert opinions, typically for clinical data or image interpretation. Since the "test set" here refers to mechanical device performance, there's no expert interpretation or adjudication involved beyond the standard engineering and quality control processes of evaluating test results against specified performance metrics.

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

This question is not applicable for this device submission.

Reasoning: The CORNERSTONE® PSR Spinal System is a physical implant (a medical device for cervical fusion), not an AI diagnostic tool or software. Therefore, there would be no "human readers," "AI assistance," or "MRMC comparative effectiveness study" in this context. The study performed involved mechanical testing of the implant itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable for this device submission.

Reasoning: This device is a physical implant, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth used for demonstrating the device's performance was based on established engineering standards and performance characteristics of legally marketed predicate devices. This includes:
- Mechanical Test Standards: ASTM F2077 (for static and dynamic axial compression, compression shear, torsion) and ASTM F2267 (for subsidence testing).
- Performance of Predicate Devices: The "substantial equivalence" claim relies on the new device's mechanical performance being comparable to or better than previously approved devices (e.g., PEEK PREVAIL™ Cervical Interbody Device, AFFINITY® Anterior Cervical Cage, BAK/C® Cervical Interbody Fusion System, etc.) for which safety and effectiveness have already been established by the FDA.

8. The Sample Size for the Training Set

This question is not applicable in the context of this 510(k) submission.

Reasoning: The "training set" concept applies to machine learning or AI models, where data is used to train an algorithm. This device is a physical implant, and its evaluation involved mechanical testing, not algorithm training.

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

This question is not applicable in the context of this 510(k) submission.

Reasoning: As explained in point 8, there is no "training set" for a physical device like this implant. Therefore, no ground truth for a training set was established.

Summary

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MEDTRONIC Sofamor Danek CORNERSTONE® PSR Spinal System Cervical Interbody Fusion Device June 2010 - K100214

. I. Medtronic Sofamor Danek, Inc. Company: 1800 Pyramid Place Memphis, Tennessee 38132 (901) 396-3133
II. Product Name: CORNERSTONE® PSR Spinal System Spinal Intervertebral Body Orthosis Regulation Name: Cervical Interbody Fusion Device Classification: 21 CFR 888.3080 - Product Code: ODP
III. Description: The CORNERSTONE® PSR Spinal System is designed for use as a cervical intervertebral body fusion device. The device is manufactured from medical grade polyetheretherketone (PEEK) and is to be used with autograft.
The device has four degrees of lordosis. The lateral walls of the device contain openings to allow for the incorporation of bone during the fusion process. The superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates and helps in resisting backout.
IV. Indications for Use: The CORNERSTONE® PSR device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE PSR device is also required to be used with autograft and is to be implanted via an open, anterior approach.
V. Performance Data: The following pre-clinical studies were conducted using worst case CORNERSTONE® PSR devices: static and dynamic axial compression, static and dynamic compression shear, and static and dynamic torsion per ASTM F2077; as well

Pay 1 £-2

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K100214

as subsidence testing per ASTM F2267. The results of these studies were found to be substantially equivalent to legally marketed devices.

Substantial Equivalence: Documentation was provided which demonstrated that the VI. subject device is substantially equivalent to previously approved devices such as the PEEK PREVAIL™ Cervical Interbody Device (K073285, SE 05/15/08), the AFFINITY® Anterior Cervical Cage (P000028, Approved - 06/13/2002), the BAK/C® Cervical Interbody Fusion System (P980048, Approved – 04/20/2001); the LDR ROI-C Cervical Interbody Fusion Device (K091088, SE 07/14/09); Biomet Spine's C-Thru Cervical Interbody Fusion Device, (K092336, SE 10/15/09; and the VERTE-STACK® Spinal System (K041197, SE 08/09/04). Documentation included mechanical test results
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JYN 2 6 2010

Medtronic Sofamor Danek, Inc. % Mr. Lee Grant 1800 Pyramid Place Memphis. Tennessee 38132

Re: K100214

Trade/Device Name: CORNERSTONE® PSR Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 16, 2010 Received: June 18, 2010

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 mav 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

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Page 2 - Mr. Lee Grant

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Caibare buelus

Mark N. Melkerso 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): KI CO214

Device Name: CORNERSTONE® PSR Spinal System

Indications for Use: The CORNERSTONE® PSR device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft and is to be implanted via an open, anterior approach.

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

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)

Arit

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

长108214 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.