The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for 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 may be implanted via a minimally invasive lateral approach.

Device Description

The CLYDESDALE® Spinal System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allow them to be packed with autogenous bone graft.

AI/ML Overview

The provided text is a 510(k) summary for the CLYDESDALE® Spinal System, which is an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with acceptance criteria and device performance in the way a clinical trial or AI device study would.

The submission states that the current device is a modified labeling version of a previously cleared device (CLYDESDALE® Spinal System K113528). The core device design, materials, indications, and sterilization remain unchanged. Therefore, the "study" described is a validation of this labeling modification.

Here's an analysis based on the provided text, structured to answer your questions where applicable:

Acceptance Criteria and Device Performance

Since this submission is for a labeling modification and asserts substantial equivalence, explicit "acceptance criteria" for device performance in a clinical or AI sense are not detailed. Instead, the acceptance criterion implicitly is that the revised labeling does not negatively impact the safety and effectiveness of the device and remains congruent with the device's original validated performance characteristics.

Table of Acceptance Criteria and Reported Device Performance (as inferred):

Acceptance Criteria (Inferred)	Reported Device Performance
Labeling modification is validated.	Data from a cadaveric surgeon validation supports the labeling modification.
Intended use has not changed.	The intended use has not changed as a result of this labeling modification.
Substantial equivalence to predicate device maintained.	The device is substantially equivalent to the predicate device K113528.

Study Details

Given the nature of this 510(k) for a labeling change, the "study" is a cadaveric surgeon validation of the new labeling.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document.
- Data Provenance: The study involved "cadaveric surgeon validation." This implies the data was generated from procedures performed on cadavers, likely in a controlled laboratory setting. The country of origin is not specified but given the submitter (Medtronic Sofamor Danek USA, Inc., Memphis, Tennessee), it likely occurred in the USA. It would be considered a prospective validation of the labeling in a simulated surgical environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: The validation was performed by a "cadaveric surgeon." This indicates the expert(s) were qualified surgeons with experience in cadaveric procedures relevant to spinal surgery. Specific years of experience or sub-specialty are not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. Given the description, it's likely qualitative feedback from the surgeon(s) performing the validation, rather than a formal adjudicated assessment required for outcome-based studies.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. This device is a physical medical implant, not an AI/imaging diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No, this is not an AI algorithm. A "standalone" performance assessment for this type of device would typically involve bench testing for mechanical properties, which is generally done for the initial device clearance, but not explicitly stated as having been re-done for this labeling change. The cadaveric validation involved human surgeons.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For the cadaveric surgeon validation of labeling, the "ground truth" would be the expert opinion/assessment of the surgeon(s) regarding the clarity, accuracy, and usability of the revised labeling in the context of performing the procedure. This is not "pathology" or "outcomes data" in a clinical sense.
The sample size for the training set:
- Training Set Sample Size: Not applicable. This is not an AI/machine learning study.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. This is not an AI/machine learning study.

Summary of the Study (Cadaveric Surgeon Validation):

The "study" conducted for this 510(k) submission was a cadaveric surgeon validation. Its purpose was to confirm that a modification to the device's labeling did not alter its intended use or fundamental scientific technology, and that the new labeling was appropriate for the device. The data from this validation supported the claim that the device (with its new labeling) remained substantially equivalent to its predicate device. This type of validation is common for minor changes in medical devices, particularly when the core technology and indications for use have already been established and cleared.

Summary

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K122591 Page 1 of 2

CLYDESDALE® Spinal System 510(k) Summary August 2012

SEP 18 2012

I. COMPANY:

II. CONTACT:

Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis, Tennessee 38132

Becky Ronner Regulatory Affairs Specialist Telephone: (901) 399-2757 Fax: (901) 346-9738

III. PROPRIETARY TRADE NAME:

IV. CLASSIFICATION NAMES:

COMMON NAME:

Intervertebral Body Fusion Device

CLYDESDALE® Spinal System

Intervertebral Fusion with Bone Graft, Lumbar

CLASS:

PRODUCT CODE:

MAX (21 CFR 888.3080)

V. PRODUCT DESCRIPTION:

The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allow them to be packed with autogenous bone graft.

VI. INDICATIONS FOR USE:

The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental

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fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to $1. 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 may be implanted via a minimally invasive lateral approach.

VII. Summary of the Technological Characteristics:

The subject system has the same indications, intended use and fundamental scientific technology as the previously FDA cleared predicate; CLYDESDALE® Spinal System K113528 (S.E. 12/20/2011). There has been no design, material, indication, sterilization changes to the previously cleared CLYDESDALE® Spinal System K113528 (S.E. 12/20/2011), the only change in the application is a modification to the labeling.

VIII. Identification of Legally Marketed Devices:

The fundamental scientific technology, design features and indications for use for the subject CLYDESDALE® Spinal System are identical to the predicate CL YDESDALE® Spinal System K113528 (S.E. 12/20/2011).

IX. Discussion of Non-Clinical Testing:

This modified labeling has been validated for the subject device by a cadaveric surgeon validation. Data from this validation supports the labeling modification. The intended use has not changed as the result of this labeling modification. This device is substantially equivalent to the predicate device.

X. Conclusion:

A validation and risk analysis was completed for the labeling change. Based on the validation, risk analysis and additional supporting documentation provided in this premarket notification. Medtronic believes the subject system demonstrates substantial equivalence to listed predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Medtronic Sofamor Danek USA, Incorporated % Ms. Becky Ronner Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K122591

Trade/Device Name: Clydesdale® Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 23, 2012 Received: August 24, 2012

Dear Ms. Ronner:

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

SEP 18 2012

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Page 2 - Ms. Becky Ronner

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 A. Milliken

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): K122591

Device Name: CLYDESDALE® Spinal System

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) Dission of Surgical, Orthopedic, and Restorative Devices

K122591 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.