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 consists of a variety of hollow vertebral body spacers featuring a convex. bullet nose design and an axial void designed to hold autogenous graft material. The subject device is comprised of medical grade PEEK Optima 1 and includes Tantalum markers for imaging purposes. This device is designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The predicate device ranges from 8mm to 16mm in height and from 45mm to 60mm in length. The purpose ofithis submission was to expand the sizes of the device to include a 40mm length device.

AI/ML Overview

Here's an analysis of the provided text regarding the CLYDESDALETM Spinal System's acceptance criteria and the study proving it meets these criteria:

Device Acceptance Criteria and Performance Study: CLYDESDALETM Spinal System

Based on the provided K100175 document, the CLYDESDALETM Spinal System is a medical device for intervertebral body fusion. The acceptance criteria and the study proving substantial equivalence are focused on mechanical performance and demonstrating that the expanded sizes of the device (specifically, the 40mm length) maintain the same safety and effectiveness as the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device must demonstrate)	Reported Device Performance (How the device met the criteria)
Static Axial Compression Performance	Demonstrated performance in accordance with ASTM 2077-03.
Dynamic Axial Compression Performance	Demonstrated performance in accordance with ASTM 2077-03.
Static Shear Compression Performance	Demonstrated performance in accordance with ASTM 2077-03.
Dynamic Shear Compression Performance	Demonstrated performance in accordance with ASTM 2077-03.
Subsidence Resistance	Not explicitly tested for the new sizes, as predicate devices were determined to be more worst-case. This implies the new sizes are expected to meet or exceed predicate performance due to design similarities/improvements.
Substantial Equivalence to Predicate Devices	Mechanical test results were provided, demonstrating substantial equivalence to: K083026 (CLYDESDALETM) and K073291 (CAPSTONE®).

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

Sample Size: The document does not specify the exact number of test samples (e.g., how many 40mm length devices were tested) for each mechanical test. It simply states that "mechanical tests... were performed."
Data Provenance: The data is generated from non-clinical mechanical tests conducted on the device itself. The document does not indicate any human or animal data, nor any specific country of origin for the testing or data. It is inherently prospective, as it's testing the specific device submitted for clearance.

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

This section is not applicable for this type of device and study. The "ground truth" for mechanical component testing is established through standardized engineering test methods (ASTM 2077-03 in this case) and physical measurements, not through expert consensus or interpretation of medical images/outcomes.

4. Adjudication Method for the Test Set

This section is not applicable for mechanical testing. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., medical image reading) where disagreement among experts needs resolution.

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 section is not applicable. The CLYDESDALETM Spinal System is a physical implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance comparison would be performed.

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

This section is not applicable. As a physical implant, there is no "algorithm only" or "human-in-the-loop" performance to evaluate. The device's performance is solely based on its mechanical properties.

7. The Type of Ground Truth Used

The ground truth used for this device's acceptance is objective mechanical performance metrics defined by internationally recognized engineering standards (specifically, ASTM 2077-03). The device's ability to withstand specified loads (static axial compression, dynamic axial compression, static shear compression, dynamic shear compression) to acceptable limits constitutes the "ground truth" for its safety and effectiveness in a mechanical context. Comparison to predicate device performance also serves as a ground truth for substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. Mechanical testing for medical devices like this does not involve "training sets" in the machine learning sense. The tests are designed to evaluate the physical properties of the manufactured device.

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

This section is not applicable for the same reasons as point 8.

Summary

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K100175 page 1 of 2

CLYDESDALETM Spinal System 510(k) Summary January 2010

I.	Company:	Medtronic Sofamor Danek2600 Sofamor Danek DriveMemphis, TN 38132(901) 396-3133	JUN - 2 2010
	Contact:	Justine VieraRegulatory Affairs Specialist

Proprietary Trade Name: CLYDESDALETM Spinal System II.

III. Classification Name: Intervertebral Body Fusion Device (21 CFR 888.3080)

IV. Product Code: MAX

V. Product Description

VI. Indications

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K1001795

VII. Substantial Equivalence

Documentation, including mechanical test results, was provided which demonstrated that the subject CLYDESDALE™ Spinal System is substantially equivalent to the predicate CLYDESDALE™ device cleared in K083026, SE 12/29/08 and the CAPSTONE® device cleared in K073291, SE 04/24/08.

Brief Discussion of the Non-Clinical Tests Submitted VIII.

The following mechanical tests of the subject CLYDESDALE™ Spinal System device were performed:

static axial compression testing in accordance with ASTM 2077-03 .
dynamic axial compression testing in accordance with ASTM 2077-03 .
static shear compression testing in accordance with ASTM 2077-03 .
. dynamic shear compression testing in accordance with ASTM 2077-03

Subsidence testing was not repeated on the CLYDESDALE™ device because the predicate devices were determined to be more worst case.

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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 features a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

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

JUN - 2 2010

Medtronic Sofamor Danek % Ms. Justine Viera Regulatory Affairs Specialist 2600 Sofamor Danek Drive Memphis, Tennessee 38132

Re: K100175

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: May 19, 2010 Received: May 21, 2010

Dear Ms. Viera:

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

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Page 2 - Ms. Justine Viera

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 yours,

Mark A. Millman

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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K100175 510(k) Number (if known): _

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)

01 10

(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 K100175

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.