The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients 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 devices are intended to be used with supplemental fixation instrumentation which has : been cleared by the FDA for use in the lumbar spine.

Device Description

The subject CRESCENT® Spinal System consists of a variety of hollow intervertebral body spacers featuring a bullet-nosed, anatomically shaped design with axial voids designed to hold bone graft material. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. The subject devices are designed with diamond V teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 7mm to 15mm in height and 36mm in length. The devices are manufactured from medical grade PEEK-Optima LTI (polyetheretherketone). These devices also contain Tantalum markers used for imaging purposes.

AI/ML Overview

This document describes a 510(k) premarket notification for the CRESCENT® Spinal System. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting new clinical study data with acceptance criteria and a detailed study proving performance. Therefore, many of the requested data points (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not typically included in such a submission.

However, I can extract the relevant information regarding the "acceptance criteria" and the "study" that supports the substantial equivalence claim.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission seeking clearance for additional sizes of an existing device, the "acceptance criteria" revolve around demonstrating that the new size does not introduce new safety or effectiveness concerns and performs equivalently to the already cleared predicate.

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance (Summary)
Mechanical Performance	Adherence to ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices" for interbody fusion devices. Specifically, ensuring the new size does not represent a "worst-case" scenario for mechanical loads.	The new 14.5mm wide PEEK implant does not introduce a new worst-case scenario compared to the cleared devices. This was supported by a confirmatory engineering rationale.
Material Equivalence	The material of construction (PEEK-Optima LTI) must be identical to the predicate device.	The material of the subject CRESCENT® Spinal System implant is identical to the predicate CRESCENT™ Spinal System (K094025).
Design Equivalence	Similar design features (hollow intervertebral body spacers, bullet-nosed, anatomically shaped, axial voids for bone graft, diamond V teeth, Tantalum markers).	The subject device features are consistent with the predicate. The submission focuses on adding a new width (14.5mm).
Indications for Use Equivalence	The device must share the same indications for use as the predicate devices.	The CRESCENT® Spinal System has the same indications as the predicate devices (K094025 and K110543).

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

Sample Size: Not applicable in the context of a 510(k) for an incremental change like a new size. There isn't a "test set" of patients or images in a clinical efficacy study sense. The "test" here refers to non-clinical, engineering testing and comparison to predicate devices.
Data Provenance: Not applicable. The "data" comes from engineering analysis and comparison to existing regulatory clearances.

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

Not applicable. Ground truth for clinical performance is not established for this type of submission. The "ground truth" for substantial equivalence is based on regulatory standards and comparison to previously cleared devices, evaluated by FDA reviewers.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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 an AI/CAD device. It is a spinal implant.

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

Not applicable. This is not an AI/CAD device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices, as determined by previous FDA clearances. The current submission's "truth" is that the new device variant (14.5mm wide PEEK implant) is equivalent to these predicates and does not introduce new risks. This is supported by:
- Engineering rationale and risk analysis: Demonstrating that the new size does not represent a "worst-case" scenario based on biomechanical principles and ASTM standards.
- Material and design comparison: Verifying identical material and similar design features to the predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this 510(k) submission for a spinal implant.

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

Not applicable.

Summary of the "Study" Proving Device Meets Acceptance Criteria:

The "study" to prove the device met acceptance criteria was a non-clinical engineering assessment and comparative analysis against legally marketed predicate devices.

Objective: To demonstrate that the addition of a 14.5mm wide PEEK implant to the CRESCENT® Spinal System is substantially equivalent to previously cleared predicate devices and does not introduce new safety or effectiveness concerns.
Methodology:
1. Identification of Predicates: The subject device was compared to CRESCENT™ Spinal System (K094025) and CRESCENT® Spinal System Titanium (K110543).
2. Material Comparison: Verification that the material (PEEK-Optima LTI) is identical to a PEEK predicate (K094025).
3. Design Comparison: Analysis of design features of the new 14.5mm wide implant against existing cleared sizes.
4. Mechanical Analysis (Worst-Case Assessment): According to the document, ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices" defines a worst-case device. Medtronic argued that since the existing cleared PEEK implants had widths of 11mm, 12mm, and 12.5mm, and the 14.5mm wide Titanium implants were already cleared, the new 14.5mm wide PEEK implant does not introduce a new "worst-case scenario" regarding mechanical performance (as its footprint is not reducing).
5. Engineering Rationale and Risk Analysis: A formal engineering justification and risk assessment were completed to support the claim that the new size does not present new risks.
Conclusion: Based on the engineering rationale, risk analysis, and supporting documentation, Medtronic concluded that the subject system demonstrates substantial equivalence to the listed predicate devices. The FDA concurred, granting clearance.

Summary

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CRESCENT® Spinal System 510(k) Summary October 2013

NOV 22222013

I. COMPANY:

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

II. CONTACT:

Ankit K. Shah Regulatory Affairs Specialist Telephone: (901) 344-1272 Fax: (901) 346-9738

CRESCENT® Spinal System

III. PROPRIETARY TRADE NAME:

IV. CLASSIFICATION NAMES:

COMMON NAME:

CLASS:

Intervertebral Fusion with Bone Graft. Lumbar

Intervertebral Body Fusion Device

CLASS:

MAX (21 CFR 888.3080)

V. PRODUCT DESCRIPTION:

PRODUCT CODE:

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K133216

surfaces to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 7mm to 15mm in height and 36mm in length. The devices are manufactured from medical grade PEEK-Optima LTI (polyetheretherketone). These devices also contain Tantalum markers used for imaging purposes.

VI. INDICATIONS FOR USE:

VII. Summary of the Technological Characteristics:

The subject CRESCENT® Spinal System has the same indications, intended use and fundamental scientific technology as the previously FDA cleared predicates: CRESCENT™ Spinal System K094025 (S.E. 04/26/2010) and CRESCENT® Spinal System Titanium K110543 (S.E. 08/09/2011). The material of subject CRESCENT® Spinal System implant is identical to the predicate CRESCENT™ Spinal System (K094025). The purpose of this submission is to seek clearance for the additional sizes of PEEK implant being added to the CRESCENT® Spinal System.

VIII. Identification of Legally Marketed Devices:

The fundamental scientific technology, design features and indications for use for the subject CRESCENT®Spinal System are identical to the predicate CRESCENT™ Spinal System K094025 (S.E. 04/26/2010) and CRESCENT® Spinal System Titanium K110543 (S.E. 08/09/2011).

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IX. Discussion of Non-Clinical Testing:

The widths of the predicate CRESCENT™ Spinal System K094025 (PEEK implants) are 1 Imm, 12mm and 12.5mm. The subject CRESCENT® Spinal System is for introducing a 14.5mm wide PEEK implant. ASTM F2077 *Test Methods for Intervertebral Body Fusion Devices," defines a worst case intervertebral body fusion device with the smallest footprint and tallest height: Medtronic believes that since the footprint is not reducing, it does not introduce a worst case.

The 14.5mm wide Titanium implants are already cleared by the FDA in the predicate CRESCENT® Spinal System Titanium K110543.

Medtronic believes that the subject 14.5mm wide PEEK implant does not introduce a new worst case scenario, which has been documented in a confirmatory engineering rationale. Medtronic believes that the subject device is substantially equivalent to the predicate device.

X. Conclusion:

An engineering rationale and risk analysis has been completed for the change. Based on the engineering rationale, 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/3/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 22, 2013

Medtronic Sofamor Danek USA, Incorporated Mr. Ankit K. Shah Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K133216

Trade/Device Name: CRESCENT® Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 17, 2013 Received: October 18, 2013

Dear Mr. Shah:

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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Ankit K. Shah

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21 CFR 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.html 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,

Lori A. Wiggins

for

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

Enclosure

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K133216 510(k) Number (if known): _

Device Name: CRESCENT® Spinal System

Indications for Use:

The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients 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 devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

Prescription Use (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)

Anton E. Dmitriev, PhD Division of Orthopedic 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.