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 spondylolishtesis 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 CRESCENT™ Spinal System consists of PEEK cages of various widths and heights which 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 allows them to be packed with autogenous bone graft. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. The devices are manufactured from medical grade PEEK-Optima LT1 (polyetheretherketone) and contains tantalum markers. These devices also contain Tantalum markers used for imaging purposes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CRESCENT™ Spinal System, specifically for additional sizes of implants and instruments. As such, it focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a detailed study that establishes specific acceptance criteria and performance metrics in the way a novel device might.

Therefore, much of the requested information regarding acceptance criteria experiments, sample sizes, expert involvement, and ground truth establishment is not available in this document because the submission's goal is to show similarity to existing approved devices, not to establish new performance benchmarks through de novo clinical trials.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly state quantitative acceptance criteria with corresponding performance results in a table format. The performance data presented are primarily focused on demonstrating that the new sizes do not negatively impact safety and effectiveness compared to the predicate devices.

Acceptance Criterion (Inferred from text)	Reported Device Performance (Summary from text)
Mechanical Strength & Expulsion Resistance (for new implant sizes)	"The mechanical strength and the expulsion resistance have been documented in a confirmatory engineering rationale." The document asserts that "the subject 40mm and 45mm longer PEEK implants do not introduce a new worst case scenario and are substantially equivalent to the predicate device." This implies that the performance for these aspects meets or exceeds that of the predicate, or at least falls within acceptable limits established for the predicate.
Biocompatibility	"Identical to the primary predicate devices the implants in the subject Crescent™ Spinal System are provided in sterile form and are made using medical grade PEEK-Optima LT1 (polyetheretherketone) and contain Tantalum markers for imaging. The non-sterile instruments are manufactured using stainless steel and are identical to the materials used for the instruments cleared in predicate... PEEK-Optima LT1 (polyetheretherketone) and stainless steel material used for the subject CRESCENT Spinal System implants and instruments have a long clinical history of safe and effective use in similar commercially available medical devices." Conclusion: "no additional biocompatibility testing is required." This indicates acceptance if the materials are the same as previously cleared, safe, and effective predicates.
Non-Pyrogenicity (Endotoxin Testing)	"Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP <161>, Transfusion and Infusion Assemblies and Similar Medical Devices."

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

Sample Size: Not explicitly stated for mechanical or endotoxin testing. For biocompatibility, reliance on "long clinical history" suggests a large, accumulated dataset from prior usage of the materials, but no specific number of devices or patients is provided for this submission. The mechanical testing refers to an "engineering rationale," which typically involves bench testing, not patient data in the context of a 510(k) for size additions.
Data Provenance: The document does not specify the country of origin for the data. The tests (mechanical, endotoxin) are likely conducted in a controlled lab environment. The "long clinical history" of materials implies data collected globally over time for various similar devices. The study type is for substantial equivalence for new sizes/instruments, not a de novo clinical study.

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 type of information is typically for diagnostic AI algorithms or clinical trials with subjective endpoints. This submission is for an intervertebral body fusion device (implant) and focuses on material science and mechanical performance benchmarks against existing predicates, not human expert interpretation of data.

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

Not applicable. Adjudication methods are typically used in clinical trials or studies involving expert review of outcomes or images. The performance data presented here are from engineering and laboratory tests.

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. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of medical images, potentially assisted by AI. This document is for a spinal implant.

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

Not applicable. This device is a physical implant, not an algorithm.

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

Mechanical Testing: Ground truth is against established engineering standards (ASTM F2077) and the performance of the predicate devices.
Biocompatibility: Ground truth is the historical safety and effectiveness of the existing materials (PEEK-Optima LT1, Tantalum, stainless steel).
Non-Pyrogenicity: Ground truth is established laboratory limits for endotoxins (e.g., 20 EU/device) as defined by standards like ANSI/AAMI ST72 and USP <161>.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" in this context refers to the development and testing of the engineering design of the implant.

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

Not applicable. As above, there is no "training set." The understanding of material properties and mechanical performance would have been established through extensive prior research, testing, and clinical use of similar devices over many years.

Summary

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

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

July 6, 2017

Medtronic Sofamor Danek USA, Inc. Mr. Ankit Shah Sr. Regulatory Affairs Specialist 1800 Pvramid Place Memphis. Tennessee 38132

Re: K171031

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: June 6, 2017 Received: June 9, 2017

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, 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 device

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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 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" (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.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,

Vincent J. Devlin -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K171031

Device Name CRESCENTTM Spinal 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)

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K171031

Page 1 of 4

CRESCENT™ Spinal System 510(k) Summary June 2017

I. Submitter:	Medtronic Sofamor Danek USA, Inc
	1800 Pyramid Place
	Memphis, Tennessee 38132
Contact:	Ankit K. Shah
	Sr. Regulatory Affairs Specialist
	Telephone: (901) 344-1272
	Fax: (901) 346-9738
Date Prepared	June 6, 2017
II. Subject Device
Proprietary Trade Name	CRESCENTTM Spinal System
Common Name	Intervertebral Body Fusion Device
Classification Names	Intervertebral Fusion with Bone Graft,
	Lumbar
Classification	Class II (Implants and Instruments)
Product Code	MAX
Regulation Number	21 CFR 888.3080
Predicates	CRESCENTTM Spinal System K094025
	S.E. 04/26/2010, (Primary Predicate)
	CRESCENTTM Spinal System Titanium
	K110543
	S.E. 08/09/2011 (Predicate 2)
	Clydesdale Spinal System K132897, S.E.
	12/11/2013 (Predicate 3)
	Rampart-O, Rampart-T K132053, S.E.
	09/16/2013 (Predicate 4)

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III. PRODUCT DESCRIPTION:

IV. 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 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.

V. Comparison of Technological Characteristics

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

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VI. Performance Data

Biocompatibility

Identical to the primary predicate devices the implants in the subject Crescent™ Spinal System are provided in sterile form and are made using medical grade PEEK-Optima LT1 (polyetheretherketone) and contain Tantalum markers for imaging. The non-sterile instruments are manufactured using stainless steel and are identical to the materials used for the instruments cleared in predicate 2 CRESCENT™ Spinal System Titanium K110543 (S.E. (S.E. LT1 (polyetheretherketone) and stainless steel material used for the subject CRESCENT Spinal System implants and instruments have a long clinical history of safe and effective use in similar commercially available medical devices. Therefore, no additional biocompatibility testing is required.

Mechanical Testing

The predicate CRESCENT™ Spinal System K094025 (PEEK implants) are 36mm in length whereas the subject CRESCENT™ Spinal System implants are 40mm and 45mm in length maintaining the same width and height as the predicate. The ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices," defines a worst case intervertebral body fusion device with the smallest footprint and tallest height. Since we are not reducing the footprint it does not introduce a worst case. The mechanical strength and the expulsion resistance have been documented in a confirmatory engineering rationale.

Medtronic believes that the subject 40mm and 45mm longer PEEK implants do not introduce a new worst case scenario and are substantially equivalent to the predicate device.

Non-Pyrogenicity Endotoxin Testing

The bacterial endotoxin test, also known as Limulus Amebocyte Lysate (LAL) test, was performed utilizing worst case subject CRESCENT™ Spinal System implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit

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specification. Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP <161>, Transfusion and Infusion Assemblies and Similar Medical Devices.

VII. 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.

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.