The Cervage cage 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 on non-operative treatment. The Cervage cage is to be used with supplemental fixation. The Cervage cage is also required to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

Device Description

The Cervage cage consists of PEEK cages of various lengths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782). The coated cages are coated with medical grade CP Ti (ASTM F1580) and are provided sterile. The non-coated cages are provided sterile or non-sterile. The device must be used with supplemental fixation. The purpose of this submission is to gain initial marketing authorization in the United States.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "Cervage," an intervertebral body fusion device. The FDA's letter indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.

Based on the provided document, here's a detailed breakdown regarding the acceptance criteria and study that proves the device meets them:

Crucially, this document states that "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." Therefore, the information requested regarding a clinical study with detailed performance metrics, sample sizes, expert involvement, and ground truth establishment will largely be absent.

The acceptance criteria for this device seem to be primarily based on non-clinical testing demonstrating mechanical performance, cleaning/sterilization effectiveness, and biocompatibility, as well as a comparison to predicate devices to establish substantial equivalence.

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

Since clinical testing was not required and no specific performance metrics like accuracy, sensitivity, or specificity are provided for an AI/algorithm-based device, the "acceptance criteria" here relate to the mechanical, chemical, and biological properties of the physical implant.

Acceptance Criteria Category	Specific Criteria (Implicitly Met)	Reported Device Performance (from document)
Material Composition	Biocompatible and industry-standard materials for implants.	Made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782). Coated cages are coated with medical grade CP Ti (ASTM F1580).
Mechanical Performance	Ability to withstand physiological loading and maintain structural integrity.	Evaluated for mechanical performance in Static and Dynamic Axial Compression, Static and Dynamic Torsion, Static and Dynamic Compression Shear according to ASTM F2077-14. Subsidence according to ASTM F2267-04 and Expulsion in accordance with ASTM F-04.25.02.02. (The specific numerical performance values are not provided in this summary, but the reference to ASTM standards implies they met the required specifications for these tests).
Sterilization & Cleaning	Device can be effectively cleaned and sterilized to prevent infection.	Cleaning and sterilization were evaluated. (Specific methods or validation results are not detailed in this summary, but the mention implies they meet the necessary standards for sterile medical devices).
Biocompatibility	Device materials are safe for implantation and do not elicit adverse biological responses.	Implantable device biocompatibility endpoints were evaluated. (No specific tests or results are presented, but this indicates compliance with relevant biocompatibility standards).
Substantial Equivalence	Device is as safe and effective as predicate devices.	The Cervage device has the "same intended use and is similar in basic shape, material and performance characteristics to the predicate device." The "technological characteristics do not raise any new questions of safety and efficacy." (This is the overarching "performance" claim for a 510(k) without clinical trials).

Regarding an AI/Algorithm-based device, which this is not:

The questions regarding sample size, data provenance, expert establishment of ground truth, MRMC studies, standalone performance, training set details, and ground truth for training are not applicable to this 510(k) submission, as it is for a physical intervertebral body fusion device and explicitly states that clinical testing was not required for substantial equivalence.

To reiterate why the following points cannot be answered from the provided document:

Sample sizes used for the test set and the data provenance: Not applicable; no clinical test set involved. The mechanical testing would have specific sample sizes (e.g., number of devices tested for compression), but that data isn't in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical test set requiring expert ground truth for interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable; no clinical test set.
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/software device, and no clinical study was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an AI/software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; no clinical data requiring ground truth collection for diagnostic or prognostic purposes.
The sample size for the training set: Not applicable; no AI algorithm to train.
How the ground truth for the training set was established: Not applicable; no AI algorithm to train.

In summary, the FDA filing for the Cervage device relies on non-clinical bench testing and comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical trial or AI model validation study.

Summary

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May 4, 2018

Precifit Medical Ltd % Kellen Hills Quality and Regulatory Consultant Orchid Design 4600 E Shelby Drive Memphis, Tennessee 38118

Re: K172568

Trade/Device Name: Cervage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: April 5, 2018 Received: April 9, 2018

Dear Kellen Hills:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

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) K172568

Device Name Cervage

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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K172568 Page 1 of 2

510(k) Summar

[As Required by 21 CFR 807.92]

(a)(1) Submitted By: Address:

Phone: Date: Contact Persons Primary: Secondary:

Proprietary Name: (a)(2) Common Name:

Classification Name and Reference:

Product Code:

(a)(3) Predicate Devices: Primary:
Additional:

Reference:

PRECIFIT MEDICAL LTD 2233 5th Street East, St Paul, MN, 55119 901-433-1990 April 5, 2018

Kellen Hills (Orchid Design Consulting) Eric Wu (Precifit Medical Ltd)

Cervage Cervical interbody fusion device, interbody cage 21 CFR 888.3080: Intervertebral Fusion Device With Bone Graft, Cervical ODP

Medtronic® ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM (K133653); Medtronic® ANATOMIC PEEK CERVICAL FUSION SYSTEM (K112444) Precifit Medical LUMFUSE-TP (K171630)

(a)(4) Device Description:

Indications for Use: (a)(5)
The Cervage cage 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 Cervage cage is to be used with supplemental fixation. The Cervage cage is also required to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

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(a)(6) Comparison of Technological Characteristics:
The Cervage device has the same intended use and is similar in basic shape, material and performance characteristics to the predicate device. The technological characteristics do not raise any new questions of safety and efficacy.

(b)(1) Non-clinical testing:

The worst case devices were evaluated for mechanical performance in Static and Dynamic Axial Compression, Static and Dynamic Torsion, Static and Dynamic Compression Shear according to ASTM F2077-14, Subsidence according to ASTM F2267-04 and Expulsion in accordance with ASTM F-04.25.02.02. Cleaning and sterilization as well as implantable device biocompatibility endpoints were also evaluated.

(b)(2) Clinical testing:

Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.

(b)(3) Conclusions:

Based on the information provided in this premarket notification, we believe that the subject Cervage device demonstrates substantial equivalence to the identified 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.