The Phenix Cervical Interbody Device (Phenix CID) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Phenix CID implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.

Device Description

The Phenix ® Cervical Interbody Device is a cervical interbody fusion device made from PEEK Optima. It is implanted from the anterior approach. The device is provided in various geometries and is designed to fit within the outer cortex of cervical spine vertebrae. It is to be packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.

AI/ML Overview

The provided text is a 510(k) summary for the Phenix® Cervical Interbody Device (Phenix® CID). It describes the device, its indications for use, and identifies predicate devices. However, it does not contain details about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria by comparing it to an AI system or human reader performance.

The "Performance Testing" section states: "The pre-clinical testing performed indicated that the Phenix CID is substantially equivalent to the predicate devices and is adequate for the intended use." This suggests that the device's performance was evaluated against the predicate devices for achieving substantial equivalence, which is a regulatory standard for medical devices. However, it does not provide quantitative acceptance criteria or detailed study results in the context of an AI device and reader performance.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated, with the understanding that detailed performance metrics are not included for AI or reader studies:

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

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices for intended use.	The pre-clinical testing indicated that the Phenix CID is substantially equivalent to the predicate devices and is adequate for the intended use.
Mechanical safety and efficacy for spinal fusion.	Inherently demonstrated by substantial equivalence to devices already proven for these purposes.
Biocompatibility (as it's a PEEK Optima implant).	Implied by the material choice, which is commonly used in medical implants.

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

Not provided. The summary mentions "pre-clinical testing" but does not detail sample sizes, data provenance, or whether the study involved human subjects (which would be the case for a test set in the context of AI/reader studies).

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/Not provided. This device is a physical implant, not an AI diagnostic tool that requires ground truth established by experts for performance evaluation in the way a diagnostic AI would. The "pre-clinical testing" would likely refer to mechanical and material tests rather than expert-adjudicated diagnostic performance.

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

Not applicable/Not provided. Similar to point 3, this is not relevant for the type of device described.

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:

No. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

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

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

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

Not applicable/Not provided in the context of AI/reader studies. For this device, "ground truth" for "pre-clinical testing" would refer to established engineering standards for mechanical and material properties (e.g., strength, durability, biocompatibility).

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device, not an AI model.

In summary, the provided document is a 510(k) summary for a cervical interbody fusion device, focusing on its physical properties and intended use, and demonstrating substantial equivalence to predicate devices. It does not contain information related to AI performance, reader studies, or the types of "test sets" and "training sets" that would be relevant for an AI-powered diagnostic device.

Summary

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K083167 Page (off)

4. 510(k) Summary according to 807.92(c)

Contact:	Tim LusbySpinal Devices TM, LLC1155 Allgood Road, Suite 6Marietta, GA 30062770-874-0935	JAN 13 2009
Trade Name:Product Class:Classification:Product Codes:Panel Code:	Phenix ® Cervical Interbody Device (Phenix ® CID)Class II888.3080ODP87
Indications for Use:	The Phenix Cervical Interbody Device (Phenix CID) is indicatedfor use in skeletally mature patients with degenerative disc disease(DDD) of the cervical spine at one disc level. DDD is defined asdiscogenic pain with degeneration of the disc confirmed by historyand radiographic studies. Phenix CID implants are used tofacilitate fusion in the cervical spine and are placed via an anteriorapproach at the C-3 to C-7 disc levels using autograft bone.Patients should have received 6 weeks of non-operative treatmentprior to treatment with the devices. The device should be usedwith supplemental fixation.
Device Description:	The Phenix ® Cervical Interbody Device is a cervical interbodyfusion device made from PEEK Optima. It is implanted from theanterior approach. The device is provided in various geometriesand is designed to fit within the outer cortex of cervical spinevertebrae. It is to be packed with autogenous bone graft tofacilitate fusion. The device is intended to provide mechanicalsupport to the implanted level until biologic fusion is achieved.
Predicate Device(s):	The predicate devices previously cleared by FDA are theBAC/Cervical Implant from Zimmer Spine (previously approvedas a PMA product under the name of Spine-Tech) (P980048), andthe Medicrea IMPIX Interbody Device (K072226).
Performance Testing:	The pre-clinical testing performed indicated that the Phenix CID issubstantially equivalent to the predicate devices and is adequate forthe intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

Public Health Service

JAN 1 C 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spinal Devices™, LLC % Mr. Tim Lusby 1155 Allgood Road, Suite 6 Marietta, Georgia 30062

Re: K083167

Trade/Device Name: Phenix® Cervical Interbody Device (Phenix® CID) Regulation Number: 21 CFR 888,3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP Dated: December 12, 2008 Received: December 16, 2008

Dear Mr. Lusby:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Tim Lusby

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Mullican

Mark N. Melkerson, Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3. Statement of Indications for Use

510(k) Number: 083167

Indications for Use: The Phenix Cervical Interbody Device (Phenix CID) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Phenix CID implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Mark A. Milkerson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K083167

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.