The Integra Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Integra Cervical Cage implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to T-1 disc levels using autograft bone. Integra Cervical implant is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Petra PLF Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Petra PLIF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The Petra PLIF Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The Integra Cervical Cage was developed as an intercorporal implant for anterior cervical spondylodesis. To prevent migration, the Integra Cervical Cage has teeth on its superior and inferior surfaces. A large window allows bony growth to form. It has two tantalum x-ray markers.

The Petra PLF Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique. The Petra PLIF implant has ridges on both its inferior and superior surfaces to prevent migration, and two large graft windows which help facilitate bony integration. It is a curved shape to facilitate insertion using a PLIF approach. The design is a wedged configuration for ease of insertion.

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)

AI/ML Overview

The provided document is a 510(k) summary for the Calvary Spine Intervertebral Body Fusion Cages (Integra Cervical Cage and Petra PLIF Lumbar Cage). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria on device performance in the way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, specific study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).

Here's why and what the document does provide:

Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria for device performance (e.g., success rates, complication rates, fusion rates). Instead, it states that "Tests performed according to ASTM F2077/F2267 indicate that the Interbody Calvary Spine Intervertebral Body Fusion Cages meet required mechanical strengths."
Study Details (Sample Sizes, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance): The document describes non-clinical tests for mechanical strength, not clinical trials assessing patient outcomes or diagnostic performance. Therefore, there's no information about:
- Sample sizes for test or training sets.
- Data provenance (country, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies (as there's no "AI" or human-in-the-loop performance being assessed).
- Standalone performance.
- Type of ground truth (as it's not a diagnostic or outcome-based study).
- Sample size for the training set.
- How ground truth for the training set was established.

Summary from the provided text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The device must meet the "required mechanical strengths" as determined by ASTM F2077/F2267.
- Reported Device Performance: "Tests performed according to ASTM F2077/F2267 indicate that the Interbody Calvary Spine Intervertebral Body Fusion Cages meet required mechanical strengths." Specific numerical values or detailed results are not provided in this summary.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. The document refers to non-clinical mechanical strength tests, not clinical data sets.
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. The "ground truth" here is compliance with mechanical strength standards, not a clinical diagnosis or outcome requiring expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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 MRMC study was done. This is a medical device for spinal fusion, not a diagnostic AI tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone performance study was done in the context of an algorithm or AI. The tests were purely mechanical.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the mechanical tests would be the specifications and requirements defined by ASTM F2077/F2267.
The sample size for the training set:
- Not applicable/Not provided. This is not a machine learning model.
How the ground truth for the training set was established:
- Not applicable/Not provided.

This 510(k) summary primarily demonstrates substantial equivalence to existing devices based on similar indications, materials, and designs, supported by non-clinical mechanical testing to ensure the new devices meet established safety and performance standards for intervertebral body fusion cages.

Summary

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K0822.60-ivf 2

510(k) Summary for the Calvary Spine Intervertebral Body Fusion Cages

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Calvary Spine Intervertebral Body Fusion Cages

Date Prepared: August 5, 2008

1.	Submitter:	Contact Person:
	Calvary Spine LLC	J.D. Webb
	308 North Wind Rd	The OrthoMedix Group, Inc.
	Towson, MD 21204	1001 Oakwood Blvd
		Round Rock, TX 78681
		Telephone: 512-388-0199

2. Trade name:	Integra Cervical and Petra PLIF Lumbar Cages
Common Name:	intervertebral body fusion device
Classification Name:	intervertebral body fusion device - cervical
	Intervertebral body fusion device - lumbar
	21 CFR section 888.3080
	ODP/MAX
	Class II

3. Predicate or legally marketed devices which are substantially equivalent:

The Calvary Spine Intervertebral Body Fusion Cages are substantially equivalent to similar previously cleared cervical and lumbar intervertebral body fusion devices.

4. Description of the device:

Materials:

PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)

റ്റ് Intended Use:

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autogenous bone graft and implanted via an open posterior approach. The Petra PLIF Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Comparison of the technological characteristics of the device to predicate and legally marketed devices: റ. The Calvary Spine Intervertebral Body Fusion Cages have indications and material, and similar designs as previously cleared devices.

7. Summary of Nonclincal Tests

Tests performed according to ASTM F2077/F2267 indicate that the Interbody Calvary Spine Intervertebral Body Fusion Cages meet required mechanical strengths.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the border.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Calvary Spine, LLC % The Orthomedix Group, Inc. Mr. J.D. Webb Official Correspondent 1001 Oakwood Boulevard Round Rock, Texas 78681

OCT 1 7 2008

Re: K082260

Trade/Device Name: Integra Cervical Cage Petra PLIF Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Names: Intervertebral body fusion device. Regulatory Class: II Product Code: MAX, ODP Dated: August 5, 2008 Received: August 8, 2008

Dear Mr. Webb:

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. J.D. Webb

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 the reporting 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. Millerson

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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K082260-1 of 2

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

The Integra Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Integra Cervical Cage implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to T-1 disc levels using autogenous bone graft. Integra Cervical implant is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nilfne Oden for mxm

Division of General. Restorative, and Neurological Devices

082260 510(k) Number

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KU82260 - 2 of 2

Indications for Use

K-082260 510(k) Number (if known): _

Device Name: Petra PLIF Lumbar Cage

Indications for Use:

The Petra PLIF Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Petra PLF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The Petra PLIF Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Prescription Use X {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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mitree Dyke for mxm

Division of General, Restorative and Neurological Devic

510(k) Number K082260

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.