The Intersomatic Cervical Device - DICOM PEEK is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-C3 disc to the C7-T1 disc). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with additional supplemental fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

The Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). DIMEI and TLIF Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The DIMEI and TLIF Spinal Implant is to be used with additional supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK were developed as implants for the stabilization of the cervical and lumbar spinal column. The implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study information for the Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, and Intersomatic Transforaminal - TLIF PEEK devices.

Based on the provided FDA 510(k) summary, these devices are intervertebral body fusion devices, and the submission primarily relies on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific, quantifiable acceptance criteria from a clinical study for a novel AI/software function.

Therefore, most of the requested fields related to AI/software performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this particular device submission. The "acceptance criteria" here refer to the regulatory standards and testing required for this type of medical implant to demonstrate safety and effectiveness equivalent to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Testing:
Invibio® PEEK Optima LT1	Conforms to ASTM F2026
Titanium alloy	Conforms to ASTM F136
Non-clinical Mechanical Testing (per ASTM F2077):
Static compression	Results indicate equivalence to predicate devices.
Dynamic compression	Results indicate equivalence to predicate devices.
Static torsion	Results indicate equivalence to predicate devices.
Dynamic torsion	Results indicate equivalence to predicate devices.
Non-clinical Subsidence Testing (per ASTM F2267):
Subsidence performance	Results indicate equivalence to predicate devices.
Overall Substantial Equivalence:	The devices are substantially equivalent to predicate devices in terms of intended use, design, materials used, mechanical safety, and performances.

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

Test Set Sample Size: Not applicable. The testing described is non-clinical mechanical testing of the physical implant, not a study involving patient data or a "test set" in the context of AI/software performance.
Data Provenance: Not applicable. The data comes from benchtop mechanical testing, not human subjects.

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. Ground truth as typically defined for AI/software (e.g., diagnostic labels) is not relevant for this type of mechanical device testing. The "ground truth" for mechanical testing is established by adherence to ASTM standards and engineering principles.

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

Not applicable. There was no clinical or expert-based adjudication in the context of this submission. The "adjudication" for mechanical testing is based on whether the device passed the specified ASTM standards.

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. No MRMC study was performed as these are physical medical implants, not AI/software for interpretation.

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

Not applicable. No algorithm-only performance study was conducted.

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

Not applicable. The "ground truth" for this submission are the established ASTM standards for mechanical testing of intervertebral body fusion devices.

8. The sample size for the training set

Not applicable. There was no "training set" in the context of an AI/software algorithm.

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

Not applicable. There was no "training set" or corresponding ground truth to establish.

Summary of the Study:

The provided document describes a 510(k) premarket notification for three intervertebral body fusion devices: Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, and Intersomatic Transforaminal - TLIF PEEK.

The study relied on non-clinical mechanical testing to demonstrate "substantial equivalence" to previously marketed predicate devices, as is common for Class II medical devices in the 510(k) pathway.

Specifically, the following analyses were conducted:

Static and dynamic compression per ASTM F2077
Static and dynamic torsion per ASTM F2077
Subsidence per ASTM F2267

The manufacturer, Osteomed Implantes, LTDA, concluded that the DICOM PEEK, DIMEI PEEK, and TLIF PEEK devices are equivalent to the predicate devices based on similarities in principles of operation, technology, materials, and indications for use, supported by the results of these non-clinical evaluations.

No clinical studies were performed. The submission explicitly states this.

Ground Truth for Non-clinical Testing: The ground truth for this type of testing is adherence to the specified ASTM international standards (ASTM F2077 for compression/torsion and ASTM F2267 for subsidence), which are recognized benchmarks for evaluating the mechanical properties of intervertebral body fusion devices. The devices are expected to meet or exceed the performance of the predicate devices under these test conditions.

Summary

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June 10, 2015

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

Osteomed Implantes, LTDA % Mr. J.D. Webb The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K143572

Trade/Device Name: Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: May 3, 2015 Received: June 5, 2015

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. 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

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Page 2 - Mr. J.D. Webb

(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 (OS) 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" (21CFR 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 yours,

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K143572

Page 1 of 1

510(k) Number (if known) K143572

Device Name

Intersomatic Cervical Device - DICOM PEEK, Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK

Indications for Use (Describe)

The Intersomatic Cervical Device - DICOM PEEK is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-C3 disc to the C7-TI disc). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with additional supplemental fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

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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510(k) Summary: DICOM PEEK and DIMEI PEEK

Date Prepared	April 20, 2015
Submitted By	Osteomed Implantes, LTDAWashington Luiz Road, km 172Condomínio Conpark - Rua 6, S/NCEP 13501-600Rio Claro - SPBRAZIL(19) 3532-3411 Tele
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-mail: jdwebb@orthomedix.net
Trade Name	Intersomatic Cervical Device - DICOM PEEKIntersomatic Intervertebral Space Maintenance Device - DIMEI PEEKIntersomatic Transforaminal - TLIF PEEK
Common Name	intervertebral body fusion device
Classification Name	intervertebral body fusion device - cervicalintervertebral body fusion device - lumbar
Class	II
Product Code	ODPMAX
CFR Section	21 CFR section 888.3080
Device Panel	Orthopedic
Primary PredicateDevice	Stryker Spine AVS® TL PEEK Spacer (K083661)
Secondary PredicateDevices	Zimmer, BAK/C Vista Interbody Fusion (P980048 S3)Spinal Elements, Crystal Cervical/Lucent Straight Interbody CagesK071724/K073351/K081968)LDR Spine Cervical Interbody Fusion System (K091088)SeaSpine, Pacifica Cage (K082310)DePuy, Brantigan I/F Cage (P960025)Surgical Dynamic, Ray Threaded Lumbar Fusion Cage (P950019)Meditech Advisors, Talos PLIF (K090707)

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Device Description	The Intersomatic Cervical Device - DICOM PEEK, Intersomatic IntervertebralSpace Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal -TLIF PEEK were developed as implants for the stabilization of the cervical andlumbar spinal column. The implants have ridges on both their inferior andsuperior surfaces to prevent migration, and graft windows which help facilitatebony integration. X-ray markers are integrated for visualization of the implantsduring and after surgery.
Materials	Invibio® PEEK Optima LT1 (ASTM F2026)Titanium alloy conforming to ASTM F136
SubstantialEquivalence Claimedto Predicate Devices	The Intersomatic Cervical Device - DICOM PEEK, Intersomatic IntervertebralSpace Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal -TLIF PEEK are substantially equivalent to the predicate devices in terms ofintended use, design, materials used, mechanical safety and performances.
Indications for Use	The Intersomatic Cervical Device - DICOM PEEK is intended for anteriorinterbody spinal fusion procedures in skeletally mature patients with degenerativedisc disease (DDD) at one disc level (C2-C3 disc to the C7-T1 disc). Cervicaldegenerative disc disease is defined as neck pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies. Thisdevice is intended for use with additional supplemental fixation systems andautogenous bone graft implanted via an open, anterior approach. Patients shouldhave at least six weeks of non-operative treatment prior to treatment withintervertebral cage.The Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK andIntersomatic Transforaminal - TLIF PEEK is indicated for intervertebral bodyspinal fusion procedures in skeletally mature patients with degenerative discdisease (DDD) at one or two contiguous levels from L2-S1. DDD is defined asdiscogenic back pain with degeneration of the disc confirmed by patient historyand radiographic studies. These DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). DIMEI and TLIF Spinal Implants are tobe used with autogenous bone graft and implanted via an open posterior ortransforaminal approach. The DIMEI and TLIF Spinal Implant is to be used withadditional supplemental fixation. Patients should have at least six (6) months ofnon-operative treatment prior to treatment with an intervertebral cage.
Non-clinical TestSummary	The following analyses were conducted:• Static and dynamic compression per ASTM F2077• Static and dynamic torsion per ASTM F2077• Subsidence per ASTM F2267The results of these evaluations indicate that the DICOM PEEK, DIMEI PEEKand TLIF PEEK are equivalent to predicate devices.
Clinical Test Summary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Osteomed Implantes considers the DICOM PEEK, DIMEI PEEK and TLIF PEEKto be equivalent to the predicate devices listed above. This conclusion is basedupon the devices' similarities in principles of operation, technology, materials andindications for use

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.