(269 days)
tezo™ is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.
The tezo™ Titanium Cage Family is comprised of three principal interbody fusion cages. The tezo-P and tezo-T devices have a basic rectangular shape while the tezo-A device has a basic kidney shape. All implants have a hollow center for placement of autograft. The tezo implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements
The provided document is a 510(k) Summary for the tezo™ Titanium Cage Family and a letter from the FDA confirming substantial equivalence. This type of regulatory submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than on proving performance against specific acceptance criteria through a full clinical study with an AI component. Therefore, much of the requested information (related to AI performance, ground truth, expert adjudication, sample sizes for training/test sets, MRMC studies) is not present in this document.
However, I can extract the information that is available regarding the device's characteristics and the performance data that was presented for its clearance.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was tested against) | Reported Device Performance (tezo™ Titanium Cage Family) |
|---|---|
| Static Compression (ASTM F2077) | Demonstrated substantial equivalence to predicate devices. |
| Dynamic Compression (ASTM F2077) | Demonstrated substantial equivalence to predicate devices. |
| Subsidence (ASTM F2267) | Demonstrated substantial equivalence to predicate devices. |
| Technological Characteristics | Same as predicate devices: intended use, basic design (hollow structure for autograft), material (titanium), manufacturing (additive), and sizes. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data for performance evaluation. The performance data presented refers to mechanical testing of the device. The sample sizes for these mechanical tests are not explicitly stated. The data provenance is derived from the manufacturing and testing of the "worst-case tezo™ device" in Germany and/or the USA, but the specific origins of the test specimens are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an intervertebral body fusion device (medical implant), not an AI algorithm. Ground truth, expert consensus, and expert qualifications are not relevant to the mechanical testing described in this 510(k) summary.
4. Adjudication method for the test set
Not applicable. This is not an AI study requiring adjudication of expert interpretations.
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. There is no AI component or human reader study described in this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no AI component described in this 510(k) summary.
7. The type of ground truth used
For the mechanical testing, the "ground truth" would be the established performance standards of ASTM F2077 and ASTM F2267, and the comparative performance of the predicate devices. There is no clinical "ground truth" (e.g., pathology, outcomes data) detailed in the context of this 510(k) summary as it relies on substantial equivalence to previously cleared devices based on mechanical properties and design.
8. The sample size for the training set
Not applicable. There is no AI component and therefore no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI component and therefore no training set.
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510(k) Summary
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Image /page/0/Picture/2 description: The image shows the logo for Ulrich medical USA. The word "Ulrich" is in a bold, sans-serif font, with the "U" extending into a black square on the left. Below "Ulrich" is the text "medical USA" in a smaller, sans-serif font.
JUN 2 1 2012
| Date: | 21 September 2012JUN 21 2013 |
|---|---|
| Sponsor: | ulrich GmbH & Co. KGBuchbrunnenweg 1289081 UlmGermanyPhone: +49 (0) 731-9654-1304Fax: +49 (0) 731-9654-2802 |
| Contact Person: | Hans Stoverulrich medical USA, Inc.612 Trade Center Blvd.Chesterfield, MO 63005(636) 519-0268 Office(636) 519-0271 Fax |
| Proposed Trade Name: | tezo™ Titanium Cage Family |
| Device Classification | Class II |
| Classification Name: | Intervertebral body fusion device |
| Regulation: | 888.3080 |
| Device Product Code: | MAX |
| Device Description: | The tezo™ Titanium Cage Family is comprised of three principalinterbody fusion cages. The tezo-P and tezo-T devices have a basicrectangular shape while the tezo-A device has a basic kidney shape.All implants have a hollow center for placement of autograft. Thetezo implants are available in an assortment of height, length, widthand anteroposterior angulation combinations to accommodate avariety of anatomic requirements |
| Intended Use: | tezo™ is indicated for intervertebral body fusion of the lumbar spine,from L2 to S1, in skeletally mature patients who have had six monthsof non-operative treatment. The device is intended for use at eitherone level or two contiguous levels for the treatment of degenerativedisc disease (DDD) with up to Grade I spondylolisthesis orretrolisthesis. DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The device is intended for use with supplemental fixationand with autograft to facilitate fusion. |
| Materials: | tezo™ devices are manufactured from Ti-6Al-4V titanium alloy whichconforms to ASTM F136. |
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Predicate Devices:
pezo™ PEEK Cage Family - K103814 Fuse Cage - K100945 and K121288
Technological Characteristics: tezo™ possesses the same technological characteristics as one or more of the predicate devices. These include:
- intended use (as described above) .
- . basic design (hollow structure for the containment of autograft),
- . material (titanium),
- manufacturing (additive) .
- sizes (dimensions are comparable to those offered by the ● predicate systems) and
The fundamental scientific technology of tezo™ is the same as previously cleared devices.
Performance Data:
Mechanical testing of the worst case tezo™ device included static and dynamic compression according to ASTM F2077 and subsidence according to ASTM F2267.
The mechanical test results demonstrate that tezo™ is substantially equivalent to the predicate devices and therefore that tezo™ is as safe and as effective as the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.
Public Health Service
June 21, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WOliti-Cloup Silver Spring, MD 20993-002
ulrich GmbH & Co. KG % ulrich medical USA. Incorporated Mr. Hans Stover President and CEO 612 Trade Center Boulevard Chesterfield. Missouri 63005
Re: K122957
Trade/Device Name: tezo TM Titanium Cage Family Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 11, 2013 Received: June 12. 2013
Dear Mr. Stover:
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 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require annroval 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 vou; 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 mav 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
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Page 2 - Mr. Hans Stover
device-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 go to http://www.fda.gov/AboutFDA/CentersOfTices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.lda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRF'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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anton E. Dmitriev
- 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 Statement
510(k) Number:___K122957 Device Name: tezo™ Titanium Cage Family
Indications for Use:
tezo™ is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.
Prescription Use _ X
AND/OR
Over-the-Counter Use_ ________________________________________________________________________________________________________________________________________________________
(21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
Page 20
§ 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.