pezo™ 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.

Device Description

The pezo™ PEEK Cage Family is comprised of three principal interbody fusion cages. The pezo-P and pezo-T devices have a basic rectangular shape while the pezo-A devices have a basic kidney shape. All implants have a hollow center for placement of autograft. The pezo implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

AI/ML Overview

The information provided describes a medical device called the "pezo™ PEEK Cage Family," an intervertebral body fusion device. The submission outlines its technological characteristics and performance data in comparison to predicate devices, rather than a study involving human subjects or AI. Therefore, many of the requested elements for AI/human reader studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Technological Characteristics equivalent to predicate devices: - Intended Use - Basic Design (hollow for autograft) - Material (polymer) - Sizes (comparable dimensions) - Fundamental scientific technology	pezo™ possesses the same technological characteristics as one or more of the predicate devices including intended use, basic design, material (polymer), sizes, and the same fundamental scientific technology.
Mechanical Performance equivalent to or better than predicate devices: - Static and dynamic compression - Subsidence	Mechanical test results demonstrate that pezo™ performs as well as or better than the predicate devices according to ASTM F2077 (static dynamic compression) and ASTM F2267 (subsidence). This indicates the device is as safe and effective as the predicates.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable. This study involves mechanical testing of the device, not a test set of data like in AI studies. The "worst case pezo™ device" was used, implying a single representative sample or a small number of samples, but specific numbers are not provided.
Data Provenance: Not applicable in the context of human data. The "data" comes from in vitro mechanical testing of the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F2077, ASTM F2267) and direct measurement, not expert consensus in the human assessment sense.
Qualifications of Experts: Not applicable. The "experts" would be the engineers and technicians performing the mechanical tests.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. Mechanical test results are objective measurements against defined standards, not subject to adjudication by multiple human reviewers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study Done: No. This submission does not describe an MRMC comparative effectiveness study involving human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study Done: No. This device is a physical intervertebral fusion cage, not an algorithm or AI system. Its performance is evaluated through mechanical testing, not a standalone algorithm study.

7. Type of Ground Truth Used:

Type of Ground Truth: The ground truth for device performance is based on established industry standards and objective material properties/mechanical strength measurements. Specifically, the device was tested according to ASTM F2077 (static and dynamic compression) and ASTM F2267 (subsidence). The performance of predicate devices against these same standards would form the basis for comparison.

8. Sample Size for the Training Set:

Sample Size: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth for Training Set: Not applicable. As there is no training set for an AI model, there is no corresponding ground truth to be established in that context.

Summary

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KIO3814

MAR 1 7 2011

Image /page/0/Picture/2 description: The image shows the logo for Ulrich medical USA. The logo consists of the word "Ulrich" in a bold, sans-serif font, with the "U" stylized to appear as if it is emerging from a black square. Below the word "Ulrich" is the phrase "medical USA" in a smaller, sans-serif font.

510(k) Summary

Date:	22 December 2010
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 TradeName:	pezo™ PEEK Cage Family
Device Classification	Class II
Classification Name:	Intervertebral body fusion device
Regulation:	888.3080
Device ProductCode:	MAX
Device Description:	The pezo™ PEEK Cage Family is comprised of three principalinterbody fusion cages. The pezo-P and pezo-T devices have abasic rectangular shape while the pezo-A devices have a basickidney shape. All implants have a hollow center for placement ofautograft. The pezo implants are available in an assortment ofheight, length, width and anteroposterior angulation combinations toaccommodate a variety of anatomic requirements.
Intended Use:	pezo™ 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:	pezo™ components are manufactured from polyetheretherketone(PEEK Optima LT1) as described by ASTM F2026. Integral markersare manufactured from tantalum according to ASTM F560.

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K103814

Predicate Devices:

Technological Characteristics:

Lumbar I/F Cage® (P960025)

Ray TFC™ Device (P950019)

AVS PEEK Spacers (K073470, K082014, K083661 and K090166)

pezo™ 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 (polymer),
sizes (dimensions are comparable to those offered by the . predicate systems) and

The fundamental scientific technology of pezo™ is the same as previously cleared devices.

Performance Data:

Mechanical testing of the worst case pezo™ device included static dynamic compression according to ASTM and F2077 and subsidence according to ASTM F2267.

The mechanical test results demonstrate that pezo™ performs as well as or better than the predicate devices and therefore that the device is as safe and as effective as the predicates.

Confidential: pezo
TM Family

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.

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

ulrich GmbH & Co. KG % ulrich medical USA. Inc. Mr. Hans Stover President and CEO 612 Trade Center Boulevard Chesterfield, Missouri 63005

MAR 1 7 2011

Re: K103814

Trade/Device Name: pezo™ PEEK Cage Family Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 22, 2010 Received: December 29, 2010

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 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

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Page 2 - Mr. Hans Stover

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); 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/CentersOffices/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.fda.gov/MedicalDevices/Safety/ReportalProblem/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

A
for
B.R h

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

Enclosure

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Indications for Use Statement

510(k) Number:_K103814

Device Name: pezo™ PEEK Cage Family

Indications for Use:

pezo™ 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 (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

(Division Sign-Off) Division of Surgical Orthopedic, and Restorative Devices

KI03814 510(k) Number.

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.