(163 days)
The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are additively manufactured interbody fusion devices for cervical implantation. The implants are designed having porous surfaces to provide surgical stabilization of the spine. Each interbody has a central cavity that can be packed with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material and lateral windows for radiographic visualization. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.
The given text describes a medical device, the uCerv Flux™-C 3D Porous Titanium Cervical Interbody, and its 510(k) premarket notification to the FDA. The document focuses on establishing substantial equivalence to a predicate device through performance testing. However, it does not contain information related to acceptance criteria or studies involving AI or human-in-the-loop performance.
Therefore, for the information requested regarding acceptance criteria, AI studies, human experts, and ground truth for AI model development, I must state that this information is not present in the provided document.
The document details mechanical testing for the interbody device to demonstrate substantial equivalence to predicate devices, but this is a different type of evaluation than what is asked for in the prompt.
Here's a breakdown of what is available in the document related to performance, even though it's not about AI:
1. A table of acceptance criteria and the reported device performance
The document states that the performance data for the uCerv Flux™-C 3D Porous Titanium Cervical Interbody included:
- Static and dynamic axial compression according to ASTM F2077.
- Static and dynamic torsion according to ASTM F2077.
- Subsidence according to ASTM F2267.
- Expulsion tests.
The reported performance is that "The mechanical test results demonstrate that the uCerv Flux™-C 3D Porous Titanium Cervical Interbody performance is substantially equivalent to the predicate devices."
However, specific numerical acceptance criteria (e.g., "must withstand X N of force") and detailed numerical results are NOT provided in the text. It only states the tests performed and the conclusion of substantial equivalence.
2. Sample sized used for the test set and the data provenance
Not applicable, as the evaluation is mechanical testing of physical device units, not a dataset for an AI model. The document does not specify the number of devices tested in the mechanical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as the evaluation is mechanical testing, not expert-based assessment.
4. Adjudication method for the test set
Not applicable, as the evaluation is mechanical testing, not a read study requiring adjudication.
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 type of study was not done or mentioned. The device is a cervical interbody fusion device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an AI algorithm.
7. The type of ground truth used
For the mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices. The document implies compliance with ASTM standards, which provide established methodologies and expected performance ranges for such devices.
8. The sample size for the training set
Not applicable, as there is no mention of an AI training set.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of an AI training set.
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August 19, 2022
ulrich medical USA, Inc. Hans Stover President & CEO 18221 Edison Avenue Chesterfield, Missouri 63005
Re: K220696
Trade/Device Name: uCerv Flux™-C 3D Porous Titanium Cervical Interbody Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 18, 2022 Received: July 19, 2022
Dear Hans 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
uCerv Flux™-C 3D Porous Titanium Cervical Interbody
Indications for Use (Describe)
The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous bone to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an 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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K220696
Page 1 of 2
510(k) Summary
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| Date: | 8 March 2022 |
|---|---|
| Sponsor: | ulrich medical USA, Inc. 18221 Edison Avenue Chesterfield, MO 63005 (636) 519-0268 Office (636) 519-0271 Fax |
| Sponsor Contact: | Hans Stover, President & CEO |
| 510(k) Contact: | Karen E. Warden, PhD BackRoads Consulting Inc. PO Box 566 Chesterland, OH 44026 Office: 440.729.8457 |
| Proposed Trade Name: | uCerv Flux™-C 3D Porous Titanium Cervical Interbody |
| Common Name: | Cervical interbody fusion device |
| Device Classification: | Class II |
| Regulation Name, Regulation Number, Product Code: | Intervertebral fusion device with bone graft, cervical, 888.3080, ODP |
| Device Description: | The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are additively manufactured interbody fusion devices for cervical implantation. The implants are designed having porous surfaces to provide surgical stabilization of the spine. Each interbody has a central cavity that can be packed with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material and lateral windows for radiographic visualization. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances. |
| Indications for Use: | The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. |
| Materials: | The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F3001). The instrumentation for implantation is manufactured from medical grade stainless steel per ASTM F899. |
| Primary Predicate: | Cascadia™ Interbody System (K2M Inc. - K160125) |
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| Performance Data: | Mechanical testing of the worst case uCerv Flux™-C 3D Porous TitaniumCervical Interbody implants included static and dynamic axial compressionand static and dynamic torsion according to ASTM F2077. In addition,subsidence according to ASTM F2267 and expulsion tests were performed.The mechanical test results demonstrate that the uCerv Flux™-C 3DPorous Titanium Cervical Interbody performance is substantially equivalentto the predicate devices. |
|---|---|
| TechnologicalCharacteristics: | The uCerv Flux™-C 3D Porous Titanium Cervical Interbody possesses thesame technological characteristics as one or more of the predicate devices.These include:• intended use (as described above)• basic design (additively manufactured structure),• material (titanium alloy) and• sizes (dimensions are comparable to those offered by the predicatesystems)The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is the same aspreviously cleared devices. |
| Conclusion: | The uCerv Flux™-C 3D Porous Titanium Cervical Interbody possesses thesame intended use and technological characteristics as the predicatedevices. Therefore the uCerv Flux™-C 3D Porous Titanium CervicalInterbody is substantially equivalent for its intended use. |
§ 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.