(140 days)
The Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Cervical Spacer is indicated to treat 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 Cervical Spacer is to be used with supplemental fixation; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.
The Cervical Spacer is an additively manufactured interbody device. These cervical implants have basic keystone shape and an open architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The Cervical Spacers are provided sterile only.
This document is a 510(k) summary for the Additive Implants Cervical Spacer. It outlines the device description, indications for use, materials, predicate devices, and performance data. The device is a cervical interbody fusion device.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the traditional sense for AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists performance testing conducted for a medical device (an implant), focusing on mechanical and biological safety. The acceptance criteria for this type of device are typically based on meeting established ASTM (American Society for Testing and Materials) standards.
Here's a summary of the performance data and implied acceptance:
| Performance Criterion (Acceptance based on ASTM Standards) | Reported Device Performance (as stated in the document) |
|---|---|
| Mechanical Testing: - Static Compression (ASTM F2077) - Dynamic Compression (ASTM F2077) - Static Torsion (ASTM F2077) | "The mechanical test results demonstrate that the Cervical Spacer performance is substantially equivalent to the predicate devices." |
| Subsidence Properties (ASTM F2267) | "The subsidence properties were evaluated according to ASTM F2267." (Implies meeting the standard's requirements for substantial equivalence). |
| Expulsion Properties (ASTM draft standard) | "expulsion according to the ASTM draft standard." (Implies meeting the draft standard's requirements). |
| Manufactured Surface Evaluation (ASTM F1978) | "The manufactured surface was evaluated according to ASTM F1978." (Implies meeting the standard's requirements). |
| Bacterial Endotoxin Testing (AAMI ST72:2011) | "bacterial endotoxin testing was conducted in accordance with AAMI ST72:2011 and met the specified testing limit." |
2. Sample size used for the test set and the data provenance
This document describes the regulatory clearance for a hardware medical device (a cervical spacer), not an AI/ML algorithm. Therefore, the concepts of "test set," "training set," "data provenance," "retrospective/prospective" studies do not apply in the context of AI/ML.
The "testing" refers to laboratory-based mechanical, material, and biological safety testing of the device prototypes, not a clinical study on patient data for AI model validation. The sample size for mechanical testing would refer to the number of devices tested, which is not specified in this summary but would be determined by the relevant ASTM standards for statistical significance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, this clearance is for a physical medical device, not an AI/ML diagnostic or prognostic tool. Ground truth in this context relates to material properties and performance under mechanical stress, verified by engineering and laboratory testing protocols, not by expert medical image annotation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of human-interpreted data.
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. This is not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective, standardized laboratory testing (e.g., mechanical load testing to failure, material composition analysis, endotoxin levels). The performance is compared to established predicate devices and known material properties as per ASTM and AAMI standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 4, 2021
Additive Implants, LLC % Karen Warden, Ph.D. President BackRoads Consulting 12520 Heath Road Chesterland, Ohio 44026
Re: K182477
Trade/Device Name: Cervical Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP
Dear Dr. Warden:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on January 28, 2019. Specifically, FDA is updating this SE Letter due to the clearance date not appearing on the original letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, (240) 402-1840, Brent.Showalter@fda.hhs.gov.
Sincerely,
Brent Showalter -S
Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image contains two logos. On the left is the logo for the U.S. Department of Health & Human Services. On the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo is in blue and includes the acronym "FDA" followed by the words "U.S. Food & Drug Administration".
Additive Implants, LLC % Karen Warden President BackRoads Consulting 12520 Heath Road Chesterland, Ohio 44026
Re: K182477
Trade/Device Name: Cervical Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 27, 2018 Received: December 27, 2018
Dear Karen Warden:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
{2}------------------------------------------------
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Hwang -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
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 Cervical Spacer
Indications for Use (Describe)
The Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Cervical Spacer is indicated to treat 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 Cervical Spacer is to be used with supplemental fixation; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous bone to facilitate fusion.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(k) Summary
| Date: | 27 December 2018 |
|---|---|
| Sponsor: | Additive Implants, LLC3101 E. Shea Blvd, Suite 114Phoenix, AZ 85028Office: 602.795.8850Fax: 602.595.7896 |
| Sponsor Contact: | Jeff Horn, Vice-President of Commercialization |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457 |
| Proposed Trade Name: | Cervical Spacer |
| Common Name: | Cervical interbody fusion device |
| Device Classification: | Class II |
| Regulation Names,Regulation Numbers,Product Codes: | Intervertebral fusion device with bone graft, 888.3080, cervical, ODP |
| Device Description: | The Cervical Spacer is an additively manufactured interbody device. Thesecervical implants have basic keystone shape and an open architecture. Avariety of height, length, width and anteroposterior angulation combinationsare available to accommodate the anatomic requirements of individualpatients. The Cervical Spacers are provided sterile only. |
| Indications for Use: | The Cervical Spacer is intended for anterior intervertebral body fusion inskeletally mature patients who have had at least six weeks of non-operativetreatment. The Cervical Spacer is indicated to treat cervical discdegeneration and/or cervical spinal instability, as confirmed by imagingstudies (radiographs, CT, MRI), that results in radiculopathy, myelopathy,and/or pain at multiple contiguous levels from C2 - T1. The Cervical Spaceris to be used with supplemental fixation; the hyperlordotic implants (≥10°)are required to be used with an anterior cervical plate. The implants aredesigned for use with autogenous and/or allogeneic bone graft comprised ofcancellous and/or corticocancellous bone to facilitate fusion. |
| Materials: | The Cervical Spacer implants are manufactured from Ti-6Al-4V ELI titaniumalloy (ASTM F3001, Grade 23). |
| Primary Predicate: | Cascadia Interbody System (K2M Inc. - K160125) |
| Additional Predicates: | ALTA Anterior Cervical Interbody Spacer (Astura Medical - K173324),Novel System (Alphatec Spine Inc. - K081730), MC+ (LDR Holding -K091088), BAK/C Interbody Fusion System (Centerpulse - SpineTech, Inc.- P980048), SynCage-C (Synthes Spine – K024364) |
| Performance Data: | Mechanical testing of the worst case Cervical Spacer included static anddynamic compression and static torsion according to ASTM F2077. Inaddition, the subsidence properties were evaluated according to ASTMF2267 and expulsion according to the ASTM draft standard. Themanufactured surface was evaluated according to ASTM F1978.The mechanical test results demonstrate that the Cervical Spacerperformance is substantially equivalent to the predicate devices.In addition, bacterial endotoxin testing was conducted in accordance withAAMI ST72:2011 and met the specified testing limit. |
| TechnologicalCharacteristics: | The Cervical Spacer possesses the same technological characteristics asone 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 Cervical Spacer is the same as previously cleared devices. |
| Conclusion: | The Cervical Spacer possesses the same intended use and technologicalcharacteristics as the predicate devices. Therefore the Cervical Spacer issubstantially equivalent for its intended use. |
{5}------------------------------------------------
§ 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.