(160 days)
The DEXA-C Cervical Interbody System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograff and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone to facilitate fusion and is to be implanted via an open, anterior approach.
The DEXA-C Cervical Interbody System is a porous 3D-printed intervertebral body fusion device that incorporates low-, mid-, or high-density lattice pattern options. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the endplates. The device is available in various footbrints and heights to accommodate variability among patients and is manufactured from titanium alloy per ASTM F3001.
This document is a marketing clearance (510(k) summary) for a medical device called the DEXA-C Cervical Interbody System. It does not describe a study involving an AI/software device that requires intricate acceptance criteria and a detailed study proving the device meets those criteria, as typically seen with diagnostic or prognostic AI systems.
Instead, this document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "performance data" section refers to non-clinical mechanical testing of the physical interbody fusion device, not a software algorithm.
Therefore, many of the requested points are not applicable to this particular document. I will address the points that are relevant based on the provided text, and explicitly state when a point is not applicable.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
Not applicable in the context of an AI/software device's performance metrics (e.g., sensitivity, specificity, AUC). For this physical device, the "acceptance criteria" are implied by the mechanical testing standards, and the "performance" is that the device met these standards demonstrating sufficient strength.
| Acceptance Criteria (Implied by standard and intended use) | Reported Device Performance |
|---|---|
| Device strength sufficient for intended use | "The results of this non-clinical testing show that the strength of DEXA-C device is sufficient for its intended use." "All data indicates substantial equivalence to the predicate system." |
| Mechanical integrity per ASTM F2077 | Tested and results support substantial equivalence. |
| Subsidence resistance per ASTM F2267 | Tested and results support substantial equivalence. |
| Expulsion resistance | Tested and results support substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This refers to mechanical testing of the physical device, not a human or image-based test set. The document does not specify the number of devices tested for each mechanical test mode, nor the provenance of "data" in the sense of patient data.
- Sample Size: Not explicitly stated for each mechanical test.
- Data Provenance: Not applicable in the context of clinical or image data. The tests are lab-based mechanical tests.
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" in this context refers to meeting mechanical engineering standards, not medical diagnoses established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There's no human adjudication process described for mechanical testing.
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 a physical interbody fusion device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical interbody fusion device, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the typical AI/software sense. For this device, the "ground truth" for proving performance would be established by the adherence to industry mechanical testing standards (ASTM F2077, ASTM F2267) and demonstrating the mechanical strength and integrity required for its intended use, as compared to predicate devices.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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August 2, 2021
Aurora Spine, Inc. % Jeffrey Brittan Vice President of Product Realization Watershed Idea Foundry 1815 Aston Ave., Suite 106 Carlsbad, California 92008
Re: K210521
Trade/Device Name: DEXA-C Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: June 30, 2021 Received: July 2, 2021
Dear Jeffrey Brittan:
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
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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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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 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
Enclosure
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Indications for Use
510(k) Number (if known) K210521
Device Name DEXA-C Cervical Interbody System
Indications for Use (Describe)
The DEXA-C Cervical Interbody System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograff and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone to facilitate fusion and is to be implanted via an open, anterior approach.
| 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: DEXA-C Cervical Interbody System
| Company: | Aurora Spine, Inc.1930 Palomar Point Way, Suite 103Carlsbad, CA 92008(760) 424-2004 |
|---|---|
| Official Contact: | Laszlo GaramszegiCTO |
| Representative/Consultant: | Jeffrey BrittanWatershed Idea Foundry(714) 287-6780jeffbrittan@watershedideas.com |
| Date Prepared: | February 15, 2021 |
| Device Name: | DEXA-C Cervical Interbody System |
| Classification: | Per 21 CFR as follows:§888.3080 Intervertebral fusion device with bone graft, cervicalProduct Code: ODPRegulatory Class: IIOrthopedic (Spinal) Review Panel |
| Predicate Devices: | Aurora Discovery Interbody Fusion System (K111484) –Primary PredicateHD Lifesciences Cervical IBFD System (K180364) |
| Reference Devices: | Nvision Biomedical Trigon Ti Stand-Alone Wedge FixationSystem (K192645)Aurora Spine Zip MIS Interspinous Fusion System(K133091) |
Purpose:
The purpose of this submission is to request clearance for the DEXA-C Cervical Interbody System.
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Device Description:
The DEXA-C Cervical Interbody System is a porous 3D-printed intervertebral body fusion device that incorporates low-, mid-, or high-density lattice pattern options. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the endplates. The device is available in various footbrints and heights to accommodate variability among patients and is manufactured from titanium alloy per ASTM F3001.
Indications for Use:
The DEXA-C Cervical Interbody System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiquous levels from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone to facilitate fusion and is to be implanted via an open, anterior approach.
Technological Characteristics:
The DEXA-C Cervical Interbody System implants are manufactured from titanium alloy per ASTM F3001, which has a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. Implants are offered in multiple footprints and heights with low-, mid-, or highdensity lattice pattern options.
Performance Data:
Non-clinical mechanical testing was performed consisting of the following test modes:
- Static and dynamic axial compression, compression-shear, and torsion per ● ASTM F2077
- Subsidence per ASTM F2267 ●
- . Expulsion
The results of this non-clinical testing show that the strength of DEXA-C device is sufficient for its intended use. All data indicates substantial equivalence to the predicate system. Clinical data and conclusions were not needed for this device.
Basis of Substantial Equivalence:
The DEXA-C Cervical Interbody System has been found to be substantially equivalent to the predicate device with respect to technical characteristics, performance, and intended use. These systems offer equivalent interbody spacer implants in a range of sizes. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device.
§ 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.