(79 days)
The Genesys Spine AIS-C Cervical Anchored Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.
The Genesys Spine AIS-C Cervical Anchored Interbody System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium allov bone anchors. The Cervical Anchored Interbody System (AIS-C) was designed to provide additional biomechanical strength to traditional ACDF procedures through integrated fixation combined with supplemental fixation.
The provided text describes a 510(k) premarket notification for a medical device, the Genesys Spine AIS-C Cervical Anchored Interbody System. This document focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical (mechanical) testing. It does not contain information about a study involving human-in-the-loop performance, AI assistance, or the establishment of ground truth by medical experts for a diagnostic or AI-powered device. Therefore, many of the requested items (e.g., sample size for test/training sets, expert qualifications, MRMC studies, standalone AI performance) are not applicable or cannot be extracted from this document.
However, I can extract information related to the acceptance criteria and the (mechanical) study that proves the device meets those criteria.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The acceptance criterion for the mechanical tests was set as follows:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical test results for the Genesys Spine AIS-C Cervical Anchored Interbody System to be equivalent to (or greater than) previously cleared interbody fusion systems. | The overall technological characteristics and mechanical performance data lead to the conclusion that the Genesys Spine AIS-C Cervical Anchored Interbody System is substantially equivalent to the Genesys Spine Apache Anchored Cervical Interbody Fusion System (K152099), the LDR Spine Cervical Interbody Fusion System - ROI-C (K091088, K113559), and the Exactech Acapella One Cervical Spacer System (K132582), SpineArt Scarlet AC-T Secured Anterior Cervical Cage (K141314), Genesys Spine Apache® IBFD System, (K103034). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated as a numerical sample size. The document mentions "all possible configurations of the AIS-C System constructs were analyzed in order to determine the worst case to be used for testing." This implies a selection of specific configurations for mechanical testing rather than a statistical sample size in the context of human data.
- Data Provenance: The data is from non-clinical mechanical testing, not human or patient data. Therefore, country of origin or retrospective/prospective classification is not applicable in the typical sense. The testing was conducted to U.S. standards (ASTM).
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. This document describes mechanical testing of a medical implant, not a diagnostic device or AI system that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the physical performance against established industry standards and predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Pertains to human review of data, not 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:
- No. This was not an MRMC study and did not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is objective mechanical testing per established ASTM standards (F2077-11 for static and dynamic axial compression, compressive-shear, and torsion; F2267-04 for static subsidence; and ASTM draft standard F-04.25.02.02 for expulsion testing). The "truth" is whether the device meets or exceeds the mechanical performance of predicate devices.
8. The sample size for the training set:
- Not Applicable. This is not an AI or machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI or machine learning device.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
March 28, 2018
Genesys Spine Benjamin Keller Product Development Engineer 1250 Capital of Texas Highway South Building 3 Suite 600 Austin, Texas 78746
Re: K180056
Trade/Device Name: Genesys Spine AIS-C Cervical Anchored Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: January 4, 2018 Received: January 8, 2018
Dear Mr. Keller:
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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);
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1000-1050.
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Vincent J. Devlin -S
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
510(k) Number (if known)
K180056
Device Name
Genesys Spine AIS-C Cervical Anchored Interbody System
Indications for Use (Describe)
The Genesys Spine AIS-C Cervical Anchored Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Genesys Spine. The word "Genesys" is in gray, and the word "spine" is in brown. To the left of the word "Genesys" is a brown symbol that looks like a "G" with lines coming out of it.
4. 510(K) SUMMARY
| Submitter's Name: | Genesys Spine |
|---|---|
| Submitter's Address: | 1250 Capital of Texas Highway SouthBuilding Three, Suite 600Austin, Texas 78746 |
| Contact Name: | Benjamin V. Keller (Primary) William W. Sowers (Secondary) |
| Submitter's Telephone: | 512-381-7093 512-381-7080 |
| Submitter's Fax: | 800-817-4938 800-817-4938 |
| Date Summary was Prepared: | March 15, 2018 |
| Trade or Proprietary Name: | Genesys Spine AIS-C Cervical Anchored Interbody System |
| Common or Usual Name: | Intervertebral Body Fusion Device, Cervical |
| Classification Name: | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Regulation Number: | 21 CFR 888.3080 |
| Product Codes: | OVE |
| Classification Panel: | Orthopedic Devices Panel |
| Legally Marketed (unmodified) devices to Which Substantial Equivalence is Claimed: | Primary Predicate: Genesys Spine Apache® Anchored CervicalInterbody Fusion System (K152099)Additional Predicates: LDR Spine Cervical Interbody Fusion System –ROI-C (K091088, K113559), Exactech Acapella One Cervical SpacerSystem (K132582), SpineArt Scarlet AC-T Secured Anterior CervicalCage (K141314), Genesys Spine Apache® IBFD System, (K103034) |
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DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine AIS-C Cervical Anchored Interbody System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium allov bone anchors. The Cervical Anchored Interbody System (AIS-C) was designed to provide additional biomechanical strength to traditional ACDF procedures through integrated fixation combined with supplemental fixation.
INDICATIONS FOR USE
The Genesys Spine AIS-C Cervical Anchored Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.
TECHNICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The Genesys Spine AIS-C Cervical Anchored Interbody System is comprised of two versions of interbodies, each of which are secured by integrated fixation Anchors. The interbodies are available in a PEEK configuration with tantalum markers or in a titanium alloy version. Both versions use the same integrated titanium alloy locking mechanism. The interbodies are to be available in several footprints, configurations, and heights. The titanium alloy cervical bone Anchors provide integrated fixation for the system and are to be offered in various lengths. The bone Anchors are deployed through the channels in the interbody and embed into the adjacent cervical vertebrae. The system is to be inserted after cervical discectomy and the integrated fixation provides additional stabilization to the spine during fusion.
The PEEK interbody devices are made of polyether-ether-ketone (Invibio's PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the PEEK implants contain tantalum markers per ASTM F560 to assist the surgeon with proper placement of the device in the disk space. The titanium alloy interbody devices, anchor locking mechanism, and the bone anchor components are manufactured from medical grade Ti6Al-4V ELI titanium alloy per ASTM F136.
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The subject and predicate devices are based on the following same technological elements:
- Integrated fixation Anchors provide additional biomechanical support to the interbody
- . Devices are offered in the same sizes and shapes (parallel, lordotic, and convex) which provide surgeons options to suit the patient's anatomy
- . Implants materials are identical: PEEK, Titanium 6Al-4V ELI allov, and Tantalum
- Use of a single inserter instrument to position the interbodies and deploy the Anchors ●
The following technological differences exist between the subject and predicate devices:
- Integrated titanium locking mechanism that provides visual feedback of Anchor securement
PERFORMANCE DATA
The predetermined pass-fail criterion was that the mechanical test results for the Genesys Spine AIS-C Cervical Anchored Interbody System be equivalent to (or greater than) previously cleared interbody fusion systems. Prior to performing mechanical testing, all possible configurations of the AIS-C System constructs were analyzed in order to determine the worst case to be used for testing.
The Genesys Spine AIS-C Cervical Anchored Interbody System was tested in static and dynamic axial compression, compressive-shear, and torsion per ASTM F2077-11, static subsidence per ASTM F2267-04, and expulsion testing per ASTM draft standard F-04.25.02.02. The system was also tested to determine the force to overcome the locking mechanism under worst-case conditions.
CONCLUSION OF NON-CLINICAL TESTS:
The overall technological characteristics and mechanical performance data lead to the conclusion that the Genesys Spine AIS-C Cervical Anchored Interbody System is substantially equivalent to the Genesys Spine Apache Anchored Cervical Interbody Fusion System (K152099), the LDR Spine Cervical Interbody Fusion System - ROI-C (K091088, K113559), and the Exactech Acapella One Cervical Spacer System (K132582), SpineArt Scarlet AC-T Secured Anterior Cervical Cage (K141314), Genesys Spine Apache® IBFD System, (K103034) .
§ 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.