(63 days)
The ACIF system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the cervical spine (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACIF implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACIF implants are to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to surgery.
The coLigne ACIF system are used to maintain disc space distraction in skeletally mature adults requiring anterior cervical interbody fusion (ACIF). This system includes two design configurations: ACIF oscar, and ACIF oscar dome. The implants are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of bone graft.
This document is a 510(k) Premarket Notification for a medical device called ACIF (Anterior Cervical Interbody Fusion) system. It outlines the device's characteristics, intended use, and substantial equivalence to previously cleared devices, a requirement for FDA clearance for Class II medical devices.
Here's an analysis of the provided text to address your specific questions regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the ACIF device is not an AI/Software as a Medical Device (SaMD). It is a physical intervertebral body fusion device. Therefore, the concept of "acceptance criteria" and "device performance" as typically applied to AI-powered diagnostic or predictive tools (e.g., sensitivity, specificity, AUC) does not apply in this context.
Instead, the acceptance criteria for this device are related to its physical, mechanical, and biological properties and its substantial equivalence to existing predicate devices.
Here's a table summarizing the relevant "performance" and "acceptance criteria" as described for this physical device:
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in 510(k)) | Reported Device Performance (as stated in 510(k)) |
|---|---|---|
| Mechanical Safety & Performance | Must demonstrate equivalent mechanical performance to predicate devices under specified test conditions. | "Mechanical testing confirmed the ACIF system demonstrated equivalent performance to the cited predicate device under the same test conditions." |
| Static Compression (per ASTM F2077) | Results "indicate that the coLigne ACIF are equivalent to predicate devices." | |
| Dynamic Compression (per ASTM F2077) | Results "indicate that the coLigne ACIF are equivalent to predicate devices." | |
| Static Torsion (per ASTM F2077) | Results "indicate that the coLigne ACIF are equivalent to predicate devices." | |
| Dynamic Torsion (per ASTM F2077) | Results "indicate that the coLigne ACIF are equivalent to predicate devices." | |
| Subsidence (per ASTM F2267) | Results "indicate that the coLigne ACIF are equivalent to predicate devices." | |
| Material Compatibility | Must use biocompatible materials with established safety profiles for implantable devices. | "Polyether ketone ether ketone ketone (ASTM F1876-98), Fiber carbon filaments, Gold (ASTM B562-95)" - stated to be similar to reference device. |
| Design & Dimensions | Must have similar basic design features, functions, and dimensions to predicate devices. | "The subject ACIF system and cited predicate devices share similar basic design features and functions." "The subject ACIF system is dimensionally similar to cited predicate devices." |
| Intended Use | Must have the same or very similar intended use as predicate devices. | "The subject ACIF system and all the predicates have similar intended uses." |
| Sterilization | Must meet appropriate sterilization requirements. | "The subject ACIF system is provided non-sterile and cited predicate devices are sterile and non-sterile for single use only." (This implies the user performs sterilization or it is used as is, and it's consistent with some similar devices.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of an AI/SaMD test set. For this physical device, the "test set" refers to the specific physical prototypes or batches of the device that underwent non-clinical mechanical testing. The document does not specify the number of individual devices tested, which is typical for a 510(k) summary focused on demonstrating equivalence through standard test methods.
- Data Provenance: The data comes from non-clinical bench testing performed by or for the manufacturer (coLigne, AG, based in Switzerland). It is not patient data, nor is it retrospective or prospective in the sense of a clinical trial.
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. The "ground truth" for a physical device like this is established by recognized engineering standards (e.g., ASTM F2077, ASTM F2267) and the results of established mechanical testing methodologies. There are no "experts" in the sense of clinical interpreters establishing ground truth as there would be for an image-based AI algorithm. The expertise lies in engineering and materials science to design and conduct these tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses for AI/SaMD test sets. For a mechanical device, the test results are quantitative (e.g., force, displacement), measured by calibrated equipment, and interpreted against predetermined thresholds or comparative data from predicate devices.
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. An MRMC study is relevant for AI/SaMD devices where human readers (e.g., radiologists) use AI assistance to improve their diagnostic accuracy. This device is a physical implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This concept is for AI/SaMD devices. The "performance" of this device is its mechanical integrity and ability to facilitate fusion, which is not an "algorithm."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the "ground truth" for demonstrating the safety and effectiveness of this physical device is based on accepted engineering standards (e.g., ASTM F2077, ASTM F2267) and direct comparative mechanical testing against a well-characterized predicate device. The goal is to show the new device performs equivalently in a mechanical sense.
8. The sample size for the training set
Not applicable. This device is not an AI/SaMD that requires a "training set" for machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of medical device.
In summary: The provided document describes a physical implantable device, not an AI/SaMD. Therefore, many of the questions asked (especially those related to "test sets," "ground truth experts," "MRMC studies," and "training sets") are not applicable to this type of device and its regulatory clearance process. The "study" that proves the device meets acceptance criteria consists of non-clinical, benchtop mechanical testing designed to demonstrate substantial equivalence to legally marketed predicate devices, not clinical trials or AI performance evaluations.
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December 1, 2017
coLigne, AG % Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd. Round Rock, Texas 78681
Re: K173148
Trade/Device Name: ACIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: September 25, 2017 Received: September 29, 2017
Dear Mr. Webb:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 medical devices and radiation-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,
Mark N. Melkerson -S
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)
K173148
Device Name
ACIF
Indications for Use (Describe)
The ACIF system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the cervical spine (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACIF implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACIF implants are to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to surgery.
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: ACIF
| Date Prepared | September 25, 2017 |
|---|---|
| Submitted By | Robert LangecoLigne, AGUtoquai 43CH 8008 ZurichSwitzerlandTelephone: +41 43 343 8000e-mail: robert.lange@coligne.com |
| Primary Contact | J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681Telephone: 512-388-0199e-mail: jdwebb@orthomedix.net |
| Trade Name | ACIF |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - cervical |
| Class | II |
| Product Code | ODP |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary PredicateDevice | DePuy, BENGAL System (K081917) |
| Secondary PredicateDevices | Spinal Elements, Crystal Cervical Cage (K073351)Zimmer, BAK/C Vista Interbody Fusion (P980048 S3)LDR Spine Cervical Interbody Fusion System (K091088)Medtronic, Affinity Anterior Cervical Cage (P000028) |
| Reference Device | ostaPek® VBR System (K072326) |
| Device Description | The coLigne ACIF system are used to maintain disc space distraction in skeletally matureadults requiring anterior cervical interbody fusion (ACIF). This system includes two designconfigurations: ACIF oscar, and ACIF oscar dome. The implants are available in a rangeof footprints and heights to suit the individual pathology and anatomical conditions ofthe patient. The implants have a hollow center to allow placement of bone graft. |
| Materials | Polyether ketone ether ketone ketone (ASTM F1876-98)Fiber carbon filamentsGold (ASTM B562-95) |
| Intended Use | The coLigne ACIF system is used to maintain disc space distraction in skeletally matureadults requiring anterior cervical interbody fusion (ACIF). |
| SubstantialEquivalence Claimedto Predicate Devices | The coLigne ACIF system is substantially equivalent to the predicate devices in termsof intended use, design, materials used, mechanical safety and performances. |
| Indications for Use | The ACIF system is indicated for use as an intervertebral body fusion device in skeletallymature patients at one or two contiguous levels of the cervical spine (C2-T1) to facilitatefusion in case of degenerative disc disease (DDD) defined as discogenic pain withdegeneration of the disc confirmed by patient history and radiographic studies. The ACIFimplants are placed via an anterior approach using autogenous bone graft and/or allograftcomprised of cancellous and/or corticocancellous bone graft. The ACIF implants are to beused with supplemental fixation. Patients should have at least six weeks of non-operativetreatment prior to surgery. |
| TechnologicalCharacteristics | Intended UseThe subject ACIF system and all the predicates have similar intended uses.MaterialsThe subject device is composed of the same materials as the reference device.Design Features/FunctionsThe subject ACIF system and cited predicate devices share similar basic design featuresand functions.DimensionsThe subject ACIF system is dimensionally similar to cited predicate devices.SterilizationThe subject ACIF system is provided non-sterile and cited predicate devices are sterileand non-sterile for single use only.Performance SpecificationMechanical testing confirmed the ACIF system demonstrated equivalent performance tothe cited predicate device under the same test conditions. |
| Non-clinical TestSummary | The following analyses were conducted:Static and dynamic compression per ASTM F2077 Static and dynamic torsion per ASTM F2077 Subsidence per ASTM F2267 The results of these evaluations indicate that the coLigne ACIFare equivalent to predicate devices. |
| Clinical TestSummary | No clinical studies were performed |
| Conclusions: Non-clinical and Clinical | coLigne, AG considers the coLigne ACIF Cervical Cages to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices' similarities inprinciples of operation, technology, materials and indications for use |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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§ 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.