(88 days)
The Facet-Link Stabilization Platform is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The system is indicated for use with bone graft, at single or multiple levels, from C2 to S1 (inclusive) for the Facet Screws and L3 to S1 (inclusive) for MINI and HEMI devices. The Platform is indicated for the treatment of any or all of the following:
- Spondylolisthesis.
- Degenerative disc disease (DDD) as defined as back pain of discogenic origin as confirmed by radiographic studies.
- Degeneration of the facets with instability.
The Facet-Link Facet Screw System is indicated for treatment of any or all of the following:
- Pseudoarthrosis and failed previous fusion;
- Spondylolisthesis; and
- Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.
The Facet-Link Stabilization Platform consists of a series of devices designed to stabilize the spine. The Platform includes the MINI and HEMI devices. The devices are secured to the bone using Facet-Link trans-articular (facet) screws. The MINI device utilizes an adjustable monorail to crossconnect the Facet Screws, while the HEMI device uses a small, fixed plate as a cross-connector. The implants are fabricated from anodized titanium alloy (Ti-6AI-4V) and are supplied in various sizes. The devices are provided non-sterile and for single patient use.
The Facet-Link Stabilization Platform requires several purpose manual orthopedic instruments for implantation, including a variety of k-wires, gauges, inserters, drills, and drivers.
The provided text describes the Facet-Link Stabilization Platform, a medical device intended to stabilize the spine. However, the document does not contain the specific information required to complete the table and answer all questions regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop system. The document focuses on regulatory approval (510(k)) based on substantial equivalence to predicate devices, and the performance data presented is for mechanical and biocompatibility testing, not clinical performance or AI diagnostic accuracy.
Here's a breakdown of what can and cannot be answered based on the provided text:
Information Available:
- Acceptance Criteria (Implicit - based on predicate device testing): The document states that the device was evaluated to demonstrate substantial equivalence to predicate devices through various bench tests and functional cadaver tests. These tests are primarily focused on mechanical performance and biocompatibility.
- Static Axial Compression Bending
- Static Torsion
- Dynamic Axial Compression Bending
- Biocompatibility (ISO 10993)
- MR Conditional (ASTM F2052-06)
- Reported Device Performance:
- "Performance of the subject constructs was substantially equivalent to that of legally marketed screw constructs."
- "Results demonstrated that repeatable and proper seating of the devices was achieved."
- "The materials of the Stabilization Platform are biocompatible for the indicated use in accordance with ISO 10993."
- "Testing demonstrated that the Stabilization Platform is MR Conditional, in accordance with ASTM F2052-06."
Information NOT Available (and thus cannot be filled in for your request):
- Specific numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy).
- Detailed quantitative results of the bench tests (e.g., actual force values, displacement).
- Any information regarding an AI component, human-in-the-loop performance, diagnostic accuracy, or clinical outcomes that would typically be evaluated with a test set of patient data, experts, and ground truth.
- Sample sizes for test sets related to human or AI performance.
- Data provenance for clinical studies (country, retrospective/prospective).
- Number of experts for ground truth establishment or their qualifications.
- Adjudication methods.
- MRMC study details or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used for clinical validation (pathology, outcomes data, etc.).
- Sample size for training sets.
- How ground truth for training sets was established.
Based on the provided document, here's how the information would be organized, with unknowns explicitly stated:
Acceptance Criteria and Study Proving Device Meets Criteria
The Facet-Link Stabilization Platform underwent a series of bench tests and functional cadaver tests to demonstrate substantial equivalence to its predicate devices, as required for 510(k) clearance. The performance data primarily focused on mechanical stability, material biocompatibility, and MR compatibility. There is no information in the provided document about an AI component, clinical diagnostic performance metrics, or a study involving human readers or a test set with established ground truth related to diagnostic outcomes.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criterion (if described) | Reported Device Performance |
|---|---|---|
| Mechanical Stability | Static Axial Compression Bending (in accordance with ASTM F1717, ASTM F1714, and ASTM F543) | Substantially equivalent to legally marketed screw constructs. |
| Static Torsion (in accordance with ASTM F1717, ASTM F1714, and ASTM F543) | Substantially equivalent to legally marketed screw constructs. | |
| Dynamic Axial Compression Bending (in accordance with ASTM F1717, ASTM F1714, and ASTM F543) | Substantially equivalent to legally marketed screw constructs. | |
| Surgical Implantation/Use | Repeatable and proper seating through cadaver implantation testing. | Achieved repeatable and proper seating of the devices. |
| Biocompatibility | Biocompatibility for indicated use (in accordance with ISO 10993). | Materials are biocompatible for the indicated use in accordance with ISO 10993. |
| MR Compatibility | MR Conditional (in accordance with ASTM F2052-06). | Demonstrated to be MR Conditional, in accordance with ASTM F2052-06. |
| Clinical Diagnostic Performance | No criteria for clinical diagnostic performance (e.g., sensitivity, specificity, accuracy) are mentioned as this is a spinal stabilization device, not a diagnostic AI system. | Not applicable - this document does not describe a diagnostic AI system or clinical performance study. |
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. The document describes bench tests and functional cadaver tests. No "test set" of patient data for diagnostic evaluation is mentioned.
- Data Provenance: Not applicable. The tests involved cadaveric specimens and laboratory equipment.
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. There is no mention of experts establishing ground truth for a diagnostic test set. The cadaver implantation testing assessed the ability of "users" to perform surgical techniques, but no specific number or qualifications are provided, and this is not establishing ground truth for a diagnostic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No diagnostic test set or adjudication method is described.
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 comparative effectiveness study was not done, and this device is not presented as an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for the performance described is based on established engineering standards (ASTM, ISO) for mechanical stability, biocompatibility, and MR compatibility, and the observable success of surgical implantation in cadavers, rather than clinical diagnostic outcomes.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2015
Facet-Link, Incorporated % Ms. Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K150223
Trade/Device Name: Facet-Link Stabilization Platform Regulatory Class: Unclassified Product Code: MRW Dated: January 30, 2015 Received: January 30, 2015
Dear Ms. Hogan:
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -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) K150223
Device Name
Facet-Link Stabilization Platform
Indications for Use (Describe)
The Facet-Link Stabilization Platform is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The system is indicated for use with bone graft, at single or multiple levels, from C2 to S1 (inclusive) for the Facet Screws and L3 to S1 (inclusive) for MINI and HEMI devices. The Platform is indicated for the treatment of any or all of the following:
-
Spondvlolisthesis.
-
Degenerative disc disease (DDD) as defined as back pain of discogenic origin as confirmed by radiographic studies.
-
Degeneration of the facets with instability.
The Facet-Link Facet Screw System is indicated for treatment of any or all of the following:
-
Pseudoarthrosis and failed previous fusion;
-
Spondylolisthesis; and
-
Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.
| 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
Facet-Link's Stabilization Platform
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Facet-Link, Inc. 101 Roundhill Drive, 200 floor Rockaway, NJ 07866
| Phone: | 973-627-4171 |
|---|---|
| Facsimile: | 973-718-4672 |
| Contact Person: | Massimo Calafiore |
| Date Prepared: | April 6, 2015 |
Device Information
| Trade Name: | Facet-Link Stabilization Platform |
|---|---|
| Common or Usual Name: | Facet Screw Spinal Device System |
| Classification: | Unclassified |
| Product Code: | MRW |
Predicate and Reference Devices:
Primary Predicate Device: Facet-Link, Inc.'s Facet Screw System (K123497) Reference Devices: Medtronic Sofamor Danek's TOWNLEY Transfacetpedicular Screw Fixation System (K013829); Medtronic Sofamor Danek's TSRH Spinal System (K081080); Spinal Concepts Inc.'s Speedlink Transverse Connector (K002082), Depuy Spine, Inc.'s EXPEDIUM SFX Cross Connectors (K070300)
Intended Use / Indications for Use
The Facet-Link Stabilization Platform is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The system is indicated for use with bone graft, at single or multiple levels, from C2 to S1 (inclusive) for the Facet Screws and L3 to S1 (inclusive) for MINI and HEMI devices. The Platform is indicated for the treatment of any or all of the following:
-
- Spondylolisthesis.
-
- Degenerative disc disease (DDD) as defined as back pain of discogenic origin as confirmed by radiographic studies.
-
- Degeneration of the facets with instability.
The Facet-Link Facet Screw System is indicated for treatment of any or all of the following:
-
- Pseudoarthrosis and failed previous fusion;
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-
- Spondylolisthesis; and
-
- Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.
Device Description
The Facet-Link Stabilization Platform consists of a series of devices designed to stabilize the spine. The Platform includes the MINI and HEMI devices. The devices are secured to the bone using Facet-Link trans-articular (facet) screws. The MINI device utilizes an adjustable monorail to crossconnect the Facet Screws, while the HEMI device uses a small, fixed plate as a cross-connector. The implants are fabricated from anodized titanium alloy (Ti-6AI-4V) and are supplied in various sizes. The devices are provided non-sterile and for single patient use.
The Facet-Link Stabilization Platform requires several purpose manual orthopedic instruments for implantation, including a variety of k-wires, gauges, inserters, drills, and drivers.
Technological Characteristics
The Stabilization Platform presents similar technological characteristics as compared to the predicate devices. The subject device and the predicate devices are available in various sizes and dimensions to accommodate individual patient anatomy. In addition, the indicated spinal levels for implantation for the Stabilization Platform devices are encompassed within the range for the predicate devices. Similar device components are included within the system, including screws plates, and/or connecting components. The Platform is composed of titanium alloy, comparable to the predicate devices. For all device systems, similar manual orthopedic instruments are used for implantation.
Performance Data
The following bench tests have been performed for the Stabilization Platform, in accordance with ASTM F1717, ASTM F1714, and ASTM F543:
- Static Axial Compression Bending -
- Static Torsion -
- -Dynamic Axial Compression Bending
Functional cadaver tests were performed with implanted functional units to demonstrate biomechanical performance under loading conditions. The biomechanical evaluations demonstrated that performance of the subject constructs was substantially equivalent to that of legally marketed screw constructs. Cadaver implantation testing was also conducted to assess the ability of users to perform the surgical technique successfully; results demonstrated that repeatable and proper seating of the devices was achieved. These tests demonstrated that the Stabilization Platform meets its intended performance specifications and is substantially equivalent to the predicate devices.
The materials of the Stabilization Platform are biocompatible for the indicated use in accordance with ISO 10993. The Facet-Link Stabilization Platform has also been evaluated in a magnetic resonance environment and testing demonstrated that the Stabilization Platform is MR Conditional, in
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accordance with ASTM F2052-06.
Conclusions
The Facet-Link Stabilization Platform has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Facet-Link Stabilization Platform and its predicate devices do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Facet-Link Stabilization Platform is substantially equivalent to its predicates.
N/A