(106 days)
When intended to provide immobilization and stabilization as an adjunct to fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3), the plate/rod, rod, hook, screw, connector and crosslink components of neon™ are indicated for the treatment of:
• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies),
• spondylolisthesis,
• spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors
The cortical (3.5mm) bone screws are limited to occipital fixation only.
The hook, rod and crosslink component placement is indicated for the cervical/upper thoracic (C1-T3) spine.
The use of neon screws (with easy fits), polyaxial connectors (with inlays and optional spacers) is limited to placement in the upper thoracic spine (T1-T3) for anchoring of the system. Screws are not intended to be placed in the cervical spine.
neon™ is a modular, posterior system used for the surgical stabilization and fixation of the occipito-cervico-thoracic regions of the spine. If necessary, the occipito-cervical junction as well as the cervico-thoracic junction may be included. The system components include longitudinal members such as hybrid plate/rods and straight rods, anchors such as self-drilling and self-tapping screws and hooks, and interconnecting devices such as anchor-to-rod connectors and a rod-to-rod crosslink.
The provided text describes the neon™ spinal fixation system, a medical device, and its 510(k) submission for FDA clearance. However, it does not contain information related to software or AI performance metrics, clinical studies with human readers, or expert adjudication specific to an AI device.
The document details the device's intended use, materials, and technological characteristics compared to predicate devices. The study mentioned focuses solely on mechanical testing of the device itself (hardware), not on the performance of a software or AI component.
Therefore, I cannot provide answers to most of your questions as they are designed for the evaluation of AI/software medical devices.
Here's the relevant information based on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate devices) | Reported Device Performance |
|---|---|
| Static and Dynamic Biocompatibility and Mechanical Testing (ASTM F1717 and ASTM F2076): Device must perform as well as or better than predicate devices. | Mechanical test results demonstrate that neon™ performs as well as or better than the predicate devices. This implies the device met the safety and effectiveness benchmarks established by these predicate devices through mechanical performance testing. |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not applicable as the "test set" refers to the specific components of the neon™ system subjected to mechanical testing. The provenance of material for these tests is implicitly the manufacturer's production. There's no data provenance in the context of clinical images or patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable. Ground truth establishment by experts relates to clinical data interpretation (e.g., radiologists labeling images). The "ground truth" for mechanical testing is defined by the ASTM standards applied and the physical properties and performance limits of the materials and constructs.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used for resolving discrepancies in expert interpretations of clinical data. For mechanical testing, the results are quantitative measurements against predefined standards.
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. This type of study is relevant for AI-assisted diagnostic or decision-support systems. The neon™ device is a physical spinal fixation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study in the context of an algorithm or AI was not done. The neon™ device is a physical implant.
7. The Type of Ground Truth Used
The ground truth for the performance of the neon™ device was based on validated mechanical testing standards (ASTM F1717 and ASTM F2076), which define acceptable parameters for spinal fixation devices. The performance was then compared to that of legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. A "training set" refers to data used to train an AI model. The neon™ device is a physical implant and does not involve AI training data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as above.
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Image /page/0/Picture/2 description: The image shows the logo for Ulrich medical USA. The word "Ulrich" is in a bold, sans-serif font, with the "U" being partially obscured by a black square. Below "Ulrich" is the text "medical USA" in a smaller, sans-serif font.
510(k) Summary
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| Date: | 10 November 2011 |
|---|---|
| Sponsor: | ulrich GmbH & Co. KGBuchbrunnenweg 1289081 UlmGermanyPhone: +49 (0) 731-9654-1304Fax: +49 (0) 731-9654-2802 |
| Contact Person: | Hans Stoverulrich medical USA, Inc.612 Trade Center Blvd.Chesterfield, MO 63005(636) 519-0268 Office(636) 519-0271 Fax |
| Proposed TradeName: | neon™ |
| Device Classification | Class II |
| Classification Name: | Spinal interlaminal fixation orthosis |
| Regulation: | 888.3050 |
| Device ProductCode: | KWP |
| Device Description: | neon™ is a modular, posterior system used for the surgicalstabilization and fixation of the occipito-cervico-thoracic regions ofthe spine. If necessary, the occipito-cervical junction as well as thecervico-thoracic junction may be included. The system componentsinclude longitudinal members such as hybrid plate/rods and straightrods, anchors such as self-drilling and self-tapping screws andhooks, and interconnecting devices such as anchor-to-rodconnectors and a rod-to-rod crosslink. |
| Intended Use: | When intended to provide immobilization and stabilization as anadjunct to fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3), the plate/rod, rod, hook, screw,connector and crosslink components of neon™ are indicated for thetreatment of:• DDD (neck pain of discogenic origin with degeneration of thedisc as confirmed by patient history and radiographicstudies),• spondylolisthesis, |
| spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors | |
| The cortical (3.5mm) bone screws are limited to occipital fixation only. | |
| The hook, rod and crosslink component placement is indicated for the cervical/upper thoracic (C1-T3) spine. | |
| The use of neon screws (with easy fits), polyaxial connectors (with inlays and optional spacers) is limited to placement in the upper thoracic spine (T1-T3) for anchoring of the system. Screws are not intended to be placed in the cervical spine. | |
| Materials: | neonTM components are manufactured from titanium (Ti Grade 2, ASTM F67) or titanium alloy (Ti-6Al-4V) as described by ASTM F136: |
| Predicate Devices: | Ascent POCT System (K033480 and K073420)Nex-Link OCT and Cervicothoracic Spinal System (K031985, K052566, K062505 and K090060)CerviFix® System (K030377 and K011966) |
| TechnologicalCharacteristics: | neonTM possesses the same technological characteristics as one or more of the predicate devices. These include: intended use (as described above) basic design (rod-based having screw and/or hook anchors), material (titanium / titanium alloy), sizes (dimensions are comparable to those offered by the predicate systems) and The fundamental scientific technology of neonTM is the same as previously cleared devices. |
| Performance Data: | Mechanical testing of the worst case neonTM constructs included static and dynamic compression bending according to ASTM F1717, and static and dynamic compression bending and torsion according to ASTM F2076.The mechanical test results demonstrate that neonTM performs as well as or better than the predicate devices and therefore that the device is as safe and as effective as the predicates. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ulrich GmbH & Co., KG % Ulrich Medical USA. Inc. Mr. Hans Stover 612 Trade Center Boulevard Chesterfield, Missouri 63005
FEB 2 8 2012
Re: K113346 Trade/Device Name: neon™ Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: February 11, 2012 Received: February 14, 2012
Dear Mr. Stover:
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
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Page 2 - Mr. Hans Stover
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.html
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K113346
Indications for Use Statement
510(k) Number:
Device Name: neon™
Indications for Use:
When intended to provide immobilization and stabilization as an adjunct to fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3), the plate/rod, rod, hook, screw, connector and crosslink components of neon™ are indicated for the treatment of
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by . patient history and radiographic studies),
- spondylolisthesis, ●
- spinal stenosis, ●
- fracture/dislocation, .
- atlantoaxial fracture with instability, .
- occipitocervical dislocation, .
- revision of previous cervical spine surgery, and .
- tumors ●
The cortical (3.5mm) bone screws are limited to occipital fixation only.
The hook, rod and crosslink component placement is indicated for the cervical/upper thoracic (C1-T3) spine.
The use of neon screws (with easy fits), polyaxial connectors (with inlays and optional spacers) is limited to placement in the upper thoracic spine (T1-T3) for anchoring of the system. Screws are not intended to be placed in the cervical spine.
| Prescription Use X | AND/OR |
|---|---|
| (21 CFR 801 Subpart D) |
Over-the-Counter Use_
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113346
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§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.