(228 days)
The Inertia™ Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
The Inertia™ Pedicle Screw System consists of rods, polyaxial screws and set screws. Rods are available in either straight or pre-contoured (curved) forms and in a variety of lengths. Polyaxial screws are available in a variety of diameter-length combinations. Set screws are used to fasten the rod and polyaxial screw.
The provided text describes a 510(k) summary for the "Inertia™ Pedicle Screw System" and details the device's characteristics and performance testing. However, it does not include information about AI algorithms, ground truth establishment for AI, expert consensus, or multi-reader multi-case studies. This submission is for a traditional medical device (pedicle screw system), not an AI/ML-driven device.
Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation cannot be filled from the provided document.
Here's a breakdown of the available information based on the request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material: Components manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136. | The Inertia™ Pedicle Screw System components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136. (Meets) |
| Technological Characteristics: Same as predicates: rod-based pedicle screw system with polyaxial screws, titanium alloy material, rod and screw sizes within the range of predicate systems, and same intended use. | The Inertia™ Pedicle Screw System possesses the same technological characteristics as the predicates. These include: basic design (rod-based pedicle screw system having polyaxial screws), material (titanium alloy), sizing (rod and screw sizes are within the range of those in the predicate systems), and intended use (as described). (Meets) |
| Mechanical Performance: Perform as well as or better than predicate devices according to ASTM F1717 for static compression bending and torsion, and dynamic compression bending of the worst-case construct. | The mechanical results demonstrated that the Inertia™ Pedicle Screw System performs as well as or better than the predicate devices. (Meets) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes mechanical performance testing on the device itself, not a test set of data like an image dataset. The "sample size" here refers to the number of constructs tested. The text does not specify the exact number of constructs tested, but typical mechanical testing involves multiple samples to ensure statistical validity.
- Sample size for test set: Not explicitly stated (refers to "worst case Inertia™ Pedicle Screw System construct" without specifying the number of samples).
- Data Provenance: Not applicable in the context of device mechanical testing (no country of origin or retrospective/prospective data collection as for clinical data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable as this is a mechanical device performance study, not an AI/ML-driven medical image analysis or diagnostic study requiring expert ground truth.
4. Adjudication Method for the Test Set
- Not applicable as this is a mechanical device performance study.
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 is a traditional medical device (pedicle screw system), not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a traditional medical device (pedicle screw system), not an AI/ML device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is its physical and mechanical performance against established engineering standards (ASTM F1717) and comparison to predicate devices, rather than a clinical ground truth like pathology or expert consensus. The "ground truth" is adherence to these mechanical standards.
8. The Sample Size for the Training Set
- Not applicable. This is a traditional medical device, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is a traditional medical device, not an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the logo for "NEXXT Spine". The word "NEXXT" is written in a bold, sans-serif font, with the two "X" characters stylized to resemble chromosomes. Below the word "NEXXT" is the word "Spine" in a smaller font.
8. 510(k) Summary
| Date: | 4 May 2010 |
|---|---|
| Sponsor: | Nexxt Spine LLC10142 Brooks School RoadFishers, IN 46037 |
| DEC 20 2010 | |
| Phone (317) 436.7801Fax (317) 245.2518 | |
| Contact Person: | Andy Elsbury, President |
| Proposed TradeName: | Inertia™ Pedicle Screw System |
| Device Classification | Class II |
| Classification Name: | Pedicle screw spinal system |
| Regulation: | 888.3070 |
| Device ProductCode: | MNI; MNH |
| Device Description: | The Inertia™ Pedicle Screw System consists of rods, polyaxialscrews and set screws. Rods are available in either straight or pre-contoured (curved) forms and in a variety of lengths. Polyaxialscrews are available in a variety of diameter-length combinations.Set screws are used to fasten the rod and polyaxial screw. |
| Intended Use: | The Inertia™ Pedicle Screw System is intended to provideimmobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion in the treatment of thefollowing acute and chronic instabilities or deformities of the thoracic,lumbar, and sacral spine (T1 to S2): severe spondylolisthesis(grades 3 and 4) of the L5-S1 vertebra; degenerativespondylolisthesis with objective evidence of neurologic impairment;fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinaltumor; and failed previous fusion (pseudarthrosis). |
| Materials: | The Inertia™ Pedicle Screw System components are manufacturedfrom titanium alloy (Ti-6Al-4V) as described by ASTM F136. |
| Predicate Devices: | CD HORIZON® (K031655, K041460) |
| Moss Miami (K992168, K022623) | |
| Synergy VLS (K950099, K974749) | |
| Ontima™ Spinal System (K924096, K031585, K051971) |
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Technological The Inertia™ Pedicle Screw System possesses the same Characteristics: technological characteristics as the predicates. These include: basic design: rod-based pedicle screw system having polyaxial . screws, material: titanium alloy, . sizing: rod and screw sizes are within the range of those in the . predate systems, and intended use: as described above . Therefore the fundamental scientific technology of the Inertia™ Pedicle Screw System is the same as previously cleared devices. Static compression bending and torsion and dynamic compression Performance Data: bending of the worst case Inertia™ Pedicle Screw System construct was performed according to ASTM F1717. The mechanical results demonstrated that the Inertia™ Pedicle Screw System performs as well as or better than the predicate devices.
.
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle with its wings spread, facing left. The eagle is drawn with thick, curved lines, giving it a modern and abstract appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Nexxt Spine LLC % Backroads Consulting Inc. Karen E. Warden, Ph.D. 8202 Sherman Road Chesterland, Ohio 44026-2141
DEC 2 0 2010
Re: K101278
Trade/Device Name: Inertia" Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: November 26, 2010 Received: November 30, 2010
Dear Dr. Warden:
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
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Page 2 - Karen E. Warden, Ph.D.
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.
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/ReportaProblem/default.html 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.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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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7. Indications for Use Statement
510(k) Number:________________________________________________________________________________________________________________________________________________________________
Device Name: Inertia™ Pedicle Screw System
DEC 2 0 2010
Page 13
Indications for Use:
The Inertia™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
| Prescription Use | X |
|---|---|
| (21 CFR 801 Subpart D) |
AND/OR
| 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 Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_K101278
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.