(50 days)
The Osseus Black Diamond 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
The Osseus Black Diamond Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.
The Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
This is a 510(k) summary for a spinal implant system and as such, it does not involve AI/ML device performance testing. The 'acceptance criteria' and 'device performance' in this context refer to mechanical and material performance rather than diagnostic accuracy or classification metrics.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Summary) |
|---|---|
| Static Compression | Results indicate equivalence to predicate devices (per ASTM F1717) |
| Dynamic Compression | Results indicate equivalence to predicate devices (per ASTM F1717) |
| Static Torsion | Results indicate equivalence to predicate devices (per ASTM F1717) |
| Materials | Ti-6Al-4V per ASTM F136; Substantially equivalent to predicate devices. |
Note: The document explicitly states "The results of this testing indicate that the Osseus Black Diamond Pedicle Screw System is equivalent to predicate devices." This implies that the device met the performance standards established by the predicate devices through these ASTM tests. The specific numerical acceptance criteria (e.g., maximum load, fatigue life) are not detailed in this summary document but would have been part of the full submission.
2. Sample Size Used for the Test Set and Data Provenance
Given this is a mechanical engineering test of a physical device, not an AI/ML system:
- Sample Size for Test Set: The document does not specify the exact number of units or replicates tested for each static and dynamic test. These would typically be defined by the ASTM F1717 standard and the test protocol.
- Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting on manufactured devices, not on human patients or data derived from them. The data is generated from physical mechanical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This question is not applicable to this type of device submission. Ground truth, in the context of device performance described here, is established by adherence to ASTM standards for mechanical testing, not by expert interpretation of data or images.
4. Adjudication Method for the Test Set
- This question is not applicable. Mechanical tests according to ASTM standards do not involve adjudication by multiple experts in the same way clinical or AI/ML studies do. The results are quantitative measurements against predefined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant to diagnostic imaging devices or AI systems where human readers interpret medical images. This submission is for a physical orthopedic implant.
- Effect Size: Not applicable as no such study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. This device is a physical pedicle screw system, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by engineering standards and specifications (specifically ASTM F136 for materials and ASTM F1717 for mechanical performance). The device's performance is compared against the known performance of legally marketed predicate devices through these standardized mechanical tests.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" in the context of a pedicle screw system's mechanical testing. This concept applies to AI/ML devices.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable. As there is no training set, there is no ground truth establishment for it.
In summary, the provided 510(k) summary describes a traditional medical device (a spinal implant) and its non-clinical mechanical testing, not an AI/ML-driven diagnostic or therapeutic device. Therefore, many of the questions related to AI/ML study design, readers, and ground truth are not relevant to this specific document. The "study" referenced is a series of mechanical tests to demonstrate substantial equivalence to predicate devices.
{0}------------------------------------------------
510(k) Summary for the Osseus Black Diamond Pedicle Screw System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Osseus Black Diamond Pedicle Screw System
1. GENERAL INFORMATION
| Date Prepared: | June 13, 2013 |
|---|---|
| Trade Name: | Osseus Black Diamond Pedicle Screw System |
| Common Name: | pedicle screw system |
| ClassificationName: | orthosis, spinal pedicle fixationorthosis, spondylolisthesis spinal fixation |
| Class: | II |
| Product Code: | MNIMNH |
| CFR section: | 21 CFR section 888.3070 |
| Device panel: | Orthopedic |
| Legally MarketedPredicate Device: | Viper Spine System - DePuy Spine (K061520 / K090648 / K102701 / K111571)Low Torque Pedicle Screw - Altus Spine (Vertebron, Ltd) K033352/K043152/K051716/K071376 / K081597Synergy VLS - open (K940631 / K950099)Moss Miami SS - DePuy Spine (K000536)PWB (now Synergy) (K920116)AUG 08 2013 |
| Submitter: | Osseus Fusion Systems, LLC4514 Cole Ave, Ste. 600Dallas, TX 75205601-420-424 |
| Contact: | J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-mail: jdwebb@orthomedix.net |
DEVICE DESCRIPTION 2.
F
The Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Materials:
Ti-6Al-4V per ASTM F136
SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES 3.
The Osseus Black Diamond Pedicle Screw System is substantially equivalent to the predicate . devices in terms of intended use, design, materials used, mechanical safety and performances.
{1}------------------------------------------------
4. INTENDED USE
The Osseus Black Diamond 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
The Osseus Black Diamond Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.
NON-CLINICAL TEST SUMMARY 5.
The following tests were conducted:
- . Static and dynamic compression per ASTM F1717
- Static torsion per ASTM F1717 .
The results of this testing indicate that the Osseus Black Diamond Pedicle Screw System is equivalent to predicate devices.
6. CLINICAL TEST SUMMARY
No clinical studies were performed
7. CONCLUSIONS NONCLINICAL AND CLINICAL
Osseus Fusion Systems, LLC considers the Osseus Black Diamond Pedicle Screw System to be equivalent to the predicate device listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials and indications for use
{2}------------------------------------------------
Image /page/2/Picture/12 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center consists of three curved lines that appear to be flowing or moving in a dynamic way. The image is in black and white and has a slightly grainy texture.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
August 8, 2013
Osseus Fusion Systems, LLC % OrthoMedix Group, Incorporated Mr. J. D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K131810
Trade/Device Name: Osseus Black Diamond Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH. MNI Dated: June 13, 2013 Received: June 19, 2013
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. Ilsting 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
{3}------------------------------------------------
Page 2 - Mr. J. D. Webb
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.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.htm.
Sincerely yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page 1 of 1
INDICATIONS FOR USE
510(k) Number (if known): _K131810
Device Name: Osseus Black Diamond Pedicle Screw System
Indications for Use:
The Osseus Black Diamond 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 of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
The Osseus Black Diamond Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.
Prescription Use X (Part 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 OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131810
§ 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.