(63 days)
The Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Pioneer Vertebral Spacer is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with the Pioneer Quantum Pedicle Screw System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). The interior of the Pioneer Vertebral Spacer implant can be packed with bone.
The Pioneer Vertebral Spacer is a radiolucent vertebral body replacement device of various heights and footprints used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy.
The provided text describes a medical device, the Pioneer Vertebral Spacer, and its regulatory clearance (K043206) in 2005. The information focuses on the device's description, intended use, classification, and substantial equivalence to a predicate device, rather than performance studies with quantitative acceptance criteria typically associated with AI/ML devices. Therefore, a direct answer to all points of your request for acceptance criteria and study details pertaining to AI/ML performance is not possible as this document does not contain that information.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics in the way one would expect for an AI/ML device. Instead, it states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical and Chemical information presented. | "Mechanical and Chemical information were presented." (No specific values or thresholds are provided in this summary.) |
| Substantial equivalence to predicate devices (EBI CAS Spine Spacer System K042268) in terms of design, indications, performance, and materials. | The device was cleared based on its substantial equivalence to the predicate device, implying it met the same general performance expectations as the predicate for its intended use. |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes a physical medical implant device, not an AI/ML system that would typically have a "test set" of data. The clearance is based on mechanical and chemical properties, as well as comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for an AI/ML model for diagnostic or classification tasks is not relevant here. The "ground true" for this device would be its mechanical and material properties as validated through engineering tests and its clinical effectiveness as observed in surgical use, which is not detailed in this summary.
4. Adjudication method for the test set
Not applicable. As there is no test set for an AI/ML model, there is no adjudication method.
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
Not applicable. This device is a surgical implant, not an AI-assisted diagnostic or decision support tool. Therefore, an MRMC study and
the concept of "human readers improving with AI assistance" are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not a standalone algorithm.
7. The type of ground truth used
For this device, the "ground truth" would relate to its structural integrity, biocompatibility, and ability to achieve its intended mechanical functions (e.g., restoring vertebral height, providing stability). This would be established through:
- Engineering testing: Mechanical (e.g., strength, fatigue) and chemical (e.g., material composition, biocompatibility) tests according to ASTM standards.
- Predicate device comparison: The EBI CAS Spine Spacer System (K042268) serves as the safety and efficacy benchmark.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that would have a training set.
9. How the ground truth for the training set was established
Not applicable.
In summary: The provided document is a 510(k) summary for a physical medical implant and does not contain the type of information related to AI/ML device performance, such as test sets, ground truth establishment for AI, or human-in-the-loop studies. The clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, backed by presented mechanical and chemical information.
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JAN ¥ 1 2005
510(k) Summary
| SPONSOR: | PIONEER SURGICAL TECHNOLOGY375 River Park CircleMarquette, MI 49855Contact: Jonathan M. Gilbert |
|---|---|
| DEVICE NAME: | Pioneer Vertebral Spacer |
| CLASSIFICATION: | The classification of the Pioneer Vertebral Spacer is Class II, as perthe Code of Federal Regulations, Title 21, Section 888.3060:Implant, fixation, spinal intervertebral body fixation orthosis devices.The product code is MQP. The Panel code is 87. |
| PREDICATE DEVICE: | EBI CAS Spine Spacer System K042268 |
| DEVICEDESCRIPTION: | The Pioneer Vertebral Spacer is a radiolucent vertebral bodyreplacement device of various heights and footprints used inconjunction with supplemental internal fixation to provide structuralstability in skeletally mature individuals following corpectomy. |
| INTENDEDUSE: | The Pioneer Vertebral Spacer is intended for use in the thoracolumbarspine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of adiseased vertebral body resected or excised for the treatment oftumors in order to achieve anterior decompression of the spinal cordand neural tissues, and to restore the height of a collapsed vertebralbody. The Pioneer Vertebral Spacer is also indicated for treatingfractures of the thoracic and lumbar spine. The Pioneer VertebralSpacer is designed to restore the biomechanical integrity of theanterior, middle and posterior spinal column, even in the absence offusion for a prolonged period of time. The system must be used withthe Pioneer Quantum Pedicle Screw System or supplemental internalfixation systems cleared for the conditions listed above (i.e., tumor ortrauma of T1-L5). The interior of the Pioneer Vertebral Spacerimplant can be packed with bone. |
| MATERIAL: | Radiolucent polymer and titanium alloy materials in conformancewith ASTM Standard Specifications. |
| PERFORMANCE: | Mechanical and Chemical information were presented. |
| BASIS OFSUBSTANTIALEQUIVALENCE: | The Pioneer Vertebral Spacer implants are similar to the componentsof previously cleared spinal systems in terms of design, indications,performance and materials. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
JAN 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jonathan Gilbert Director, Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855
Re: K043206 Trade/Device Name: PIONEER Vertebral Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: November 18, 2004 Received: November 19, 2004
Dear Mr. Gilbert:
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). and occinerefore, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 – Mr. Jonathan Gilbert
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hanketing your avenee of your dever to a legally premarket nothication. THC FDA maing of basification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your do november on a more one the regulation entitled, colliation of Compullios as (21 t notification" (21CFR Part 807.97). You may obtain "Misoranding by relevelec to premance notificalledalisms. In Act from the Division of Small other general information on your responsions at its toll-free number (800) 638-204 or Manufacturers, International and Consalhers http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
L. Mark A. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KOY3206
Indications for Use
| 510(k) Number (if known): | K043206 |
|---|---|
| Device Name: | PIONEER Vertebral Spacer |
| Indications for Use: | The Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Pioneer Vertebral Spacer is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with the Pioneer Quantum Pedicle Screw System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). The interior of the Pioneer Vertebral Spacer implant can be packed with bone. |
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| AND/OR | |
| Over-The-Counter Use (21 CFR 807 Subpart C) |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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510(k) Number K043206
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§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.