(125 days)
The Oracle Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures for the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Oracle Spacer is intended to be used with Synthes internal fixation systems, e.g., Pangea, USS (including Click'X), Small Stature USS, ATLP, TSLP, and Ventrofix. The interior of the spacer can be packed with bone (autograft or allograft). The Oracle 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.
The Synthes Oracle Spacer is a radiolucent vertebral body replacement device used in conjunction with supplemental fixation that provides structural stability in skeletally mature individuals following partial or total corpectomy. The Oracle Spacer has an oval shape and may be used to accommodate the anatomical requirements of the space created by the corpectomy. The spacer has an open architecture for packing bone graft material and it is available in various heights, cross-sectional sizes and lordosis angles to suit individual pathology and anatomical conditions.
The provided document is a 510(k) summary for the Synthes Oracle Spacer. It details the device's description, intended use, and claims of substantial equivalence. However, it does not contain information about specific acceptance criteria or an analytical study with defined performance metrics, a test set, ground truth, or expert involvement as typically required for AI/algorithm-based devices.
The "Performance Data" section states: "Mechanical test data is presented in conformance with the “Guidance for Spinal System 510(k)s”, issued May 3, 2004." This indicates that the device's performance was evaluated through physical/mechanical testing, common for implantable medical devices, rather than through an analysis of an algorithm's output on digital data.
Therefore, many of the requested fields cannot be filled as they pertain to studies evaluating the performance of an algorithm or AI system, which is not what this document describes.
Here's a breakdown of the available information and why other fields cannot be completed:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance with "Guidance for Spinal System 510(k)s" | "Mechanical test data is presented in conformance with the “Guidance for Spinal System 510(k)s”, issued May 3, 2004." (Exact quantitative results are not provided in this summary.) |
| Substantial equivalence to predicate devices (K011037, K010530) | "Documentation has been provided that demonstrates that the Synthes Oracle Spacer is substantially equivalent to the previously cleared Synthes Vertebral Spacer (K011037) and the Interpore Cross Geo™ Structure (K010530)." |
| Material conformance to ASTM Standards | "Radiolucent polymer and titanium alloy materials in conformance with ASTM Standards." |
| Restoration of biomechanical integrity of the spinal column | "The Oracle 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." (This is an intended design feature, not a quantitative performance metric from a study in this summary.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes mechanical testing of a physical implant, not an algorithm evaluated on a data test set.
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. Ground truth for an AI algorithm is not relevant for the mechanical testing of a physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an algorithm evaluation 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
- Not applicable. This device is a physical implant, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For mechanical testing, the "ground truth" would be the physical properties and performance measured against engineering specifications and industry standards rather than a medical diagnosis.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or corresponding ground truth.
In summary: The provided 510(k) summary is for a physical medical device (vertebral body replacement) and details its substantial equivalence to predicate devices and conformance to mechanical testing guidance. It does not involve any AI or algorithmic component, and therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" as it pertains to AI/algorithms cannot be extracted.
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L062933
5.0 510 (k) Summary
| JAN 3 1 2007 | |
|---|---|
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
| 510 (k) Contact: | Bonnie Smith, RACSynthes Spine Regulatory Affairs |
| Trade Name: | Oracle |
| Common /Classification Name: | Vertebral Body Replacement Device |
| Device ProductCode andClassification: | MQP21 CFR 888.3060: Class II |
| Predicate: | K011037 - Synthes Vertebral SpacerK010530 - Interpore Cross Geo™ Structure |
| Device Description: | The Synthes Oracle Spacer is a radiolucent vertebral body replacementdevice used in conjunction with supplemental fixation that providesstructural stability in skeletally mature individuals following partial ortotal corpectomy.The Oracle Spacer has an oval shape and may be used to accommodatethe anatomical requirements of the space created by the corpectomy.The spacer has an open architecture for packing bone graft material andit is available in various heights, cross-sectional sizes and lordosisangles to suit individual pathology and anatomical conditions. |
| Intended Use/Indications for Use: | The Oracle Spacer is a vertebral body replacement device intended foruse in the thoracolumbar spine (T1-L5) to replace a diseased vertebralbody resected or excised during partial and total vertebrectomyprocedures for the treatment of tumor or trauma (i.e., fracture), toachieve anterior decompression of the spinal cord and neural tissues,and to restore the height of the collapsed vertebral body. The OracleSpacer is intended to be used with Synthes internal fixation systems,e.g., Pangea, USS (including Click'X), Small Stature USS, ATLP,TSLP, and Ventrofix. The interior of the spacer can be packed withbone (autograft or allograft).The Oracle Spacer is designed to restore the biomechanical integrity ofthe anterior, middle, and posterior spinal column even in the absence offusion for a prolonged period. |
| SubstantialEquivalence: | Documentation has been provided that demonstrates that the SynthesOracle Spacer is substantially equivalent to the previously clearedSynthes Vertebral Spacer (K011037) and the Interpore Cross Geo™Structure (K010530). |
| Material: | Radiolucent polymer and titanium alloy materials in conformance withASTM Standards. |
| Performance Data: | Mechanical test data is presented in conformance with the “Guidancefor Spinal System 510(k)s”, issued May 3, 2004. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design. The eagle is facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SYNTHES Spine Co., L.P. % Ms. Bonnie Smith, RAC Regulatory Affairs Project Manager 1302 Wrights Lane East West Chester, Pennsylvania 19380
JAN 3 1 2007
Re: K062933
Trade/Device Name: Synthes Oracle Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: December 8, 2006 Received: December 11, 2006
Dear Ms. Smith:
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.
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 - Ms. Bonnie Smith, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sarbare Boucher
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4.0 Indications for Use Statement
510(k) Number (if known):
Device Name: Oracle Spacer
Indications for Use:
The Oracle Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures for the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Oracle Spacer is intended to be used with Synthes internal fixation systems, e.g., Pangea, USS (including Click'X), Small Stature USS, ATLP, TSLP, and Ventrofix. The interior of the spacer can be packed with bone (autograft or allograft).
The Oracle 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.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE).
AND/OR
Barbara Buettner
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062933
000015 1 of 1
Synthes Spine Co., L.P. Oracle Spacer 510(k)
CONFIDENTIAL
§ 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.