(129 days)
SYNTHES® Contoured SynMesh® Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The SYNTHES® Contoured SynMesh® Spacer is intended to be used with SYNTHES® supplemental internal fixation systems, e.g., ATLP, Ventrofix, TSLP, and USS, Dual Opening USS, Small Stature USS, and Click'X. The interior of the spacer component of the SYNTHES® SynMesh® Spacer can be packed with bone.
SYNTHES® Contoured SynMesh® Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The SYNTHES® Contoured SynMesh® Spacer is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy / vertebrectomy.
The provided text describes a 510(k) premarket notification for a medical device, the SYNTHES® Contoured SynMesh® Spacer. However, it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and the study proving the device meets those criteria.
This document is a regulatory submission for a spinal implant, which typically focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a performance study with detailed acceptance criteria, sample sizes, and expert adjudications as would be common for diagnostic or AI-driven devices.
Here's a breakdown of what can be extracted and what information is missing based on your specific questions:
1. A table of acceptance criteria and the reported device performance
- This document does not describe specific quantitative acceptance criteria or reported device performance metrics in the way you'd typically find for a diagnostic efficacy study. The "performance" demonstrated here is primarily the substantial equivalence to a predicate device based on material, design, and intended use.
- For an implant like this, "performance" would relate to mechanical testing (e.g., strength, fatigue) and biocompatibility, which are not detailed 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/Not provided. This submission is about a physical implant, not a data-driven device that uses test sets or data provenance in the context of an algorithm's performance.
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/Not provided. Ground truth establishment with experts is relevant for diagnostic accuracy studies, not for the substantial equivalence of a spinal implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This is relevant for diagnostic accuracy studies.
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/Not provided. This is relevant for diagnostic AI studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This pertains to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the context of a "test set" as understood for AI or diagnostic devices. The "ground truth" for a spinal implant's safety and effectiveness relies on established engineering principles, biocompatibility testing, pre-clinical mechanical testing, and clinical historical data of similar devices, all of which support the claim of substantial equivalence.
8. The sample size for the training set
- Not applicable/Not provided. This is relevant for AI-driven devices.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is relevant for AI-driven devices.
Summary of Available Information from the Provided Text:
The document focuses on demonstrating substantial equivalence of the SYNTHES® Contoured SynMesh® Spacer to a legally marketed predicate device (SYNTHES® SynMesh® Spacer System - K003275). This is the primary "acceptance criterion" for a 510(k) submission for this type of device.
- Device Type: Spinal intervertebral body fixation orthosis (vertebral body replacement device).
- Intended Use: For use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). It provides anterior spinal column support.
- Material: Commercially pure titanium.
- Predicate Device: SYNTHES® SynMesh® Spacer System (K003275).
- Basis for Equivalence: Documentation provided demonstrates that the new device is "Substantially Equivalent" to other legally marketed SYNTHES® devices. This typically involves comparing design, materials, manufacturing processes, intended use, and performance characteristics (e.g., mechanical properties) to the predicate device. The FDA's letter explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."
Therefore, for this particular document, the "study" proving the device meets acceptance criteria is the 510(k) submission itself and the FDA's determination of substantial equivalence to the predicate device, based on the comparative information submitted by the manufacturer. The details of the specific tests (e.g., mechanical, biocompatibility) that underpin this claim are not provided in this summary.
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3.0 Premarket Notification 510 (k) Summary OCT 1 - 2004
| Date Prepared: | May 21, 2004 |
|---|---|
| Sponsor Information:Name and Address: | SYNTHES® Spine.1230 Wilson DriveWest Chester, PA 19380 |
| Telephone: | (484) 356-9616 |
| Contact Person: | Angela Mikroulis |
| Device Name:Trade or Proprietary Name: | SYNTHES® Contoured SynMesh® Spacer |
| Common Name: | Implant, fixation, spinal intervertebral bodyfixation orthosis device. |
| Classification Name/Class: | Per 21 CFR 888.3060: Spinal intervertebralbody fixation orthosis, Class II. |
| Device Description: | The SYNTHES® Contoured SynMesh® Spaceris a titanium vertebral body replacement deviceused in conjunction with supplemental internalfixation to provide structural stability inskeletally mature individuals followingcorpectomy / vertebrectomy. |
| Predicate Device (s): | SYNTHES® SynMesh® Spacer System(K003275) |
| Intended Use: | The SYNTHES® Contoured SynMesh® Spaceris a vertebral body replacement device intendedfor use in the thoracolumbar spine (T1-L5) toreplace a collapsed, damaged, or unstablevertebral body due to tumor or trauma (i.e.,fracture). The SYNTHES® ContouredSynMesh® Spacer is designed to provideanterior spinal column support even in theabsence of fusion for a prolonged period. |
| Material: | Commercially pure titanium |
| Substantial Equivalence: | Documentation is provided which demonstratesthat the SYNTHES® Contoured SynMesh®Spacer for Spinal intervertebral body fixationorthosis is Substantially Equivalent to otherlegally marketed SYNTHES® devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 - 2004
Ms. Angela Mikroulis Regulatory Affairs Specialist Synthes Spine 1230 Wilson Drive West Chester, Pennsylvania 19380
Re: K041389
Trade/Device Name: SYNTHES® Contoured SynMesh® Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: September 1, 2004 Received: September 3, 2004
Dear Ms. Mikroulis:
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. Angela Mikroulis
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your arrivalence of your device to a legally premarket notheation. The PDA miang 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 as 10-1) 276-0120. Also, please note the regulation entitled, Colliation of Compullios as (210) = 17 = 17 = 15 = 1 = 1 807.97). You may obtain Misblanding of reference to premail.orgibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or 1011) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Mark N 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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SYNTHES® Special 510 (k): Device Modification / Line Extension SYNTHES® SynMesh Spacer System-(K003275)
2.0 Indications for Use Statement
રિભ જિલ્લ 510(k) Number (if known):
Device Name: SYNTHES® Contoured SynMesh® Spacer
Indications for Use: SYNTHES® Contoured SynMesh® Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The SYNTHES® Contoured SynMesh® Spacer is intended to be used with SYNTHES® supplemental internal fixation systems, e.g., ATLP, Ventrofix, TSLP, and USS, Dual Opening USS, Small Stature USS, and Click'X. The interior of the spacer component of the SYNTHES® SynMesh® Spacer can be packed with bone.
SYNTHES® Contoured SynMesh® Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Prescription Use______________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Mark N. Milken
Division of General, Restorative, and Neurological Devices
510(k) Number K041389
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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.