(110 days)
The Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P VA should be packed with autogenous bone graft and implanted via an anterior approach.
The Synthes Zero-P VA is a radiolucent and radiopaque intervertebral body fusion device. The Synthes Zero-P VA is composed of a spacer made from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with a single posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque marker. The marker allows accurate intra-operative radiographic assessment of the position of the implant. The spacer component is preassembled with a mating titanium alloy (Ti-6Al-7Nb; TAN; ASTM F1295) interbody plate. The device is implanted anteriorly by inserting two screws (TAN) through the plate, one screw per vertebral body. The interbody plate incorporates a lock-catch mechanism in each screw hole comprised of a TAV lock-screw and catch, as well as an Elgiloy (ASTM F1058) spring. The screws offered with the Zero-P VA system are 3.7mm in diameter.
This document describes the Synthes Zero-P VA device, which is an intervertebral body fusion device. The provided text outlines the device description, indications for use, and a comparison to predicate devices, including performance data. However, this document does not contain information about explicit acceptance criteria for a device's performance with numerical targets or a study validating those criteria in the context of device performance in terms of accuracy or efficacy metrics.
The "Performance Date (Nonclinical and/or Clinical)" section primarily discusses bench testing to demonstrate substantial equivalence to predicate devices in mechanical performance, not clinical outcomes or specific performance criteria like accuracy, sensitivity, or specificity that would be typical for an AI/ML-based device.
Therefore, for the information requested in the prompt:
1. A table of acceptance criteria and the reported device performance:
Based on the provided text, there are no explicit "acceptance criteria" for accuracy, sensitivity, specificity, or similar performance metrics as would be found for an AI/ML-based device. The performance data presented is for bench testing to demonstrate substantial equivalence in mechanical properties.
| Acceptance Criteria (Not explicitly stated for clinical efficacy/accuracy) | Reported Device Performance |
|---|---|
| Mechanical performance comparable to predicate devices (Implied) | Bench testing (ASTM F2077-03 and ASTM F2267-04) for: - Static Axial Compression - Dynamic Axial Compression - Static Compression Shear - Dynamic Compression Shear - Static Torsion - Dynamic Torsion - Subsidence (Conclusions: Substantially equivalent in performance to Synthes Zero-P (K072981), Sulzer BAK™/Cervical IBF (P980048), and Medtronic PEEK Prevail (K073285)). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The document describes bench testing of the physical medical device, not a test set of data for an AI/ML system.
- Data Provenance: Not applicable in the context of clinical data. The performance data is from laboratory bench tests.
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 system is not relevant for this device's submission which focuses on mechanical equivalence.
4. Adjudication method for the test set:
- Not applicable.
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 is a physical intervertebral fusion device, not an AI-assisted diagnostic or therapeutic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the bench testing, the "ground truth" would be the engineering specifications and established ASTM standards (ASTM F2077-03 and ASTM F2267-04) that dictate acceptable mechanical performance for intervertebral body fusion devices. This is not "ground truth" in the AI/ML sense.
8. The sample size for the training set:
- Not applicable. The device is not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
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| Synthes Zero-P VA (K112068)510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
| 510(k) Contact: | Stacey BonnellSenior Regulatory Affairs Specialist, Synthes SpineTelephone: 610-719-5895Facsimile: 610-719-5102Email: bonnell.stacey@synthes.com |
| Date Prepared: | November 7, 2011 |
| Trade Name: | Synthes Zero-P VA |
| Classification: | 21 CFR 888.3080 - Intervertebral Body Fusion DeviceClass II (special controls)Orthopaedic and Rehabilitation Devices Panel (87)Product Code OVE (Intervertebral Fusion Device w/ Integrated Fixation,Cervical) |
| Predicates: | Synthes Zero-P device (K072981);Sulzer BAK™/Cervical IBF (P980048);Synthes Vectra (K050451);Synthes Vectra-T (K051665);Globus Coalition (K083389)Medtronic PEEK Prevail (K073285)RSB InterPlate C-P (K092070) |
| Device Description: | The Synthes Zero-P VA is a radiolucent and radiopaqueintervertebral body fusion device. The Synthes Zero-P VA iscomposed of a spacer made from Invibio® PEEK-Optima® LT-1(ASTM F2026) with a single posterior titanium alloy (Ti-6Al-4VELI; TAV; ASTM F136-2a) radiopaque marker. The marker allowsaccurate intra-operative radiographic assessment of the position ofthe implant. The spacer component is preassembled with a matingtitanium alloy (Ti-6Al-7Nb; TAN; ASTM F1295) interbody plate.The device is implanted anteriorly by inserting two screws (TAN)through the plate, one screw per vertebral body. The interbody plateincorporates a lock-catch mechanism in each screw hole comprisedof a TAV lock-screw and catch, as well as an Elgiloy (ASTMF1058) spring. The screws offered with the Zero-P VA system are3.7mm in diameter. |
| Intended Use/ | The Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion |
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| Indications for Use: | device indicated for use in skeletally mature patients with degenerativedisc disease (DDD) with accompanying radicular symptoms at one levelfrom C2-T1. DDD is defined as discogenic pain with degeneration of thedisc confirmed by history and radiographic studies. These patients shouldhave had six weeks of non-operative treatment. The interior of the spacercomponent of the Synthes Zero-P VA should be packed with autogenousbone graft and implanted via an anterior approach. |
|---|---|
| Comparison of thedevice to predicatedevice(s): | The Synthes Zero-P VA is substantially equivalent to the establishedpredicates in design, function, material and intended use. |
| Performance Date(Nonclinical and/orClinical): | Non-Clinical Performance and Conclusions:Synthes conducted the following bench testing (as recommended withinFDA Guidance and in accordance with ASTM F2077-03 and ASTMF2267-04): Static Axial Compression; Dynamic Axial Compression; StaticCompression Shear; Dynamic Compression Shear; Static Torsion;Dynamic Torsion; and Subsidence. The conclusions drawn from testingdemonstrate that the Synthes Zero-P VA device is substantially equivalentin performance to the following predicate devices: Synthes Zero-P device(K072981); Sulzer BAK™/Cervical IBF (P980048); and Medtronic PEEKPrevail (K073285).Clinical Performance and ConclusionsClinical data and conclusions were not needed for this device. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 7 2011
Synthes Spine Co., L.P. % Ms. Stacey Bonnell Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K112068
Trade/Device Name: Synthes Zero-P Variable Angle (VA) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: October 04, 2011 Received: October 05, 2011
Dear Ms. Bonnell:
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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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.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/Resourcesfor You/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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@ SYNTHES® Spine
4 Indications for Use Statement
510(k) Number: K112068 (if known)
Device Name: Synthes Zero-P VA
Indications for Use: The Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P VA should be packed with autogenous bone graft and implanted via an anterior approach.
Prescription Use X (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 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 of Surgical, Orthopedic,
and Restorative Devices
KITZO68 510(k) Number.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.