(154 days)
Lumbar System Indications
The Tyber Medical PT Interbody System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Cervical System Indications
The Tyber Medical PT Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.
This submission is to add additional shape configurations, with an optional optimized coating process, to the previously cleared interbody system.
This submission does not include any new instruments. However, part of the changes to implants, were made to interface with instruments that were cleared with previous submissions.
The Tyber Medical PT Interbody System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights, and lordotic configurations with an open architecture to accept packing of bone graft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device comes in PEEK with a plasma-sprayed commercially pure titanium coating.
The provided document is a 510(k) summary for the Tyber Medical PT Interbody Spacer System, which is a medical device for spinal fusion. This specific document outlines the product's regulatory submission to the FDA, demonstrating its substantial equivalence to previously cleared predicate devices.
Critical Analysis of the Document:
It is crucial to understand that a 510(k) submission, like the one presented, does not involve a clinical study in the way one might typically think of an "AI clinical trial" or a "diagnostic device performance study." Instead, it focuses on demonstrating substantial equivalence to an already legally marketed device. This means the manufacturer is showing that the new device is as safe and effective as a device that is already on the market, usually by comparing mechanical properties, materials, design, and intended use.
Therefore, the specific questions regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance of an AI algorithm, and training sets are not applicable in the context of this 510(k) submission. This document pertains to a physical implantable device, not an AI software/algorithm.
Addressing the Prompts Based on the Provided Document:
Given the nature of the document (a 510(k) for a physical medical implant), the requested information as it relates to AI/software performance is not present. However, I can extract the relevant information about the device's performance testing as detailed in the document, which primarily focuses on non-clinical (mechanical) testing.
Response to the Request:
The provided document describes a 510(k) premarket notification for a physical medical device, the "Tyber Medical PT Interbody Spacer System," which is an implant used for intervertebral body fusion. This type of regulatory submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance through a clinical study involving human patients in the way an AI or diagnostic device would. Therefore, many of the questions asked, particularly those related to AI algorithm performance, human-in-the-loop studies, and the specifics of clinical ground truth establishment, are not applicable to this document.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical and biological testing performed to demonstrate that the new device is as safe and effective as its predicate.
Here's an breakdown based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines "acceptance criteria" for substantial equivalence based on mechanical testing compared to the predicate device. The performance results are framed as successfully meeting these comparative standards.
| Acceptance Criteria (Implicit) | Reported Device Performance (as stated in the document) |
|---|---|
| Mechanical Properties (Static and Dynamic Compression) per ASTM F2077, comparable to predicate. | "The following tests were performed on the Tyber Medical PT Interbody Spacer and the results were compared to with the previously cleared 510k K130573: Static and Dynamic Compression Test per ASTM F2077... The addition of the new interbody device does not add a new worst-case device for mechanical testing purposes, as demonstrated by mechanical test results." The conclusion states: "The new Tyber Medical PT Interbody System is substantially equivalent to the predicate device because the material, tooth profile, worst case construct, smallest cross sectional and manufacturing process are all unchanged." |
| Mechanical Properties (Static and Dynamic Compression Shear) per ASTM F2077, comparable to predicate. | "Static and Dynamic Compression Shear per ASTM F2077..." (Results are implicitly comparable to predicate, leading to substantial equivalence conclusion). |
| Mechanical Properties (Wear Debris) per ASTM F2077 and ASTM F1877, comparable to predicate. | "Wear Debris per ASTM F2077 and ASTM F1877..." (Results are implicitly comparable to predicate, leading to substantial equivalence conclusion). |
| Mechanical Properties (Static Torsion) per ASTM F2077, comparable to predicate. | "Static Torsion per ASTM F2077..." (Results are implicitly comparable to predicate, leading to substantial equivalence conclusion). |
| Biocompatibility (Pyrogenicity) per ST72:2011, acceptable. | "Pyrogenicity testing was performed per ST72:2011." (Results implicitly met the standard for device to be considered substantially equivalent). |
| Equivalence in Material, Tooth Profile, Worst Case Construct, Smallest Cross Sectional & Manufacturing Process to Predicate. | "The new Tyber Medical PT Interbody System is substantially equivalent to the predicate device because the material, tooth profile, worst case construct, smallest cross sectional and manufacturing process are all unchanged." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each mechanical test. Mechanical testing typically involves a small, statistically justified number of physical samples (e.g., 5-10 per test condition) rather than a large "dataset" of patient cases.
- Data Provenance: The data comes from non-clinical performance testing of the device itself (physical samples), not from patients or clinical studies. No geographical or temporal provenance for "data" in the sense of patient records is applicable. The tests were conducted according to specified ASTM and ST standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This relates to physical device testing, not the establishment of ground truth by clinical experts for a diagnostic or AI algorithm.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication is relevant for interpreting patient data, such as images or clinical outcomes, often in the context of diagnostic performance or clinical trials. This document describes mechanical device testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, not performed. This type of study is relevant for evaluating the impact of AI or diagnostic tools on human reader performance, which is not the subject of this 510(k) submission for a physical implant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This refers to the evaluation of AI algorithms. The Tyber Medical PT Interbody Spacer System is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
- Engineering/Mechanical Test Standards: The "ground truth" for the device's performance is established by the well-defined, standardized test methods (e.g., ASTM F2077, ASTM F1877, ST72:2011) and the comparison of results against predetermined acceptance criteria derived from the predicate device's performance.
8. Sample Size for the Training Set:
- Not applicable. This concept pertains to machine learning algorithms. The device undergoes manufacturing and quality control processes, but there isn't a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
Summary of Device and its Proof of Meeting Criteria (from document's perspective):
The Tyber Medical PT Interbody Spacer System is an intervertebral body fusion device made from PEEK-Optima® with an optional titanium coating. It is intended to facilitate spinal fusion in skeletally mature patients with degenerative disc disease. The device comes in various shapes and sizes to accommodate lumbar (L2-S1) and cervical (C2-T1) spine applications.
Proof of Meeting Criteria (Substantial Equivalence):
The manufacturer demonstrated that the new device meets the criteria for "substantial equivalence" to its previously cleared predicate device (Tyber Medical Interbody Spacer System K130573) and other additional predicates (Synthes ACIS, DePuy Spine Concorde Curve, DePuy Spine Lateral System, Aesculap ASpace, CESpace, Prospace, T-Space). This was established through non-clinical performance data (mechanical and biocompatibility testing).
The key argument for substantial equivalence is that:
- The indications for use are the same.
- The design, materials, application, and anatomic mechanical properties are considered identical or have been shown to be equivalent through testing.
- The mechanical tests (Static and Dynamic Compression, Compression Shear, Wear Debris, Static Torsion per ASTM F2077, F1877) and pyrogenicity testing (per ST72:2011) demonstrate that the new device's performance is comparable to the predicate and that the new configurations do not introduce a "new worst-case" scenario for mechanical performance.
- The material, tooth profile, worst-case construct, smallest cross-sectional area, and manufacturing process are unchanged from the predicate, further supporting equivalence.
The FDA's determination of substantial equivalence indicates that, based on the provided non-clinical data, the device is considered as safe and effective as a legally marketed device and can be marketed without requiring a premarket approval application (PMA) which typically involves more extensive clinical trial data.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2017
Tyber Medical, LLC Mark F. Schenk Vice President of Regulatory and Quality 83 South Commerce Way, Suite 310 Bethlehem, Pennsylvania 18017
Re: K172185
Trade/Device Name: Tyber Medical PT Interbody Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: November 7, 2017 Received: November 15, 2017
Dear Mr. Schenk:
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 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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172185
Device Name
Tyber Medical PT Interbody Spacer System
Indications for Use (Describe)
Lumbar System Indications
The Tyber Medical PT Interbody System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Cervical System Indications
The Tyber Medical PT Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary:
TYBER MEDICAL PT Interbody Spacer System K172185
| Submitted by | Tyber Medical, LLC83 South Commerce WaySuite 310Bethlehem, PA 18017 |
|---|---|
| Contact Person | Mark F. SchenkVice President of Regulatory and QualityPhone: (610) 849-0645 Fax: (866) 889-9914Email: mschenk@tybermed.com |
| Date Prepared | December 19, 2017 |
| Common Names | Interbody Spacer System |
| Trade Name | Tyber Medical PT Interbody Spacer System |
| Classification Nameand Number | Intervertebral body fusion device(21 CFR 888.3080) |
| Product Code | ODP and MAX |
| Predicate Device | Tyber Medical Interbody Spacer System (K130573) |
| Additional Predicates | Synthes ACIS (K120275), DePuy Spine Concorde Curve (K101923), DePuySpine Lateral System (K090899); Aesculap ASpace, CESpace, Prospace,T-Space (K071983) |
| Device Description | This submission is to add additional shape configurations, with an optionaloptimized coating process, to the previously cleared interbody system.This submission does not include any new instruments. However, part ofthe changes to implants, were made to interface with instruments that werecleared with previous submissions.The Tyber Medical PT Interbody System, manufactured from PEEK-Optima®,consist of implants available in various foot prints, heights, and lordoticconfigurations with an open architecture to accept packing of bone graftmaterials. The exterior of the device has "teeth" or other generally sharpengagement members on the superior and inferior surfaces to help preventthe device from migrating once it is surgically positioned. The device comesin PEEK with a plasma-sprayed commercially pure titanium coating. |
| Intended Use/Indications for use | Lumbar System IndicationsThe Tyber Medical PT Interbody System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.Cervical System IndicationsThe Tyber Medical PT Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used. |
| Performance Data(Non-Clinical) | The following tests were performed on the Tyber Medical PT Interbody Spacer and the results were compared to with the previously cleared 510k K130573.Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear per ASTM F2077 Wear Debris per ASTM F2077 and ASTM F1877 Static Torsion per ASTM F2077 Pyrogenicity testing was performed per ST72:2011. |
| Performance Data(Clinical) | Clinical data and conclusions were not needed for this device. |
| Statement ofTechnologicalComparison | The Tyber Medical PT Interbody System and its predicate devices have the same indications for use, same design, are made of identical materials, identical application, and have the same anatomic mechanical properties. |
| Conclusion | The new Tyber Medical PT Interbody System is substantially equivalent to the predicate device because the material, tooth profile, worst case construct, smallest cross sectional and manufacturing process are all unchanged.The addition of the new interbody device does not add a new worst-case device for mechanical testing purposes, as demonstrated by mechanical test results. Given the above, Tyber Medical PT Interbody System is determined to be substantially equivalent to the predicate device. |
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§ 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.