(92 days)
The Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium® PL Cage is to be implanted via a posterior approach.
The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The Tritanium® PL Intervertebral Body Fusion Cage is intended for use as an aid in lumbar spinal fixation. The cage is a hollow, rectangular implant that consists of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The cage is offered in a variety of footprints to adapt to a variety of patient anatomies. It has serrations on the superior and inferior porous surfaces of the implant for fixation, an ergonomically shaped anterior edge, and a flat posterior edge. The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine.
The Tritanium® PL Cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08) and are provided sterile.
The provided text describes a 510(k) premarket notification for a medical device, the Tritanium® PL Cage. It outlines the device's indications for use, its characteristics, and references performance data to demonstrate substantial equivalence to a predicate device. However, this document does not describe acceptance criteria for a study proving device meets acceptance criteria, nor does it detail a clinical study with human readers or specific statistical performance metrics often associated with AI/software devices.
This document specifically focuses on a physical implant (intervertebral body fusion device) and its mechanical performance testing. The "Summary of Performance Data" refers to engineering analyses and mechanical tests, not clinical studies or AI algorithm performance.
Therefore, many of the requested fields cannot be filled from the provided text as they relate to AI/software performance evaluations.
Here's an attempt to answer based only on the information provided, highlighting what is not available:
Acceptance Criteria and Device Performance
The document states that "Verification and validation activities demonstrated that all relevant acceptance criteria were met." However, it does not explicitly list the acceptance criteria themselves, nor does it provide specific numerical results of the device's performance against those criteria. Instead, it refers to multiple mechanical tests according to ASTM standards, implying that meeting the standards' requirements was the acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet requirements of Static and Dynamic Compression Shear (ASTM F2077-14) | Demonstrated through Engineering Analysis (including FEA) |
| Meet requirements of Static and Dynamic Torsion (ASTM F2077-14) | Demonstrated through Engineering Analysis (including FEA) |
| Meet requirements of Static and Dynamic Compression (ASTM F2077-14) | Demonstrated through Engineering Analysis (including FEA) |
| Meet requirements of Subsidence (ASTM F2267-04) | Demonstrated through Engineering Analysis (including FEA) |
| Meet requirements of Expulsion (ASTMF04-25-02-02 (Draft)-2000) | Demonstrated through Engineering Analysis (including FEA) |
| Meet requirements of Wear Debris Analysis | Demonstrated through Engineering Analysis (including FEA) |
| Meet requirements of Impaction | Demonstrated through Engineering Analysis (including FEA) |
Study Details (as inferable from the document)
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Sample size used for the test set and the data provenance: This refers to the mechanical tests conducted. The document does not specify the number of samples (e.g., number of implants or test specimens) used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not applicable or stated for these engineering analyses and mechanical tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these mechanical tests would be the physical properties and performance metrics measured according to the ASTM standards, not expert clinical interpretations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to clinical studies with expert reviewers, not mechanical testing.
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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 for an AI/imaging device, not a physical implant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for an AI/software device, not a physical implant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical tests, the "ground truth" is typically defined by the precise measurement outcomes of the physical tests according to established scientific and engineering principles and standards (e.g., maximum load at failure, displacement under load, wear rates).
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The sample size for the training set: Not applicable. This is for an AI/software device. The "Engineering Analysis" mentions two FEAs (Finite Element Analyses), which are computational simulations, but there is no "training set" in the context of device performance in this document.
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How the ground truth for the training set was established: Not applicable. This is for an AI/software device.
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July 18, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Stryker Spine Mr. Travis Catania Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K181014
Trade/Device Name: Tritanium® PL Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 18, 2018 Received: May 21, 2018
Dear Mr. Catania:
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 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,
Brent Showalter -S
for 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)
Device Name Tritanium® PL Cage
Indications for Use (Describe)
The Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium® PL Cage is to be implanted via a posterior approach.
The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
| 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: Tritanium® PL Cage | |
|---|---|
| Submitter: | Stryker Spine |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Contact Person : | Name: Travis Catania |
| Phone: (201) 749-8038 | |
| Fax: (201) 962-4070 | |
| Email: Travis.Catania@stryker.com | |
| Date Prepared: | 5/23/2018 |
| Trade Name: | Tritanium® PL Cage |
| Common Name: | Intervertebral body fusion device |
| Proposed Class: | Class II |
| Classification Name: | Intervertebral Body Fusion Device (21 CFR §888.3080) |
| Product Code: | MAX: Intervertebral Body Fusion Device with Bone Graft, Lumbar |
| Predicate Devices: | Primary Predicate: |
| Tritanium® PL Cage(K160955) | |
| Predicate Devices: | Additional Predicates: |
| N/A | |
| Predicate Devices: | Reference Devices: |
| N/A | |
| Device Description: | The Tritanium® PL Intervertebral Body Fusion Cage is intended for use as an |
| aid in lumbar spinal fixation. The cage is a hollow, rectangular implant that | |
| consists of a unique configuration of both solid and porous structures that are | |
| simultaneously built using Laser Rapid Manufacturing (LRM) method | |
| applying Stryker's proprietary Tritanium® In-Growth Technology. The cage | |
| is offered in a variety of footprints to adapt to a variety of patient anatomies. | |
| It has serrations on the superior and inferior porous surfaces of the implant | |
| for fixation, an ergonomically shaped anterior edge, and a flat posterior edge. | |
| The implant is designed to be used with supplemental fixation cleared for use | |
| in the lumbosacral spine. | |
| The Tritanium® PL Cages are constructed from Titanium alloy: Ti-6Al-4V | |
| (ASTM F1472-08) and are provided sterile. | |
| 510(k) Summary: Tritanium® PL Cage | |
| Intended Use: | The Stryker Spine Tritanium® PL Cage is an intervertebral body fusiondevice indicated for use with autograft and/or allogenic bone graft comprisedof cancellous and/or corticocancellous bone graft when used as an adjunct tofusion in patients with degenerative disc disease (DDD) at one level or twocontiguous levels from L2 to S1.DDD is defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. The DDD patients may alsohave up to Grade I spondylolisthesis at the involved level(s). These patientsshould be skeletally mature and have six months of nonoperative therapy.Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion inpatients diagnosed with degenerative scoliosis.The Tritanium® PL Cage is to be implanted via a posterior approach.The Tritanium® PL Cage is intended to be used with supplemental spinalfixation systems that have been cleared for use in the lumbosacral spine. |
| Summary of theTechnologicalCharacteristics | The subject Tritanium® PL Cage shares the same materials, fundamentalscientific technologies, and design characteristics as the predicateTritanium® PL Cages. The purpose of this submission is to introduce andsummarize the proposed design changes to the Tritanium® PL Cages, whichretain the previously FDA cleared indications / intended use and mode ofoperation as presented in the previous 510(k) submission, K160955. |
| Summary of thePerformance Data | The Stryker Spine Tritanium® PL Cage, with the incorporation of the proposeddesign changes, has demonstrated substantial equivalence to the predicatedevice. The Engineering Analysis, which included two FEAs, has demonstratedthat the proposed design changes do not adversely affect the performance ofthe Tritanium® PL Cage and do not represent a new, worst case scenario in anyof the test methods presented in the predicate submission including:• Static and Dynamic Compression Shear (per ASTM F2077-14)• Static and Dynamic Torsion (per ASTM F2077-14)• Static and Dynamic Compression (per ASTM F2077-14)• Subsidence (per ASTM F2267-04)• Expulsion (per ASTMF04-25-02-02 (Draft)-2000)• Wear Debris Analysis• ImpactionNo additional performance data is provided as part of this submission. |
| Conclusion | Verification and validation activities demonstrated that all relevantacceptance criteria were met. The modified device is substantially equivalentto the predicate Tritanium PL® Cage. |
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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.