(311 days)
The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex Stem is indicated for use as a replacement of deficient humeral heads disabled by:
- Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) .
- . Traumatic arthritis.
The Tornier Pyrocarbon Humeral Head Shoulder Prosthesis, combined with the Tornier Flex Humeral Stem, are to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain.
Note: The coated humeral stem is intended for cementless use. The noncoated humeral stem is for cemented use only
The Tornier Pyrocarbon Humeral Head is a prescription use device that is comprised of the pyrolytic carbon (pyrocarbon) articulating surface and a cobalt chromium alloy double taper neck. The humeral head is provided pre-assembled to the double taper to the end user and is compacted onto 510(k) cleared compatible humeral stems (K151293) for replacement of deficient humeral heads disabled by noninflammatory arthritis, or traumatic arthritis. The pyrocarbon articulating surface is made of a graphite substrate core, coated with a layer of pyrolytic carbon deposited onto the substrate via chemical vapor deposition. The pvrocarbon articulating surface is pressed into the cobalt chromium alloy double taper neck during the manufacturing process, is provided as a singular construct to the end user, and is not intended to be disassembled by the end user. Compatible monoblock humeral stems are available in titanium plasma spray coated or uncoated versions. The humeral stems are designed with a female taper connection to accept the mating male taper connection of the pyrocarbon humeral heads.
The provided text describes the acceptance criteria and a clinical study that proves the Tornier Pyrocarbon Humeral Head device meets these criteria. However, it does not detail a study involving AI or human readers for diagnostic image analysis. Instead, the "study" referenced is a clinical trial evaluating the safety and effectiveness of a medical implant.
Therefore, many of the requested points related to AI model evaluation, such as "number of experts used to establish ground truth," "adjudication method," and "MRMC comparative effectiveness study," are not applicable to this document's content.
I will provide the information that is available in the document regarding the acceptance criteria and the clinical study of the implant.
Acceptance Criteria and Device Performance for Tornier Pyrocarbon Humeral Head (Hemiarthroplasty Implant)
The acceptance criteria for this medical device are primarily defined through bench testing (non-clinical performance) and clinical study endpoints (safety and effectiveness in patients).
1. Table of Acceptance Criteria and Reported Device Performance
A. Bench Testing (Non-Clinical Mechanical Performance)
| Acceptance Criteria (Performance Criteria) | Reported Device Performance (Results) |
|---|---|
| Construct Fatigue Endurance: Required to survive 5 million cycles to pre-specified test parameters without any cracks, breakage, damage, or dissociation. | All tested implants survived 5 million cycles without any cracks, breakage, damage, or dissociation from the stem. |
| Taper Disassembly Resistance - Axial Pull-off: No pre-determined acceptance criteria defined; results compared to another humeral head with the same intended use. | The minimum pull-off load for the Tornier Pyrocarbon Humeral Head exceeded the pull-off load of another humeral head. |
| Taper Disassembly Resistance - Torque-off: Torsional resistance force between pyrocarbon articulating surface and CoCr double taper neck must exceed anticipated clinically relevant loading conditions including an appropriate factor of safety. | All samples met the pre-determined acceptance criteria for torsional resistance. |
| Taper Disassembly Resistance - Lever-off: No pre-determined acceptance criteria defined; results compared to another humeral head with the same intended use. | The minimum lever-off load for the Tornier Pyrocarbon Humeral Head exceeded the lever-off load of another humeral head. |
| Fretting and Corrosion Resistance: No pre-determined acceptance criteria defined; visual scoring, ion release analysis, and particulate analysis results compared to another humeral head with the same intended use. | Qualitative damage determined by visual scoring, ion release analysis, and particulate analysis demonstrated comparable performance to another humeral head with the same intended use. |
| Humeral Head Burst Testing (Static Compression): A safety factor applied to the mean fatigue load to determine a minimum acceptance criteria for burst. (Safety factor derived from FDA guidance for ceramic hip systems). | All samples met the pre-determined acceptance criteria. |
| Humeral Head Subcritical Crack Propagation: A safety factor applied to the mean fatigue load to determine a minimum acceptance criteria for burst. (Safety factor derived from FDA guidance for ceramic hip systems and ISO standards). | All samples met the pre-determined acceptance criteria. |
| Third Body Wear: No pre-determined acceptance criteria defined; abrasive wear results compared to another humeral head with the same intended use. | Tornier Pyrocarbon Humeral Head demonstrated lesser surface roughening when exposed to an abrasive condition compared to another humeral head with the same intended use. Wear particulate analysis demonstrated wear particulates were consistent with wear particulates from other arthroplasty devices. |
| Range of Motion (ROM): Flexion ≥ 90°, Extension ≥ 45°, Abduction ≥ 90°, Internal Rotation ≥ 90°, External Rotation ≥ 45° (per ASTM F1378 for shoulder prostheses). | All simulated constructs met the pre-determined acceptance criteria. |
| Spring Impactor Testing: Performance of the instrument (e.g., spring stiffness and ability to impact the humeral head onto the stem) should not be impacted from repeated use, cleaning, or sterilization. | The spring impactor's performance was not impacted from extended cycles of simulated use, cleaning, or sterilization of the device. |
B. Clinical Performance (Primary Endpoint for Clinical Success at 24 Months)
| Acceptance Criteria (Success Definition) | Reported Device Performance (Pyrocarbon Group) | Reported Device Performance (Control Group - for comparison) |
|---|---|---|
| A patient was considered a success if (all conditions met at 24 months):1. Change in Constant score is ≥ 17;2. No revision surgery;3. No radiographic evidence of system disassembly or fracture;4. No system-related serious adverse event. | Composite Clinical Success (CCS):- Intent to Treat (ITT): 82.7%- Per Protocol (PP): 87.9%Component Success Rates:- Free of Revision: 98.1% (154/157)- Constant Score improved 17+ points (among those with evaluable scores): 84.6% (121/143)- Free of disassembly or fracture: 100.0% (157/157)- Free of device related SAE: 96.8% (152/157) | Composite Clinical Success (CCS):- Intent to Treat (ITT): 66.8%- Per Protocol (PP): 63.1%Component Success Rates:- Free of Revision: 94.7% (160/169)- Constant Score improved 17+ points (among those with evaluable scores): 73.1% (49/67)- Free of disassembly or fracture: 100.0% (169/169)- Free of device related SAE: 94.7% (160/169) |
2. Sample Size and Data Provenance for the Clinical Test Set
- Sample Size (Test Set):
- Pyrocarbon (Investigational) Group: 157 subjects enrolled.
- Control Group: 169 subjects selected after Propensity Score (PS) matching from a historical dataset.
- Data Provenance:
- Pyrocarbon Group: Prospective, multi-center, single-arm investigational study (IDE G140202 - Pyrocarbon IDE Study). Data collected from 18 sites within the US.
- Control Group: Retrospective, derived from the Aequalis Post-Market Outcomes Study dataset. The exact country of origin for the Aequalis dataset is not explicitly stated, but given context with US-based clinical trials, it is likely also primarily US data or from similar western healthcare systems.
3. Number of Experts and Qualifications for Ground Truth
This question is not applicable as the document describes a clinical trial for a medical implant, not an AI model requiring human expert labeling of data. The "ground truth" for the clinical study is the patient's actual clinical outcome, measured through direct observation (e.g., revision surgery, radiographic findings) and patient-reported outcomes (e.g., Constant score changes).
4. Adjudication Method for the Test Set
This question is not applicable in the context of diagnostic performance evaluation for an AI model. For the clinical study of the implant:
- The primary endpoint was a composite outcome, objectively defined.
- "Unanticipated Adverse Device Effects" were determined by an independent medical monitor.
- Clinical data collection and evaluation would have followed standard clinical trial protocols, typically involving investigators at sites and a data monitoring committee. Explicit "adjudication" in the sense of resolving disagreements among multiple human readers of image data is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specific to evaluating the diagnostic performance of AI or other tools when used by human readers (e.g., radiologists interpreting images). The study described is a clinical trial comparing a new implant to a historical control.
6. If a Standalone (Algorithm Only) Performance Study was done
No, this question is not applicable as the document is about a physical medical implant, not an AI algorithm. Its "standalone performance" is demonstrated through bench testing (mechanical performance, biocompatibility, sterility) rather than diagnostic accuracy.
7. The Type of Ground Truth Used
For the clinical study:
- Clinical Outcomes Data: This includes hard endpoints such as occurrence of revision surgery, radiographic evidence of system disassembly or fracture, and presence of system-related serious adverse events.
- Patient-Reported Outcomes (PROs): These are quantitative measures of patient experience and function, such as the Constant score, ASES score, SANE, EQ-5D, and VAS pain scale. Improvement in these scores contributes to the definition of "success."
For the bench testing:
- Direct Measurement/Observation: Mechanical properties are empirically measured (e.g., force to cause disassembly, visual inspection for cracks, measured ROM).
- Comparative Data: For some tests without absolute acceptance criteria (e.g., taper disassembly, fretting/corrosion, third-body wear), performance was compared to another cleared humeral head with the same intended use.
8. The Sample Size for the Training Set
This question is not applicable as the document describes a physical medical device (implant) and its clinical evaluation, not an AI model that requires a "training set" of data in the machine learning sense. The "training" for this device would refer to its manufacturing process and quality control, and the "data" is the clinical and bench testing data.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the reasons stated above.
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DE NOVO CLASSIFICATION REQUEST FOR TORNIER PYROCARBON HUMERAL HEAD
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis. A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon, and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty.
NEW REGULATION NUMBER: 888.3695
CLASSIFICATION: Class II
PRODUCT CODE: OKW
BACKGROUND
DEVICE NAME: Tornier Pyrocarbon Humeral Head
SUBMISSION NUMBER: DEN220012
DATE DE NOVO RECEIVED: February 8, 2022
SPONSOR INFORMATION:
Tornier SAS % Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, Minnesota 55437
INDICATIONS FOR USE
The Tornier Pyrocarbon Humeral Head is indicated as follows:
The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex Stem is indicated for use as a replacement of deficient humeral heads disabled by:
- Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) .
- . Traumatic arthritis.
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The Tornier Pyrocarbon Humeral Head Shoulder Prosthesis, combined with the Tornier Flex Humeral Stem, are to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain.
Note: The coated humeral stem is intended for cementless use. The noncoated humeral stem is for cemented use only
LIMITATIONS
The sale, distribution, and use of the Tornier Pyrocarbon Humeral Head are restricted to prescription use in accordance with 21 CFR 801.109.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
Implant Description
The Tornier Pyrocarbon Humeral Head (Figure 1) is a prescription use device that is comprised of the pyrolytic carbon (pyrocarbon) articulating surface and a cobalt chromium alloy double taper neck. The humeral head is provided pre-assembled to the double taper to the end user and is compacted onto 510(k) cleared compatible humeral stems (K151293) for replacement of deficient humeral heads disabled by noninflammatory arthritis, or traumatic arthritis. The pyrocarbon articulating surface is made of a graphite substrate core, coated with a layer of pyrolytic carbon deposited onto the substrate via chemical vapor deposition. The pvrocarbon articulating surface is pressed into the cobalt chromium alloy double taper neck during the manufacturing process, is provided as a singular construct to the end user, and is not intended to be disassembled by the end user. Compatible monoblock humeral stems are available in titanium plasma spray coated or uncoated versions. The humeral stems are designed with a female taper connection to accept the mating male taper connection of the pyrocarbon humeral heads.
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Image /page/2/Picture/0 description: The image shows a shoulder joint replacement. On the left is the humeral head component, which is a metal ball that replaces the head of the humerus. In the middle is the scapula, which is the bone that forms the shoulder blade. On the right is the glenoid component, which is a plastic socket that replaces the glenoid fossa of the scapula.
Figure 1: Tornier Pyrocarbon Humeral Head, with the pyrocarbon articulating surface pre-assembled onto the cobalt chromium alloy double taper neck alone (left), and with the Tornier Flex Shoulder humeral stem in a hemi-shoulder arthroplasty configuration (right)
Instrument Description
The Tornier Pyrocarbon Humeral Head and compatible humeral stems are implanted using Class I surgical instruments regulated under 21 CFR 888.4540, product code LXH: trials regulated under 21 CFR 888.4800, product code HWT; class II instruments previously cleared with the compatible humeral stems (K151293); and the following device specific instrumentation specific to facilitate implantation of the Tornier Pyrocarbon Humeral Head:
- . Spring impactor, impactor tip supports, and pyrocarbon head impactor tip: Reusable instruments designed to deliver an appropriate amount of energy to impact the Tornier Pyrocarbon Humeral Head onto the humeral stem without damaging the pyrolytic carbon articulating surface.
- Manual planar reamers and reamer tip: Reusable instruments provided for . reaming the humeral cut surface following stem implantation to ensure the bone cut is perfectly aligned so as to not interfere with seating of the Tornier Pyrocarbon Humeral Head.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The Tornier Pyrocarbon Humeral Head is manufactured from the following patient contacting materials:
Table 2: Manufactured Materials of Patient-Contacting Device Components
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| Description | Material | DirectPatientContact | Contact Duration |
|---|---|---|---|
| ArticulatingSurface | Pyrocarbon | Yes | Permanent (>30 d) |
| DoubleTaper | Cobalt Chromium Alloy perISO 5832-7 (Implants forsurgery — Metallic materials —Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy) | Yes | Permanent (>30 d) |
| Patient-contactingInstruments | Medical Grade Stainless Steel,Polypropylene, and Silicone | Yes | Limited (≤24 h) |
Biocompatibility evaluation has been completed according to 2020 FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
For the permanent implant, the Table 3 shows the biocompatibility testing performed and the results, which were acceptable for a permanent implant in contact with bone/tissue:
| Test Description | Result |
|---|---|
| Cytotoxicity (per ISO 10993-5 (Biologicalevaluation of medical devices — Part 5:Tests for in vitro cytotoxicity)) | Non-cytotoxic |
| Irritation (per ISO 10993-10 (Biologicalevaluation of medical devices — Part 10:Tests for irritation and skin sensitization)) | Non-Irritant |
| Sensitization (per ISO 10993-10(Biological evaluation of medical devices— Part 10: Tests for irritation and skinsensitization)) | Non-Sensitizing |
| Implantation Effects (per ISO 10993-6(Biological evaluation of medical devices— Part 6: Tests for local effects afterimplantation)) | Null to Minimal Reactivity |
| Material Mediated Pyrogenicity (per ISO10993-11 (Biological evaluation ofmedical devices — Part 11: Tests forsystemic toxicity)) | Non-Pyrogenic |
Table 3: Implant Biocompatibility Testing Performed
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| Acute/Subacute/Subchronic/ChronicSystemic Toxicity, Genotoxicity andCarcinogenicity (addressed throughchemical characterization andtoxicological risk assessment per ISO10993-18 (Biological evaluation ofmedical devices — Part 18: Chemicalcharacterization of medical devicematerials within a risk managementprocess)/ISO 10993-17 (Biologicalevaluation of medical devices — Part 17:Establishment of allowable limits for | Non-systemicallytoxic/genotoxic/carcinogenic |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------- |
For the reusable silicone instruments, the Table 4 shows the biocompatibility testing performed and the results, which were acceptable for instruments in limited contact with bone/tissue:
| Test Description | Result |
|---|---|
| Cytotoxicity (per ISO 10993-5 (Biologicalevaluation of medical devices — Part 5:Tests for in vitro cytotoxicity)) | Non-cytotoxic |
| Irritation (per ISO 10993-10 (Biologicalevaluation of medical devices — Part 10:Tests for irritation and skin sensitization)) | Non-Irritant |
| Sensitization (ISO 10993-10 (Biologicalevaluation of medical devices — Part 10:Tests for irritation and skin sensitization)) | Non-Sensitizing |
| Acute Systemic Toxicity (per ISO 10993-11 (Biological evaluation of medicaldevices — Part 11: Tests for systemictoxicity)) | Non-Toxic |
Table 4: Silicone Instrument Biocompatibility Testing Performed
In addition to the biocompatibility testing of silicone instruments, reference to a master file was provided to support the Material Mediated Pyrogenicity Endpoint to demonstrate the instrument is non-pyrogenic.
For the reusable stainless steel and polypropylene instruments, a manufacturing rationale was provided to demonstrate acceptable biocompatibility for instruments in limited contact with bone/tissue.
STERILITY / PACKAGING AND SHELF-LIFE / PYROGENICITY
Sterility:
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The Tornier Pyrocarbon Humeral Head is a single-use device provided clean and sterile to the end user. Gamma Sterilization of the device has been validated to provide a Sterility Assurance Level (SAL) of 10-6 based on the VDmax-5 method as recommended by FDA Recognized Consensus Standard series ANSI/AAMI/ISO 11137-1 (Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices)/-2 (Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose).
Packaging and Shelf-Life:
The sterile barrier system consists of a double blister package sealed with Tyvek lids which is placed into a protective cardboard box. Sterilized samples accelerated aged to 5 years were used to determine the sterile shelf-life of the device. The mechanical performance of the device is not expected to degrade over time. Distribution testing (ASTM D4169 (Standard practice for performance testing of shipping containers and systems)), package integrity testing (bubble leak test. ASTM F2096 (Standard test method for detecting gross leaks in packaging by internal pressurization (bubble test))), and seal strength testing (ASTM F88/F88M (Standard test method for seal strength of flexible barrier materials)) were used to validate the sterile shelf-life of the device. Nonclinical performance testing of the implant was used to assess the shelf-life of the device. The testing confirmed a 5 year shelf-life.
Pyrogenicity:
Bacterial endotoxins testing (BET) was performed to determine whether the Tornier Pyrocarbon Humeral Head met pyrogen limit specifications. All tested devices passed with a reported value of <1 EU/device. meeting the recommended endotoxin limits per ANSI/AAMI ST72:2011 ("Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing").
Reprocessing:
Certain instruments for use with the Tornier Pyrocarbon Humeral Head are provided nonsterile and are to be cleaned and sterilized by the end user. Validated reprocessing instructions are included in their own separate labeling document.
Steam sterilization method was validated per ISO 17665 Half Cycle Method (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices) and AAMI ST79 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities) to ensure that a minimum SAL of 106 is achieved. Instruments are to be sterilized using a pre-vacuum steam autoclave. For the pre-vacuum steam autoclave cycle, the validated parameters call for an exposure time of 4 minutes at 270°F (132°C) and a dry time of 20 minutes at 270°F (132°C). Users are advised to use an FDA- cleared sterilization wrap.
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MAGNETIC RESONANCE (MR) COMPATIBILITY
The Tornier Pyrocarbon Humeral Head was not evaluated for safety and compatibility in a Magnetic Resonance Environment.
PERFORMANCE TESTING - BENCH
A summary of non-clinical mechanical performance evaluations is provided in Table 5:
| Test | Purpose | Method | PerformanceCriteria | Results |
|---|---|---|---|---|
| Construct fatigueendurance | The aim of this test is toassess the risk ofcomponent looseningand potential damagefollowing fatigue forthe worst-case devicesand test parameters. | 5 million cycles ofcompressive loadwas applied in aworst-caseorientation. | The implants wererequired to survive5 million cycles tothe pre-specifiedtest parameterswithoutany cracks,breakage, damage,or dissociation. | All tested implantssurvived 5 millioncycles without anycracks, breakage,damage, ordissociation fromthe stem. |
| Taper disassemblyresistance - axial pull-off | The aim of this test is toassess the disassemblyresistance of thehumeral head sub-components and of thehumeral head from thehumeral stem to axialpull-off in the worst-case configuration. | The test methodfollowsrecommendationsdescribed in ASTMF2009 (Standardtest method fordetermining theaxial disassemblyforce of taperconnections ofmodularprostheses). | No pre-determinedacceptance criteriawere defined.Disassembly resultswere compared toanother humeralhead with the sameintended use. | The minimum pull-off load for theTornier PyrocarbonHumeral Headexceeded the pulloff load of anotherhumeral head. |
| Taper disassemblyresistance - torque off | The aim of this test is toassess the disassemblyresistance of thehumeral head sub-components and of thehumeral head from thehumeral stem to torque-off in the worst-caseconfiguration. | Test methods wereadapted for shoulderprostheses frommethods describedin ISO 7206-13(Implants forsurgery - Partial andtotal hip jointprostheses - Part 13:Determination ofresistance to torqueof head fixation ofstemmed femoralcomponents). | The torsionalresistance forcebetween thePyrocarbonarticulating surfaceand the CoCrdouble taper neckmust exceedanticipatedclinically relevantloading conditionsincluding anappropriate factor ofsafety. | All samples met thepre-determinedacceptance criteriafor torsionalresistance. |
| Taper disassemblyresistance - lever-off | The aim of this test is toassess the disassemblyresistance of thehumeral head sub-components and of the | A static lever-offload was applied ata constant rate untildissociation or | No pre-determinedacceptance criteriawere defined.Disassembly resultswere compared to | The minimum lever-off load for theTornier PyrocarbonHumeral Headexceeded the lever-off load of another humeral head. |
| Test | Purpose | Method | PerformanceCriteria | Results |
| humeral head from thehumeral stem to lever-off in the worst-caseconfiguration. | breakage of thecomponents. | another humeralhead with the sameintended use. | off load of anotherhumeral head. | |
| Fretting and corrosionresistance | The aim of this test is toevaluate the fretting andcorrosion resistance ofthe humeral prosthesesfor worst-casecompatiblecomponents. | 5 million cycles ofcompressive loadwere applied in aworst-caseorientation in aphysiologicenvironment. | No pre-determinedacceptance criteriawere defined.Visual scoring, ionrelease analysis, andparticulate analysisresults werecompared to anotherhumeral head withthe same intendeduse. | Qualitative damagedetermined byvisual scoring, ionrelease analysis, andparticulate analysisdemonstratedcomparableperformance toanother humeralhead with the sameintended use. |
| Humeral head bursttesting (staticcompression) | The aim of this test is toevaluate the maximumcompressive load thatthe humeral head mayexperience prior tobreakage whenconsidering worst-casecomponents. | Static compressiveload to failuretesting was adaptedto evaluate shouldercomponents frommethods describedin ISO 7206-10(Implants forsurgery - Partial andtotal hip-jointprostheses - Part 10:Determination ofresistance to staticload of modularfemoral heads). | A safety factor wasderived from FDAguidance document:"GuidanceDocument for thePreparation ofPremarketNotification forCeramic Ball HipSystem," and thefatigue loadrequirements forfemoral stems fromISO 7206-4(Implants forsurgery - Partialand total hip jointprostheses - Part4: Determination ofenduranceproperties andperformance ofstemmed femoralcomponents). Thissafety factor wasapplied to the meanfatigue load todetermine aminimumacceptance criteriafor burst. | All samples met thepre-determinedacceptance criteria. |
| Humeral headsubcritical crackpropagation | The aim of this test is toevaluate the risk ofdelayed componentfracture of the humeralhead for worst-casecomponents | Incremental loadrelease testing wasadapted to evaluateshoulder implantsfrom methodsdescribed in ISO | A safety factor wasderived from FDAguidance document:"GuidanceDocument for thePreparation of | All samples met thepre-determinedacceptance criteria. |
| Test | Purpose | Method | PerformanceCriteria | Results |
| orientation due tosubcritical crackgrowth. | 11491 (Implants forsurgery –Determination ofimpact resistance ofceramic femoralheads for hip jointprostheses). | PremarketNotification forCeramic Ball HipSystem,” and thefatigue loadrequirements forfemoral stems fromISO 7206-4(Implants forsurgery – Partialand total hip jointprostheses – Part4: Determination ofenduranceproperties andperformance ofstemmed femoralcomponents). Thissafety factor wasapplied to the meanfatigue load todetermine aminimumacceptance criteriafor burst. | ||
| Third body wear | The aim of this test is toevaluate the articularwear of the humeralhead in an abrasivecondition to debriscirculating within thejoint. | Abrasive wearconditions weresimulated on thebench referencingliterature, ASTMF2028 (Standardtest methods forDynamic Evaluationof GlenoidLoosening orDisassociation, andISO 14242(Implants forsurgery – Wear oftotal hip-jointprostheses). | No pre-determinedacceptance criteriawere defined.Abrasive wearresults werecompared to anotherhumeral head withthe same intendeduse. | Tornier PyrocarbonHumeral Headdemonstrated lessersurface rougheningwhen exposed to anabrasive conditioncompared to anotherhumeral head withthe same intendeduse. Wearparticulate analysisdemonstrated wearparticulates wereconsistent with wearparticulates fromother arthroplastydevices. |
| Range of motion(ROM) | The aim of this test is tocharacterize the ROMof the humeralprosthesis for worst-case components. | Smallest and largestcomponents wereevaluated whenpaired with virtualscapula models todetermine the ROMof the system priorto implantation inaccordance withASTM F1378(Standard | Performance criteriawere defined fromASTM F1378(Standardspecification forshoulderprostheses):Flexion shall beequal to or greaterthan 90°. Extensionshall be equal to or | All simulatedconstructs met thepre-determinedacceptance criteria. |
| Test | Purpose | Method | PerformanceCriteria | Results |
| specification forshoulderprostheses). | greater than 45°.Abduction shall beequal to or greaterthan 90°. InternalRotation shall beequal to or greaterthan 90°. Externalrotation shall beequal to or greaterthan 45°. | |||
| Spring impactor testing | The aim of this test is toassess the function ofthe impactor instrumentin response to bothfatigue testing andextended cycles ofcleaning andsterilization. | The spring impactorwas cycled throughextended simulateduse, cleaning, andsterilization cycles. | The performance ofthe instrument (e.g.,spring stiffness andability to impact thehumeral head ontothe stem) should notbe impacted fromrepeated use,cleaning, orsterilization. | The springimpactor'sperformance wasnot impacted fromextended cycles ofsimulated use,cleaning, orsterilization of thedevice. |
Table 5: Summary of Non-clinical Mechanical Performance Evaluations
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SUMMARY OF CLINICAL INFORMATION
Study Design
The sponsor conducted a prospective, multi-center, single-arm investigational study under IDE G140202 - Pyrocarbon IDE Study. A total of 157 subjects were enrolled across 18 sites within the US. While the study was originally designed as a performance goal study, the study design changed to a non-inferiority historically controlled study with Propensity Score (PS) analysis at FDA's request. Control data originated from the Aequalis Post-Market Outcomes Study dataset for a 510(k) cleared cobalt chromium humeral head hemiarthroplasty device (i.e. Tornier Flex Cobalt Chromium Humeral Head). A blinded independent statistician implemented a two-stage, outcome-free PS design, and after PS matching, 169 control subjects were selected. The purpose of the study was to evaluate the safety and effectiveness of the pyrocarbon humeral head as a hemiarthroplasty for patients with non-inflammatory arthritis or post-traumatic arthritis when compared to cobalt chromium humeral heads. Subjects were followed to Month 24 posttreatment for study endpoint analysis.
Subject Demographics
A total of 157 subject were enrolled for the investigational trial. After PS matching, 169 control subjects were selected from the Aequalis Post-Market Outcomes Study dataset. The two treatment groups were similar in terms of demographics and baseline characteristics, with an overall mean age and standard deviation of 52.1 ± 10.8 years for the Pyrocarbon group, and 54.9 ± 11.4 years for the control group. The study population was 79% male for the Pyrocarbon group and 72.8% for the control group with average body mass index (BMI) of 30.4 ± 7.0, and 29.2 ± 5.9, respectively. The primary diagnosis in both treatment groups was primary glenohumeral arthritis, comprising 86.6% of patients for the Pyrocarbon group and 82.8% of the control group.
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Breakdown of age (beyond mean), race, and ethnicity specific data were not reported in the clinical study. Table 6 presents a summary of the baseline characteristics for the Pyrocarbon group and control groups (with and without outcome data):
| Measure | Pyrocarbon | Control(Overall) | Control(with outcomedata) | Control(withoutoutcome data) |
|---|---|---|---|---|
| N | 157 | 169 | 73 | 96 |
| Age, years | 52.1 ± 10.8 | 54.9 ± 11.4 | 55.9 ± 10.2 | 54.1 ± 12.2 |
| BMI, kg/m2 | 30.4 ± 7.0 | 29.2 ± 5.9 | 29.2 ± 5.9 | 29.2 ± 5.9 |
| Constant Activity Score | 7.8 ± 3.7 | 6.9 ± 3.2 | 6.8 ± 3.4 | 7.1 ± 3.3 |
| Constant Pain Score | 4.9 ± 3.2 | 3.4 ± 2.2 | 3.4 ± 2.3 | 3.3 ± 2.3 |
| Adjusted Constant Score | 49.1 ± 17.4 | 46.0 ± 17.5 | 47.4 ± 17.8 | 44.9 ± 17.6 |
| Sex = Male, % | 79.0% | 72.8% | 78.1% | 68.8% |
| Diagnosis, % | ||||
| Avascular Necrosis | 7.6% | 10.7% | 6.9% | 13.5% |
| Post-traumatic Arthritis | 5.7% | 6.5% | 8.2% | 5.2% |
| Primary Glenohumeral Arthritis | 86.6% | 82.8% | 84.9% | 81.3% |
| Dexterity = Right, % | 86.0% | 91.1% | 90.4% | 91.7% |
| Operated Shoulder = Right, % | 58.0% | 59.2% | 65.8% | 54.2% |
| Hospital with Large Number ofBeds, % | 65.6% | 72.8% | 75.3% | 70.8% |
| Private Institution, % | 62.4% | 79.9% | 82.2% | 78.1% |
Table 6. Patient Baseline Characteristics
Primary Endpoint
The primary composite endpoint for the study was defined as the rate of patient success at 24 months. A patient was considered a success at 24 months if:
- Their change in Constant score is ≥ 17; .
- o They did not have revision surgery:
- . There is no radiographic evidence of system disassembly or fracture; AND
- . They did not have a system-related serious adverse event.
For the intent to treat set, using multiple imputation to account for missing data, the success rate was 82.7% for the Pvrocarbon group, and 66.8% for the control group. The success rate of Pyrocarbon group led the control by 15.9%. For the per protocol set, after imputation, the success rate was 87.9% for the Pyrocarbon group, and 63.1% for the control group, success rate for Pyrocarbon group was 24.8% higher than for the control group. The sponsor applied a twowav generalized linear model to adjust for propensity score subclass, and used model results to support the non-inferiority claim. Results are presented in Table 7 for all study subjects.
| Pyrocarbon | Control | |||||
|---|---|---|---|---|---|---|
| Outcome | N | n | % | N | n | % |
| Free of Revision | 157 | 154 | 98.1% | 169 | 160 | 94.7% |
| Constant Score improved 17+ points | 143 | 121 | 84.6% | 67 | 49 | 73.1% |
Table 7: Primary Endpoint Success at Month 24 Post-treatment
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| Pyrocarbon | Control | |||||
|---|---|---|---|---|---|---|
| Outcome | N | n | % | N | n | % |
| Free of disassembly or fracture | 157 | 157 | 100.0% | 169 | 169 | 100.0% |
| Free of device related SAE | 157 | 152 | 96.8% | 169 | 160 | 94.7% |
| Composite Clinical Success (CCS) | 157 | -- | 82.7% | 169 | -- | 66.8% |
| CCS - Completers | 146 | 120 | 82.2% | 73 | 49 | 67.1% |
| CCS - Best Case | 157 | 131 | 83.4% | 169 | 49 | 29.0% |
| CCS - Worst-case | 157 | 120 | 76.4% | 169 | 145 | 85.8% |
While the historical control group was missing a significant portion of outcome data, all control subjects with missing data are conservatively assumed to be a success in the primary endpoint analysis. To assess for potential selection bias, the sponsor provided an analysis of baseline characteristics for control completers comparing with control subjects with missing data. The analysis indicated that there are no significant differences in baseline demographics or comorbidity characteristics between control completers and control subjects with missing data. The performance of the control group was also compared to literature, noting that the revision rate and the mean improvement in Constant Score are consistent with published data in literature and real-world data, as presented in Table 8.
| Name | Endpoint | Average FollowUp (months) | Sample Size | Estimate |
|---|---|---|---|---|
| Historical Control | Revision Rate | 24 | 169 | 5.3% |
| Meta Analyses ofHemiarthroplastyLiterature | Revision Rate | 55 | 835 | 11.1% |
| Australian JointRegistry 2021 | Revision Rate | 24 | 5332 | 5.45% |
| Historical Control | Constant ScoreChange frombaseline | 24 | 57 | 28.6±19.9 |
| Meta Analyses ofHemiarthroplastyLiterature | Constant ScoreChange frombaseline | 56 | 626 | 31.8±10.3 |
| Fonte et. al. MetaAnalysis1 | Constant ScoreChange frombaseline | 14-240 | 341 | 29.6 |
Table 8: Control Group Performance Comparison to Literature and Real World Data
In addition to the comparison of baseline characteristics between control subjects with or without complete outcome data, and the comparison of outcome data of the control subjects to literature, a tipping point analysis was conducted to analyze the sensitivity of missing data. Compared to the multiple imputation model, the tipping point analysis does not require the same statistical assumptions as it analyzes every possible combination of the missing data. Based on modeling where all possible combinations of missing data were used to assess success or failure in the
1 Fonte H, Amorim-Barbosa T, Diniz S, Barros L. Ramos J, Claro R. Shoulder Arthroplasty Options for Glenohumeral Osteoarthritis in Young and Active Patients (<60 Years Old): A Systematic Review. J Shoulder Elb Arthroplast. 2022;6:24715492221087014. Published 2022 Mar 23. doi:10.1177/24715492221087014
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overall success measurement, only 68 of the 1.164 (5.8%) scenarios would change the study conclusions. The overall success criterion was met in the other 1,096 (>94%) potential missing data combinations. This indicates that the tipping point analysis, along with the multiple imputation analysis and supporting information, demonstrate that the non-inferiority result is insensitive to the presence of missing data.
Secondary Endpoints
Secondary endpoints assessed during the study included the Constant Score, Adjusted Constant Score, American Shoulder and Elbow Surgeons (ASES) Score, Single Assessment Numeric Evaluation (SANE), EQ-5D, Pain measured by a visual analog scale (VAS), ROM, and strength. The Adjusted Constant Score change of 40.5 points in 24 months, observed in the Pyrocarbon IDE study is greater than the minimally clinical important differences (MCID) determined by Holmgren et al who defined a MCID in the Adjusted Constant score for subjects treated conservatively for subacromial pain to be between 17-24 points.2 The Constant Score change of 34.3 observed in the Pyrocarbon IDE study is greater than the MCID determined by additional literature that reports the MCID in Constant Score for shoulder arthroplasty to be 5.7-9.4.3 The ASES change of 43.4 in 24 months, observed in the Pyrocarbon IDE study is greater than the MCID determined by Tashiian et al (12-17 points) for rotator cuff disease (tendonitis or tears).4 The SANE change of 49.5 points observed in the Pyrocarbon IDE study is greater than the MCID determined by Zhou et al (27.25 points) for rotator cuff repairs.6 EQ-5D change of 0.21 points observed in the Pyrocarbon IDE study is greater than the MCID determined by Hao et al (0.02-0.11) for subacromial pain.6
Pain was assessed in the study using a 10-pt (0-no pain at all. 10-pain as bad as it can be) pain VAS (taken from the pain portion of the ASES standardized score). The mean subject reported pain went from 5.5 to 1.1 on the VAS scale with a mean change of -4.2 ± 2.8. The change observed in the Pyrocarbon IDE study is greater than the MCID determined by Hao et al (-1.5) for subacromial pain. The ROM change observed in the Pyrocarbon IDE study at two years are consistent with the results observed by Sowa et al who assessed change in ROM at an average of four years after shoulder hemiarthroplasty. 7 The mean change in strength observed was 5.0±7.6 lbs. at 24 months. These results in the Pyrocarbon IDE study at 24 months are consistent with the
2 Holmgren T. Oberg B. Adolfsson L. Björnsson Hallgren H. Minimal important changes in the Constant-Murley score in patients with subacromial pain. J Shoulder Elbow Surg. 2014;23(8):1083-1090. doi:10.1016/j.jse.2014.01.014
3 Dabija DI, Jain NB. Minimal Clinically Important Difference of Shoulder Outcome Measures and Diagnoses: A Systematic Review. Am J Phys Med Rehabil. 2019;98(8):671-676. doi:10.1097/PHM.00000000001169
4 Tashian RZ. Deloach J. Green A. Porucznik CA. Powell AP. Minimal clinically important differences in ASES and simple shoulder test scores after nonoperative treatment of rotator cuff disease. J Bone Joint Surg Am. 2010:92(2):296-303. doi:10.2106/JBJS.H.01296
5 Zhou L. Nataraian M. Miller BS. Gagnier JJ. Establishing Minimal Important Differences for the VR-12 and SANE Scores in Patients Following Treatment of Rotator Cuff Tears. Orthop J Sports Med.
2018:6(7):2325967118782159. Published 2018 Jul 26. doi:10.1177/2325967118782159
6 Hao O. Devii T. Zeraatkar D. et al. Minimal important differences for improvement in shoulder condition patientreported outcomes: a systematic review to inform a BMJ Rapid Recommendation. BMJ Open. 2019:9(2):e02877. Published 2019 Feb 20. doi:10.1136/bmjopen-2018-028777
7 Sowa B. Thierjung H. Bülhoff M, et al. Functional results of hemi- and total shoulder arthroplasty according to diagnosis and patient age at surgery. Acta Orthop. 2017;88(3):310-314. doi:10.1080/17453674.2017.1280656
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12-month results observed by Sperling et al who assessed change in strength after total shoulder arthroplasty on subjects with an intact rotator cuff.8
Safety Analysis
There were no Unanticipated Adverse Device Effects as determined by the independent medical monitor. All device- and procedure-related serious adverse events (SAEs) were considered expected complications for total shoulder arthroplasty. In the IDE data, there were 3 revisions (3/157, 1.91%) and zero instances of humeral head fracture and/or disassembly at 24 months for the Pyrocarbon group. In Historical Control, SAEs reported include 9 revisions (9/169, 5.33%), which is consistent with the hemiarthroplasty revision rate (5.45%) reported in the 2021 Australian joint registry.
SAEs possibly related to the device include rotator cuff tear (2/157, 1.27%). SAEs possibly related to the procedure include: arthrofibrosis, atelectasis, biceps rupture, brachial plexus palsy, deep vein thrombosis, pain, pulmonary emboli, rotator cuff tear, stroke, and infection.
Pediatric Extrapolation
In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.
LABELING
The labeling consists of the following: device description, indications for use, instructions for use including surgical steps (e.g., device selection and placement), principles of device operation, identification of device materials, contraindications, warnings, precautions, a list of potential adverse effects, and importance of patient compliance with postoperative activity restrictions. Furthermore, the sterile packaging includes a shelf-life for the device. The labeling meets the requirements of 21 CFR 801.109 for prescription devices.
RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of the shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis and the measures necessary to mitigate these risks.
| Identified Risks to Health | Mitigation Measures |
|---|---|
| Adverse events of the index shoulder includingpain, unanticipated adverse device effects,subsequent surgical interventions, wear of thenative bone, osteolysis, loosening andmigration, and revision, including revision due | Clinical dataNon-clinical performance testingBiocompatibility evaluation |
8 Sperling JW. Kaufman KR. Schleck CD. Cofield RH. A biomechanical analysis of strength and motion following total shoulder arthroplasty. Int J Shoulder Surg. 2008;2(1):1-3. doi:10.4103/0973-6042.39579
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| Identified Risks to Health | Mitigation Measures |
|---|---|
| to device wear, component dissociation, ordevice brittle fracture | |
| Adverse tissue reaction due to• Device materials• Fretting and corrosion• Wear particulates | Biocompatibility evaluationNon-clinical performance testing |
| Infection | Sterilization validationReprocessing validationShelf-life testingPyrogenicity testingLabeling |
| Insufficient range of motion | Non-clinical performance testing |
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the shoulder joint humeral (hemishoulder) ceramic head / metallic stem cemented prosthesis is subject to the following special controls:
-
- Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
- a. Evaluation of improvement of shoulder function and reduction of symptoms, including pain and function, for the indications for use; and
- b. Evaluation of adverse events, including pain, unanticipated adverse device effects, subsequent surgical interventions, wear of the native bone, osteolysis, loosening and migration, and revision, including revision due to device wear, component dissociation, or device brittle fracture.
-
- Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
- a. Evaluation of the mechanical function (mechanical fatigue strength including evaluation of fretting and corrosion, static mechanical strength, modular component disassembly strength, and wear analysis) and durability of the implant; and
- b. Evaluation of worst-case device range of motion.
-
- All patient-contacting components of the device must be demonstrated to be biocompatible.
-
- Performance data must support the sterility and pyrogenicity of the device components intended to be sterile.
-
- Performance data must validate the reprocessing instructions for the reusable components of the device.
-
- Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf-life.
-
- Labeling must include the following:
- a. Validated methods and instructions for reprocessing of any reusable components; and
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- b. A shelf-life.
BENEFIT-RISK DETERMINATION
BENEFITS:
-
- The clinical study demonstrates Tornier Pyrocarbon Humeral Head leads to clinically meaningful improvements in shoulder function and symptoms (e.g., reduction in pain) that are maintained over time to at least 24 months;
-
- Performance has demonstrated to be non-inferior to Cobalt Chrome Hemiarthroplasty;
-
- Literature on clinical use and in vitro testing demonstrate decreases in native glenoid wear when compared to Cobalt Chrome devices;
-
- The Tornier Pyrocarbon Humeral Head secondary endpoint results (Constant Score, ASES, SANE, VAS, Strength, and Revision Rate) support clinically meaningful, patientvalued benefits at a magnitude similar to, or numerically greater than, those observed with the Control device: AND
-
- Improvement in long-term implant survival rates and delay of TSA conversion.
RISKS:
-
- Adverse events of the index shoulder including pain, unanticipated adverse device effects, subsequent surgical interventions, wear of the native bone, osteolysis, loosening and migration, and revision, including revision due to device wear, component dissociation, or device brittle fracture:
-
- Adverse tissue reactions due to device materials: fretting and corrosion: and wear particulates:
-
- Infection: AND
-
- Insufficient range of motion.
Based on the totality of the evidence, the Tornier Pyrocarbon Humeral Head demonstrated a reasonable assurance of safety and effectiveness for the device for its intended use/indications for use and while there is a medium degree of uncertainty in this finding due to missing data from the control group in the clinical study, the risks are not greater than the current standard of care. In addition, the pyrocarbon humeral head demonstrated lower revision rates over the course of the clinical study, and literature and in vitro testing demonstrate a probable benefit of decreased glenoid wear when compared to a cobalt chrome hemiarthroplasty. In conclusion, the benefits of using the Tornier Pyrocarbon Humeral Head for its intended use/indications for use outweigh the risks to health.
PATIENT PERSPECTIVES
Patient perspectives considered for the Tornier Pyrocarbon Humeral Head during the review include:
The primary composite study endpoints included assessment of improvement in pain and function using patient reported metrics (e.g., Constant score) at month 24.
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Additionally, pre-specified secondary effectiveness study endpoints included the following scales: Constant score, ASES, SANE, EQ5D, VAS Pain Scale, ROM, and change in strength to evaluate the treatment effect at 24 months. These patient reported outcomes (PROs) are used to demonstrate a clinically meaningful improvement in pain and function.
BENEFIT/RISK CONCLUSION
In conclusion, given the available information above, for the following indication statement:
"The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex Stem is indicated for use as a replacement of deficient humeral heads disabled by:
- · Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis).
- . Traumatic arthritis.
The Tornier Pyrocarbon Humeral Head Shoulder Prosthesis, combined with the Tornier Flex Humeral Stem, are to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain.
Note: The coated humeral stem is intended for cementless use. The noncoated humeral stem is for cemented use only"
The probable benefits outweigh the probable risks for the Tornier Pyrocarbon Humeral Head. The device provides benefits, and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The De Novo for the Tornier Pyrocarbon Humeral Head is granted and the device is classified as follows:
Product Code: OKW Device Type: Shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis Regulation Number: 21 CFR 888.3695 Class: Class II
N/A