(195 days)
The TRAUMACEM™ V+ Injectable Bone Cement is indicated for augmentation of the TFN-ADVANCED® Proximal Femoral Nailing System through cannulated implants and instruments for patients with poor bone quality (e.g., osteoporosis).
TRAUMACEM™ V+ Injectable Bone Cement consists of sterile packed powder and liquid components to create radiopaque TRAUMACEM™ V+ Injectable Bone Cement. The powder component is pre-packed in the mixer. The liquid component is stored in a glass ampoule. A transfer lid for the mixing and transfer of the bone cement in the application system is also contained in the kit. Mixing the two sterile components produces the injectable bone cement.
The provided text describes the regulatory filing for a medical device, TRAUMACEM™ V+ Injectable Bone Cement, and discusses its substantial equivalence to predicate devices, supported by various performance tests and clinical evidence. However, this document does not describe a study that proves a device meets acceptance criteria related to an AI/ML algorithm or a comparative effectiveness study involving human readers with and without AI assistance.
The information provided pertains to the premarket notification (510(k)) process for a physical medical device (bone cement). The "acceptance criteria" discussed are in the context of demonstrating substantial equivalence to a legally marketed predicate device, primarily through physical, chemical, and biomechanical testing, as well as review of existing clinical data.
Therefore, many of the requested points related to AI/ML device validation (e.g., sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone AI performance) are not applicable to the content of this document.
Here's a breakdown based on the provided text, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a formal table of acceptance criteria and corresponding performance for the bone cement in the way one would for an AI/ML diagnostic device with specific metrics like sensitivity, specificity, or AUC. Instead, it states that the device was compared to predicate and reference devices and "meets the requirements of ASTM F451-08/ISO 5833:2002 (apart from setting and dough time)." It also lists various performance tests conducted:
| Acceptance Criterion (Implicit) | Reported Device Performance (Implied, from tests conducted) |
|---|---|
| Material Standards Compliance | Meets the requirements of ASTM F451-08/ISO 5833:2002 (apart from setting and dough time). |
| Biomechanical Performance | Biomechanical evaluation of cut-out resistance conducted. (Specific metrics not provided, but implies satisfactory performance given 510(k) clearance). |
| Cadaveric Performance | Cadaveric evaluation of cut-out resistance conducted. (Specific metrics not provided). |
| Delivery/Handling (via cannulated implants) | Cannulated implant removal evaluation conducted. TRAUMACEM™ V+ Injectable Bone Cement was designed to have increased radiopacity and working time to facilitate delivery through cannulated implants and instruments. |
| Radiopacity | Radiopacity comparison conducted. TRAUMACEM™ V+ Injectable Bone Cement was designed to have increased radiopacity. |
| Biocompatibility | Cytotoxicity, Irritation, Sensitization, Material mediated pyrogenicity, Genotoxicity (in vitro and in vivo), Implantation, Chemical characterization conducted. (The conclusion is that benefits outweigh risks, implying satisfactory biocompatibility). |
| Clinical Outcomes (for its intended use) | One prospective, multicenter, randomized, postmarket study conducted outside the US comparing outcomes in patients with unstable trochanteric fractures treated with or without Traumacem V+ Augmentation. Two peer-reviewed publications summarizing short-term and long-term outcomes of patients with trochanteric fractures treated with cephalomedullary nail augmentation with PMMA bone cements. Reported Outcomes: No cases of cut-out were observed. Potential risks (e.g., cement leakage) had a low rate of occurrence. Data correlated well with real-world market experience outside the US. Indications, method of use, and patient populations confirmed to align with intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (for clinical evidence):
- One prospective, multicenter, randomized, postmarket study conducted. The sample size for this specific study is not provided in the document.
- Two summaries of peer-reviewed publications. The sample sizes for these publications are not provided.
- Data Provenance: Studies were conducted outside the US. The randomized study described was prospective and postmarket. The publications summarized outcomes from patients treated with PMMA bone cements (presumably retrospective or prospective depending on the original study designs, but not specified here). Real-world market experience outside the United States also mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the studies described are clinical outcome studies for a bone cement, not diagnostic studies where experts establish ground truth from images. The "ground truth" here would be clinical outcomes (e.g., presence/absence of cut-out, leakage rates) observed by clinicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is relevant for diagnostic studies with image interpretations, not for a bone cement clinical outcome study. Clinical outcomes would be determined by treating physicians and follow-up assessments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This document describes a physical bone cement, not an AI/ML diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. The device is a physical bone cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the clinical evidence presented, the "ground truth" was outcomes data (e.g., presence/absence of cut-out, cement leakage rates) gathered from clinical studies and real-world market experience.
8. The sample size for the training set
- Not applicable. This isn't an AI/ML device that uses a training set.
9. How the ground truth for the training set was established
- Not applicable. This isn't an AI/ML device that uses a training set.
In summary: The provided document is a regulatory clearance letter and summary for a physical medical device (bone cement). It demonstrates the device's equivalence to existing products through a combination of physical, chemical, biomechanical, and biocompatibility testing, along with references to existing clinical studies and real-world data. It does not provide information relevant to the validation of an AI/ML-driven diagnostic or treatment planning system.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) Products, LLC Christopher J. Medberry, Ph.D. Project Leader, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380 September 28, 2017
Re: K170802
Trade/Device Name: TRAUMACEM™ V+ Injectable Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD Dated: August 25, 2017 Received: August 25, 2017
Dear Dr. Medberry:
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
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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) K170802
Device Name
TRAUMACEM™ V+ Injectable Bone Cement
Indications for Use (Describe)
The TRAUMACEM™ V+ Injectable Bone Cement is indicated for augmentation of the TFN-ADVANCED® Proximal Femoral Nailing System through cannulated implants and instruments for patients with poor bone quality (e.g., osteoporosis).
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) |
|---|---|
| ------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
escription OSC (Part 21 CFR 801 Subpart D)
Use (21 CFR 801 Subpart C)
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| K170802 510(k) Summary | |
|---|---|
| Sponsor: | Synthes (USA) Products, LLC |
| Primary Contact: | |
| Christopher J. Medberry, Ph.D. | |
| Project Leader, Regulatory Affairs | |
| Synthes (USA) Products, LLC | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 Phone: | |
| (610) 719- 6806 | |
| cmedberr@its.jnj.com | |
| Alternate Contact: | |
| Stacey Bonnell | |
| Associate Director, Regulatory Affairs | |
| Synthes (USA) Products, LLC | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| Phone: (610) 719-5895 | |
| sbonnell@its.jnj.com | |
| DatePrepared: | September 28th, 2017 |
| ProprietaryName: | TRAUMACEM™ V+ Injectable Bone Cement |
| Classification: | Classification: 888.3027Product Code: LOD |
| PredicateDevice: | Simplex P (K062553) - primary |
| ReferenceDevices: | BonOs Inject (K090460), Vertecem (K090435), Vertecem II(K121876) |
| DeviceDescription: | TRAUMACEM™ V+ Injectable Bone Cement consists of sterilepacked powder and liquid components to create radiopaqueTRAUMACEM™ V+ Injectable Bone Cement. The powder componentis pre-packed in the mixer. The liquid component is stored in a glassampoule. A transfer lid for the mixing and transfer of the bone cementin the application system is also contained in the kit. Mixing the twosterile components produces the injectable bone cement. |
| Indicationsfor Use: | The TRAUMACEM™ V+ Injectable Bone Cement is indicated foraugmentation of the TFN-ADVANCED® Proximal Femoral NailingSystem through cannulated implants and instruments for patients withpoor bone quality (e.g., osteoporosis). |
| SubstantialEquivalence: | The proposed TRAUMACEM™ V+ Injectable Bone Cement hascomparable indications, design characteristics, materials, andperformance characteristics in comparison to the predicate device. |
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Summary Comparison of Technological Characteristics In specific, the subject, predicate, and reference devices are selfpolymerizing two-component systems comprising a powder and a liquid that polymerize at room temperature immediately after they are mixed together in an exothermic reaction. The major powder component of the subject and predicate devices is acrylic polymer. The indications for the TRAUMACEM™ V+ Injectable Bone Cement are highly similar to a subset of the indications for predicate device Simplex P (K062553) and utilized in the same patient population (e.g., patients with poor bone quality or loss of bone substance). Both TRAUMACEM™ V+ Injectable Bone Cement and Simplex P (K062553) meet the requirements of ASTM F451-08/ISO 5833:2002 (apart from setting and dough time). The major differences between the subiect and predicate cement are radiopacity and handling properties. TRAUMACEM™ V+ Injectable Bone Cement was designed to have increased radiopacity and working time to facilitate delivery through cannulated implants and instruments. As these differences influence physical and chemical properties, the subject device was then compared to reference devices BonOs Inject (K090460) and Vertecem (K090435) to demonstrate compliance with the Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA (dated July 17th, 2002). Reference device Vertecem II (K121876) was also included as a material reference in support of the biological risk evaluation. The following performance tests have also been provided in support of this 510(k):
- Biomechanical evaluation of cut-out resistance ●
- Cadaveric evaluation of cut-out resistance ●
- Cannulated implant removal evaluation ●
- Radiopacity comparison ●
- Cytotoxicity ●
- Irritation ●
- 0 Sensitization
- Material mediated pyrogenicity ●
- Genotoxicity (in vitro and in vivo) ●
- Implantation ●
- Chemical characterization. ●
Summary of Clinical Evidence
Three clinical studies conducted outside the US were presented in support of the subject device. One was a prospective, multicenter, randomized, postmarket study comparing outcomes in patients with unstable trochanteric fractures that were treated with or without Traumacem V+ Injectable Bone Cement Augmentation. Two were
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| summaries of peer-reviewed publications summarizing the short-termand long-term outcomes of patients with trochanteric fractures whowere treated with cephalomedullary nail augmentation with PMMAbone cements. The three studies were evaluated with respect toclinical indications, method of use and patient populations, whichwere confirmed to align with the intended use of the subject device.No cases of cut-out were observed. Potential risks associated withaugmentation (e.g., cement leakage) had a low rate of occurrence.These data correlated well with presented real-world marketexperience on the use of Traumacem V+ Injectable Bone Cementoutside the United States. |
|---|
| ConclusionsOverall, the performance testing and clinical evidence from thepostmarket randomized study, postmarket case series, and outsidethe US market experience support that the benefits of usingTraumacem V+ Injectable Bone Cement outweigh the potential riskswhen utilized in accordance with its indications for use and supportsthe substantial equivalence of the subject device. |
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”