(119 days)
Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.
Kyphon® Xpede™ Bone Cement is provided as a two component system. The powder component consists of a PMMA copolymer (polymethylmethacrylate/ methyl-methacrylate-styrene copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.
The provided text is a 510(k) summary for a medical device, Kyphon® Xpede™ Bone Cement. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data to support substantial equivalence.
However, the questions posed (regarding acceptance criteria, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment, specifically for an AI/ML powered device) are not applicable to the information provided in this document.
This document pertains to a Polymethylmethacrylate (PMMA) bone cement, which is a material used in surgical procedures. It is a traditional medical device, not an AI/ML powered diagnostic or assistive technology. The "acceptance criteria" and "study" described in the document relate to the physical and chemical properties of the bone cement, its biocompatibility, and its performance in cadaveric studies and clinical literature review to demonstrate safety and efficacy for its intended use, primarily by comparing it to already approved predicate devices.
Therefore, I cannot answer the questions as they are phrased because the information requested is for AI/ML device validation, which is not what this document describes.
To directly address the request, if we were to reinterpret the provided text in the context of "acceptance criteria" and "study" for this specific bone cement device, here's what could be extracted, noting that it will not fit the AI/ML framework:
Reinterpretation for a PMMA Bone Cement Device (Not AI/ML)
1. A table of acceptance criteria and the reported device performance
The document does not present quantitative acceptance criteria in a formal table or specific reported device performance metrics beyond qualitative statements about safety and efficacy. The study aims to show "substantial equivalence" to predicate devices, rather than meeting predefined numerical thresholds for a novel AI algorithm.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicates) | Reported Device Performance (from text) |
|---|---|
| Safe and efficacious for indicated uses | Retrospective clinical literature review of 5 articles examining PMMA bone cement in sacral vertebroplasty/sacroplasty procedure found clinical outcomes on 462 patients demonstrating safety and efficacy. |
| Extravasation rate comparable to published literature | Cadaver study showed calculated extravasation rate for Kyphon® Xpede™ Bone Cement was within the extravasation rate range of published sacroplasty literature. |
| Equivalent implant materials, sterilization methods, bacterial endotoxin testing, and pyrogen limits as predicate devices. | Stated as having "same or similar indications for use, intended use, materials and fundamental scientific technology as the predicates." Utilizes "equivalent implant materials, sterilization methods and bacterial endotoxin testing applying the same 20 EU/ml pyrogen limit specifications utilizing the gel clot test method as the predicate." |
2. Sample sizes used for the test set and the data provenance
- Test set (Clinical Literature Review): 5 articles reviewed, covering clinical outcomes for 462 patients.
- Test set (Cadaver Study): The document states "A cadaver study... was completed." It does not specify the number of cadavers or specific test cases.
- Data Provenance: Not explicitly stated, but clinical literature typically includes studies from various global regions. The cadaver study would have been performed by the manufacturer or a contracted lab. It is retrospective for the literature review and prospective for the cadaver study within the context of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cadaver Study: "The procedure and imaging review was performed by trained physicians." The exact number and specific qualifications (e.g., years of experience, specialty) are not provided.
- Clinical Literature Review: Ground truth is established by the findings and conclusions of the published clinical studies themselves. The experts involved would be the authors and peer reviewers of those articles.
4. Adjudication method for the test set
- Cadaver Study: Not explicitly described. It's stated that "trained physicians" performed the review, but the method for resolving discrepancies or reaching consensus (if multiple physicians were involved per case) is not detailed.
- Clinical Literature Review: The 'adjudication' would be inherent in the peer-review process of the scientific literature and the interpretation by the device manufacturer's team.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, this is not an MRMC study. This type of study is specifically relevant to diagnostic imaging systems or AI tools where human readers interpret images with or without AI assistance. The studies performed here are a literature review of clinical outcomes and a cadaveric study of the bone cement's physical behavior (e.g., extravasation).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical material (bone cement), not an algorithm or software. "Standalone performance" in this context would refer to the in-vitro and in-vivo properties of the cement itself, which were evaluated through material testing and the cadaver study.
7. The type of ground truth used
- Clinical Literature Review: The "ground truth" is derived from the reported clinical outcomes in peer-reviewed publications. This is a form of outcomes data and expert clinical assessment as reported in those studies.
- Cadaver Study: The "ground truth" for extravasation was established by direct observation and imaging review by trained physicians during the physical testing in cadaveric models.
8. The sample size for the training set
- Not applicable. This device is a material, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See point 8)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2017
Medtronic Inc. Ms. Pamela Edwards Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K163032
Trade/Device Name: Kyphon® Xpede " Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: January 27, 2017 Received: January 30, 2017
Dear Ms. Edwards:
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 (reporting of medical devicerelated 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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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 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 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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
Indications for Use
510(k) Number (if known)
K163032
Device Name Kyphon® Xpede™ Bone Cement
Indications for Use (Describe)
Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.
| 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 Medtronic Sofamor Danek USA, Inc.
October 21, 2016
| Submitter | Medtronic Sofamor Danek USA, Inc. |
|---|---|
| 1800 Pyramid Place | |
| Memphis, Tennessee 38132 | |
| Telephone: (901) 396-3133 | |
| Fax: (901) 346-9738 | |
| Contact | Pamela Edwards |
| Principal Regulatory Affairs Specialist | |
| Direct Telephone: 901-399-2125 | |
| Jeff Sprague | |
| Sr. Regulatory Affairs Program Manager | |
| Direct Telephone: 901-344-1326 | |
| Date Prepared | October 21, 2016 |
| Common Name | Kyphon® Xpede™ Bone Cement |
| Regulatory Class | Class II |
| Regulation Number | 21 CFR 888.3027 |
| Regulation Name and Device | Polymethylmethacrylate (PMMA) bone cement |
| Product Classification Code | NDN |
| Predicate Devices | Vertaplex® High Viscosity (HV) Radiopaque Bone Cement |
| K150582, S.E. 06/12/2015 (Primary Predicate) | |
| Kyphon® Xpede™ Bone Cement | |
| K151227, S.E. 11/16/2015 | |
| The predicate devices have not been subject to a design related recall. | |
| Description of Device | Kyphon® Xpede™ Bone Cement is provided as a two component system. The |
| powder component consists of a PMMA copolymer (polymethylmethacrylate/ | |
| methyl-methacrylate-styrene copolymer) with barium sulfate as a radiopacifier | |
| and benzoyl peroxide as an initiator. The liquid component consists of | |
| methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer | |
| and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid | |
| components are mixed prior to use. | |
| Indications for Use: | Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological |
| fractures of the vertebral body due to osteoporosis, cancer, or benign lesionsusing a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is alsoindicated for the fixation of pathological fractures of the sacral vertebral body orala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myelomaand metastatic lesions, including those arising from breast or lung cancer, orlymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologicfracture may include a symptomatic vertebral body microfracture (asdocumented by appropriate imaging and/or presence of a lytic lesion) withoutobvious loss of vertebral body height. | |
| Comparison ofTechnologicalCharacteristicswiththe | The subject Kyphon® Xpede™ Bone Cement has the same or similar indicationsfor use, intended use, materials and fundamental scientific technology as the |
| Predicate Devices | predicates Vertaplex® High Viscosity (HV) Radiopaque Bone Cement |
| (K150582, S.E. 06/12/2015) and Kyphon® Xpede™ Bone Cement (K151227, | |
| S.E. 11/16/2015). The subject device utilizes equivalent implant materials,sterilization methods and bacterial endotoxin testing applying the same 20 | |
| EU/ml pyrogen limit specifications utilizing the gel clot test method as the | |
| predicate Kyphon® Xpede™ Bone Cement (K151227, S.E. 11/16/2015). | |
| Performance Data | Clinical literature data and cadaveric testing was provided to support the |
| substantial equivalence of the subject device. | |
| A retrospective clinical literature review was performed to examine the potentialbenefits and associated risks of using PMMA bone cement using a sacralvertebroplasty or sacroplasty procedure. The five articles reviewed providedclinical outcomes of 462 patients utilizing both the long-axis and short-axissurgical technique demonstrating the safety and efficacy of PMMA bone cementwhen used in the sacrum. | |
| A cadaver study in support of the expanded indication was completed. Thisstudy was performed to evaluate the extravasation behavior of the Kyphon®Xpede™ Bone Cement during sacroplasty procedures. The study also definedthe surgical procedure steps and imaging needed to minimize the risk ofextravasation for the sacroplasty procedure. Both the long-axis and short-axissurgical techniques were evaluated for cement extravasation. The procedure andimaging review was performed by trained physicians. The calculatedextravasation rate with the Kyphon® Xpede™ Bone Cement was within theextravasation rate range of the published sacroplasty literature. | |
| Conclusion | Based on the provided performance data, the subject Kyphon® Xpede™ Bone |
| Cement is substantially equivalent to the primary predicate Vertaplex® HighViscosity (HV) Radiopaque Bone Cement (K150582, S.E. 06/12/2015) and | |
| Kyphon® Xpede™ Bone Cement (K151227, S.E. 11/16/2015). |
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§ 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.”