(21 days)
SmartSet MV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.
SmartSet MV Bone Cement is a self-curing, radiopaque, polymethylmethacrylate based cement. The bone cement is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that "SmartSet MV Bone Cement" meets those criteria. The document is a 510(k) summary for a premarket notification for a medical device, which focuses on establishing substantial equivalence to a predicate device rather than presenting performance criteria and a study to meet them.
The text includes:
- Device Name: SmartSet MV Bone Cement
- Intended Use: Fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures.
- Equivalency to Predicate Devices: SmartSet MV Endurance Bone Cement and SmartSet HV Bone Cement.
- Regulatory information: Product Code LOD, 21 CFR 888.3027.
However, it does not contain:
- A table of acceptance criteria and reported device performance.
- Details of a study's sample size, data provenance, number of experts, adjudication methods, MRMC study, standalone performance, or how ground truth was established for either a test or training set.
- Any mention of AI or machine learning.
Therefore, I cannot fulfill your request for a description of acceptance criteria and a study proving the device meets them based on the provided text.
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510(k) Summary
K081155
MAY 14 2008
| Date Prepared: | 21 April 2008 |
|---|---|
| 510(k) Sponsor: | DePuy Orthopaedics, Inc700 Orthopaedic DriveWarsaw, Indiana 46581 - 0988 |
| Establishment RegistrationNo: | 1818910 |
| Contact Person: | Suzana OtañoProject Manager, Regulatory AffairsTelephone: 305-269-6386Fax: 305-269-6441Email: sotano@dpyus.jnj.com |
| Trade Name of Device: | SmartSet MV Bone Cement |
| Common Name: | Bone cement |
| Classification Name: | Bone cement (21 CFR 888.3027, Product Code LOD) |
| Equivalent to: | SmartSet MV Endurance Bone Cement (P960001, previouslybranded Endurance Bone Cement)SmartSet HV Bone Cement (K023012) |
| Device Description: | SmartSet MV Bone Cement is a self-curing, radiopaque,polymethylmethacrylate based cement. The bone cement isused for securing a metal or polymeric prosthesis to livingbone in arthroplasty procedures. |
| Intended Use: | SmartSet MV Bone Cement is indicated for the fixation ofprostheses to living bone in orthopaedic musculoskeletalsurgical procedures for rheumatoid arthritis, osteoarthritis,traumatic arthritis, osteoporosis, avascular necrosis,collagen disease, severe joint destruction secondary totrauma or other conditions, and revision of previousarthroplasty. |
| TechnologicalCharacteristics: | The technological characteristics of the SmartSet MV BoneCement are equivalent to the predicate devices. |
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Substantial Equivalence:
The indications, intended use, formulation and finished product specifications of the SmartSet MV Bone Cement are equivalent to the predicate devices.
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Special 510(k) SmartSet MV Bone Cement April 2008
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is composed of thick, black lines. Surrounding the eagle is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
MAY 1 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Suzana Otano Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, IN 46581-0988
Re: K081155
Trade/Device Name: SmartSet MV Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: April 21, 2008 Received: April 23, 2008
Dear Ms. Otano:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Ms. Suzana Otano
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number:
Device Name: SmartSet MV Bone Cement
Indications For Use:
SmartSet MV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.
× Prescription Use
(Per 21 CFR 801 Subpart D)
AND/OR Over-the-Counter
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mitke Dola for mkm
Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K081155
Special 510(k) SmartSet MV Bone Cernent April 2008
Page 24 of 108
§ 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.”