(89 days)
The DFine SPACE CpsXL Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
The DFine SPACE CpsXL Bone Cement is a self-curing polymethylmethacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. DFine SPACE CpsXL Bone Cement is provided as a two-component system. The powder component of both devices consists of a PMMA polymer with a barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liguid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N,Ndimethyl-p-toluidine as a promoter.
The provided text describes a 510(k) premarket notification for the "DFine SPACE CpsXL Bone Cement." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting an effectiveness study with specific performance metrics against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, human reader performance, and ground truth establishment is not present in this document.
Here's an breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission is a 510(k) for substantial equivalence, which primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a legally marketed predicate device. It does not typically involve setting specific performance acceptance criteria for a new clinical study.
The document states: "Based upon the testing and comparison to the predicate device and commercially available bone cements, the DFine SPACE CpsXL Bone Cement, performs as intended and is substantially equivalent to the predicate device." This is a general conclusion of substantial equivalence, not a report against specific performance criteria.
2. Sample sized used for the test set and the data provenance
This information is not provided in the document. The testing mentioned ("Physical, chemical and mechanical testing") is likely bench testing or non-clinical, not a clinical study with a "test set" in the context of human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document, as there is no mention of a clinical study or human expert review to establish ground truth for a test set.
4. Adjudication method for the test set
This information is not provided in the document, as there is no mention of a clinical study or adjudication process.
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
There is no mention of an MRMC study or AI assistance in this document. The device is a bone cement, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a bone cement, not an algorithm.
7. The type of ground truth used
This information is not directly provided for a "test set" because no clinical effectiveness study is described. The "ground truth" for demonstrating substantial equivalence for this type of device typically revolves around established performance characteristics of the predicate device and relevant industry standards for material properties and biomechanical performance. The document only mentions "Physical, chemical and mechanical testing."
8. The sample size for the training set
This information is not applicable as the device is a bone cement and would not typically have a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable as the device is a bone cement and would not typically have a "training set" in the context of machine learning or AI.
In summary: The provided document is a 510(k) summary for a medical device (bone cement) that focuses on demonstrating substantial equivalence to a predicate device through physical, chemical, and mechanical testing. It does not include the details of a clinical effectiveness study with acceptance criteria, human reader performance, or ground truth establishment as would be expected for a diagnostic AI device.
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Image /page/0/Picture/0 description: The image shows the date August 30, 2006. The month is represented by the abbreviation AUG. The day is represented by the number 30. The year is represented by the number 2006.
Image /page/0/Picture/1 description: The image shows handwritten text that appears to be a combination of alphanumeric characters. The top line reads 'K061531', with the '0' possibly representing the number zero. Below this, the text 'PG 1 of 2' is written, indicating a page number within a document. The handwriting is clear and legible, suggesting it could be a reference or identification code for a document or file.
Cupertino, California 950
Premarket Notification [510(K)] Summary (per 21 CFR 807.92)
510(k) number
Submitted by: 1.
DFine, Inc. 19450 Stevens Creek Blvd., Suite 100 Cupertino, CA 95014
| Contact Person: | Robert D. Poser, DVM |
|---|---|
| Vice-President, Scientific and Medical Affairs | |
| Telephone: | 408-725-1515 ext 224 |
| Facsimile: | 408-725-1517 |
30 May 2006 Date Prepared:
2. Device Name
Trade/Proprietary Name Common/Usual Name Classification Name
DFine SPACE CpsXL Bone Cement Bone Cement for Vertebroplasty Filler, Bone Cement
3. Predicate Device:
The DFine SPACE CpsXL Bone Cement is substantially equivalent to other bone cements intended for vertebroplasty, including the Mendec Spine bone cement, cleared under 510(k) K042415 by TECRES S.p.A., Verona, Italy.
4. Intended use of the device
The DFine SPACE CpsXL Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
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Description of the Device 5.
The DFine SPACE CpsXL Bone Cement is a self-curing polymethylmethacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure.
DFine SPACE CpsXL Bone Cement is provided as a two-component system. The powder component of both devices consists of a PMMA polymer with a barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liguid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N,Ndimethyl-p-toluidine as a promoter.
Summary of the technological characteristics of the device 6. compared to the predicate device.
Documentation is provided which demonstrated the DFine SPACE CpsXL Bone Cement to be substantially equivalent to other legally marketed devices. Both the DFine SPACE CpsXL Bone Cement and the predicate are bone cements intended for use in vertebroplasty, and are similar with respect to chemical composition and fundamental scientific technology. Any differences do not significantly affect the safety and effectiveness of the device.
7. Testing
Physical, chemical and mechanical testing of the DFine SPACE CpsXL Bone Cement has been conducted.
8. Conclusions
Based upon the testing and comparison to the predicate device and commercially available bone cements, the DFine SPACE CpsXL Bone Cement, performs as intended and is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" and is arranged in a circular fashion around the symbol. The symbol is an abstract representation of a human figure, with three stylized lines forming the head, body, and legs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2006
Dfine, Inc. % Dr. Robert D. Poser, DVM Vice President, Scientific and Medical Affairs 19450 Stevens Creek Boulevard Suite 100 Cupertino, California 95014
Re: K061531
Trade/Device Name: DFine SPACE CpsXL Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: August 18, 2006 Received: August 21, 2006
Dear Dr. Poser:
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 – Dr. Robert D. Poser, DVM
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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Harbare Bocheum
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: DFine SPACE CpsXL Bone Cement
Indications for Use:
The DFine SPACE CpsXL Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma) and malignant lesions (metastatic cancers, myeloma).
Prescription Use X (Part 21 CFR 801 Subpart D)
510(k) Numl
AND/OR
Over-The-Counter Use (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)
Ckeubera Buempomym
(Division Sign-Off)
Page 1 of 1
ion of General, Restorative. and Neurological Devices
DFine, Inc.
DFine SPACE CosXL Bon
§ 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.”