(773 days)
Bone Solutions. Inc., OsteoCrete™ Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. OsteoCrete™ Bone Void Filler is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
OsteoCrete™ is an injectable, moldable, and biocompatible Bone Void Filler. The OsteoCrete™ Bone Void Filler Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.
The provided text describes the OsteoCrete™ Bone Void Filler and its 510(k) submission but does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding the test set, expert involvement, or statistical methods typically associated with AI/ML device evaluations.
The relevant section in the document states:
"OsteoCrete™ Bone Void Filler was subjected to performance testing Performance Data: (bench and animal) in accordance with the FDA Guidance Document, 'Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler; Guidance for Industry and FDA.' The testing confirmed substantial equivalence to the predicate device."
This indicates that the device underwent non-clinical performance testing (bench and animal studies) to demonstrate substantial equivalence to predicate devices, as per FDA guidance for this type of medical device (resorbable calcium salt bone void filler). These types of devices are not typically AI/ML-driven, and therefore, the information requested in your prompt regarding AI/ML study design (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this 510(k) submission.
Therefore, I cannot populate the table or answer the specific questions below with the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the text for this non-AI/ML device. | Not provided in the text for this non-AI/ML device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler) and its 510(k) submission focusing on bench and animal testing for substantial equivalence, not a clinical study involving a test set of data with human-in-the-loop or standalone AI performance.
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)
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler) and its 510(k) submission focusing on bench and animal testing for substantial equivalence, not a clinical study involving experts establishing ground truth for data for AI/ML validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler) and its 510(k) submission, not an AI/ML study requiring adjudication methods for a test set.
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
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler) and its 510(k) submission. MRMC studies are specific to evaluating human reader performance with and without AI assistance, which is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler). Standalone algorithm performance is relevant to AI/ML devices, not to this product.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler). "Ground truth" in the context of AI/ML validation is not relevant here. The "performance data" mentioned refers to bench and animal testing results demonstrating physical and biological properties.
8. The sample size for the training set
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler). Training sets are relevant to AI/ML model development, not to this product.
9. How the ground truth for the training set was established
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler). Training set ground truth is relevant to AI/ML model development, not to this product.
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510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92
| Submitted by: | Bone Solutions, Inc.9400 N. Central Expressway, Suite 1250, L.B.103Dallas, TX 75231 USAPhone: 214-762-8066Tony Copp, Ph.D., COOemail: copp@bonesolutionsinc.comFax: 800-417-8196 |
|---|---|
| Contact Person for premarket notification:Christine Emanuel, Regulatory Consultant1205 De La Vina StreetSanta Barbara, CA 93101Phone: 805.963.4312Fax: 805.564.8642Email: cemanuel@west.net | |
| Date Prepared: | May 4, 2009 |
| Proprietary Name: | OsteoCrete™ Bone Void Filler |
| Common Name: | Resorbable calcium salt bone void filler device |
| Classification: | Class II, MQV, 21 CFR 888.3045 |
| Predicate Devices: | Synthes (USA). Norian SRS Bone Void Filler, 510(k) numberK011897Synthes (USA). Norian SRS Fast Set Putty, 510(k) numberK041842Futura Biomedical. OsteoCure Resorbable Bead Kit, 510(k)number K051406Bone Support AB. Cerament Bone Void Filler, 510(k)number K051951 |
| Device Description: | OsteoCrete™ is an injectable, moldable, and biocompatibleBone Void Filler. The OsteoCrete™ Bone Void Filler Packetcontains powder (Magnesium based compound) and a mixingsolution (Buffered saline). It is a sterile, single use device,packaged with mixing and administration tools. |
| Indication for Use: | Bone Solutions, Inc., OsteoCrete™ Bone Void Filler isintended only for bony voids or defects that are not intrinsic to |
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OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bones and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
OsteoCrete™ Bone Void Filler was subjected to performance testing Performance Data: (bench and animal) in accordance with the FDA Guidance Document, "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler; Guidance for Industry and FDA." The testing confirmed substantial equivalence to the predicate device.
Image /page/1/Picture/2 description: The image shows the text "Page 2 of 2" written in cursive. The word "Page" is written with a capital "P" and the number "2" is written in numerical form. The words "of" and the second "2" are smaller in size compared to the word "Page".
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bone Solutions Incorporated % Mr. Tony Copp Director, Executive Vice President, Chief Operating Officer 9400 North Central Expressway, Suite 1250 Dallas, Texas 75231
MAY 2 1 2009
Re: K071004
Trade/Device Name: OsteoCrete™ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 26, 2008 Received: August 28, 2008
Dear Mr. Copp:
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 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 device-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.
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Page 2- Mr. Tony Copp
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Request for additional information from the FDA to Bone Solutions regarding K071004.
Indications for Use
510(k) Number (if known): K071004
Device Name: Bone Solutions, Inc. OsteoCrete™ Bone Void Filler
Indications for Use:
Bone Solutions. Inc., OsteoCrete™ Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. OsteoCrete™ Bone Void Filler is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millman
Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1_
510(k) Number _
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.