(62 days)
The paste made with OsteoCure is intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.
OsteoCure paste cured in-situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.
OsteoCure Kits are provided sterile for single use only. Because the device is biodegradable and biocompatible, it may be used at an infected site.
OsteoCure Resorbable Bead Kit and OsteoCure Injectable Graft Kit consist of premeasured surgical grade calcium sulfate, pre-measured mixing solution, and the tools necessary to mix the components into a paste. These products are provided sterile for single patient use. When mixed according to directions, the OsteoCure Kits produce biodegradable, radiopaque paste/molded beads that resorb in approximately 30-60 days, when used according to labeling.
After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.
The provided document, K051406, is a 510(k) premarket notification for the OsteoCure Resorbable Bead Kit and OsteoCure Injectable Graft Kit. A 510(k) notification primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific, quantitative acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the document does not contain the specific information requested about acceptance criteria and a dedicated study to prove the device meets these criteria in the way one might find for a novel diagnostic or AI device.
However, based on the information provided, here's a breakdown of what can be inferred and what is not available:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly stated in the provided 510(k) summary. The submission focuses on demonstrating substantial equivalence to predicate devices (Biogeneration, ProFusion Bone Graft Substitute Kits and Wright Medical OsteoSet) in terms of:
- Intended Use: The OsteoCure Kits are intended for filling non-load bearing bone voids/gaps, which may be surgically created or due to traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The paste also augments provisional hardware for temporary support.
- Material Composition: "The OsteoCure Kits have the equivalent chemical composition...as the predicate device."
- Technological Characteristics: "The OsteoCure Kits have...the technological characteristics as the predicate device."
- Performance Data: "Testing demonstrated that the performance of the OsteoCure Kits are substantially equivalent to the performance of the predicate device."
Without specific acceptance criteria for a new clinical outcome or performance benchmark, it's impossible to create a table of acceptance criteria and reported device performance. The "performance data" mentioned is not detailed, but broadly states "substantially equivalent."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not available in the provided document. The 510(k) summary does not describe a clinical study in the traditional sense with a "test set" of patients. The performance data mentioned likely refers to non-clinical (e.g., in-vitro, mechanical, animal) testing to support material and characteristic equivalence.
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 information is not applicable/not available. As there is no described clinical study with a "test set" and a need for "ground truth" establishment by experts (e.g., for diagnostic accuracy), this detail is not present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable/not available for the same reasons as point 3.
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:
This information is not applicable/not available. The OsteoCure devices are bone void fillers, not an AI or diagnostic imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not available. The OsteoCure devices are not algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/not available. Since there is no detailed clinical study described requiring ground truth for performance evaluation (e.g., diagnostic accuracy), this information is not present. For device performance in equivalence, the "ground truth" would be the known and accepted performance characteristics of the predicate device, which is established through its own regulatory history and performance data.
8. The sample size for the training set:
This information is not applicable/not available. The OsteoCure devices are not AI models requiring training sets.
9. How the ground truth for the training set was established:
This information is not applicable/not available for the same reason as point 8.
In summary:
The provided document is a 510(k) summary demonstrating substantial equivalence to predicate devices, primarily through comparison of materials, indications for use, and general performance. It does not detail a study designed to prove the device meets specific, quantitative acceptance criteria through a clinical trial with human subjects and associated performance metrics, as would be expected for a novel device or an AI/diagnostic product. The "acceptance criteria" here are implicitly meeting the standards of the predicate device to establish substantial equivalence.
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AUG 1 - 2005
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
| Prepared: | May 26, 2005 |
|---|---|
| Applicant: | Futura Biomedical990 Park Center DriveVista, CA 92081 |
| Telephone: | 760-599-1670 |
| Fax: | 760-599-1675 |
| Contact: | Louise M. Focht |
| Device Name: | Filler, Bone Void, Calcium Compound |
| Device Trade Name: | OsteoCure Resorbable Bead KitOsteo Cure Injectable Graft Kit |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 21 CFR 888.3045 |
| Product Code: | 87 MQV |
| Predicate Device: | Biogeneration, ProFusion Bone GraftSubstitute Kits, K031838, K973704,Wright Medical K010532, K024336 |
| Registration Number: | 2030833 |
| Owner Operator Number: | 9028319 |
Device Description:
OsteoCure Resorbable Bead Kit and OsteoCure Injectable Graft Kit consist of premeasured surgical grade calcium sulfate, pre-measured mixing solution, and the tools necessary to mix the components into a paste. These products are provided sterile for single patient use. When mixed according to directions, the OsteoCure Kits produce biodegradable, radiopaque paste/molded beads that resorb in approximately 30-60 days, when used according to labeling.
After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.
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Materials:
The materials used for the OsteoCure Kits are substantially equivalent to Biogeneration, Profusion Bone Graft Substitute Kit and Wright Medical OsteoSet.
Indications for Use:
The paste made with OsteoCure is intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.
OsteoCure paste cured in situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.
OsteoCure Kits are provided sterile for single use only. Because the device is biodegradable and biocompatible, it may be used at an infected site.
Comparison to Predicate Device:
Technological Characteristics:
The OsteoCure Kits have the equivalent chemical composition and the technological characteristics as the predicate device.
Performance data:
Testing demonstrated that the performance of the OsteoCure Kits are substantially equivalent to the performance of the predicate device.
Summary:
The intended use, material composition, and design features of the OsteoCure Injectable Graft Kit paste cured in situ and OsteoCure Resorbable Bead Kits are substantially equivalent to the intended use, material composition and design features of the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 - 2005
Ms. Louise M. Focht Futura Biomedical 990 Park Center Drive, Suite H Vista, California 92081
Re: K051406
Trade/Device Name: OsteoCure Resorbable Bead Kit Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device. Regulatory Class: II Product Code: MQV Dated: May 26, 2005 Received: May 31, 2005
Dear Ms. Focht:
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. Louise M. Focht
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/cdrh/industry/support/index.html
Sincerely yours,
Stipt Ruvola
2 Mark N. Melkerson Acting 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
| 510(k) Number (if known): | K051406 |
|---|---|
| Device Name: | Osteo Cure Resorbable Bead Kit |
| Indications for Use: |
The paste made with OsteoCure is intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.
OsteoCure paste cured in-situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.
OsteoCure Kits are provided sterile for single use only. Because the device is biodegradable and biocompatible, it may be used at an infected site.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUATION ON OTHER PAGE OF NEEDED)
(Division Sign Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
4
§ 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.