(93 days)
Sygnal DBM is a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Sygnal DBM can be used to fill bone voids in the extremities and pelvis. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.
Sygnal DBM is for single patient use only.
Sygnal DBM is completely resorbable and is composed of donated cortical bone. The bone granules are mixed with sodium hyaluronate (Hy) and carboxymethylcellulose (CMC). Sygnal DBM is available in sizes of 0.5 cc, 1.0 cc, 2.5 cc, 5.0 cc, and 10.0 cc.
The provided text describes the Sygnal™ DBM (Demineralized Bone Matrix) device, its indications for use, and a general statement about its safety and effectiveness. However, it does not contain details about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically reported for AI/algorithm-based devices (e.g., sensitivity, specificity, accuracy).
The document seems to be a 510(k) summary for a bone void filler, which is a biological product, not an AI or imaging device that would typically have performance metrics like those requested.
Therefore, I cannot fulfill most of the requested points because the information is not present in the provided text. I can only extract general information about the product itself.
Here's what can be inferred or stated based on the text:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied): The primary implied acceptance criterion for a DBM product for lot release is "Osteoinduction assay results in the athymic mouse model must prove positive for lot release."
- Reported Device Performance: "Every lot of final product is assayed in vivo for its osteoinductive potential." The text states that "Standard testing performed in an athymic mouse model must prove positive for lot release."
- Limitation: The document explicitly states: "Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects." This highlights that while this is a critical quality control step, it's not a direct measure of clinical performance in humans in the way an AI diagnostic might be measured.
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Sample sized used for the test set and the data provenance
- Not applicable/Not provided in the context of typical device performance studies (e.g., for AI/imaging). The "test set" here refers to "every lot" of the DBM in an athymic mouse model. No human test set size or data provenance is mentioned for device performance evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for the lot release assay is determined by the "positive" result in the athymic mouse model, not by human experts interpreting clinical data.
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Adjudication method for the test set
- Not applicable. The athymic mouse model is the assay, and the outcome is binary ("positive" or not).
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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. This is not an AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm-only device.
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The type of ground truth used
- Ground Truth: For lot release, the ground truth is "positive osteoinductive potential" as demonstrated in an athymic mouse model.
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The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses a "training set."
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How the ground truth for the training set was established
- Not applicable.
In summary, the provided text pertains to the regulatory submission for a bone void filler, focusing on its composition, indications, biocompatibility, sterility, and osteoinductive potential as assessed in an in vivo animal model for lot release. It does not describe a clinical study or performance evaluation that would generate the typical acceptance criteria and performance metrics (e.g., sensitivity, specificity, accuracy) associated with medical devices for diagnosis or AI applications.
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Sygnal™ DBM 510(k) Premarket Notification
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VII. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS
PROPRIETARY NAME: Sygnal™ DBM COMMON NAME: Bone Void Filler Containing Human Demineralized Bone Matrix (DBM) REGULATORY CLASS: Class II CLASSIFICATION IDENTIFICATION: 21 C.F.R. §888.3045 Resorbable calcium salt bone void filler device PRODUCT CODE: MBP, MOV PANEL CODE: 87-Orthopedic Devices SPONSOR: Musculoskeletal Transplant Foundation 125 May Street Edison, NJ 08837 732-661-0202 723-661-2189 fax
INDICATIONS FOR USE:
Sygnal DBM is a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Sygnal DBM can be used to fill bone voids in the extremities and pelvis. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.
Sygnal DBM is for single patient use only.
DEVICE DESCRIPTION:
Sygnal DBM is completely resorbable and is composed of donated cortical bone. The bone granules are mixed with sodium hyaluronate (Hy) and carboxymethylcellulose (CMC). Sygnal DBM is available in sizes of 0.5 cc, 1.0 cc, 2.5 cc, 5.0 cc, and 10.0 cc.
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SAFETY AND EFFECTIVENESS INFORMATION:
Biocompatibility of Sygnal DBM components has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. Sygnal DBM is single-donor processed using aseptic techniques and is tested for sterility per current USP <71>.
OSTEOINDUCTIVE POTENTIAL:
Sygnal DBM is osteoconductive, and has been shown to have osteoinductivity potential in an athymic mouse model. Every lot of final product is assayed in vivo for its osteoinductive potential. Standard testing performed in an athymic mouse model must prove positive for lot release. Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects.
VIRAL CLEARANCE AND INACTIVATION:
The method for processing the demineralized bone matrix contained in Sygnal DBM was evaluated for its viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
FEB 28 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Musculoskeletal Transplant Foundation % Ms. Nancy Bennewitz Regulatory Affairs Submission Specialist 123 May Street Suite 300 Edison, NJ 08837
Re: K073329
Trade/Device Name: Sygnal™ DBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MBP, MQV Dated: February 20, 2008 Received: February 21, 2008
Dear Ms. Bennewitz:
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. Nancy Bennewitz
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 vours.
Mark M. Mulhausen
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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V. INDICATIONS FOR USE
510(k) Number (if known): not known
Device Name: Sygnal™ DBM
Indications for Use:
Sygnal DBM is a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Sygnal DBM can be used to fill bone voids in the extremities and pelvis. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.
Sygnal DBM is for single patient use only.
OR
Prescription Use X (Per 21 CFR 801 Subpart D) Over-The-Counter Use (Per 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)
Mark M. Wilkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
73329
§ 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.