(87 days)
The OsteoSymbionics Patient Specific Cranial Implants are designed individually for each patient to correct defects in craniofacial bone.
The OsteoSymbionics Patient Specific Cranial Implants are individually sized and shaped implantable prosthetic cranioplasty plates intended to fill defects in a specific patient's cranial/craniofacial skeleton. The implants are composed of polymethyl methacrylate and are fabricated using the patient's CT imaging data. The devices are provided non-sterile for sterilization prior to implantation and are attached to the native bone with commercially available cranioplasty fasteners.
This document is a 510(k) Summary of Safety and Effectiveness for the OsteoSymbionics Patient-Specific Cranial Implant. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not present in the provided text.
Based on the provided text, here's what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The document is a 510(k) summary demonstrating substantial equivalence for a physical implant, not a study evaluating specific performance metrics against pre-defined acceptance criteria.
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. Since this is a 510(k) for a physical implant, there's no mention of a "test set" in the context of evaluating algorithm performance or diagnostic accuracy using patient data. The device is manufactured based on individual patient CT imaging data.
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 available. There is no "test set" in the context of diagnostic performance that would require ground truth established by experts. The "ground truth" for the implant design is the patient's individual CT imaging data of their cranial defect.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available. There is no "test set" and thus no adjudication method described.
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 and not available. This document is for a physical patient-specific cranial implant, not an AI/software device intended to assist human readers or provide diagnostic interpretations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not available. The device described is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the design and manufacturing of the implant, the "ground truth" for the patient's anatomy and defect is the patient's CT imaging data.
8. The sample size for the training set
This information is not applicable and not available. The device is a physical implant custom-made for each patient; there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
This information is not applicable and not available.
In summary, the provided text is a regulatory submission for a physical medical device (patient-specific cranial implant) under a 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain the kind of performance study details typically associated with the evaluation of AI/software medical devices, as it is not an AI/software device.
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Image /page/0/Picture/1 description: The image shows the logo for OsteoSymbionics. The logo consists of the word "osteo" followed by a stylized symbol that resembles a circle with a diagonal line through it. The word "symbionics" appears to the right of the symbol, with the letters in a smaller font size. The letters "TM" are in superscript.
510(k) Summary of Safety and Effectiveness
(as required by 21 CFR § 807.92)
| 510(k) Submitter | OsteoSymbionics, LLC1768 East 25th StreetCleveland, Ohio 44114 | |
|---|---|---|
| Contact Person | Ms. Cynthia Brogan, PresidentPhone: (216) 881-8500e-mail: cb@osteosymbionics.com | DEC 1 0 2007 |
| Date Prepared | September 12, 2007 | |
| Device Name | Proprietary Name: OsteoSymbionics Patient-Specific Cranial ImplantCommon Name: patient-specific cranial implantClassification Name: "plate, cranioplasty, preformed, non-alterable," aclass II device in accordance with 21 CFR § 882.5330 | |
| Device Description | The OsteoSymbionics Patient Specific Cranial Implants are individuallysized and shaped implantable prosthetic cranioplasty plates intended tofill defects in a specific patient's cranial/craniofacial skeleton. Theimplants are composed of polymethyl methacrylate and are fabricatedusing the patient's CT imaging data. The devices are provided non-sterile for sterilization prior to implantation and are attached to thenative bone with commercially available cranioplasty fasteners. | |
| Indication for Use | The OsteoSymbionics Patient-Specific Cranial Implants are designedindividually for each patient to correct defects in craniofacial bone. | |
| SubstantialEquivalence | The OsteoSymbionics Patient-Specific Cranial Implants are substantiallyequivalent in terms of safety and effectiveness to the following legallymarketed devices:Synthes Patient Specific Cranial/Craniofacial Implants - K033868Synthes (USA)Stryker® Patient.Specific Polymer Implant - K043250Stryker LiebingerCodman Cranioplastic - K873689Codman Division of Johnson & Johnson |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC】0 2007
OsteoSymbionics, LLC % Ms. Cynthia Brogan President 1768 East 25th Street Cleveland, OH 44114
Re: K072601
Trade/Device Name: OsteoSymbionics Patient-Specific Cranial Implant Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: GXP, GXN Dated: September 12, 2007 Received: September 14, 2007
Dear Ms. Brogan:
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 (OS) 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. Cynthia Brogan
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 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 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 M. Milliman
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: | K072601 |
|---|---|
| Device Name: | OsteoSymbionics Patient-Specific Cranial Implants |
| Indications for Use: | The OsteoSymbionics Patient Specific Cranial Implants are designed individually for each patient to correct defects in craniofacial bone. |
| Prescription Use | X | AND/OR | Over-The-Counter Use | No |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K072601 |
|---|---|
| --------------- | --------- |
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§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).