(56 days)
The OptOssol™ Compression Device System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use.
The GenOssis OptOssol™ Compression Device System implants consists of screws designed to compact juxtaposed bone fragments in compression to enhance bone healing and fusion through the immobilization of the fragments with or without the use of bone graft. The wires are inserted using standard wire drivers present in the operating room and compression is conducted using the provided driver. The partially threaded Wires are available with a Sleeve, and in various diameters and lengths to accommodate patient anatomy.
The provided text describes the GenOssis OptOssol™ Compression Device System, a medical device for internal fixation of fractures, fusions, and revisions. The FDA 510(k) summary indicates that the device's substantial equivalence was determined based on performance data derived from mechanical testing.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
Unfortunately, the document does not explicitly state specific numerical acceptance criteria for the device’s performance or provide a detailed table of reported device performance in relation to such criteria. Instead, it broadly states that "Mechanical testing was performed per ASTM F543:2013 Standard Specification and Test Methods for Metallic Medical Bone Screws." The conclusion reached from this testing is a qualitative statement: "Based upon the results of the performance testing the OptOssol™ Compression Device System was determined to be substantially equivalent to the predicate devices."
Therefore, I cannot create a table with specific criteria and reported values. The document implies that meeting the standards of ASTM F543:2013 was the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It only mentions "Mechanical tesing" (sic) without detailing the number of devices or components tested.
The data provenance is from mechanical testing performed in a laboratory setting, not from human or animal subjects, clinical trials, or retrospective/prospective studies. Therefore, country of origin related to patient data is not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this submission. The "ground truth" for mechanical testing is established by the specifications and methods outlined in the ASTM F543:2013 standard and the physical properties of the materials and device design. There is no mention of human experts establishing a "ground truth" in the context of this mechanical performance study, as it's not a diagnostic or interpretive device.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. Mechanical testing against a standard does not involve such human adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes mechanical testing of the device itself, not a study evaluating human readers' performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The OptOssol™ Compression Device System is a mechanical implant, not an algorithm or AI-driven device. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The "ground truth" for this study was the established engineering specifications and performance characteristics defined by the ASTM F543:2013 standard for metallic medical bone screws. The device's performance was measured against these predefined physical and mechanical properties.
8. The Sample Size for the Training Set
This question is not applicable. As a mechanical device, there is no "training set" in the context of machine learning. The device's design and manufacturing process are based on established engineering principles and material science, not on a machine learning model trained on data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8. There is no training set for this type of medical device submission.
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MAY 3 0 2014
K140875 page 1 of 2
510(k) SUMMARY
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GenOssis, LLC
OptOssol™ Compression Device Systeṃ
| Sponsor: | Manufacturer | GenOssis LLC426 Pennsylvania Avenue, Suite 120Fort Washington, PA 19034 |
|---|---|---|
| Official ContactPhone:Fax: | Barry E. Sands978-358-7307978-358-7384 | |
| Date prepared: | April 1, 2014 | |
| Device Name: | OptOssol™ Compression Device System | |
| ClassificationName: | Smooth or Threaded Metallic Bone Fixation FastenerSingle/multiple Component Metallic Bone Fixation Appliances andAccessories | |
| ClassificationNumber: | 21 CFR Sec. 888.3030 and 21 CFR 888.3040Class 2Product Code: HTN, JDW and HWC | |
| Description: | The GenOssis OptOssol™ Compression Device System implants consists of screwsdesigned to compact juxtaposed bone fragments in compression to enhance bonehealing and fusion through the immobilization of the fragments with or without theuse of bone graft. The wires are inserted using standard wire drivers present in theoperating room and compression is conducted using the provided driver.The partially threaded Wires are available with a Sleeve, and in various diametersand lengths to accommodate patient anatomy. | |
| Intended Use: | The OptOssol™ Compression Device System is indicated for use in the internalfixation of fractures, fusions and revisions, The system is intended for but notlimited to hand surgery, orthopedic surgery and podiatric surgery - but is notintended for Spinal Use. | |
| Material: | The OptOssol™Compression Device System is composed of 316 LVM ASTM F138.The material composition has been established as a biocompatible material fororthopedic permanent implants |
April 2, 2014
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| The instruments associated with the OptOssol™ Compression Device System arecomposed of 17-4PH Stainless Steel and Custom 465® Stainless Steel (ASTM F899).Both of these tissue-contacting materials have an established biocompatible profilefor surgical instruments in orthopedics. | |
|---|---|
| Comparison toPredicateDevices | OptOssol™ Compression Device System has the same intended use as the predicatedevice contained in K130298. The technological characteristics of materialcomposition and dimensional specifications fall within the range of the predicatedevices identified. Therefore, the OptOssol™ Compression Device System isequivalent to the predicate devices identified. |
| PerformanceData: | Mechanical tesing was performed per ASTM F543:2013 Standard Specification andTest Methods for Metallic Medical Bone Screws. |
| Performanceand SEDetermination: | Based upon the results of the performance testing the OptOssol™ CompressionDevice System was determined to be substantially equivalent to the predicatedevices. |
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April 2, 2014
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2014
GenOssis. LLC % Mr. Barry E. Sands RQMIS, Incorporated 29 Water Street. Suite 305 Newburyport, Massachusetts 01950
Re: K140875
. Trade/Device Name: GenOssis OptOssol™ Compression Device System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW, HTN, HWC Dated: April 2. 2014 Received: April 4, 2014
Dear Mr. Sands:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (sec above) into cither 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
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Page 2 – Mr. Barry E. Sands
forth in the quality systems (QS) regulation (R1 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincercly vours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
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K140875 510(k) Number (if known):_
Device Name: GenOssis OptOssol™ Compression Device System
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Indications for Use:
The OptOssol™ Compression Device System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use.
OR
Prescription Use _ X (Per 21 CFR 801.109) Over-the-Counter Use _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Elizabeth lägrank -S
Division of Orthopedic Devices
GenOssis, Inc. OptOssol™ Compression Device System April 2, 2014
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.