(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.
§ 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.