(147 days)
Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.
Fine Osteotomy disposable instrumentation is intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.
Fine Osteotomy is a patient-specific device.
The Fine Osteotomy™ System is a patient-specific orthopedic device designed to assist surgeons in planning and performing precise osteotomies around the knee. It utilizes patient imaging data to create 3D anatomical models used for the design of cutting guides and fixation implants tailored to the individual anatomy. The system includes single-use cutting guides manufactured from PA 12 polymer and fixation components made of titanium alloy (Ti-6Al-4V ELI). The implants are designed to support stable bone fixation following the osteotomy. The device operates without an energy source and relies on mechanical alignment and rigid fixation principles. Minor refinements have been incorporated to improve compatibility with surgical planning and instrument design, without affecting the intended use or fundamental function of the system. The device is supplied non-sterile and includes a combination of patient-specific and reusable components.
This FDA 510(k) clearance letter for the Fine Osteotomy™ system does not contain the detailed information required to describe the acceptance criteria and the specific study that proves the device meets those criteria.
The document primarily focuses on the regulatory aspects of the 510(k) submission, confirming substantial equivalence to a predicate device. While it mentions "non-clinical testing" was performed, it provides a high-level summary and lacks the specific data points requested in your prompt.
Here's a breakdown of why the requested information cannot be extracted from this document:
- Acceptance Criteria and Reported Device Performance: The document states, "All tests confirmed that the device meets applicable requirements and continues to perform as intended." However, it does not specify what those "applicable requirements" or performance metrics are, nor does it provide a table of actual results against specific acceptance criteria.
- Sample Size and Data Provenance: The document does not mention sample sizes for any tests, nor the country of origin of data, or whether it was retrospective or prospective.
- Experts for Ground Truth Establishment: There is no mention of experts, ground truth establishment, or any details related to human interpretation or readings.
- Adjudication Method: Not applicable as there's no mention of expert review or ground truth establishment requiring adjudication.
- Multi-Reader Multi-Case (MRMC) Study: The document explicitly states, "No clinical testing was necessary, as the modifications do not alter the intended use, safety, or effectiveness of the device." Therefore, no MRMC study was conducted. There is no information about human readers or AI assistance.
- Stand-alone (Algorithm Only) Performance: While the device has a software component("support usability through a software update"), the document does not break down performance specific to an algorithm's standalone performance. It focuses on the overall system (hardware and software).
- Type of Ground Truth Used: Not applicable, as no ground truth for diagnostic accuracy is discussed. The testing mentioned appears to be related to mechanical/dimensional properties and software verification.
- Training Set Sample Size: No information about a training set is provided, as the document mainly describes the device and its regulatory clearance process, not its development or training of any AI/ML components.
- How Ground Truth for Training Set was Established: Not applicable as no training set is discussed.
Conclusion:
This 510(k) clearance letter for Fine Osteotomy™ is a regulatory approval document. It confirms that the device is substantially equivalent to a previously cleared predicate and that non-clinical testing was sufficient to demonstrate this. However, it does not provide the detailed scientific study results, acceptance criteria, ground truth methodology, or clinical performance metrics (especially for diagnostic accuracy or human-AI interaction) that you are requesting. These details would typically be found in a more comprehensive clinical study report or a detailed design verification and validation document, which are not part of this public FDA clearance letter.
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