(28 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 the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.
Fine OsteotomyTM is a patient-specific device.
Fine Osteotomy™ is a system for planning and performing osteotomies of the distal femur and proximal tibia and for stabilizing the bone with bone screws and a patientspecific bone plate that fits the patient's anatomy. Fine Osteotomy™ consists of patientspecific surgical planning and instrument guides designed from images of the patient's bones, a patient-specific bone plate designed from the patient's images, compression and/or locking bone screws, and class 1 reusable manual instruments. The bone plate is a patient-specific, single-use implant; the surgical planning and instrument guides are patient-specific, single-use. Fine Osteotomy™ is offered in three configurations: 1) as a system of patient specific implants and single use instruments for performing osteotomies and implanting hardware to stabilize the resection, 2) as patient specific single use instruments alone for performing osteotomies, and 3) as a patient specific bone plate and screws for stabilizing a bone resection or fracture.
When used as a system, Fine Osteotomy™ enables the surgeon to perform an osteotomy and stabilize the bone around the knee that matches the pre-surgical plan using the patient-specific cutting guides and bone plate. When the planning guides and resection instruments are used alone, Fine Osteotomy™ enables the surgeon to perform an osteotomy around the knee that matches the pre-surgical plan using the patientspecific cutting guides designed from the patient's CT images. When the bone plate and screws are used alone, Fine Osteotomy™ enables the surgeon to stabilize fractured or resected bone per the pre-surgical plan using the patient's CT images in design of the Bodycad plate and use of the bone models intra operatively to guide placement of the implants and alignment of bone. Fine Osteotomy is provided clean, non-sterile.
The purpose of this Special 510(k) Device Modification is to notify the FDA of changes and additions to the single use instruments and added software option for segmentation of images and creation of STL files of the bone models.
Materials: Wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6Al4V ELI: ASTM F136-13) for the bone plates and screws, additively manufactured Nylon-12 for patient specific, single use resection guides and models.
The provided text does not contain detailed information about specific acceptance criteria, a study that proves the device meets those criteria, or the performance of the device in relation to such criteria. The document is a 510(k) summary for a medical device (Fine Osteotomy™) being submitted to the FDA, asserting substantial equivalence to a previously cleared predicate device.
Here's what can be extracted and what information is missing based on your request:
Missing Information:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications used to establish ground truth for the test set.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size of human reader improvement with AI assistance.
- Whether a standalone (algorithm only) performance study was done.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
Information provided in the document related to performance/validation:
The document mentions "Verification and validation (V&V) activities" but details are limited.
G. PERFORMANCE DATA
Verification and validation (V&V) activities included the following:
- Engineering analyses of updated and new single-use instruments demonstrating "no new risks and no new worst case." (This is a safety assessment, not a performance metric against acceptance criteria).
- Surgeon user evaluations demonstrating the new and updated instruments "to work as intended." (This is a qualitative statement, lacking specific metrics or criteria).
- Validation of the new software option for segmentation of patient image files and creation of STL files and virtual models "with similar resolution as previously 510(k) cleared Bodycad segmentation software." (This hints at a comparative resolution study, but no specific acceptance criteria or quantitative performance data are provided).
In summary, the provided FDA 510(k) summary focuses on establishing substantial equivalence for device modifications rather than detailing a comprehensive clinical or performance study with defined acceptance criteria and quantitative results, which would typically be included in a more extensive study report.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.