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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

Fine Osteotomy™ is a system for planning osteotomies of the distal femur and proximal tibia, and for stabilizing the bone with bone screws and a patient-specific bone plate that fits the patient's anatomy " consists of patient-specific surgical planning and instrument guides designed from images of the 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, and discarded after surgery. 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 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 the presurgical plan using the patient-specific cutting guident'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 quide placement of the implants and alignment of bone. The Fine Osteotomy System is provided clean, not sterile to the user.

Materials: Wrought Titanium-6Alum ELI Alloy (Ti6AV ELJ; 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 the requested information regarding acceptance criteria and the study that proves the device meets them.

The document is an FDA 510(k) Premarket Notification clearance letter for the "Fine OsteotomyTM" device. While it mentions some non-clinical tests were conducted (Mechanical Engineering Analysis, Sawbone Model Testing, Reprocessing Instructions Validation), it does not provide details about acceptance criteria or specific performance metrics achieved that would go into a table.

Specifically, the document lacks:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Details about standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcome data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on the regulatory aspects of the device, its intended use, a comparison to a predicate device, and the changes made since the previous clearance (K240066). The non-clinical tests mentioned are very brief summaries and do not include the detailed performance data asked for.

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