(114 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.
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 patient's CT images in design of the Bodycad plate and use of the bone models intra operatively to guide placement of bone. The Fine Osteotomy System is provided clean, not sterile to the user.
This 510(k) submission is intended to notify the FDA of the mechanical locking system, the addition of new screw lengths, and option to use a new in-house for planning and cutting quide design in the Fine Osteotomy System, previously cleared in K240703.
Materials: Wrought Titanium-6Alum ELI Alloy (Ti6A4V 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 is a U.S. FDA 510(k) summary for the "Fine Osteotomy™" device. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices, including non-clinical testing. However, it does not include specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.
The document primarily focuses on demonstrating substantial equivalence based on:
- Technological comparison: The device retains the same intended use and technological characteristics as predicate devices, with enhancements to the mechanical locking system, additional screw lengths, and a new in-house tool for planning and cutting guide design.
- Non-clinical tests: Mechanical testing was conducted to demonstrate performance.
Here's an attempt to extract and format the information based on the provided text, highlighting what is available and what is explicitly not available:
Acceptance Criteria and Device Performance Study for Fine Osteotomy™
The provided 510(k) summary focuses on demonstrating substantial equivalence through technological comparison and non-clinical mechanical testing. It does not present specific quantitative acceptance criteria or a detailed study report in the requested format (e.g., with effect sizes for human readers, sample sizes for test sets with detailed provenance, or adjudication methods for ground truth). The information below is extracted or inferred from the available text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (Implicit) | Acceptance Criteria (Implicit/Inferred) | Reported Device Performance (Summary) |
|---|---|---|---|
| Mechanical Performance | Torsional Strength | Exceed predicate device performance | Exceeded performance of predicate devices |
| Pull-Out Strength | Exceed predicate device performance | Exceeded performance of predicate devices | |
| Bending Resistance (Static) | Enhanced structural integrity | Confirmed enhanced structural integrity | |
| Bending Resistance (Dynamic) | Enhanced structural integrity | Confirmed enhanced structural integrity | |
| Push-Out Force | Crucial for osteotomy repair stability | Measured for stability | |
| Software Validation | (Not specified) | Meet necessary performance/safety standards | Met all necessary performance and safety standards |
2. Sample Size for the Test Set and Data Provenance
The document describes non-clinical mechanical testing and software validation. It does not specify a "test set" in the context of patient data or clinical images. The tests were performed on the device components themselves (locking screws, bone plates) and through software validation. Therefore:
- Sample size for test set: Not applicable in the context of patient or image data. The "sample" would be the device components tested, but specific numbers are not provided.
- Data provenance: Not applicable. The data is generated from laboratory mechanical testing and software validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the described tests are non-clinical mechanical and software validation. There is no "ground truth" derived from expert review of patient data in this context.
4. Adjudication Method for the Test Set
This information is not applicable as the described tests are non-clinical mechanical and software validation, not involving human expert adjudication of a test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or described in the provided document. The submission focuses on device performance and substantial equivalence based on physical and software characteristics, not on the effectiveness of human readers with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
The device includes "patient-specific surgical planning and instrument guides" and "in-house for planning and cutting guide design." While the document mentions "software validation," it does not specifically detail a standalone algorithm-only performance study with quantitative metrics for its planning or design components. The software's role is to aid in creating physical instruments and implants.
7. Type of Ground Truth Used
For the non-clinical mechanical tests, the "ground truth" is established by standard engineering principles and test methodologies (e.g., ASTM standards for material properties and mechanical strength). For software validation, the "ground truth" refers to meeting predefined functional and non-functional requirements and safety standards. It is not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
There is no mention of a "training set" in the context of machine learning or AI algorithm development. The software capabilities mentioned are for "converting medical into 3D models manually" and designing guides, implying a rule-based or CAD-like system rather than a machine learning model that requires a discrete training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for a machine learning model, this information is not provided.
§ 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.