(90 days)
Fine Osteotomy is a system intended for 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.
Specifically,
-
The Fine Osteotomy tibial plates are indicated for open- and closed-wedge osteotomies of the medial tibia, treatment of bone and joint deformities, fractures, non-unions, and malalignment caused by injury or disease, such as osteoarthritis, of the proximal tibia.
-
The Fine Osteotomy femoral plates are indicated for open- and closed wedge osteotomies of the medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur.
-
Fine Osteotomy instrument guides are 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™ for the knee 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 patient-specific bone plate designed to fit the patient's anatomy. Fine Osteotomy™ consists of patient-specific surgical planning and instrument guides designed from long-standing x-ray and computed tomography (CT) images of the patient's bones, a patient-specific bone plate designed from the CT images, compression and/or locking bone screws, and manual reusable instruments. The bone plate is a patient-specific, single-use implant; the patient-specific surgical planning and instrument guides are 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 the osteotomy and implanting hardware to stabilize the resection. 2) as patient specific single use instrumentation for performing an osteotomy alone, and 3) as 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 via the patient-specific cutting guides and bone plate designed from the patient's CT images. When the planning guides and resection instruments are used alone, Fine Osteotomy™ enables the surgeon to perform an osteotomy the bone around the knee that matches the pre-surgical plan via the patient-specific 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.
Materials: Wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6A14V ELI; ASTM F136-13) for the bone plates and screws. ADM Nylon-12 for patient specific resection quides and models.
Here's a breakdown of the acceptance criteria and study information for the "Fine Osteotomy" device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly list distinct "acceptance criteria" with numerical targets in the same way a diagnostic AI device might. Instead, it details that pre-clinical performance testing was conducted according to various standards and guidance documents, and the results demonstrated substantial equivalence to predicate and reference devices.
Therefore, the "acceptance criteria" are implicitly defined by compliance with these standards and the achievement of "substantial equivalence." The reported device performance is the affirmation that these criteria were met.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Material Properties: | |
| Compliance with ASTM F136-13 (Ti6Al4V ELI) for bone plates and screws. | Ti6A14V ELI (ASTM F136-13) used. Conforms. |
| Compliance with ADM Nylon-12 for patient-specific resection guides and models. | ADM Nylon-12 used. Conforms. |
| Mechanical Performance: | |
| Compliance with ASTM F543 regarding metallic bone screws and washers. | Testing performed per ASTM F543. Substantial equivalence demonstrated. |
| Compliance with ISO 5835 (implants for osteosynthesis - screws). | Testing performed per ISO 5835. Substantial equivalence demonstrated. |
| Compliance with ISO 10664 (wrought titanium alloy for surgical implants). | Testing performed per ISO 10664. Substantial equivalence demonstrated. |
| Compliance with FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers, Performance Criteria for Safety and Performance Based Pathway". | Testing performed per FDA Guidance. Substantial equivalence demonstrated. |
| Mechanical bending strength characteristics of worst-case plate relative to minimum section modulus / design. | Evaluation performed using ASTM F382. Substantial equivalence demonstrated. |
| Biomechanical characteristics of subject devices in simulated HTO model comparable to predicate/reference devices. | Evaluation performed. Substantial equivalence demonstrated. |
| Software Performance: | |
| Validation and verification of software per FDA guidance documents. | Validation and verification performed. Implies satisfactory performance. |
| Biocompatibility: | |
| Evaluation of biocompatibility per ISO 10993-1. | Evaluation performed. Conforms. |
| Reprocessing & Stability: | |
| Validation of reusable instrument reprocessing parameters (cleaning, sterilization). | Validation performed. Implies satisfactory performance. |
| Validation for dimensional stability of ADM Nylon-12 resection guides. | Validation performed. Implies satisfactory performance. |
| Validation for particulate debris of ADM Nylon-12 resection guides. | Validation performed. Implies satisfactory performance. |
| Accuracy of Correction & Implant Position (Cadaver): | |
| Measurement of accuracy of correction and position of implants relative to surgical plan, conventional technique, and reference devices. | Cadaver simulation performed, measurements taken. Substantial equivalence demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not provide specific numerical sample sizes for the mechanical testing or cadaver studies. It mentions:
- "Evaluation of biomechanical characteristics of subject devices in simulated HTO model"
- "Cadaver simulation of use of the Fine Osteotomy system"
The provenance of this data is implicitly from pre-clinical lab testing and cadaver studies, conducted by or for Bodycad Laboratories Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For pre-clinical mechanical and cadaver studies, "ground truth" often refers to measurements against established physical standards or surgical outcomes in a simulated environment, rather than expert consensus on medical images.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes by multiple human readers, often for AI or diagnostic devices. This document describes pre-clinical engineering and cadaver testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The document focuses on pre-clinical performance and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device includes "patient-specific surgical planning and instrument guides designed from long-standing x-ray and computed tomography (CT) images." The summary mentions "Validation and verification of software per FDA guidance documents."
This indicates that the software component (which creates the patient-specific guides and plates) was evaluated in a standalone manner (algorithm only) to ensure it performs according to specifications. However, no specific performance metrics for the standalone algorithm (e.g., accuracy of measurement extraction, segmentation accuracy) are provided in this summary. The "acceptance criteria" for the software are broadly stated as "validation and verification per FDA guidance documents."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the pre-clinical studies, the "ground truth" would be established by:
- Engineering Specifications/Standards: For mechanical testing (e.g., ASTM, ISO standards).
- Physical Measurements: In the cadaver study, the "accuracy of correction and position of implants" would be measured directly against the pre-surgical plan and possibly conventional surgical outcomes, serving as the ground truth.
- Design Specifications: For the software, the ground truth would be the intended design output when processing CT images (e.g., correct anatomical measurements, precise guide designs).
8. The Sample Size for the Training Set
This information is not provided and is likely not applicable in the traditional sense. The device is not learning from a "training set" of medical images for diagnostic purposes. Instead, the software is programmed based on algorithms to generate patient-specific designs from individual CT images. If any "training" occurred, it would be in the development and refinement of the design algorithms, not in the context of a machine learning training set for diagnostic output.
9. How the Ground Truth for the Training Set Was Established
As above, this information is not provided and likely not applicable as there's no mention of a traditional machine learning "training set" for diagnostic classification. The software's "ground truth" would be its ability to accurately translate CT image data into precise, patient-specific surgical plans, instrument guides, and implant designs according to engineering and anatomical principles. This would be established through internal design validation and verification processes.
§ 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.