(61 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 and performing 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. Fine Osteotomy™ consists of patient-specific surgical planning and instrument quides 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, 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 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 patient-specific cutting quides 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. The Fine Osteotomy System is provided clean, not sterile to the user.
The purpose of this 510(k) is to notify the FDA of changes to the software, implants, single use instruments, packaging, and labeling of the Fine Osteotomy System cleared in K193614.
Materials: Wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6AI4V ELI; ASTM F136-13) for the bone plates and screws, ADM Nylon-12 for patient specific resection guides and models.
I am sorry, but the provided text does not contain the detailed information necessary to fully address all aspects of your request regarding the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report or explicit acceptance criteria for device performance.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance. While it mentions mechanical performance testing and engineering analysis, it doesn't quantify specific targets (e.g., "accuracy within X mm") or provide numerical results for those targets.
- Sample sizes used for the test set. The performance data section refers to "testing" and "engineering analysis" but does not specify sample sizes for any experimental validation or testing.
- Number of experts used to establish ground truth or their qualifications. The document does not describe any studies involving human experts establishing ground truth.
- Adjudication method for the test set. Given that no human expert evaluation is described, no adjudication method is mentioned.
- Details on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, effect size regarding AI assistance, or standalone performance. This document describes a surgical planning system and instruments, not an AI/Software as a Medical Device (SaMD) that typically undergoes MRMC studies to evaluate AI assistance.
- The type of ground truth used. The validation discussed is engineering analysis and mechanical testing, not a ground truth derived from clinical outcomes or expert consensus in an AI context.
- Sample size for the training set or how ground truth for the training set was established. This information would be relevant for an AI/machine learning device, which this submission does not explicitly describe. The "software re-validation" is mentioned but without details on its nature (e.g., whether it involves machine learning model training).
What the document does convey regarding device performance and validation:
The document states that the "changes to the software and implant and instrument design were analyzed, tested, and validated." The performance data summarized relates to demonstrating that the modified device (Fine Osteotomy™ K211646) is substantially equivalent to its predicate (K193614), not necessarily a comprehensive clinical performance study.
Here's a summary of the performance data and validation mentioned, organized to implicitly address parts of your request where information is available:
1. Acceptance Criteria and Reported Device Performance (Implicit/Inferred):
While a specific table isn't present, the document implies the following "acceptance criteria" through its performance testing descriptions, with the "reported performance" being that these were met sufficiently to demonstrate substantial equivalence.
| Implicit Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical Performance (Torsional Strength & Fixation) | "The results of this testing showed no significant difference in torsional strength and fixation into simulated bone between the subject T20 and the primary predicate T15 bone screws." (ASTM F543 and FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers, Performance Criteria for Safety and Performance Based Pathway") |
| Bone Plate Strength/Worst Case Analysis | "Engineering analysis of the subject bone plate device relative to the minimum section modulus / design of the primary predicate bone plate demonstrated that no new worst case was created relative to the least strong predicate bone plate." This was based on: (1) Same minimum cross-section modulus and bounding-box, (2) No change in minimum distances between screw holes and osteotomy location. |
| Software Equivalence | "Verification and validation activities demonstrated that the Bodycad software used to design the subject device patient specific guides and implants is substantially equivalent to the Bodycad software used to design the primary predicate devices." The software was "re-validated per FDA guidance documents." |
| Biocompatibility | "The original assessment of biocompatibility of the primary predicate device was adopted for the subject device because no new materials, manufacturing processes, or worst-case device was created by the line extension of T20 screws and minor design updates." (Evaluated per ISO 10993-1). |
| Cleaning and Sterilization (for modified components) | "The original cleaning and sterility validation of the implant and disposable instrument kit and the reusable instrument kit were applicable to the subject device because no new worst cases were created by the updates to the Fine Osteotomy System." AND "Cleaning and sterilization was validated to a SAL of 10⁻⁶ by Nelson Labs for a new screw tray caddy and bone screws per ANSI/AAMI/ISO 17665-1:2006/(R)2013, Annex D and ANSI/AAMI/ISO 14937:2009/(R)2013, Annex D (Approach 3)." This indicates that the validation for new components (screw tray caddy, T20 screws) met the sterility assurance level (SAL) of 10⁻⁶, a standard acceptance criterion for sterile medical devices. |
2. Sample Sizes and Data Provenance:
- Test Set Sample Sizes: Not specified. The document mentions "testing" (e.g., mechanical) and "engineering analysis" but does not provide numbers of devices or simulations.
- Data Provenance: Not specified. The manufacturing and submitting companies are Canadian (Quebec), but the origin of any data used for design or validation (e.g., patient imaging data that the software processes) is not mentioned. The studies are retrospective in the sense that they are engineering and mechanical tests based on device design, not prospective human trials.
3. Number of Experts and Qualifications:
- Not applicable as the described validation is primarily engineering and mechanical testing, not a human reader study for an AI device.
4. Adjudication Method:
- Not applicable for the reasons above.
5. MRMC Comparative Effectiveness Study:
- No MRMC or human-in-the-loop study is mentioned. This device is a surgical planning and instrument guide system, not an AI for image analysis or diagnosis. Therefore, a comparative effectiveness study showing human readers improve with AI assistance is not relevant to this submission type.
6. Standalone Performance:
- The "performance data" section details the device's mechanical and software performance attributes as a standalone product (e.g., screw strength, bone plate strength, software function), but not "standalone algorithm performance" in the context of an AI device. The device itself (the surgical guides, plates, and screws) has performance characteristics validated.
7. Type of Ground Truth Used:
- For mechanical testing, the "ground truth" is established by physical measurement and standardized test methods (e.g., ASTM F543) and engineering principles (e.g., section modulus calculations).
- For software, the "ground truth" for re-validation would likely involve software verification and validation protocols ensuring that the software performs its intended functions (e.g., designing guides/implants from CT images) accurately according to specifications.
- For biocompatibility and sterilization, the "ground truth" is adherence to international standards (ISO 10993-1, ISO 17665-1, ISO 14937) and achieving specified safety levels (e.g., SAL of 10⁻⁶).
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning model where a "training set" in that sense would exist. The software develops patient-specific designs from patient CT images, implying it's a rule-based or algorithmic design system, not a trained neural network.
9. How Ground Truth for the Training Set was Established:
- Not applicable for the reasons above.
In summary, the provided FDA 510(k) document focuses on demonstrating substantial equivalence for a modified surgical device through mechanical and engineering analyses, rather than detailing a rigorous clinical study with patient outcomes, human expert review, or AI model performance validation that would typically include the requested criteria.
§ 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.