(113 days)
The intended use of the Ortho Solutions Trauma Plates for Osteosynthesis of fixation device(s) is to draw two or more aligned bone fragments together to facilitate healing.
Ortho Solutions Bone Plates, Bone Screws, and Washers System is indicated for use in fixation of various fractured bones. Mini plates and screws 3.5mm or smaller are intended for use in small bones in the hand or foot and include the metacarpal, metatarsal, and phalange bones. Small and large plates and screws 4.0mm and larger are intended for use in large and long bones which can include the clavicle, scapula, pelvis, calcaneus, talus and long bones (humerus, ulna, radius, femur, tibia, and fibula) in the skeletal anatomy.
Ortho Solutions Compression Hip Screw CHS/SCS System is indicated for fracture fixation in the proximal and distal regions of the human anatomy skeletal femur. Specific indications include: intracapsular fractures of the femoral neck; trochaneric and subtrochanteric neck fractures; osteotomies for patients with diseases or deformities of the hip; hip arthrodesis; supracondylar fractures and distal femoral fractures.
The Ortho Solutions Trauma Plates for Osteosynthesis is not intended for spinal use.
The Ortho Solutions Trauma Plates for Osteosynthesis consists of general predicate type trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'general trauma implant devices' consist of the following categories:
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Bone Plates, Bone Screws and Washers System
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Adult Compression Hip Screw (CHS/SCS) System
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Bone Plates, Bone Screws and Washers System: This implant system consists of a Mini Fragment System (MFS), a Small Fragment System (SFS), and a Large Fragment System (LFS).
The Mini Fragment System is composed of 2.7mm A.C.P Plates in various hole lengths. These mini plates are secured to bone using 1.5mm, 2.0mm, and 2.7mm Cortical Screws. All Mini Fragment System plates and screws are intended for use in small bone extremity skeletal anatomy. The Small Fragment System is composed of 1/3 Tubular, 3.5mm A.C.P., 3.5mm Reconstruction, 3.5mm Cloverleaf, and 3.5mm 'T' - Plates in various hole lengths, Left, Right, and Oblique configurations. These small fragment plates are secured to bone using 3.5mm and 4.0mm cortical and cancellous screws, selftapping, partial, and fully threaded. A 7 x 3.6mm Washer is also offered. All Bone Screws with or without the washer can be used separate from the plates. All Small Fragment plates and screws are intended for use in small bone skeletal anatomy. The Large Fragment System is composed of 4.5mm Narrow A.C.P, 4.5mm Broad A.C.P., 'T', 'T-Buttress', and 'L-Buttress' Left & Right Angled Plates in various hole length configurations. These large plates are secured to bone using 4.5mm, 4.0mm Malleolar, and 6.5mm cortical and cancellous screws, self-tapping, partial, and fully threaded. A washer is also offered. All bone screws with or without the washer can be used separate from the plates. All large fragment plates and screws are intended for use in large and long bone skeletal anatomy. All bone plates, bone screws, and washers are made of surgical grade 316LVM Stainless Steel to ASTM F138. All plates, screws, and washers are offered 'sterile' to the customer.
- Adult Compression Hip Screw (CHS/SCS) System: This implant system consists of various angled (950 for SCS, 130°, 135°, and 150° for CHS) high strength forged plates in multiple hole lengths, various Lag Screw lengths with various length Compression Screws, and various length 4.5mm Cortical Screws for securing the plate to femoral bone. Associated guide pin, drills, and ancillary instrumentation is available. The system is intended for use in repair of fractures of the femoral hip neck/head and supra-condylar area of the skeletal femur. All components are manufactured of surgical grade 316LVM Stainless Steel to ASTM F138. All plates and screws are offered 'sterile' to the customer.
This 510(k) summary for the Ortho Solutions Trauma Plates for Osteosynthesis does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be described for a device employing AI or requiring such rigorous validation.
Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on material, geometry, design/markings, and indications for use. It's a regulatory submission for a traditional, hardware-based medical device (bone plates, screws, and washers), not a software or AI-driven diagnostic or treatment device.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for AI/software-based devices, is not present in this document.
However, I can extract the information that is implicitly part of a substantial equivalence claim for a traditional medical device:
Implicit Acceptance Criteria and "Study" for Substantial Equivalence
For a traditional device like the Ortho Solutions Trauma Plates, the "acceptance criteria" and "study" are interpreted through the lens of regulatory substantial equivalence. The "study" isn't a clinical trial or algorithm performance test, but rather a comparison to legally marketed predicate devices. The "acceptance criteria" are the demonstration that the new device is as safe and effective as the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Material Equivalence: Device materials meet established standards and are equivalent to predicates. | "All bone plates, bone screws, and washers are made of surgical grade 316LVM Stainless Steel to ASTM F138." (Page 2) "All components are manufactured of surgical grade 316LVM Stainless Steel to ASTM F138." (Page 2) "The Ortho Solutions Trauma Plates for Osteosynthesis is Similar in Material, Geometry Design/Markings, and Indications to many predicate systems currently sold in the U.S. market." (Page 3) |
| Geometric/Design Equivalence: Device geometry and design are equivalent to predicates and suitable for intended use. | "The Ortho Solutions Trauma Plates for Osteosynthesis consists of general predicate type trauma implant components commonly found with large companies with orthopedic markets in the United States." (Page 2) Detailed descriptions of various plates, screws, and washers, their sizes, configurations (e.g., 2.7mm ACP plates, 3.5mm Reconstruction plates, 4.5mm Narrow ACP, various angled hip plates), and intended bone locations. (Page 2) "The Ortho Solutions Trauma Plates for Osteosynthesis is Similar in Material, Geometry Design/Markings, and Indications to many predicate systems currently sold in the U.S. market." (Page 3) |
| Indications for Use Equivalence: Device is indicated for the same or very similar uses as predicates, without raising new questions of safety or effectiveness. | "The intended use of the Ortho Solutions Trauma Plates for Osteosynthesis of fixation device(s) is to draw two or more aligned bone fragments together to facilitate healing." (Page 3) Specific indications are listed for bone plates/screws (small bones in hand/foot, large and long bones) and for the Compression Hip Screw System (fracture fixation in proximal/distal femur, including various types of hip/femoral neck fractures, osteotomies, hip arthrodesis, supracondylar/distal femoral fractures). (Page 3 & 5) "The Ortho Solutions Trauma Plates for Osteosynthesis is Similar in Material, Geometry Design/Markings, and Indications to many predicate systems currently sold in the U.S. market." (Page 3) "The Ortho Solutions Trauma Plates for Osteosynthesis is substantially equivalent to predicate systems from many orthopedic companies (as listed)." (Page 3) |
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| Safety and Effectiveness: Implied by equivalence to predicates that are already deemed safe and effective. New device is safe and effective in its 'sterile' and 'single-use' condition. | "The Ortho Solutions Trauma Plates for Osteosynthesis is shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting." (Page 3) The FDA's substantial equivalence determination implies that the device is considered as safe and effective as the predicate devices for its stated indications. |
| Sterility & Biocompatibility: Device components can be supplied sterile and are biocompatible for implantation. (Implicit, as 316LVM Stainless Steel is a well-established implant material) | "All plates, screws, and washers are offered 'sterile' to the customer." (Page 2) "All plates and screws are offered 'sterile' to the customer." (Page 2) Implicitly, surgical grade 316LVM Stainless Steel is known to be biocompatible for its stated use. |
| Manufacturing Quality: Device is manufactured under appropriate quality systems. (Implicit, as a requirement for all medical devices cleared by FDA) | The FDA letter mentions: "good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)." (Page 4) This is a general regulatory requirement for the firm, not a specific performance metric, but central to device safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of an "algorithm only" or "human-in-the-loop" study. The "test set" here refers to the comparison of the device's specifications against predicate devices. The "sample" is the detailed technical specifications and intended use of the Ortho Solutions device components compared to the listed predicate devices.
- Data Provenance: Not applicable. This is a comparison of technical specifications and regulatory clearances, not clinical data or images.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Establishing "ground truth" with experts, typical for diagnostic software, is not relevant here. The ground truth for substantial equivalence is the established safety and effectiveness of the predicate devices as determined by regulatory bodies and clinical consensus over time.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no human adjudication of algorithm output in this context. The "adjudication" is the FDA's regulatory review process, determining if the comparison to predicate devices is sufficient for substantial equivalence.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this type of study is entirely irrelevant for a bone fixation hardware device. There are no "human readers" or "AI assistance" involved in the device's function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No, this device does not involve any algorithms. It is a physical implant.
7. The type of ground truth used
- Ground Truth: The "ground truth" implicitly used for this type of submission is the established safety and effectiveness profile of the legally marketed predicate devices against which the Ortho Solutions device is compared. This is based on years of clinical use, regulatory review, and scientific understanding of biomechanics and biomaterials.
8. The sample size for the training set
- Sample Size: Not applicable. There is no "training set" as this device does not use machine learning or AI.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable. Refer to point 8.
In summary, the provided document is a 510(k) summary for a traditional medical device (bone plates and screws), demonstrating substantial equivalence to existing products. The framework for "acceptance criteria" and "study" in your request is designed for AI/software devices and therefore does not directly apply to this submission. The "study" here is the comparative analysis presented in the 510(k) demonstrating that the new device is "similar in material, geometry design/markings, and indications" to cleared predicate devices.
§ 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.