(59 days)
The OrthoPediatrics Fracture and Osteotomy Bone Plate System is intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies.
The OrthoPediatrics Fracture and Osteotomy Bone Plate System will combine implants and instruments in one convenient system. This system will offer the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety.
The provided document describes the 510(k) premarket notification for the OrthoPediatrics Fracture and Osteotomy Bone Plate System. This type of submission relies on demonstrating substantial equivalence to predicate devices rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the same way a novel device might.
Therefore, the document does not contain information on acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) for a diagnostic or AI-driven device, nor does it detail a study proving the device meets such criteria. Instead, the "performance analysis" section focuses on demonstrating mechanical equivalence and similarity to already-approved predicate devices.
Here's a breakdown of the information that is present, organized to address your request as much as possible, along with what is explicitly not applicable (N/A) for this type of submission:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (based on substantial equivalence to predicates) | Reported Device Performance |
|---|---|
| Technological Characteristics: | |
| Plate thickness(s) and width(s) substantially equivalent to predicates | Similar configuration, sizes, and design as predicate device(s). |
| Identical materials to cited predicates | All implant components manufactured from medical grade metals (316L stainless steel, BIODUR stainless steel) meeting ASTM standards. |
| Range of plate angles substantially equivalent to predicates | Similar configuration, sizes, and design as predicate device(s). |
| Range of screw sizes and threads substantially equivalent to predicates | Similar configuration, sizes, and design as predicate device(s). |
| Indications for Use substantially equivalent to predicates | The OrthoPediatrics Fracture and Osteotomy Bone Plate System's Indications for Use are substantially equivalent to predicates. This is the core of the 510(k) submission. |
| Mechanical Performance: | |
| Equivalent or better strength and resistance to bending moments compared to predicates | Engineering calculations with worst-case loading confirmed equivalent or better strength and resistance to bending moments. |
| Safety and Effectiveness: | |
| Support safety and effectiveness based on predicate device history | A review of the MAUDE complaint database of similar predicate devices supports the safety and effectiveness. |
| Expected safety and efficacy given material, intended use, and technological features are similar to predicates | Safety and efficacy expected to be equivalent due to similar materials, intended use, and technological features. |
2. Sample size used for the test set and the data provenance:
- N/A. This device is a bone plate system, not a diagnostic or AI device that would typically use a "test set" in the context of performance metrics like sensitivity/specificity. The "performance analysis" is based on engineering calculations and comparison to predicate devices, not analysis of a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This information is not relevant to a 510(k) submission for a bone plate system showing substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not applicable, as there is no "test set" in the sense of a clinical or image analysis study.
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:
- N/A. This is a medical device (bone plate system), not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI improvement metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used:
- The "ground truth" in this context is established by the performance and safety history of the predicate devices (K062872, K072095, K083286, K082949, K100240, K070906, K003496) and the established engineering principles for biomechanical testing and material standards.
- Engineering calculations (for strength and bending moments).
- MAUDE complaint database review for similar predicate devices.
8. The sample size for the training set:
- N/A. This is not an AI device or a diagnostic device that requires a "training set."
9. How the ground truth for the training set was established:
- N/A. Not applicable.
In summary, the provided document details a 510(k) submission for a Class II medical device (bone plate system). The "acceptance criteria" and "study" are not based on clinical performance metrics or AI algorithm validation. Instead, they are centered on demonstrating substantial equivalence to legally marketed predicate devices through comparison of technological characteristics, materials, intended use, and biomechanical engineering analysis. Therefore, many of the requested points related to AI/diagnostic study design are not present.
§ 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.