(80 days)
The Global Modular Replacement System (GMRS™) Pediatric Tibial Bearing Component is intended to be used to mate the distal femoral components of the Global Modular Replacement (GMRS™) System or the femoral components of the Modular Rotating Hinge (MRH) System to the Pediatric All Polyethylene Tibial Components of the Modular Replacement System The indications for use for the GMRS™ Pediatric Tibial Bearing Component are listed below:
Replacement of the distal femur and/or proximal tibia in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is intended for use with bone cement.
The GMRS™ Pediatric Tibial Bearing Component is a single use device that is available in one size. The GMRS™ Pediatric Tibial Bearing Component is designed to mate with the all sizes of the femoral components of the GMRS™ or the MRH systems, and the MRS pediatric all poly tibial components. The design of this GMRS™ Pediatric Tibial Component is similar to the design of the existing MRH XS/XL Tibial Bearing Component - this component is stemmed, and connects to the femoral component by a set of bushings and an axle. A bumper locks this assembly. In terms of dimensions, the subject The GMRS™ Pediatric Bearing has a smaller distal stem diameter, and reduced anterior-posterior and medio-lateral dimensions when compared to the MRH XS/XL Tibial Bearing Component. These reduced dimensions are identical to those seen in the MRS Pediatric Tibial Bearing Component.
This document describes a 510(k) premarket notification for a medical device, the Global Modular Replacement System (GMRS™) Pediatric Tibial Bearing Component. It focuses on demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the way a diagnostic AI product might.
Therefore, many of the requested categories (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of submission.
However, I can extract information related to the device description and the method used to demonstrate equivalence.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a diagnostic performance study (e.g., sensitivity, specificity thresholds). Instead, the pivotal point for device acceptance in a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs the same intended use. | Intended Use: "mate the distal femoral components of the Global Modular Replacement (GMRS™) System or the femoral components of the Modular Rotating Hinge (MRH) System to the Pediatric All Polyethylene Tibial Components of the Modular Replacement System." (Page 1) This is identical to predicate devices. |
| Technological Equivalence: Device has similar technological characteristics. | Design Similarity: "The design of this GMRS™ Pediatric Tibial Component is similar to the design of the existing MRH XS/XL Tibial Bearing Component - this component is stemmed, and connects to the femoral component by a set of bushings and an axle. A bumper locks this assembly." (Page 2) |
| Material Equivalence: Device uses similar materials. | (Not explicitly detailed in the provided text, but implied by "similar technological characteristics" of other metal/polymer constrained cemented prostheses) |
| Performance Equivalence: Device performs as safely and effectively as the predicate. | Performance Evaluation Method: "Finite element analysis (FEA) was presented to support a claim of substantial equivalence." (Page 3) No specific FEA results or thresholds are given in this summary. |
| Biocompatibility: (Implied, not explicitly detailed for this component in the summary) | (Not detailed in the provided text) |
| Sterility: (Implied, as it's a single-use device) | (Not detailed in the provided text) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This was not a clinical trial with a "test set" in the context of diagnostic performance. The evaluation was based on a comparison to predicate devices and engineering analysis.
- Data Provenance: Not applicable in the context of clinical data. The "data" provided was primarily design specifications and an engineering analysis (FEA) comparing the new device to existing designs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. There was no "test set" requiring ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There was no "test set" requiring adjudication.
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
- Not applicable. This is a mechanical orthopedic implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the conventional sense. The "ground truth" for this submission revolves around the design, materials, and functional equivalence to already approved predicate devices. The primary evidence presented was Finite Element Analysis (FEA), which is a computational method to predict how a product reacts to forces, heat, fluid flow, and other physical effects. Its "truth" is based on established engineering principles and validation against physical testing methods, though no specific validation data is in this summary.
8. The sample size for the training set
- Not applicable. There was no "training set."
9. How the ground truth for the training set was established
- Not applicable. There was no "training set."
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.