(189 days)
The GMK HINGE® knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation require the implantation of a constrained prosthesis.
The GMK HINGE® knee system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, . rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability
- Considerable loss of function of the knee joint .
- High-grade joint destruction requiring additional stabilization with stems and . reconstruction of bone defects with metal augmentation
- Failure of a primary prosthesis (e.g. infection, loosening) .
- Former revision arthroplasty .
- Post traumatic loss of joint configuration .
- Avascular necrosis of femoral condyle .
Tibial augmentations are to be screwed to the tibial baseplate with both of the two provided fixing screws.
When a GMK HINGE® implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.
The GMK Hinge System is a hinged-knee system for total knee replacement. The GMK Hinge femoral component is designed to preserve bone stock. The hinge-post system is comprised of the hinge post and the hinge post extension and has been developed in order to reduce the impingement with the patellar tendon and provide mechanical resistance. There is a UHMWPE bushing between the femoral component and the hinge post in order to avoid contact between metal parts. The tibial component has an asymmetric design to provide coverage of the bone after tibia resection. The surface is mirror polished and the holes for the tibial augmentations are on the bottom. The UHMWPE tibial insert is fixed to the tibial component through a screw and is designed to provide high rotational control and a high varus/valgus constraint. The femoral and tibial augments allow the surgeon to selectively fill bone deficiencies and to aid in restoring the ioint line. The fixation between the augmentations and the femoral component or tibial trav is assured by a screw fixation. The GMK Hinge provides two solutions for the patella prosthesis: an inset patella and a resurfacing patella. The GMK Hinge System would be used most often in patients with poor bone quality or marked bone loss, and in these circumstances, extension stems are helpful to obtain a stable construct. An extension stem in combination with the right offset connector provides intramedullary femoral and tibial fit and fill.
The provided text describes the 510(k) premarket notification for the Medacta International SA GMK Hinge, a total knee prosthesis. It details the device's design, indications for use, comparison to predicate devices, and performance testing. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth, expert adjudication, or sample sizes related to AI/algorithm performance.
The document is a regulatory submission for a medical device (knee prosthesis), not an AI/ML-driven device, so the requested information about AI model performance is not applicable or present in this context. The "performance testing" section refers to mechanical testing of the physical implant against established medical device standards.
Therefore, most of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as "acceptance criteria" in terms of performance metrics. The text states the GMK Hinge "was tested according to the following standards: ISO 21534, ISO 7207-1, ASTM F1800, ASTM F2083-11, ASTM F1223-08." The acceptance criteria would be successful adherence to these standards, but the specific metrics are not detailed.
- Reported Device Performance: The document states, "The comparison to predicate devices and the mechanical testing performed demonstrate that the GMK Hinge does not introduce any issues in regards to safety and effectiveness." No specific quantitative performance data is provided beyond this general statement of compliance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This refers to the testing of a physical device, not an algorithm. The "test set" would be the prototypes or representative samples of the knee prosthesis subjected to mechanical tests.
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/Not provided. Ground truth in this context would implicitly be successful mechanical performance as defined by the standards. No "experts" are mentioned for establishing this but rather accredited testing laboratories or engineers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is compliance with established mechanical testing standards (ISO and ASTM).
8. The sample size for the training set
- Not applicable/Not provided. This is a physical device, not an AI model.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
Summary of available information from the text:
- Device: GMK Hinge (Total Knee Prosthesis)
- Applicant: Medacta International SA
- Regulatory Status: 510(k) cleared as a Class II device (KRO product code).
- Predicate Devices: K003504 (RT-Plus), K013385 (NexGen Rotating Hinge Knee), K002552 (Modular Rotating Hinge Knee), K101815 (Enduro RHK), K896048 (S-ROM/NOILES).
- Performance Testing Standards: ISO 21534, ISO 7207-1, ASTM F1800, ASTM F2083-11, ASTM F1223-08.
- Conclusion of Performance Testing: "The comparison to predicate devices and the mechanical testing performed demonstrate that the GMK Hinge does not introduce any issues in regards to safety and effectiveness."
- Ground Truth (Implication): Compliance with the specified ISO and ASTM mechanical testing standards for knee prostheses.
Given the input document is for a physical medical device (a knee prosthesis) and not an AI/ML-driven device, most of the questions related to AI model performance, ground truth establishment, expert adjudication, and sample sizes for training/test sets are inapplicable.
Here's the information that can be extracted from the document, though it doesn't align with the AI/ML-focused questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 21534 | Met standards |
| Compliance with ISO 7207-1 | Met standards |
| Compliance with ASTM F1800 | Met standards |
| Compliance with ASTM F2083-11 | Met standards |
| Compliance with ASTM F1223-08 | Met standards |
| Note: The document states that the mechanical testing performed demonstrates the GMK Hinge "does not introduce any issues in regards to safety and effectiveness" and is "substantially equivalent" to predicate devices based on these tests. Specific performance values are not provided in this summary. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the mechanical tests. (This refers to physical prototypes of the device, not data for an algorithm.)
- Data Provenance: Not applicable in the context of an AI/ML device. The "data" here would be the results from mechanical testing of the physical knee prosthesis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this device is compliance with established engineering and material standards for knee prostheses. This would typically be assessed by accredited testing laboratories and engineers, not clinical experts establishing a "ground truth" diagnosis.
4. Adjudication method for the test set:
- Not applicable. The assessment is against objective mechanical standards, not subjective interpretation 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:
- No. This is not an AI/ML device, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device.
7. The type of ground truth used:
- Compliance with established international and American national mechanical testing standards for knee prostheses (ISO 21534, ISO 7207-1, ASTM F1800, ASTM F2083-11, ASTM F1223-08).
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical device, not an AI model.
Conclusion: The provided text is a 510(k) summary for a traditional medical device (a knee prosthesis). It details the device's design, indications, materials, and compliance with mechanical testing standards to demonstrate substantial equivalence to predicate devices. It does not pertain to an AI/ML-driven device, and therefore, most of the requested information regarding AI model evaluation is not present.
§ 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.