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510(k) Data Aggregation
(178 days)
The Ring-Lok™ Modular Bi-Polar System is intended for use in combination with other previously cleared femoral components including the Rig-Fix™ Hip Stem (K072101), C-fit Performa (K923898) or the Stability Hip Stem (K915787 and K934457) for uncemented primary or revision hemi-arthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- Femoral neck and trochanteric fractures of the proximal femur .
- Osteonecrosis of the femoral head .
- Revision procedures where other treatments or devices or these indications have failed.
The Ring-Lok™ Modular Bi-Polar System is intended for use in combination with the previously cleared femoral components including Rig-Fix™ Hip Stem (K072101), C-fit Performa (K923898) or the Stability Hip Stem (K915787 and K934457)). The Ring-Lok™ Modular Bipolar System consists of a factory assembled UHMWPE liner in a cobalt chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 62 mm, in 1mm increments, to properly fit the patient anatomy. The inner diameter mates with a 22.225, 26 or 28 mm diameter femoral head.
Implant International supplies Ring-Lok™ Bi-Polar Instrumentation for use with the Ring-Lok™ Modular Bi-Polar System.
Here's a breakdown of the acceptance criteria and study information for the Ring-Lok™ Modular Bipolar System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Range of Motion | Performance substantially equivalent to predicate devices. | Met all acceptance criteria. |
| Lever Out | Performance substantially equivalent to predicate devices. | Met all acceptance criteria. |
| Pull Out | Performance substantially equivalent to predicate devices. | Met all acceptance criteria. |
| Overall Performance | As safe, effective, and performs as well as or better than predicate devices. | Substantially equivalent to predicate devices. |
Note: The document states that the testing was "to written protocols with pre-defined acceptance criteria," but it does not explicitly list the quantitative acceptance criteria for each test beyond requiring substantial equivalence to predicate devices. The reported performance consistently states that the criteria were met.
2. Sample Size for Test Set and Data Provenance
- Sample Size: "worst case component size and option/design." The exact number is not specified, but it implies a focused selection of the most challenging configurations for testing.
- Data Provenance: The testing was conducted by Implant International Limited, based in the UK. Therefore, the data provenance is likely UK-based, non-clinical (laboratory), and prospective (as it was part of design verification for this specific device).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The testing described is non-clinical performance testing (mechanical/engineering tests), not clinical studies involving human patients or expert interpretation of clinical data. Therefore, the concept of "ground truth" established by medical experts for a test set in the usual sense does not apply here.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. As explained above, the tests are non-clinical engineering evaluations, not clinical data requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical performance test comparing the device to predicate devices through engineering evaluations.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to this medical device. The "Ring-Lok™ Modular Bipolar System" is a physical implant (a hip prosthesis component), not an AI algorithm or software. Therefore, there's no "algorithm only" or "human-in-the-loop" performance to evaluate in this context. The standalone performance refers to the device itself performing its intended biomechanical function without direct human intervention during its operation in the body.
7. Type of Ground Truth Used
The "ground truth" in this context is the performance of established predicate devices (Medacta Bi-Polar Head K091967 and BioPro Bi-Polar Head K082705) in similar non-clinical tests, and the engineering specifications/standards that these types of devices are expected to meet. The aim was to demonstrate "substantial equivalence" to these predicates.
8. Sample Size for the Training Set
This information is not applicable/not provided. There is no "training set" in the context of this device's non-clinical performance testing. Training sets are relevant for machine learning algorithms, which is not what this device is.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated in point 8.
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(47 days)
The CER-MET™ III Acetabular Cup System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
The CER-MET™ III Acetabular Cup System is a non-cemented acetabular cup system with a complete assortment of neutral and 10° hooded poly inserts as well as acetabular screws and screw hole covers (screw hole occluders).
Here's an analysis of the provided text regarding the CER-MET™ III Acetabular Cup System, focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical Equivalence to legally marketed predicate devices for in-vivo loading. | "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." |
| Material Equivalence to legally marketed predicate devices. | "The CER-MET™ III Acetabular Cup System is equivalent to other legally marketed acetabular cup systems in design, materials and intended use." |
| Design Equivalence to legally marketed predicate devices. | "The CER-MET™ III Acetabular Cup System is equivalent to other legally marketed acetabular cup systems in design, materials and intended use." |
| Intended Use Equivalence to legally marketed predicate devices. | "The CER-MET™ III Acetabular Cup System is equivalent to other legally marketed acetabular cup systems in design, materials and intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not specify the sample size used for the biomechanical tests. It only states that "Biomechanical tests have been performed."
The document also does not specify the country of origin of the data or whether the study was retrospective or prospective.
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)
The provided text does not mention the use of experts to establish ground truth for the biomechanical tests. The evaluation appears to be based on physical material and design testing rather than expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The provided text does not mention any adjudication method for the test set, as the study described is biomechanical testing, not a clinical study involving human interpretation.
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
A multi-reader, multi-case (MRMC) comparative effectiveness study was not performed. This document describes the premarket notification for a medical device (acetabular cup system), which primarily relies on biomechanical testing and equivalence to predicate devices, not AI assistance or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device described is a physical implant (acetabular cup system), not an algorithm or AI system. Therefore, standalone algorithm performance testing was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biomechanical tests, the ground truth would be established by engineering standards and established performance metrics for acetabular cups, comparing the device's performance against these predetermined benchmarks and against the performance of the identified predicate devices. It is based on physical measurements and mechanical properties, not clinical or pathological outcomes directly.
8. The sample size for the training set
This question is not applicable. The device is a physical implant and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as #8.
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