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510(k) Data Aggregation
(123 days)
The ConforMIS metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee Repair Systems, in patients with:
- joint impairment due to osteoarthritis or traumatic arthritis of the knee .
- previous tibial condyle or plateau fracture, creating loss of function .
- valgus or varus deformity of the knee .
The ConforMIS metal backed tibial component is intended only for use with bone cement
The ConforMIS Metal Backed Tibial Component is to be used with either the ConforMIS Unicondylar | Knee Repair System or the ConforMIS BiCompartmental Knee Repair System to provide the surgeon with an alternative tibial component in the event that he/she prefers to use a metal backed component rather than an all polyethylene component. It consists of a cobalt-chrome alloy (CoCrMo) tray and a polyethylene insert. The X/Y dimensions of the device (i.e. the twodimensional shape or "footprint") are designed to conform to the patient's anatomy as closely as possible based on images (MRI or CT scan) of the patient's knee.
This 510(k) summary (K063432) for the ConforMIS Metal Backed Tibial Component (mBT) does not contain detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically seen for performance evaluations of novel devices. Instead, it relies on substantial equivalence to predicate devices and prior testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the Metal Backed Tibial Component itself as it is a modification of an existing system. The "performance" described is about its substantial equivalence.
| Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness | "Testing completed as part of the design verification procedure for the ConforMIS Unicondylar Knee System found this device to be as safe and effective as the predicate further devices, confirming substantial equivalence." |
| Design | "The ConforMIS Metal Backed Tibial Component substantially equivalent to is the tibial components cleared for the ConforMiS Unicondylar and BiCompartmental Knee Repair Systems in the is use of imaging data to design a patient-matched implant geometry, as well terms of design and production process, as well as materials and indications. It is substantially equivalent to the cited predicate devices in terms of design, materials, mechanical safety and intended use. All are intended for cemented use only." |
| Material Composition | Consists of a cobalt-chrome alloy (CoCrMo) tray and a polyethylene insert. Stated to be substantially equivalent to predicate devices in terms of materials. |
| Function/Intended Use | Intended for use with ConforMIS Unicondylar Knee Repair System and BiCompartmental Knee Repair Systems for specific knee conditions (osteoarthritis, traumatic arthritis, fracture, valgus/varus deformity). Intended for cemented use only. Stated to be substantially equivalent to predicate devices in function and intended use. |
| Mechanical Safety | Stated to be substantially equivalent to predicate devices in terms of mechanical safety. |
| New Safety or Effectiveness Issues | "the ConforMIS Metal Backed Tibial Component raises no new safety or effectiveness issues." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on a specific "test set" for the Metal Backed Tibial Component. The testing mentioned refers to "design verification procedures for the ConforMIS Unicondylar Knee System." No details on sample size or data provenance (country, retrospective/prospective) for those verification procedures are included in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The submission focuses on engineering and material equivalence, not clinical decision-making validated by experts.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. This submission is for a knee implant component, and such studies are typically associated with imaging devices or diagnostic algorithms.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical knee implant component, not an algorithm or software. Its performance is inherent in its physical properties and design when implanted, not standalone algorithmic output.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on engineering and performance characteristics deemed acceptable for existing, legally marketed predicate devices. The substantial equivalence argument relies on the new device having similar design, materials, and function such that its performance is expected to be equivalent to devices already proven safe and effective. It explicitly states: "Clinical data and conclusions are not necessary to demonstrate substantial equivalence."
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this traditional medical device submission. "Training sets" are relevant for AI/ML algorithms, not for the design and testing of a knee implant component.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" in the context of this device submission.
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(90 days)
Partial replacement of the articulating surfaces of the knee when only one side of the Joint is anceced due to the compartmental primary degenerative or posttraumatic arthritis, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is intended to be used with bone cement.
The tibial component consists of ArCom®, ultrahigh molecular weight polyethylene (UHMWPE) bearings in right and left medial/lateral allocations.
The provided document, K042093, is a 510(k) summary for the Biomet Manufacturing, Corp.'s Vanguard M™ Series Unicondylar Tibial Bearings. This document outlines the device description, indications for use, and a summary of non-clinical testing. However, it explicitly states that no clinical testing was provided as a basis for substantial equivalence. Therefore, the information requested regarding acceptance criteria based on clinical studies, sample sizes, expert qualifications, and ground truth establishment for a study cannot be provided from this document.
From the provided document, the following can be extracted related to non-clinical testing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Device to be functional within its intended use. | "The results indicated that the device was functional within its intended use." |
2. Sample Size and Data Provenance (for any testing done):
- Sample Size: Not specified for non-clinical testing.
- Data Provenance: Not applicable as no clinical data was used for substantial equivalence. Non-clinical testing was performed in a laboratory setting by the manufacturer.
3. Number of Experts and Qualifications (for establishing ground truth):
- Not applicable. No clinical study with expert ground truth establishment was conducted or submitted for substantial equivalence.
4. Adjudication Method:
- Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was mentioned or performed.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable as this is a medical device (tibial bearing) and not an algorithmic/AI device.
7. Type of Ground Truth Used:
- Not applicable as no clinical study or ground truth establishment based on clinical data was performed. For non-clinical testing, the "ground truth" would be engineering specifications and functional benchmarks.
8. Sample Size for the Training Set:
- Not applicable as no clinical study or AI algorithm requiring a training set was performed.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
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