(33 days)
The ConforMIS iDuo Bicompartmental Knee Repair System (iDuo KRS) is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only a single knee compartment, such as unicondylar or patellofemoral prosthesis. The indications for use including restoring joint function and relief of pain due to:
- painful joint disease due to osteoarthritis, traumatic arthritis or rheumatoid arthritis of the knee.
- post traumatic loss of joint function
- failed osteotomies, hemiarthroplasties and unicondylar implants
The iDuo KRS may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of these conditions. The iDuo KRS is intended for cemented use only.
The iDuo KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component (patellar component packaged separately). The product design incorporates a bone preserving approach with minimal bone resection for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. It is intended for use in those patients whose condition cannot be appropriately or effectively addressed using a device that treats only a single knee compartment (i.e. a unicompartmental or patellofemoral prosthesis) when the medial or lateral condyle and the patellofemoral regions are affected. Using patient imaging (either CT or MR scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The device is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. Two tibial components are offered: a single-piece all polyethylene tibial component manufactured from ultra-high molecular weight polyethylene ("UHMWPE") or a two-piece metal-backed tibial component which includes a metal tray manufactured from CoCrMo alloy and a polyethylene insert manufactured from UHMWPE. The patellar component is manufactured from UHMWPE.
The provided text describes a 510(k) summary for a medical device, the ConforMIS® iDuo® Bicompartmental Knee Repair System (iDuo® KRS). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria through device performance.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document.
Here's a breakdown of the information that can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available | Not Available |
| (Specific performance metrics, e.g., range of motion, wear rates, load bearing capacity, durability, etc., for the modified device are not | |
| explicitly stated as acceptance criteria or results of a specific performance study in this summary.) | The submission states that "Nonclinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the proposed intended use." This implies performance was comparable but doesn't specify criteria or results. |
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. No clinical or standalone performance test set is described. The submission focuses on non-clinical laboratory testing for substantial equivalence.
- Data Provenance: Not applicable. The "nonclinical laboratory testing" details are not provided.
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. No clinical test set with human-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set is described.
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 device is a knee repair system (implant), not an AI diagnostic tool. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is an implantable medical device, not a standalone algorithm. The submission mentions "patient imaging (either CT or MR scans)" being used to design the patient-specific implant, but this is part of the manufacturing process, not an algorithm's standalone performance evaluation in the context of diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth for device performance in a clinical or diagnostic context is detailed in this 510(k) summary. The basis for substantial equivalence was "a detailed device description" and "nonclinical laboratory testing."
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" in the context of machine learning or AI for this device. The device itself is patient-specific, designed using patient imaging, but this is a design input, not a "training set" for an algorithm being evaluated.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is described in the context of this device's submission.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.