(29 days)
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved,
- Failure of previous joint replacement procedure,
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy or Arthrodesis
- Device designed for use in patients with metal sensitivity. .
- Standard surgical and rehabilitative procedures are indicated with . this device.
- The device is a single use device intended for use with bone . cement.
The femoral components found in this submission (AGC® and Maxim®) are identical to their predecessors (K981996) with the exception of the vendor who will complete the nitrogen ion implantation on the Ti-6Al-4V femoral surfaces.
The provided document is a 510(k) summary for a medical device (Titanium Femoral Knee Components) and a related FDA letter. It does not describe an AI medical device or a study involving AI. The device is a traditional medical implant.
Therefore, many of the requested fields related to AI performance, ground truth, experts, and training/test sets are not applicable to this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, particularly regarding a vendor change for nitrogen ion implantation.
Here's an attempt to answer the questions based only on the provided text, indicating "Not applicable" or "Not provided" where the information is not present for this type of device and submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (K981996) | Achieved. The device is "functional within their intended use." |
| Material unchanged from predicate | Confirmed. The femoral components "have not been modified from their original state in terms of materials." |
| Design unchanged from predicate | Confirmed. The femoral components "have not been modified from their original state in terms of... design." |
| Sizing unchanged from predicate | Confirmed. The femoral components "have not been modified from their original state in terms of... sizing." |
| Indications unchanged from predicate | Confirmed. The femoral components "have not been modified from their original state in terms of... indications." |
| Nitrogen ion implantation process is comparable/acceptable | Not explicitly detailed, but implied by the "non-clinical laboratory testing" result that the device is "functional within their intended use." |
| No significant safety or effectiveness concerns compared to predicate | Implied by the FDA's substantial equivalence determination. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This submission is for a knee implant based on substantial equivalence, not an AI device with test sets. The "non-clinical testing" likely refers to bench testing, not patient data.
- Data Provenance: Not applicable. No patient data or test set information is provided. Non-clinical testing implies lab/bench data.
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)
- Number of Experts: Not applicable. This is not an AI device nor an AI-based study.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This is not an AI device nor an AI-based study.
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
- MRMC Study: No, not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable for an AI context. For this device, "ground truth" would relate to the physical and mechanical properties of the device meeting design specifications and performance standards, likely established through engineering specifications and material science testing.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI device that undergoes training.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. This is not an AI device.
§ 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.