(211 days)
The STRIDE Unicondylar Knee devices are indicated for patients with:
- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
- Previous tibial condyle or plateau fractures with loss of anatomy or function.
- Varus or valgus deformities.
- Revision of previous arthroplasty procedures.
These devices are indicated for cemented use only.
The STRIDE Unicondylar Knee device is a unicompartmental prosthetic implant that resurfaces one femoral condyle, and one side of the tibial plateau. The femoral component is made of cobalt chrome and the tibial component is. made of titanium with a UHMWPE insert that snaps into place. The device is nonconstrained; the articulating surface of the UHMWPE insert is flat and joint stability is maintained by ligaments and other soft tissue surrounding the knee.
The provided text describes the 510(k) summary for the STRIDE Unicondylar Knee, a unicompartmental prosthetic implant. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through engineering analysis and non-clinical bench testing. It does not include information about clinical studies with human subjects or AI/algorithm-based performance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test/Analysis | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Finite Element Analysis (FEA) | Not explicitly stated as "acceptance criteria," but implied to demonstrate similar load stresses to predicate devices. | Compared load stresses at 0, 15, 20, 60, 90, 120, and 155 degrees of flexion. FEA Stress Analysis Comparison at +/- 10 degrees of varus/valgus and 0, 15, and 60 degrees of flexion. |
| Contact pressure bench testing | Follows ASTM F2083-10 standards. | Contact pressure bench testing performed to ASTM F2083-10 for Stride. |
| Tibial component fatigue | Not explicitly stated as "acceptance criteria," but implied to meet design specifications. | Engineering analysis for Stride tibial component fatigue. |
| Tibial trav and insert interlocking strength/force | Not explicitly stated as "acceptance criteria," but implied to meet design specifications. | Tibial trav and insert interlocking strength and force analysis. |
| Range of motion analysis | Not explicitly stated as "acceptance criteria," but implied to meet design specifications. | Range of motion analysis. |
| Biocompatibility | Per ISO 10993 standards. | Biocompatibility of materials analysis per ISO 10993. |
| Sterilization | Sterilization to a Sterility Assurance Level (SAL) of 10-6. | Sterilization to SAL of 10-6. |
| Packaging and shelf life | Not explicitly stated as "acceptance criteria," but implied to demonstrate double sealed containers, double sterile barriers, and a shelf life of 2 years (as per predicate device description). | Packaging and shelf life analysis. |
| Overall conclusion | Device meets its design specifications; no new issues of safety or effectiveness compared to predicates. | Analysis and testing results demonstrated that the subject device meets its design specifications. Test results and comparative performance data indicate that differences do not present any new issues of safety or effectiveness. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the submission describes engineering analysis and non-clinical (bench) testing, not a clinical study on a test set of 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)
This information is not applicable as the submission describes engineering analysis and non-clinical (bench) testing, not a clinical study requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the submission describes engineering analysis and non-clinical (bench) testing, not a clinical study 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
This information is not applicable. The device is a physical knee implant, not an AI or imaging diagnostic tool, and therefore no MRMC study, human readers, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a physical knee implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable as the device is a physical knee implant and the testing focused on engineering and material performance rather than diagnostic accuracy against a ground truth. The "ground truth" here is implied to be engineering specifications and predicate device performance.
8. The sample size for the training set
This information is not applicable as the submission pertains to a physical medical device and its engineering analysis, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the submission pertains to a physical medical device and its engineering analysis, not a machine learning model requiring a training set and its associated ground truth.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.