(78 days)
The Implex Hedrocel Posterior Stabilized (PS) Tibial Component is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty. In addition, the Hedrocel PS Tibial Component is indicated for use in the presence of knee instability caused by a compromised or non-functional posterior cruciate ligament.
The Implex Hedrocel PS Tibial Component, Cemented, is available in 8 thickness sizes from 10 mm to 22 mm, in 2 mm increments, and a 26 mm option; and A-P dimensions from 41 mm to 57 mm, and M-L dimensions from 62 mm to 89 mm. The Hedrocel PS Tibial Component is comprised of Hedrocel porous tantalum and UHMWPE and is intended to be implanted using the Implex Continuum Knee System Instrumentation and Surgical Protocol. In addition, the Hedrocel PS Tibial component is offered in two fixation post options; option A with hexagonal Hedrocel® posts, and option B with polyethylene fixation pegs.
This 510(k) summary describes a medical device (The Implex Hedrocel Posterior Stabilized (PS) Tibial Component, Cemented), not an AI/ML powered medical device. Therefore, the questions related to AI/ML powered medical device performance, ground truth establishment, reader studies, and training/test sets are not applicable.
Here's the relevant information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as acceptance criteria in the document, but the basis for approval is "substantial equivalence" to predicate devices. | Previous testing of the predicate devices and associated materials supports a determination of substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Not applicable as this is a medical device, not an AI/ML powered medical device. Performance is based on prior testing of predicate devices and their materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable.
4. Adjudication method for the test set
- Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable.
7. The type of ground truth used
- Not applicable for an AI/ML context. For this medical device, the "ground truth" for demonstrating safety and effectiveness implicitly refers to established clinical performance and material properties of the predicate devices.
8. The sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.