(30 days)
The TC-PLUS™ Porous Femoral Component is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for degenerative, posttraumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patellofemoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery.
The TC-PLUS™ Porous Femoral Components are identical to the predicate device, except that they are Ti-Plasma coated on the underside. They are identical in indications for use, geometry, material, and surface characteristics to the predicate device, and they are intended for use only with bone cement. These additional porous coated femoral components are available in right and left, sizes 2, 4, 6, 8, 10, and 12. The tibial components as well as the tibial PE inserts have not been changed and are identical to the predicate device.
The provided text describes a 510(k) summary for the TC-PLUS™ Porous Femoral Components, a knee prosthesis modification. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biomechanical Equivalence | Sufficient for in vivo loading; equivalent to predicate device. | "Biomechanical tests have been performed. The test results are included in this submission and show that the additional components were equivalent to the predicate device and are sufficient for in vivo loading." |
| Material/Design Equivalence | Identical in indications for use, geometry, material, and surface characteristics (except for porous coating). Intended for use only with bone cement. | "The TC-PLUS™ Porous Femoral Components are identical to the predicate device, except that they are Ti-Plasma coated on the underside. They are identical in indications for use, geometry, material, and surface characteristics to the predicate device, and they are intended for use only with bone cement." |
| Tibial Component/PE Insert Equivalence | No changes from the predicate device. | "The tibial components as well as the tibial PE inserts have not been changed and are identical to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that "Biomechanical tests have been performed," but it does not specify the sample size for these tests.
It also does not mention the country of origin of the data or whether the study was retrospective or prospective. The tests are described as biomechanical, implying a laboratory setting rather than human subject data for this specific submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not refer to "experts" or "ground truth" in the context of establishing performance for the biomechanical tests. The performance criteria were based on equivalence to a predicate device and engineering standards for in vivo loading. This type of submission (modification of an existing device) typically relies on engineering and material science expertise rather than clinical expert consensus for the initial bench testing.
4. Adjudication Method for the Test Set:
This information is not applicable to biomechanical testing where objective measurements are taken rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This information is not applicable. The device is a knee prosthesis, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study involving human readers and AI would have been conducted or reported for this type of medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used:
For the biomechanical tests, the "ground truth" would be established by engineering specifications, material properties, and established biomechanical standards for knee prostheses. The goal was to prove the modified component was "equivalent to the predicate device and are sufficient for in vivo loading," which implies meeting predefined performance benchmarks in a lab setting.
8. The Sample Size for the Training Set:
This information is not applicable. As a physical medical implant, there would be no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 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.