(61 days)
The EMPOWR Partial Knee System is 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 procedures where other treatments or devices have failed.
- · These devices are indicated for cemented use only.
The EMPOWR Partial Knee is a unicompartmental knee system that is unconstrained in the anteroposterior and mediolateral directions, allowing unconstrained internal/external rotation between the femoral and tibial components. This system includes a cobalt chrome femoral component, titanium tibial baseplate, and Vitamin E Polyethylene insert.
This document is a 510(k) summary for the EMPOWR Partial Knee system. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than on establishing performance criteria against a predefined standard. While it describes non-clinical testing performed, it does not provide acceptance criteria, reported device performance metrics against those criteria, or the details of a study proving the device meets them in the way typically expected for a detailed performance study.
Here's an analysis based on the provided text, highlighting the absence of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The document states "Mechanical testing has demonstrated the device's ability to perform under expected conditions" and lists types of tests, but does not give specific acceptance criteria (e.g., minimum strength in MPa, maximum wear rate in mm^3/year) or quantitative results from these tests.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified for any of the listed mechanical tests.
- Data Provenance: The tests are non-clinical (mechanical and material tests) conducted by the manufacturer, DJO Surgical, in Austin, TX. The data is internally generated by the manufacturer. It is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the testing is non-clinical mechanical testing, not a study evaluating human performance or diagnosis.
4. Adjudication method for the test set:
This is not applicable as the testing is non-clinical mechanical testing.
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 is not applicable. The device is a partial knee implant, not an AI-powered diagnostic or assistive tool. Clinical testing was explicitly stated as "not required."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical knee implant, not an algorithm.
7. The type of ground truth used:
For the mechanical testing, the "ground truth" would be engineering specifications, industry standards (e.g., ISO for implants), and the performance characteristics of the predicate device. However, the document does not explicitly state these specific ground truths or the quantitative reference points against which the tests were compared, only that the tests aimed to demonstrate substantial equivalence to the predicate.
8. The sample size for the training set:
This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
This is not applicable.
Summary of what the document does provide regarding testing:
The 510(k) summary states that "Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions." It lists the following tests:
- FEA (Finite Element Analysis) for Femur Component Strength
- Tibial Baseplate Component Strength Testing
- Range of Motion Assessment
- Tibial-femoral Contact Area Testing
- Static Locking Mechanism Disassembly
- Endotoxin Assessment (for pyrogen limit specifications)
The conclusion is that "All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified." This "substantial equivalence" is the primary acceptance criterion for a 510(k) submission, rather than meeting specific quantifiable performance targets presented in this document.
§ 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.