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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.

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Intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.

The additional components that are the subject of this Special 510(k) submission are the tibial inserts and baseplates. These components are to be used with the femoral components of the Uni Knee cleared in K020741.

The tibial inserts of this submission are the similar the tibial components in K020741 with the addition of a snap feature on the non-articulating side. This snap feature is meant to be used with the tibial baseplate. The tibial inserts are manufactured from UHMWPE that conforms to ASTM F648 and are available in 5 sizes (35-45 mm) and 3 thicknesses (6-8 mm).

The tibial baseplates are manufactured from CoCr alloy that conforms to ASTM F75 and are available in 5 sizes (35-45 mm) and 2 configurations (left medial/right lateral and right medial/left lateral).

The provided text describes a submission for "Uni Knee Additional Components" to the FDA, but it does not contain any information regarding acceptance criteria, device performance metrics, or the details of a study that proves the device meets specific criteria.

The 510(k) summary focuses on:

• Device identification: Submitter, device name (Uni Knee Additional Components), common name, classification, and predicate devices.
• Device description: Details the tibial inserts (UHMWPE, snap feature, 5 sizes, 3 thicknesses) and tibial baseplates (CoCr alloy, 5 sizes, 2 configurations).
• Intended use: Partial replacement of articulating knee surfaces for specific conditions, for single use with bone cement.
• Basis for Substantial Equivalence: States similarity in design, materials, and indications to a previously cleared device (K020741).

The FDA's response letter (K022437) confirms that the device is substantially equivalent to legally marketed predicate devices. This indicates that the FDA found the device to be as safe and effective as existing devices, based on the information provided in the 510(k) submission.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving device performance because it is not present in the provided document. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.

To address the specific points you requested, if such information were available, here's how it would typically be presented:

Hypothetical Response (if the information were available in the provided text):

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): [e.g., N=10 implants for fatigue testing, N=5 animal models for biocompatibility]
• Data Provenance: [e.g., In-vitro lab testing conducted in the USA, Retrospective clinical data from European clinics, Prospective animal study conducted in Canada]

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: [e.g., 3 orthopedic surgeons]
• Qualifications: [e.g., Each with over 15 years of experience in knee arthroplasty, Board-certified and affiliated with major academic medical centers]

4. Adjudication Method for the Test Set

• Adjudication Method: [e.g., 2+1 (two experts agree, or a third expert resolves disagreement), Consensus panel, Majority rule, None (if ground truth is objective, like pathology reports)]

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Conducted?: [Yes/No]
• Effect Size (Human Readers with AI vs. Without AI): *[e.g., "Human readers demonstrated a 15% improvement in diagnostic accuracy with AI assistance (p

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