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MAKO Surgical Corp. Unicondylar Knee Implant System II components are for use in unicompartmental knee arthroplasty as a result of:

• Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
• Revision of previous unsuccessful unicompartmental knee replacement
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis

These components are single use only and are intended for implantation with bone cement.

This device consists of a CoCMo femoral condyle component, a titanium baseplate, and ultra-high molecular weight polyethylene tibial onlay and inlay components have been designed to fit the medial and lateral compartments and are intended for cemented, one-time use only. The femoral condyle component features a polished articular surface, a cement pocket, and 2 fixation pegs. The design of the fenoral condyle component allows for up to 155° flexion. The tibial components consist of a tibial onlay (tibial baseplate and tibial onlay insert) and a tibial inlay insert. The tibial onlay components snap together with an interlocking mechanism. The tibial inlay insert contains a waffle pattern on the bottom side and a peripheral cement channel to enhance fixation when cemented in the tibia.

The provided text describes a 510(k) premarket notification for a medical device, the MAKO Surgical Corp. Unicondylar Knee Implant System II. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than new clinical trials proving safety and effectiveness. Therefore, the document does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth, sample sizes, or expert adjudication as typically found in studies for novel devices or AI/software components.

The submission is primarily focused on demonstrating that the new device shares similar technological characteristics and intended use with existing, legally marketed predicate devices.

Here's an analysis based on the information provided, highlighting what's present and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as this is a 510(k) submission for substantial equivalence. The "acceptance criteria" here is that the device is substantially equivalent to predicate devices.
• Reported Device Performance: The document provides a description of the device's components, sizes, materials, instrumentation, sterilization, packaging, and biocompatibility, comparing them implicitly to the predicate devices. There are no performance metrics (e.g., accuracy, sensitivity, specificity, or clinical outcomes) reported as would be in a study for novel technology.

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

• Test Set Sample Size: Not applicable. This 510(k) submission does not include a test set in the conventional sense of a study designed to evaluate performance metrics.
• Data Provenance: Not applicable. No study data is presented.

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

• Not applicable. There is no test set or ground truth establishment described.

4. Adjudication Method for the Test Set:

• Not applicable. There is no test set or adjudication process described.

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

• No MRMC study was done. This 510(k) process focuses on demonstrating substantial equivalence by comparing the proposed device's design and materials to existing predicate devices, not on comparative effectiveness studies involving human readers and AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No standalone study was done. The device is a physical knee implant system, not a software algorithm or AI. Performance in this context refers to the physical and mechanical properties and clinical outcomes which are typically inferred from predicate device history or established through post-market surveillance.

7. Type of Ground Truth Used:

• Not applicable. No ground truth is established as part of this 510(k) premarket notification for device performance. The "truth" in a 510(k) context is the established safety and effectiveness of the legally marketed predicate devices.

8. Sample Size for the Training Set:

• Not applicable. This is not a study involving a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. No training set or ground truth establishment is described.

Summary of what the document implies about meeting acceptance criteria:

The "acceptance criteria" for a 510(k) submission are met by demonstrating substantial equivalence to existing legally marketed predicate devices. The document does this by:

• Listing predicate devices: Zimmer Unicompartmental Knee System K033363; Stryker ElUS, K992287 & K033769; Encore EPIK Uni Knee System K020741 & K022437; Biomet Repicci II Unicondylar Knee, K971938; MAKO Surgical Corp. Unicondylar Knee Implant System K060017 & K073248.
• Describing the new device's features: Implant components, sizes, materials, instrumentation, sterilization, packaging, and biocompatibility.
• Stating the intended use/indications for use: These are expected to be the same or very similar to the predicate devices. The listed indications (moderately disabling joint disease, revision of previous unsuccessful unicompartmental knee replacement, alternative to tibial osteotomy for unicompartmental osteoarthritis) are consistent with the known uses for unicompartmental knee implants.

The FDA's letter (K080368) confirms that they "have determined the device is substantially equivalent...to legally marketed predicate devices." This determination is the "proof" that the device meets the "acceptance criteria" of the 510(k) pathway.

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