FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:

· Total Knee Arthroplasty (TKA)
The implant systems compatible with the system:
· Triathlon Total Knee System (CR/CS/PS cemented and cementless primary)
· Triathlon Total Knee System (TS inserts cemented primary)
· Kinetis Total Knee System (CR/UC)

The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Make System is indicated for use in surgical knee and hip procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:

· Unicondylar knee replacement and/or patellofemoral knee replacement
· Total Hip Arthroplasty (THA)

Device Description

The Mako System with the subject Total Hip Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.

The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides stereotactic/haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive/intraoperative navigation of the patient's anatomy.

Once configured for a specific application, the Mako robotic-arm can serve as surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

The Mako System with the subject Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.

AI/ML Overview

The provided text describes the regulatory clearance for the Mako Total Hip Application and Mako Total Knee Application, but it does not contain information about acceptance criteria or specific study details proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results with acceptance criteria.

Specifically, it mentions:

Non-clinical performance testing: "Software testing", "Treatment Design Application Full Software Run Through", "Bone Registration Accuracy Verification", and "Mako Total Hip/Knee Application Full System Run Through".
Conclusion: "Performance testing has demonstrated that the characteristics of the subject Mako Total Hip/Knee Application is equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness."

However, it does not provide:

A table of acceptance criteria and reported device performance.
Sample sizes used for the test set or data provenance.
Number of experts, their qualifications, or ground truth establishment details for the test set.
Adjudication methods.
MRMC study information.
Standalone performance details.
Type of ground truth used.
Training set sample size.
How ground truth for the training set was established.

Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the level of detail requested as this information is not present in the document. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than detailing the full performance study methodology and results.

The document only states that "Performance testing has demonstrated that the characteristics of the subject Mako Total Hip Application/Mako Total Knee Application is equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness." It mentions non-clinical performance testing including:

Treatment Design Application Full Software Run Through
Bone Registration Accuracy Verification
Mako Total Hip/Knee Application Full System Run Through

However, it does not provide any specific quantitative acceptance criteria, the results against these criteria, or the detailed methodologies (like sample size, type of ground truth, expert qualifications, etc.) of these performance tests.

To answer your request, the following information is missing from the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The document states performance testing was done and concluded equivalence and safety/effectiveness, but no specific metrics or targets are given.
Sample sizes used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 for this type of device, which is a surgical robotic system for guidance, not an AI-assisted diagnostic tool for human readers. No MRMC study details are provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document refers to "non-clinical performance testing" including software run-throughs and accuracy verification, which might be considered standalone testing of system components, but it doesn't provide details on what constitutes "standalone performance" in this context or its results.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided. The testing relates to "Bone Registration Accuracy Verification," implying an objective measurement against a known standard, but the specific ground truth methodology is not detailed.
The sample size for the training set: Not applicable based on the nature of the device (surgical guidance system, not a machine learning model requiring a separate training set for algorithm development described here). If it were a machine learning algorithm, this would be highly relevant, but the description points to verifying the performance of a software tool that processes CT data for surgical planning and guidance.
How the ground truth for the training set was established: Not applicable for the same reason as point 8.

Summary

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).