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The MAKO Surgical Unicondylar Knee is a single use device intended for cemented reconstruction of the medial or lateral femur and corresponding tibial surface of moderately disabled and/or painful knee resulting from osteoarthritis, traumatic arthritis provided there is evidence of sufficient bone to seat the implant. Indications for use include moderate joint impairment from painful arthritis (osteo and/or post-traumatic), and as an alternative to tibial osteotomy in patients with unicompartmental arthritis.

Device Description

The MAKO Surgical Unicondylar Knee System is for use in reconstruction of either the medial or lateral femoral and corresponding tibial surface. The MAKO Surgical Unicondylar Knee System consists of the following basic components. These components are intended for cemented, one-time use.

CoCr distal femoral component.
UHMWPE tibial resurfacing component -- includes radiographic pin.
Standard unicondylar knee instrumentation is also provided with the system. This includes for example femoral sizers, femoral templates with handles & peg drill assembly, tibial instrument tray, tibial sizers, tibial leveling guide, impactor, inserters, extractors, etc. Essentially, the instrumentation is the same as that of the predicate device.

AI/ML Overview

This document describes the MAKO Surgical Unicondylar Knee System and its substantial equivalence to a predicate device, as part of a 510(k) submission to the FDA. The information provided heavily focuses on the device's characteristics and intended use rather than a study proving its performance against specific acceptance criteria.

Therefore, many of the requested categories (acceptance criteria, specific study details, sample sizes, ground truth establishment methods, MRMC studies, standalone performance, expert involvement) cannot be extracted from the provided text as they are not present. The document is a regulatory submission for substantial equivalence based on material and design similarities, not a clinical study report.

Here's a summary of what can be extracted and a clear indication of what cannot.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criterion	Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (Explicitly Stated in Document)
Intended Use / Indications for Use	Not explicitly stated as an "acceptance criterion" in a quantitative sense, but rather as statements of intended use that the device meets.	The MAKO Surgical Unicondylar Knee System is "a single use device intended for cemented reconstruction of the medial or lateral femur and corresponding tibial surface of moderately disabled and/or painful knee resulting from osteoarthritis, traumatic arthritis provided there is evidence of sufficient bone to seat the implant. Indications for use include moderate joint impairment from painful arthritis (osteo and/or post-traumatic), and as an alternative to tibial osteotomy in patients with unicompartmental arthritis." This matches the predicate device's intended use, indicating equivalence.
Implant Components	Implied: Components should be equivalent to predicate.	Consists of CoCr femoral component, UHMWPE tibial component with a radiographic marker pin.
Sizes	Implied: Sizes should provide adequate range.	Femoral components available in 5 sizes (left and right for each). Tibial components in 5 sizes with 3 thicknesses (6.5mm, 7.5mm, 8.5mm). Thinnest section of 6.5mm tibial component is 6.0mm.
Congruency	Implied: Congruency should be within an acceptable range.	20 – 27% congruency.
Materials	Implied: Materials should be biocompatible and meet standards.	Femoral component – CoCr per ASTM F-75. Tibial component – UHMWPE per ASTM F-648 Type 2. Radiographic marker pin – titanium wire per ASTM F-1341. "Both devices are made of materials for surgical implant applications per ASTM standards listed above."
Sterilization & Packaging	Implied: Sterilization and packaging methods should be effective.	Implants and tibial components – gamma radiation. Instrumentation – prevacuum steam. Packaging: double sealed containers maintaining double sterile barriers; tibial component packaged in Argon gas environment.
Biocompatibility	Implied: Biocompatible.	"Both devices are made of materials for surgical implant applications per ASTM standards listed above."

2. Sample size used for the test set and the data provenance

Not provided. This document is a 510(k) summary, not a clinical study report. It focuses on demonstrating substantial equivalence based on design, materials, and intended use to a predicate device (Stelkast Corporation's Unicondylar Knee System, K032824), rather than presenting results from a performance study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. No test set or ground truth establishment by experts is mentioned as part of this 510(k) submission document.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or adjudication method is mentioned.

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

No, this is not an AI-powered device. This is a medical implant (knee replacement system). Therefore, MRMC studies and AI assistance are not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, this is not an AI-powered device. This is a medical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided. The document describes a medical implant system and its characteristics for substantial equivalence, not a diagnostic or AI device requiring ground truth.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/algorithm-based device that would require a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. As above, no training set or ground truth establishment for a training set is relevant or mentioned.

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