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The KMI Subtalar MBA System™ will be used on indications that are common with presently marketed devices. The primary indications for use of the Subtalar MBA System™ is as a spacer for stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion out blocking excessive pronation and the resulting sequela.

The Subtalar MBA System is indicated for use in the treatment of the hyperpronated foot displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela

Severely pronated foot Walking intemperance Calcaneal stance position greater than 5° Manually correctable deformity Mid-tarsal breech (arch pain) Forefoot varus greater than 10°

The KMI Subtalar MBA System™ will be offered in Ti-6AI-4V ELI. It will be available in a range of diameters and will be cannulated for precise location of the implant. Initially, a range of four diameters will be made available in 15mm lengths. All four diameters (6,8,10, and 12mm) are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated at center.

This submission K960692 for the KMI Subtalar MBA System™ is a 510(k) Premarket Notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than submitting extensive clinical study data to prove safety and effectiveness.

Therefore, the document does not describe traditional acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial would. Instead, it focuses on demonstrating that the device is as safe and effective as a previously cleared device.

Here's an analysis based on the provided text, addressing the points you requested where applicable, and explaining why some points are not relevant to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) like one would find for a diagnostic AI device. The "acceptance criteria" for a 510(k) are met by demonstrating substantial equivalence to a predicate device in terms of:

• Intended Use: Similar indications for use.
• Technological Characteristics: Similar design, materials, and function.
• Performance: Meets recognized voluntary standards where applicable.

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

• Not applicable / Not specified for traditional clinical testing. This is a 510(k) premarket notification for a mechanical implant, not a diagnostic or AI device requiring a "test set" for performance evaluation in the typical sense. Substantial equivalence is demonstrated through comparison of design, materials, and intended use with a predicate device. The document mentions "over 20 years of clinical evaluation" for the basic design concept of subtalar joint stabilization in general, but this refers to the established clinical understanding of these types of devices, not a specific clinical study for the KMI device itself.

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

• Not applicable. As above, no "test set" with ground truth in the context of an AI or diagnostic device evaluation is described. Material standards and design principles are followed.

4. Adjudication method for the test set

• Not applicable. No test set or corresponding adjudication method is specified.

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

• Not applicable. This device is a subtalar arthroereisis implant, not an AI or imaging diagnostic device that would involve human "readers" or AI assistance.

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

• Not applicable. This device is a physical implant, not an algorithm or AI system.

7. The type of ground truth used

• Not applicable in the typical sense. The "ground truth" for this type of submission is:
  • Predicate Device Equivalence: The existence and established safety/effectiveness of the predicate devices (e.g., Wright Medical K792670).
  • Voluntary Standards: Meeting established ASTM standards for materials and design.
  • Clinical General Knowledge: The well-known and documented clinical performance of subtalar joint implant systems in general over many years.

8. The sample size for the training set

• Not applicable. This device is not an AI system that requires a training set.

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

• Not applicable. As above, no training set is involved.

Summary of the K960692 Submission Context:

This 510(k) submission for the KMI Subtalar MBA System™ is primarily concerned with demonstrating substantial equivalence to already approved devices. The "study" proving it meets "acceptance criteria" is essentially the comparison of its design, materials, and intended use to identified predicate devices and its adherence to relevant voluntary material and manufacturing standards (e.g., ASTM standards). The FDA's acceptance is based on the determination that the new device is as safe and effective as a legally marketed predicate device, rather than requiring a de novo clinical trial with specific performance metrics.

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